Ciprofloxacin (Cipro)
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Ciprofloxacin (Cipro)

CIPRO®
(ciprofloxacin hydrochloride) Tablets

CIPRO®
(ciprofloxacin*) Oral Suspension

WARNING

Fluoroquinolones, including CIPRO®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants (see WARNINGS).

Fluoroquinolones, including CIPRO, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis (see WARNINGS).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO Tablets and CIPRO Oral Suspension and other antibacterial drugs, CIPRO Tablets and CIPRO Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION

CIPRO (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin*) Oral Suspension are synthetic broad spectrum antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8. Its empirical formula is C17H18FN3O3•HCl•H2O and its chemical structure is as follows:

Ciprofloxacin Hydrochloride Structural Formula Illustration

Ciprofloxacin is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C17H18FN3O3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance and its chemical structure is as follows:

Ciprofloxacin Structural Formula Illustration

CIPRO film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets are white to slightly yellowish. The inactive ingredients are cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol.

Ciprofloxacin Oral Suspension is available in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. Ciprofloxacin Oral Suspension is a white to slightly yellowish suspension with strawberry flavor which may contain yellow-orange droplets. It is composed of ciprofloxacin microcapsules and diluent which are mixed prior to dispensing (See instructions for USE/HANDLING). The components of the suspension have the following compositions:

Microcapsules-ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20.

Diluent-medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor.

* Does not comply with USP with regard to “loss on drying” and “residue on ignition”.

What are the possible side effects of ciprofloxacin (Cipro, Cipro XR, Proquin XR)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ciprofloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, unusual...

Read All Potential Side Effects and See Pictures of Cipro »

What are the precautions when taking ciprofloxacin (Cipro)?

Before taking ciprofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics such as norfloxacin, gemifloxacin, levofloxacin, moxifloxacin, or ofloxacin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (e.g., recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, liver disease, myasthenia gravis, nervous system disorder (e.g., peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors,...

Read All Potential Precautions of Cipro »

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

CIPRO is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions and patient populations listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.

Adult Patients

Urinary Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter diversus, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis in females caused by Escherichia coli or Staphylococcus saprophyticus.

Chronic Bacterial Prostatitis caused by Escherichia coli or Proteus mirabilis.

Lower Respiratory Tract Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or penicillin-susceptible Streptococcus pneumoniae. Also, Moraxella catarrhalis for the treatment of acute exacerbations of chronic bronchitis.

NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Acute Sinusitis caused by Haemophilus influenzae, penicillin-susceptible Streptococcus pneumoniae, or Moraxella catarrhalis.

Skin and Skin Structure Infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Infectious Diarrhea caused by Escherichia coli (enterotoxigenic strains), Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.

Typhoid Fever (Enteric Fever) caused by Salmonella typhi.

NOTE: The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

Uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae.

Pediatric patients (1 to 17 years of age)

Complicated Urinary Tract Infections and Pyelonephritis due to Escherichia coli.

NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. (See WARNINGS, PRECAUTIONS, Pediatric Use, ADVERSE REACTIONS and Clinical Studies.) Ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals. (See Animal Pharmacology.)

Adult and Pediatric Patients

Inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.5 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001. (See also, Inhalational Anthrax – Additional Information).

†Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. Therapy with CIPRO may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CIPRO Tablets and CIPRO Oral Suspension and other antibacterial drugs, CIPRO Tablets and CIPRO Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

Adults

CIPRO Tablets and Oral Suspension should be administered orally to adults as described in the Dosage Guidelines table.

The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient's host-defense mechanisms, and the status of renal function and hepatic function.

The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.

ADULT DOSAGE GUIDELINES

Infection Severity Dose Frequency Usual Durations†
Urinary Tract Acute Uncomplicated 250 mg q 12 h 3 days
Mild/Moderate 250 mg q 12 h 7 to 14 days
Severe/Complicated 500 mg q 12 h 7 to 14 days
Chronic Bacterial Prostatitis Mild/Moderate 500 mg q 12 h 28 days
Lower Respiratory Tract Mild/Moderate 500 mg q 12 h 7 to 14 days
Severe/Complicated 750 mg q 12 h 7 to 14 days
Acute Sinusitis Mild/Moderate 500 mg q 12 h 10 days
Skin and Mild/Moderate 500 mg q 12 h 7 to 14 days
Skin Structure Severe/Complicated 750 mg q 12 h 7 to 14 days
Bone and Joint Mild/Moderate 500 mg q 12 h ≥ 4 to 6 weeks
Severe/Complicated 750 mg q 12 h ≥ 4 to 6 weeks
Intra-Abdominal* Complicated 500 mg q 12 h 7 to 14 days
Infectious Diarrhea Mild/Moderate/Severe 500 mg q 12 h 5 to 7 days
Typhoid Fever Mild/Moderate 500 mg q 12 h 10 days
Urethral and Cervical Uncomplicated 250 mg single dose single dose
Gonococcal Infections        
Inhalational anthrax (post-exposure)** 500 mg q 12 h 60 days  
* used in conjunction with metronidazole
† Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).
** Drug administration should begin as soon as possible after suspected or confirmed exposure.

This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information.

Conversion of I.V. to Oral Dosing in Adults

Patients whose therapy is started with CIPRO I.V. may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (See CLINICAL PHARMACOLOGY and table below for the equivalent dosing regimens).

Equivalent AUC Dosing Regimens

Cipro Oral Dosage Equivalent Cipro I.V. Dosage
250 mg Tablet q 12 h 200 mg I.V. q 12 h
500 mg Tablet q 12 h 400 mg I.V. q 12 h
750 mg Tablet q 12 h 400 mg I.V. q 8 h

Adults with Impaired Renal Function

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:

RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION

Creatinine Clearance (mL/min) Dose
> 50 See Usual Dosage.
30 – 50 250 – 500 mg q 12 h
5 – 29 250 – 500 mg q 18 h
Patients on hemodialysis or Peritoneal dialysis 250 – 500 mg q 24 h (after dialysis)

When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.

Men: Creatinine clearance (mL/min) = Weight (kg) x (140 - age) /72 x serum creatinine (mg/dL)

Women: 0.85 x the value calculated for men.

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.

Pediatrics

CIPRO Tablets and Oral Suspension should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS and Clinical Studies.)

Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.

PEDIATRIC DOSAGE GUIDELINES

Infection Route of Administration Dose (mg/kg) Frequency Total Duration
Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) Intravenous 6 to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 8 hours 10-21 days*
Oral 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients weighing > 51 kg) Every 12 hours
Inhalational Anthrax (Post-Exposure)** Intravenous 10 mg/kg (maximum 400 mg per dose) Every 12 hours 60 days
Oral 15 mg/kg (maximum 500 mg per dose) Every 12 hours
* The total duration of therapy for complicated urinary tract infection and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).
** Drug administration should begin as soon as possible after suspected or confirmed exposure to Bacillus anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit.5 For a discussion of ciprofloxacin serum concentrations in various human populations, see Inhalational Anthrax – Additional Information.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m²).

HOW SUPPLIED

CIPRO (ciprofloxacin hydrochloride) Tablets are available as round, slightly yellowish film-coated tablets containing 250 mg ciprofloxacin. The 250 mg tablet is coded with the word “BAYER” on one side and “CIP 250” on the reverse side. CIPRO is also available as capsule shaped, slightly yellowish film-coated tablets containing 500 mg or 750 mg ciprofloxacin. The 500 mg tablet is coded with the word “BAYER” on one side and “CIP 500” on the reverse side. The 750 mg tablet is coded with the word “BAYER” on one side and “CIP 750” on the reverse side. CIPRO 250 mg, 500 mg, and 750 mg are available in bottles of 50, 100, and Unit Dose packages of 100.

  Strength NDC Code Tablet Identification
Bottles of 50: 750 mg NDC 0085-1756-01 CIPRO 750
Bottles of 100: 250 mg NDC 0085-1758-01 CIPRO 250
500 mg NDC 0085-1754-01 CIPRO 500
Unit Dose Package of 100: 250 mg NDC 0085-1758-02 CIPRO 250
500 mg NDC 0085-1754-02 CIPRO 500
750 mg NDC 0085-1756-02 CIPRO 750

Store below 30°C (86°F).

CIPRO Oral Suspension is supplied in 5% and 10% strengths. The drug product is composed of two components (microcapsules containing the active ingredient and diluent) which must be mixed by the pharmacist. See Instructions To The Pharmacist For Use/Handling.

Strengths Total volume after reconstitution Ciprofloxacin Concentration Ciprofloxacin contents per bottle NDC Code
5% 100 mL 250 mg/5 mL 5,000 mg 0085-1777-01
10% 100 mL 500 mg/5 mL 10,000 mg 0085-1773-01

Microcapsules and diluent should be stored below 25°C (77°F) and protected from freezing.

Reconstituted product may be stored below 30°C (86°F) for 14 days. Protect from freezing. A teaspoon is provided for the patient.

Instructions To The Pharmacist For Use/Handling Of CIPRO Oral Suspension

CIPRO Oral Suspension is supplied in 5% (5 g ciprofloxacin in 100 mL) and 10% (10 g ciprofloxacin in 100 mL) strengths. The drug product is composed of two components (microcapsules and diluent) which must be combined prior to dispensing.

One teaspoonful (5 mL) of 5% ciprofloxacin oral suspension = 250 mg of ciprofloxacin.

One teaspoonful (5 mL) of 10% ciprofloxacin oral suspension = 500 mg of ciprofloxacin.

Appropriate Dosing Volumes of the Oral Suspensions:

Dose 5% 10%
250 mg 5 mL 2.5 mL
500 mg 10 mL 5 mL
750 mg 15 mL 7.5 mL

Preparation of the suspension:

1. The small bottle contains the microcapsules, the large bottle contains the diluent.

Contents of the ottles - Illustration

2. Open both bottles. Child-proof cap: Press down according to instructions on the cap while turning to the left.

Child-proof cap - Illustration

3. Pour the microcapsules completely into the larger bottle of diluent. Do not add water to the suspension.

Pour the microcapsules completely into the larger bottle of diluent - Illustration

4. Remove the top layer of the diluent bottle lable (to reveal to CIPRO Oral Suspension label). Close the large bottle completely according to the directions on the cap and shake vigorously for about 15 seconds. The suspension is ready for use.

Shake vigorously - Illustration

CIPRO Oral Suspension should not be administered through feeding or NG (nasogastric) tubes due to its physical characteristics.

Instruct the patient to shake CIPRO Oral Suspension vigorously each time before use for approximately 15 seconds and not to chew the microcapsules.

REFERENCES

2. Clinical and Laboratory Standards Institute, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline – Second Edition. CLSI Document M45-A2, CLSI, Wayne, PA, 2010.

5. 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).

Manufactured by : Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470. Distributed by:Schering Corporation, a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. 03/11.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse Reactions in Adult Patients

During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug. Most of the adverse events reported were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment. Ciprofloxacin was discontinued because of an adverse event in 1% of orally treated patients.

The most frequently reported drug related events, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

Additional medically important events that occurred in less than 1% of ciprofloxacin patients are listed below.

BODY AS A WHOLE: headache, abdominal pain/discomfort, foot pain, pain, pain in extremities, injection site reaction (ciprofloxacin intravenous)

CARDIOVASCULAR: palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis, phlebitis, tachycardia, migraine, hypotension

CENTRAL NERVOUS SYSTEM: restlessness, dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression, paresthesia, abnormal gait, grand mal convulsion

GASTROINTESTINAL: painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis

HEMIC/LYMPHATIC: lymphadenopathy, petechia

METABOLIC/NUTRITIONAL: amylase increase, lipase increase

MUSCULOSKELETAL: arthralgia or back pain, joint stiffness, achiness, neck or chest pain, flare up of gout

RENAL/UROGENITAL: interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis, breast pain

RESPIRATORY: dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, hemoptysis, bronchospasm, pulmonary embolism

SKIN/HYPERSENSITIVITY: allergic reaction, pruritus, urticaria, photosensitivity/ phototoxicity reaction, flushing, fever, chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, sweating

SPECIAL SENSES: blurred vision, disturbed vision (change in color perception, overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus, hearing loss, bad taste, chromatopsia

In several instances nausea, vomiting, tremor, irritability, or palpitation were judged by investigators to be related to elevated serum levels of theophylline possibly as a result of drug interaction with ciprofloxacin.

In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets (500 mg BID) to cefuroxime axetil (250 mg - 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, ciprofloxacin demonstrated a CNS adverse event profile comparable to the control drugs.

Adverse Reactions in Pediatric Patients

Ciprofloxacin, administered I.V. and /or orally, was compared to a cephalosporin for treatment of complicated urinary tract infections (cUTI) or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety within 6 weeks of therapy and through one year of follow-up in the 335 ciprofloxacin- and 349 comparator-treated patients enrolled.

An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse events as well as all patients with an abnormal gait or abnormal joint exam (baseline or treatment-emergent). These events were evaluated in a comprehensive fashion and included such conditions as arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint. The affected joints included: knee, elbow, ankle, hip, wrist, and shoulder. Within 6 weeks of treatment initiation, the rates of these events were 9.3% (31/335) in the ciprofloxacin-treated group versus 6 % (21/349) in comparator-treated patients. The majority of these events were mild or moderate in intensity. All musculoskeletal events occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment. Radiological evaluations were not routinely used to confirm resolution of the events. The events occurred more frequently in ciprofloxacin-treated patients than control patients, regardless of whether they received I.V. or oral therapy. Ciprofloxacin-treated patients were more likely to report more than one event and on more than one occasion compared to control patients. These events occurred in all age groups and the rates were consistently higher in the ciprofloxacin group compared to the control group. At the end of 1 year, the rate of these events reported at any time during that period was 13.7% (46/335) in the ciprofloxacin-treated group versus 9.5% (33/349) comparator-treated patients.

An adolescent female discontinued ciprofloxacin for wrist pain that developed during treatment. An MRI performed 4 weeks later showed a tear in the right ulnar fibrocartilage. A diagnosis of overuse syndrome secondary to sports activity was made, but a contribution from ciprofloxacin cannot be excluded. The patient recovered by 4 months without surgical intervention.

Findings Involving Joint or Peri-articular Tissues as Assessed by the IPSC

  Ciprofloxacin Comparator
All Patients (within 6 weeks) 31/335 (9.3%) 21/349 (6%)
95% Confidence Interval* (-0.8%,+7.2%)
Age Group    
≥ 12 months < 24 months 1/36 (2.8%) 0/41
≥ 2 years < 6 years 5/124 (4%) 3/118 (2.5%)
≥ 6 years < 12 years 18/143 (12.6%) 12/153 (7.8%)
≥ 12 years to 17 years 7/32 (21.9%) 6/37 (16.2 %)
All Patients (within 1 year) 46/335 (13.7%) 33/349 (9.5%)
95% Confidence Interval* (-0.6%,+ 9.1%)
*The study was designed to demonstrate that the arthropathy rate for the ciprofloxacin group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that ciprofloxacin group had findings comparable to the control group.

The incidence rates of neurological events within 6 weeks of treatment initiation were 3% (9/335) in the ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse events regardless of relationship to study drug and within 6 weeks of treatment initiation were 41% (138/335) in the ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent events were gastrointestinal: 15% (50/335) of ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse events were seen in 7.5% (25/335) of ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse event was observed in 3% (10/335) of ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse events that occurred in at least 1% of ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, accidental injury 3%, rhinitis 3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

In addition to the events reported in pediatric patients in clinical trials, it should be expected that events reported in adults during clinical trials or post-marketing experience may also occur in pediatric patients.

Post-Marketing Adverse Event Reports

The following adverse events have been reported from worldwide marketing experience with fluoroquinolones, including ciprofloxacin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug.

Agitation, agranulocytosis, albuminuria, anaphylactic reactions (including life-threatening anaphylactic shock), anosmia, candiduria, cholesterol elevation (serum), confusion, constipation, delirium, dyspepsia, dysphagia, erythema multiforme, exfoliative dermatitis, fixed eruption, flatulence, glucose elevation (blood), hemolytic anemia, hepatic failure (including fatal cases), hepatic necrosis, hyperesthesia, hypertonia, hypesthesia, hypotension (postural), jaundice, marrow depression (life threatening), methemoglobinemia, moniliasis (oral, gastrointestinal, vaginal), myalgia, myasthenia, exacerbation of myasthenia gravis, myoclonus, nystagmus, pancreatitis, pancytopenia (life threatening or fatal outcome), peripheral neuropathy, phenytoin alteration (serum), photosensitivity/phototoxicity reaction, potassium elevation (serum), prothrombin time prolongation or decrease, pseudomembranous colitis (The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.), psychosis (toxic), renal calculi, serum sickness like reaction, Stevens-Johnson syndrome, taste loss, tendinitis, tendon rupture, torsade de pointes, toxic epidermal necrolysis (Lyell's Syndrome), triglyceride elevation (serum), twitching, vaginal candidiasis, and vasculitis. (See PRECAUTIONS.)

Adverse events were also reported by persons who received ciprofloxacin for anthrax post-exposure prophylaxis following the anthrax bioterror attacks of October 2001. (See also Inhalational Anthrax-Additional Information.)

Adverse Laboratory Changes

Changes in laboratory parameters listed as adverse events without regard to drug relationship are listed below:

Hepatic –Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase (0.8%), LDH (0.4%), serum bilirubin (0.3%).

Hematologic–Eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), elevated blood platelets (0.1%), pancytopenia (0.1%).

Renal–Elevations of serum creatinine (1.1%), BUN (0.9%), CRYSTALLURIA, CYLINDRURIA, AND HEMATURIA HAVE BEEN REPORTED.

Other changes occurring in less than 0.1% of courses were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, leukocytosis.

Read the Cipro (ciprofloxacin) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

In a pharmacokinetic study, systemic exposure of tizanidine (4 mg single dose) was significantly increased (Cmax 7-fold, AUC 10-fold) when the drug was given concomitantly with ciprofloxacin (500 mg bid for 3 days). The hypotensive and sedative effects of tizanidine were also potentiated. Concomitant administration of tizanidine and ciprofloxacin is contraindicated.

As with some other quinolones, concurrent administration of ciprofloxacin with theophylline may lead to elevated serum concentrations of theophylline and prolongation of its elimination half-life. This may result in increased risk of theophylline-related adverse reactions. (See WARNINGS.) If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Some quinolones, including ciprofloxacin, have also been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and a prolongation of its serum half-life.

Concurrent administration of a quinolone, including ciprofloxacin, with multivalent cation-containing products such as magnesium/aluminum antacids, sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or products containing calcium, iron, or zinc may substantially decrease its absorption, resulting in serum and urine levels considerably lower than desired. (See DOSAGE AND ADMINISTRATION for concurrent administration of these agents with ciprofloxacin.)

Histamine H2-receptor antagonists appear to have no significant effect on the bioavailability of ciprofloxacin.

Altered serum levels of phenytoin (increased and decreased) have been reported in patients receiving concomitant ciprofloxacin.

The concomitant administration of ciprofloxacin with the sulfonylurea glyburide has, on rare occasions, resulted in severe hypoglycemia.

Some quinolones, including ciprofloxacin, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly.

Quinolones, including ciprofloxacin, have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. When these products are administered concomitantly, prothrombin time or other suitable coagulation tests should be closely monitored.

Probenecid interferes with renal tubular secretion of ciprofloxacin and produces an increase in the level of ciprofloxacin in the serum. This should be considered if patients are receiving both drugs concomitantly.

Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin potentially leading to increased plasma levels of methotrexate. This might increase the risk of methotrexate associated toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant ciprofloxacin therapy is indicated.

Metoclopramide significantly accelerates the absorption of oral ciprofloxacin resulting in shorter time to reach maximum plasma concentrations. No significant effect was observed on the bioavailability of ciprofloxacin.

Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Tendinopathy and Tendon Rupture

Fluoroquinolones, including CIPRO, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors. Tendon rupture can occur during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. CIPRO should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon. Patients should be advised to rest at the first sign of tendinitis or tendon rupture, and to contact their healthcare provider regarding changing to a non-quinolone antimicrobial drug.

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including CIPRO, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid CIPRO in patients with known history of myasthenia gravis. (See PATIENT INFORMATION and ADVERSE REACTIONS: Post-Marketing Adverse Event Reports.)

Pregnant Women

THE SAFETY AND EFFECTIVENESS OF CIPROFLOXACIN IN PREGNANT AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED. (See PRECAUTIONS: Pregnancy, and Nursing Mothers subsections.)

Pediatrics

Ciprofloxacin should be used in pediatric patients (less than 18 years of age) only for infections listed in the INDICATIONS AND USAGE section. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See ADVERSE REACTIONS.)

In pre-clinical studies, oral administration of ciprofloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. (See Animal Pharmacology.)

Cytochrome P450 (CYP450)

Ciprofloxacin is an inhibitor of the hepatic CYP1A2 enzyme pathway. Coadministration of ciprofloxacin and other drugs primarily metabolized by CYP1A2 (e.g. theophylline, methylxanthines, tizanidine) results in increased plasma concentrations of the coadministered drug and could lead to clinically significant pharmacodynamic side effects of the coadministered drug.

Central Nervous System Disorders

Convulsions, increased intracranial pressure, and toxic psychosis have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving ciprofloxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones, ciprofloxacin should be used with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). (See PRECAUTIONS: General, PATIENT INFORMATION, DRUG INTERACTIONS and ADVERSE REACTIONS.)

Theophylline

SERIOUS AND FATAL REACTIONS HAVE BEEN REPORTED IN PATIENTS RECEIVING CONCURRENT ADMINISTRATION OF CIPROFLOXACIN AND THEOPHYLLINE. These reactions have included cardiac arrest, seizure, status epilepticus, and respiratory failure. Although similar serious adverse effects have been reported in patients receiving theophylline alone, the possibility that these reactions may be potentiated by ciprofloxacin cannot be eliminated. If concomitant use cannot be avoided, serum levels of theophylline should be monitored and dosage adjustments made as appropriate.

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management, including intubation, should be administered as indicated.

Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (see PATIENT INFORMATION and ADVERSE REACTIONS).

Pseudomembranous Colitis

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including CIPRO, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Peripheral neuropathy

Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving quinolones, including ciprofloxacin. Ciprofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness, or is found to have deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength in order to prevent the development of an irreversible condition.

Syphilis

Ciprofloxacin has not been shown to be effective in the treatment of syphilis. Antimicrobial agents used in high dose for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with ciprofloxacin should have a follow-up serologic test for syphilis after three months.

PRECAUTIONS

General

Crystals of ciprofloxacin have been observed rarely in the urine of human subjects but more frequently in the urine of laboratory animals, which is usually alkaline. (See Animal Pharmacology.) Crystalluria related to ciprofloxacin has been reported only rarely in humans because human urine is usually acidic. Alkalinity of the urine should be avoided in patients receiving ciprofloxacin. Patients should be well hydrated to prevent the formation of highly concentrated urine.

Central Nervous System

Quinolones, including ciprofloxacin, may also cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia. (See WARNINGS, PATIENT INFORMATION, and DRUG INTERACTIONS.)

Renal Impairment

Alteration of the dosage regimen is necessary for patients with impairment of renal function. (See DOSAGE AND ADMINISTRATION.)

Photosensitivity/Phototoxicity

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs (See ADVERSE REACTIONS/Post-Marketing Adverse Events).

As with any potent drug, periodic assessment of organ system functions, including renal, hepatic, and hematopoietic function, is advisable during prolonged therapy.

Prescribing CIPRO Tablets and CIPRO Oral Suspension in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Information for Patients

Patients should be advised:

  • that fluoroquinolones like CIPRO may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Patients should call their healthcare provider right away if they have any worsening muscle weakness or breathing problems.
  • to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue CIPRO treatment. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
  • that antibacterial drugs including CIPRO Tablets and CIPRO Oral Suspension should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When CIPRO Tablets and CIPRO Oral Suspension is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CIPRO Tablets and CIPRO Oral Suspension or other antibacterial drugs in the future.
  • that ciprofloxacin may be taken with or without meals and to drink fluids liberally. As with other quinolones, concurrent administration of ciprofloxacin with magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder, other highly buffered drugs, or with other products containing calcium, iron or zinc should be avoided. Ciprofloxacin may be taken two hours before or six hours after taking these products. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products.
  • that ciprofloxacin may be associated with hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash or other allergic reaction.
  • that photosensitivity/phototoxicity has been reported in patients receiving quinolones. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking quinolones. If patients need to be outdoors while using quinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, patients should contact their physician.
  • that peripheral neuropathies have been associated with ciprofloxacin use. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, they should discontinue treatment and contact their physicians.
  • that ciprofloxacin may cause dizziness and lightheadedness; therefore, patients should know how they react to this drug before they operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
  • that ciprofloxacin increases the effects of tizanidine (Zanaflex®). Patients should not use ciprofloxacin if they are already taking tizanidine.
  • that ciprofloxacin may increase the effects of theophylline and caffeine. There is a possibility of caffeine accumulation when products containing caffeine are consumed while taking quinolones.
  • that convulsions have been reported in patients receiving quinolones, including ciprofloxacin, and to notify their physician before taking this drug if there is a history of this condition.
  • that ciprofloxacin has been associated with an increased rate of adverse events involving joints and surrounding tissue structures (like tendons) in pediatric patients (less than 18 years of age). Parents should inform their child's physician if the child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child's physician of any joint-related problems that occur during or following ciprofloxacin therapy. (See WARNINGS, PRECAUTIONS, Pediatric Use and ADVERSE REACTIONS.)
  • that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:

Salmonella/Microsome Test (Negative)

E. coli DNA Repair Assay (Negative)

Mouse Lymphoma Cell Forward Mutation Assay (Positive)

Chinese Hamster V79 Cell HGPRT Test (Negative)

Syrian Hamster Embryo Cell Transformation Assay (Negative)

Saccharomyces cerevisiae Point Mutation Assay (Negative)

Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)

Rat Hepatocyte DNA Repair Assay (Positive)

Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results:

Rat Hepatocyte DNA Repair Assay

Micronucleus Test (Mice)

Dominant Lethal Test (Mice)

Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 250 and 750 mg/kg to rats and mice, respectively (approximately 1.7- and 2.5- times the highest recommended therapeutic dose based upon mg/m²).

Results from photo co-carcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered ciprofloxacin. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and ciprofloxacin (mouse dose approximately equal to maximum recommended human dose based upon mg/m²), as opposed to 34 weeks when animals were treated with both UVA and vehicle. The times to development of skin tumors ranged from 16-32 weeks in mice treated concomitantly with UVA and other quinolones.4

In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice. The clinical significance of these findings to humans is unknown.

Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon mg/m²) revealed no evidence of impairment.

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data=fair), but the data are insufficient to state that there is no risk.8

A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation.9 In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1-5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children.

Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).10 There were 70 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found. The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin.

No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy.8,9 However, these small post-marketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother (see WARNINGS).

Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin. In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4- and 1.3-times the highest recommended therapeutic dose based upon mg/m²) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level. After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon mg/m²) no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed. (See WARNINGS.)

Nursing Mothers

Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential for serious adverse reactions in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Ciprofloxacin, like other quinolones, causes arthropathy and histological changes in weight-bearing joints of juvenile animals resulting in lameness. (See Animal Pharmacology.)

Inhalational Anthrax (Post-Exposure)

Ciprofloxacin is indicated in pediatric patients for inhalational anthrax (post-exposure). The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate. For information regarding pediatric dosing in inhalational anthrax (post-exposure), see DOSAGE AND ADMINISTRATION and Inhalational Anthrax – Additional Information.

Complicated Urinary Tract Infection and Pyelonephritis

Ciprofloxacin is indicated for the treatment of complicated urinary tract infections and pyelonephritis due to Escherichia coli. Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to the controls, including events related to joints and/or surrounding tissues. The rates of these events in pediatric patients with complicated urinary tract infection and pyelonephritis within six weeks of follow-up were 9.3% (31/335) versus 6% (21/349) for control agents. The rates of these events occurring at any time up to the one year follow-up were 13.7% (46/335) and 9.5% (33/349), respectively. The rate of all adverse events regardless of drug relationship at six weeks was 41% (138/335) in the ciprofloxacin arm compared to 31% (109/349) in the control arm. (See ADVERSE REACTIONS and Clinical Studies.)

Cystic Fibrosis

Short-term safety data from a single trial in pediatric cystic fibrosis patients are available. In a randomized, double-blind clinical trial for the treatment of acute pulmonary exacerbations in cystic fibrosis patients (ages 5-17 years), 67 patients received ciprofloxacin I.V. 10 mg/kg/dose q8h for one week followed by ciprofloxacin tablets 20 mg/kg/dose q12h to complete 10-21 days treatment and 62 patients received the combination of ceftazidime I.V. 50 mg/kg/dose q8h and tobramycin I.V. 3 mg/kg/dose q8h for a total of 10-21 days. Patients less than 5 years of age were not studied. Safety monitoring in the study included periodic range of motion examinations and gait assessments by treatment-blinded examiners. Patients were followed for an average of 23 days after completing treatment (range 0-93 days). This study was not designed to determine long term effects and the safety of repeated exposure to ciprofloxacin.

Musculoskeletal adverse events in patients with cystic fibrosis were reported in 22% of the patients in the ciprofloxacin group and 21% in the comparison group. Decreased range of motion was reported in 12% of the subjects in the ciprofloxacin group and 16% in the comparison group. Arthralgia was reported in 10% of the patients in the ciprofloxacin group and 11% in the comparison group. Other adverse events were similar in nature and frequency between treatment arms. One of sixty-seven patients developed arthritis of the knee nine days after a ten day course of treatment with ciprofloxacin. Clinical symptoms resolved, but an MRI showed knee effusion without other abnormalities eight months after treatment. However, the relationship of this event to the patient's course of ciprofloxacin can not be definitively determined, particularly since patients with cystic fibrosis may develop arthralgias/arthritis as part of their underlying disease process.

Geriatric Use

Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as CIPRO. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing CIPRO to elderly patients especially those on corticosteroids. Patients should be informed of this potential side effect and advised to discontinue CIPRO and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur (See BOXED WARNING, WARNINGS, and ADVERSE REACTIONS/Post-Marketing Adverse Event Reports).

In a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION.)

In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using CIPRO with concomitant drugs that can result in prolongation of the QT interval (e.g., class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia).

REFERENCES

4. Report presented at the FDA's Anti-Infective Drug and Dermatological Drug Product's Advisory Committee meeting, March 31, 1993, Silver Spring, MD. Report available from FDA, CDER, Advisors and Consultants Staff, HFD-21, 1901 Chapman Avenue, Room 200, Rockville, MD 20852, USA.

5 . 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).

6. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7.

7. Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42.

8. Friedman J, Polifka J. Teratogenic effects of drugs: a resource for clinicians (TERIS). Baltimore, Maryland: Johns Hopkins University Press, 2000:149-195.

9. Loebstein R, Addis A, Ho E, et al. Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study. Antimicrob Agents Chemother. 1998;42(6):1336-1339.

10. Schaefer C, Amoura-Elefant E, Vial T, et al. Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European network of teratology information services (ENTIS). Eur J Obstet Gynecol Reprod Biol. 1996;69:83-89.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

In the event of acute overdosage, reversible renal toxicity has been reported in some cases. The stomach should be emptied by inducing vomiting or by gastric lavage. The patient should be carefully observed and given supportive treatment, including monitoring of renal function and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of ciprofloxacin. Adequate hydration must be maintained. Only a small amount of ciprofloxacin ( < 10%) is removed from the body after hemodialysis or peritoneal dialysis.

Single doses of ciprofloxacin were relatively non-toxic via the oral route of administration in mice, rats, and dogs. No deaths occurred within a 14-day post treatment observation period at the highest oral doses tested; up to 5000 mg/kg in either rodent species, or up to 2500 mg/kg in the dog. Clinical signs observed included hypoactivity and cyanosis in both rodent species and severe vomiting in dogs. In rabbits, significant mortality was seen at doses of ciprofloxacin > 2500 mg/kg. Mortality was delayed in these animals, occurring 10-14 days after dosing.

In mice, rats, rabbits and dogs, significant toxicity including tonic/clonic convulsions was observed at intravenous doses of ciprofloxacin between 125 and 300 mg/kg.

CONTRAINDICATIONS

Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antimicrobial agents, or any of the product components.

Concomitant administration with tizanidine is contraindicated. (See PRECAUTIONS: DRUG INTERACTIONS.)

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Absorption

Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations and area under the curve are shown in the chart for the 250 mg to 1000 mg dose range.

Dose (mg) Maximum Serum Concentration (μg/mL) Area Under Curve (AUC)
250 1.2 4.8
500 2.4 11.6
750 4.3 20.2
1000 5.4 30.8

Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500, or 750 mg are 0.1, 0.2, and 0.4 μg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Serum concentrations increase proportionately with doses up to 1000 mg.

A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours. A 750 mg oral dose results in a Cmax similar to that observed with a 400 mg I.V. dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg ciprofloxacin given every 12 hours.

Steady-state Pharmacokinetic Parameters Following Multiple Oral and I.V. Doses

Parameters 500 mg q12h, P.O. 400 mg q12h, I.V. 750 mg q12h, P.O. 400 mg q8h, I.V.
AUC (μg•hr/mL) 13.7a 12.7a 31.6b 32.9c
Cmax (μg/mL) 2.97 4.56 3.59 4.07
aAUC 0-12h
bAUC 24h=AUC0-12h x 2
cAUC 24h=AUC0-8h x 3

Distribution

The binding of ciprofloxacin to serum proteins is 20 to 40% which is not likely to be high enough to cause significant protein binding interactions with other drugs.

After oral administration, ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate. Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions. Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid (CSF); however, CSF concentrations are generally less than 10% of peak serum concentrations. Low levels of the drug have been detected in the aqueous and vitreous humors of the eye.

Metabolism

Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin. Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Coadministration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the coadministered drug (see CONTRAINDICATIONS; WARNINGS; PRECAUTIONS: DRUG INTERACTIONS).

Excretion

The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. After a 250 mg oral dose, urine concentrations of ciprofloxacin usually exceed 200 μg/mL during the first two hours and are approximately 30 μg/mL at 8 to 12 hours after dosing. The urinary excretion of ciprofloxacin is virtually complete within 24 hours after dosing. The renal clearance of ciprofloxacin, which is approximately 300 mL/minute, exceeds the normal glomerular filtration rate of 120 mL/minute. Thus, active tubular secretion would seem to play a significant role in its elimination. Co-administration of probenecid with ciprofloxacin results in about a 50% reduction in the ciprofloxacin renal clearance and a 50% increase in its concentration in the systemic circulation.

Although bile concentrations of ciprofloxacin are several fold higher than serum concentrations after oral dosing, only a small amount of the dose administered is recovered from the bile as unchanged drug. An additional 1 to 2% of the dose is recovered from the bile in the form of metabolites. Approximately 20 to 35% of an oral dose is recovered from the feces within 5 days after dosing. This may arise from either biliary clearance or transintestinal elimination.

With oral administration, a 500 mg dose, given as 10 mL of the 5% CIPRO Suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to the 500 mg tablet. A 10 mL volume of the 5% CIPRO Suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to a 5 mL volume of the 10% CIPRO Suspension (containing 500 mg ciprofloxacin/5mL).

Drug-drug Interactions

When CIPRO Tablet is given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour whereas there is no delay observed when CIPRO Suspension is given with food. The overall absorption of CIPRO Tablet or CIPRO Suspension, however, is not substantially affected. The pharmacokinetics of ciprofloxacin given as the suspension are also not affected by food. Concurrent administration of antacids containing magnesium hydroxide or aluminum hydroxide may reduce the bioavailability of ciprofloxacin by as much as 90%. (See PRECAUTIONS.)

The serum concentrations of ciprofloxacin and metronidazole were not altered when these two drugs were given concomitantly.

Concomitant administration with tizanidine is contraindicated (See CONTRAINDICATIONS). Concomitant administration of ciprofloxacin with theophylline decreases the clearance of theophylline resulting in elevated serum theophylline levels and increased risk of a patient developing CNS or other adverse reactions. Ciprofloxacin also decreases caffeine clearance and inhibits the formation of paraxanthine after caffeine administration. (See WARNINGS: PRECAUTIONS.)

Special Populations

Pharmacokinetic studies of the oral (single dose) and intravenous (single and multiple dose) forms of ciprofloxacin indicate that plasma concentrations of ciprofloxacin are higher in elderly subjects ( > 65 years) as compared to young adults. Although the Cmax is increased 16-40%, the increase in mean AUC is approximately 30%, and can be at least partially attributed to decreased renal clearance in the elderly. Elimination half-life is only slightly (~20%) prolonged in the elderly. These differences are not considered clinically significant. (See PRECAUTIONS: Geriatric Use.)

In patients with reduced renal function, the half-life of ciprofloxacin is slightly prolonged. Dosage adjustments may be required. (See DOSAGE AND ADMINISTRATION.)

In preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. The kinetics of ciprofloxacin in patients with acute hepatic insufficiency, however, have not been fully elucidated.

Following a single oral dose of 10 mg/kg ciprofloxacin suspension to 16 children ranging in age from 4 months to 7 years, the mean Cmax was 2.4 μg/mL (range: 1.5 – 3.4 μg/mL) and the mean AUC was 9.2 μg*h/mL (range: 5.8 – 14.9 μg*h/mL). There was no apparent age-dependence, and no notable increase in Cmax or AUC upon multiple dosing (10 mg/kg TID). In children with severe sepsis who were given intravenous ciprofloxacin (10 mg/kg as a 1-hour infusion), the mean Cmax was 6.1 μg/mL (range: 4.6 – 8.3 μg/mL) in 10 children less than 1 year of age; and 7.2 μg/mL (range: 4.7 – 11.8 μg/mL) in 10 children between 1 and 5 years of age. The AUC values were 17.4 μg*h/mL (range: 11.8 – 32.0 μg*h/mL) and 16.5 μg*h/mL (range: 11.0 – 23.8 μg*h/mL) in the respective age groups. These values are within the range reported for adults at therapeutic doses. Based on population pharmacokinetic analysis of pediatric patients with various infections, the predicted mean half-life in children is approximately 4 - 5 hours, and the bioavailability of the oral suspension is approximately 60%.

Microbiology

Mechanism of Action

The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Drug Resistance

The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of penicillins, cephalosporins, aminoglycosides, macrolides, and tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to ciprofloxacin and other fluoroquinolones. There is no known cross-resistance between ciprofloxacin and other classes of antimicrobials. In vitro resistance to ciprofloxacin develops slowly by multiple step mutations. Resistance to ciprofloxacin due to spontaneous mutations occurs at a general frequency of between < 10-9 to 1x10-6.

Activity in vitro and in vivo

Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms. Ciprofloxacin is slightly less active when tested at acidic pH. The inoculum size has little effect when tested in vitro . The minimal bactericidal concentration (MBC) generally does not exceed the minimal inhibitory concentration (MIC) by more than a factor of 2.

Ciprofloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section of the package insert for CIPRO (ciprofloxacin hydrochloride) Tablets and CIPRO (ciprofloxacin*) 5% and 10% Oral Suspension.

Aerobic gram-positive microorganisms

Enterococcus faecalis (Many strains are only moderately susceptible.)
Staphylococcus aureus
(methicillin-susceptible strains only)
Staphylococcus epidermidis
(methicillin-susceptible strains only)
Staphylococcus saprophyticus

Streptococcus pneumoniae
(penicillin-susceptible strains only)
Streptococcus pyogenes

Aerobic gram-negative microorganisms

Campylobacter jejuni Proteus mirabilis
Citrobacter diversus Proteus vulgaris
Citrobacter freundii Providencia rettgeri
Enterobacter cloacae Providencia stuartii
Escherichia coli Pseudomonas aeruginosa
Haemophilus influenzae Salmonella typhi
Haemophilus parainfluenzae Serratia marcescens
Klebsiella pneumoniae Shigella boydii
Moraxella catarrhalis Shigella dysenteriae
Morganella morganii Shigella flexneri
Neisseria gonorrhoeae Shigella sonnei

Ciprofloxacin has been shown to be active against Bacillus anthracis both in vitro and by use of serum levels as a surrogate marker (see INDICATIONS AND USAGE and Inhalational Anthrax – Additional Information).

The following in vitro data are available, but their clinical significance is unknown.

Ciprofloxacin exhibits in vitro minimum inhibitory concentrations (MICs) of 1 μg/mL or less against most ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of ciprofloxacin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Aerobic gram-positive microorganisms

Staphylococcus haemolyticus
Staphylococcus hominis

Streptococcus pneumoniae
(penicillin-resistant strains only)

Aerobic gram-negative microorganisms
Acinetobacter Iwoffi Pasteurella multocida
Aeromonas hydrophila Salmonella enteritidis
Edwardsiella tarda Vibrio cholerae
Enterobacter aerogenes Vibrio parahaemolyticus
Klebsiella oxytoca Vibrio vulnificus
Legionella pneumophila Yersinia enterocolitica

Most strains of Burkholderia cepacia and some strains of Stenotrophomonas maltophilia are resistant to ciprofloxacin as are most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile.

Susceptibility Tests
  • Dilution Techniques: Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on a dilution method1 (broth or agar) or equivalent with standardized inoculum concentrations and standardized concentrations of ciprofloxacin powder. The MIC values should be interpreted according to the criteria outlined in Table 1.
  • Diffusion Techniques: Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. One such standardized procedure3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 5-μg ciprofloxacin to test the susceptibility of microorganisms to ciprofloxacin.

Reports from the laboratory providing results of the standard single-disk susceptibility test with a 5-μg ciprofloxacin disk should be interpreted according to the criteria outlined in Table 1. Interpretation involves correlation of the diameter obtained in the disk test with the MIC for ciprofloxacin.

Table 1: Susceptibility Interpretive Criteria for Ciprofloxacin

Species MIC (μ g/mL) Zone Diameter (mm)
S I R S I R
Enterobacteriacae ≤ 1 2 ≥ 4 ≥ 21 16-20 ≤ 15
Enterococcus faecalis ≤ 1 2 ≥ 4 ≥ 21 16-20 ≤ 15
Methicillin susceptible Staphylococcus species ≤ 1 2 ≥ 4 ≥ 21 16-20 ≤ 15
Pseudomonas aeruginosa ≤ 1 2 ≥ 4 ≥ 21 16-20 ≤ 15
Haemophilus influenzae ≤ 1a g g ≥ 21b g g
Haemophilus parainfluenzae ≤ 1a g g ≥ 21b g g
Penicillin susceptible Streptococcus pneumoniae ≤ 1c 2c ≥ 4c ≥ 21d 16-20d ≤ 15d
Streptococcus pyogenes ≤ 1c 2c ≥ 4c ≥ 21d 16-20d ≤ 15d
Neisseria gonorrhoeae ≤ 0.06e 0.12 – 0.5e ≥ 1e ≥ 41f 28-40f ≤ 27f
S=Susceptible, I=Intermediate, and R=Resistant.
a This interpretive standard is applicable only to broth microdilution susceptibility tests with Haemophilus influenzae and Haemophilus parainfluenzae using Haemophilus Test Medium (HTM)1.
b This zone diameter standard is applicable only to tests with Haemophilus influenzae and Haemophilus parainfluenzae using Haemophilus Test Medium (HTM)3.
cThese interpretive standards are applicable only to broth microdilution susceptibility tests with streptococci using cation-adjusted Mueller-Hinton broth with 2-5% lysed horse blood.
dThese zone diameter standards are applicable only to tests performed for streptococci using Mueller-Hinton agar supplemented with 5% sheep blood incubated in 5% CO2.
e This interpretive standard is applicable only to agar dilution test with GC agar base and 1% defined growth supplement.
fThis zone diameter standard is applicable only to disk diffusion tests with GC agar base and 1% defined growth supplement.
g The current absence of data on resistant strains precludes defining any results other than “Susceptible”. Strains yielding MIC results suggestive of a “nonsusceptible” category should be submitted to a reference laboratory for further testing.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of “Intermediate” indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone, which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of “Resistant” indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Quality Control: Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. For dilution technique, standard ciprofloxacin powder should provide the MIC values according to criteria outlined in Table 2. For diffusion technique, the 5-μg ciprofloxacin disk should provide the zone diameters outlined in Table 2.

Table 2: Quality Control for Susceptibility Testing

Strains MIC range (μg/mL) Zone Diameter (mm)
Enterococcus faecalis ATCC 29212 0.25–2 -
Escherichia coli ATCC 25922 0.004–0.015 30–40
Haemophilus influenzae ATCC 49247 0.004–0.03a 34–42d
Pseudomonas aeruginosa ATCC 27853 0.25–1 25–33
Staphylococcus aureus ATCC29213 0.12–0.5 -
Staphylococcus aureus ATCC25923 - 22–30
Neisseria gonorrhoeae ATCC 49226 0.001–0.008b 48–58e
C. jejuni ATCC 33560 0.06–0.25 and 0.03–0.12c -
a This quality control range is applicable to only H. influenzae ATCC 49247 tested by a broth microdilution procedure using Haemophilus Test Medium (HTM)1.
b N. gonorrhoeae ATCC 49226 tested by agar dilution procedure using GC agar and 1% defined growth supplement in a 5% CO2 environment at 35-37°C for 20-24 hours3.
c C. jejuni ATCC 33560 tested by broth microdilution procedure using cation adjusted Mueller Hinton broth with 2.5-5% lysed horse blood in a microaerophilic environment at 36-37°C for 48 hours and for 42°C at 24 hours, respectively.
d These quality control limits are applicable to only H. influenzae ATCC 49247 testing using Haemophilus Test Medium (HTM)3.
e These quality control limits are applicable only to tests conducted with N. gonorrhoeae ATCC 49226 performed by disk diffusion using GC agar base and 1% defined growth supplement.

Animal Pharmacology

Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested. (See WARNINGS.) Damage of weight bearing joints was observed in juvenile dogs and rats. In young beagles, 100 mg/kg ciprofloxacin, given daily for 4 weeks, caused degenerative articular changes of the knee joint. At 30 mg/kg, the effect on the joint was minimal. In a subsequent study in young beagle dogs, oral ciprofloxacin doses of 30 mg/kg and 90 mg/kg ciprofloxacin (approximately 1.3- and 3.5-times the pediatric dose based upon comparative plasma AUCs) given daily for 2 weeks caused articular changes which were still observed by histopathology after a treatment-free period of 5 months. At 10 mg/kg (approximately 0.6-times the pediatric dose based upon comparative plasma AUCs), no effects on joints were observed. This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them.

Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with ciprofloxacin. This is primarily related to the reduced solubility of ciprofloxacin under alkaline conditions, which predominate in the urine of test animals; in man, crystalluria is rare since human urine is typically acidic. In rhesus monkeys, crystalluria without nephropathy was noted after single oral doses as low as 5 mg/kg. (approximately 0.07-times the highest recommended therapeutic dose based upon mg/m²). After 6 months of intravenous dosing at 10 mg/kg/day, no nephropathological changes were noted; however, nephropathy was observed after dosing at 20 mg/kg/day for the same duration (approximately 0.2-times the highest recommended therapeutic dose based upon mg/m²).

In dogs, ciprofloxacin at 3 and 10 mg/kg by rapid I.V. injection (15 sec.) produces pronounced hypotensive effects. These effects are considered to be related to histamine release, since they are partially antagonized by pyrilamine, an antihistamine. In rhesus monkeys, rapid I.V. injection also produces hypotension but the effect in this species is inconsistent and less pronounced.

In mice, concomitant administration of nonsteroidal anti-inflammatory drugs such as phenylbutazone and indomethacin with quinolones has been reported to enhance the CNS stimulatory effect of quinolones.

Ocular toxicity seen with some related drugs has not been observed in ciprofloxacin-treated animals.

Clinical Studies

Complicated Urinary Tract Infection and Pyelonephritis – Efficacy in Pediatric Patients

NOTE: Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues.

Ciprofloxacin, administered I.V. and/or orally, was compared to a cephalosporin for treatment of complicated urinary tract infections (cUTI) and pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety.

Patients were evaluated for clinical success and bacteriological eradication of the baseline organism(s) with no new infection or superinfection at 5 to 9 days post-therapy (Test of Cure or TOC). The Per Protocol population had a causative organism(s) with protocol specified colony count(s) at baseline, no protocol violation, and no premature discontinuation or loss to follow-up (among other criteria).

The clinical success and bacteriologic eradication rates in the Per Protocol population were similar between ciprofloxacin and the comparator group as shown below.

Clinical Success and Bacteriologic Eradication at Test of Cure (5 to 9 Days Post-Therapy)

  CIPRO Comparator
Randomized Patients 337 352
Per Protocol Patients 211 231
Clinical Response at 5 to 9 Days Post-Treatment 95.7% (202/211) 92.6% (214/231)
  95% CI [-1.3%, 7.3%]
Bacteriologic Eradication by Patient at 5 to 9 Days Post-Treatment* 84.4% (178/211) 78.3% (181/231)
  95% CI [-1.3%, 13.1%]
Bacteriologic Eradication of the Baseline Pathogen at 5 to 9 Days Post-Treatment
Escherichia coli 156/178 (88%) 161/179 (90%)
* Patients with baseline pathogen(s) eradicated and no new infections or superinfections/total number of patients. There were 5.5% (6/211) ciprofloxacin and 9.5% (22/231) comparator patients with superinfections or new infections.

Inhalational Anthrax In Adults And Pediatrics–Additional Information

The mean serum concentrations of ciprofloxacin associated with a statistically significant improvement in survival in the rhesus monkey model of inhalational anthrax are reached or exceeded in adult and pediatric patients receiving oral and intravenous regimens. (See DOSAGE AND ADMINISTRATION.) Ciprofloxacin pharmacokinetics have been evaluated in various human populations. The mean peak serum concentration achieved at steady-state in human adults receiving 500 mg orally every 12 hours is 2.97 μg/mL, and 4.56 μg/mL following 400 mg intravenously every 12 hours. The mean trough serum concentration at steady-state for both of these regimens is 0.2 μg/mL. In a study of 10 pediatric patients between 6 and 16 years of age, the mean peak plasma concentration achieved is 8.3 μg/mL and trough concentrations range from 0.09 to 0.26 μg/mL, following two 30-minute intravenous infusions of 10 mg/kg administered 12 hours apart. After the second intravenous infusion patients switched to 15 mg/kg orally every 12 hours achieve a mean peak concentration of 3.6 μg/mL after the initial oral dose. Long-term safety data, including effects on cartilage, following the administration of ciprofloxacin to pediatric patients are limited. (For additional information, see PRECAUTIONS, Pediatric Use.) Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication.5

A placebo-controlled animal study in rhesus monkeys exposed to an inhaled mean dose of 11 LD50 (~5.5 x 105 spores (range 5-30 LD50) of B. anthracis was conducted. The minimal inhibitory concentration (MIC) of ciprofloxacin for the anthrax strain used in this study was 0.08 μg/mL. In the animals studied, mean serum concentrations of ciprofloxacin achieved at expected Tmax (1 hour post-dose) following oral dosing to steady-state ranged from 0.98 to 1.69 μg/mL. Mean steady-state trough concentrations at 12 hours post-dose ranged from 0.12 to 0.19 μg/mL.6 Mortality due to anthrax for animals that received a 30-day regimen of oral ciprofloxacin beginning 24 hours post-exposure was significantly lower (1/9), compared to the placebo group (9/10) [p= 0.001]. The one ciprofloxacin-treated animal that died of anthrax did so following the 30-day drug administration period.7

More than 9300 persons were recommended to complete a minimum of 60 days of antibiotic prophylaxis against possible inhalational exposure to B. anthracis during 2001. Ciprofloxacin was recommended to most of those individuals for all or part of the prophylaxis regimen. Some persons were also given anthrax vaccine or were switched to alternative antibiotics. No one who received ciprofloxacin or other therapies as prophylactic treatment subsequently developed inhalational anthrax. The number of persons who received ciprofloxacin as all or part of their post-exposure prophylaxis regimen is unknown.

Among the persons surveyed by the Centers for Disease Control and Prevention, over 1000 reported receiving ciprofloxacin as sole post-exposure prophylaxis for inhalational anthrax. Gastrointestinal adverse events (nausea, vomiting, diarrhea, or stomach pain), neurological adverse events (problems sleeping, nightmares, headache, dizziness or lightheadedness) and musculoskeletal adverse events (muscle or tendon pain and joint swelling or pain) were more frequent than had been previously reported in controlled clinical trials. This higher incidence, in the absence of a control group, could be explained by a reporting bias, concurrent medical conditions, other concomitant medications, emotional stress or other confounding factors, and/or a longer treatment period with ciprofloxacin. Because of these factors and limitations in the data collection, it is difficult to evaluate whether the reported symptoms were drug-related.

REFERENCES

1. Clinical and Laboratory Standards Institute, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard – Eighth Edition. CLSI Document M7-A8, Vol. 29, No. 2, CLSI, Wayne, PA, January, 2009.

3. Clinical and Laboratory Standards Institute, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard – Tenth Edition. CLSI Document M2-A10 Vol. 29, No. 1, CLSI, Wayne, PA, January, 2009.

5. 21 CFR 314.510 (Subpart H – Accelerated Approval of New Drugs for Life-Threatening Illnesses).

6. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys. J Infect Dis 1992; 166:1184-7.

7. Friedlander AM, et al. Postexposure prophylaxis against experimental inhalational anthrax. J Infect Dis 1993; 167:1239-42.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

MEDICATION GUIDE

CIPRO®
(Sip-row)
(ciprofloxacin hydrochloride) Tablets

CIPRO®
(Sip-row)
(ciprofloxacin) Oral Suspension

CIPRO® XR
(Sip-row)
(ciprofloxacin extended-release tablets)

CIPRO® I.V.
(Sip-row)
(ciprofloxacin) For Intravenous Infusion

Read the Medication Guide that comes with CIPRO® before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about CIPRO?

CIPRO belongs to a class of antibiotics called fluoroquinolones. CIPRO can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take CIPRO.

  • Tendon rupture or swelling of the tendon (tendinitis)
    • Tendons are tough cords of tissue that connect muscles to bones.
    • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including CIPRO. The risk of getting tendon problems is higher if you:
    • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
    • Other reasons for tendon ruptures can include:
      • physical activity or exercise
      • kidney failure
      • tendon problems in the past, such as in people with rheumatoid arthritis (RA)
  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking CIPRO until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of CIPRO. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking CIPRO. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
    • hear or feel a snap or pop in a tendon area
    • bruising right after an injury in a tendon area
    • unable to move the affected area or bear weight
  • Worsening of myasthenia gravis (a disease which causes muscle weakness).
    Fluoroquinolones like CIPRO may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

See the section “What are the possible side effects of CIPRO?” for more information about side effects.

What is CIPRO?

CIPRO is a fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria. Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking CIPRO. CIPRO should not be used as the first choice of antibiotic medicine in children under 18 years of age. CIPRO Tablets, CIPRO Oral Suspension and CIPRO I.V. should not be used in children under 18 years old, except to treat specific serious infections, such as complicated urinary tract infections and to prevent anthrax disease after breathing the anthrax bacteria germ (inhalational exposure). It is not known if CIPRO XR is safe and works in children under 18 years of age. Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including CIPRO, do not kill viruses. Call your healthcare provider if you think your condition is not getting better while you are taking CIPRO.

Who should not take CIPRO?

Do not take CIPRO if you:

  • have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in CIPRO. Ask your healthcare provider if you are not sure. See the list of ingredients in CIPRO at the end of this Medication Guide.
  • also take a medicine called tizanidine (Zanaflex®). Serious side effects from tizanidine are likely to happen.

What should I tell my healthcare provider before taking CIPRO?

See “What is the most important information I should know about CIPRO?

Tell your healthcare provider about all your medical conditions, including if you:

  • have tendon problems
  • have a disease that causes muscle weakness (myasthenia gravis)
  • have central nervous system problems (such as epilepsy)
  • have nerve problems
  • have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
  • have a history of seizures
  • have kidney problems. You may need a lower dose of CIPRO if your kidneys do not work well.
  • have rheumatoid arthritis (RA) or other history of joint problems
  • have trouble swallowing pills
  • are pregnant or planning to become pregnant. It is not known if CIPRO will harm your unborn child.
  • are breast-feeding or planning to breast-feed. CIPRO passes into breast milk. You and your healthcare provider should decide whether you will take CIPRO or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. CIPRO and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

  • an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take CIPRO or other fluoroquinolones may increase your risk of central nervous system effects and seizures. See “What are the possible side effects of CIPRO?
  • a blood thinner (warfarin, Coumadin®, Jantoven®)
  • tizanidine (Zanaflex®). You should not take CIPRO if you are already taking tizanidine. See “Who should not take CIPRO?
  • theophylline (Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
  • glyburide (Micronase®, Glynase®, Diabeta®, Glucovance®). See “What are the possible side effects of CIPRO?
  • phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin Sodium®, Prompt Penytoin Sodium®, Phenytek®)
  • products that contain caffeine
  • a medicine to control your heart rate or rhythm (antiarrhythmics) See “What are the possible side effects of CIPRO?
  • an anti-psychotic medicine
  • a tricyclic antidepressant
  • a water pill (diuretic)
  • a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. See “What is the most important information I should know about CIPRO?
  • methotrexate (Trexall®)
  • Probenecid (Probalan®, Col-probenecid®)
  • Metoclopromide (Reglan®, Reglan ODT®)
  • Certain medicines may keep CIPRO Tablets, CIPRO Oral Suspension from working correctly.
    Take CIPRO Tablets and Oral Suspension either 2 hours before or 6 hours after taking these products:
    • an antacid, multivitamin, or other product that has magnesium, calcium, aluminum, iron, or zinc
    • sucralfate (Carafate®)
    • didanosine (Videx®, Videx EC®)

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take CIPRO?

  • Take CIPRO exactly as prescribed by your healthcare provider.
  • Take CIPRO Tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • Take CIPRO Oral Suspension in the morning and evening at about the same time each day. Shake the CIPRO Oral Suspension bottle well each time before use for about 15 seconds to make sure the suspension is mixed well. Close the bottle completely after use.
  • Take CIPRO XR one time each day at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • CIPRO I.V. is given to you by intravenous (I.V.) infusion into your vein, slowly, over 60 minutes, as prescribed by your healthcare provider.
  • CIPRO can be taken with or without food.
  • CIPRO should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
  • Drink plenty of fluids while taking CIPRO.
  • Do not skip any doses, or stop taking CIPRO even if you begin to feel better, until you finish your prescribed treatment, unless:
    • you have tendon effects (see “What is the most important information I should know about CIPRO?”),
    • you have a serious allergic reaction (see “What are the possible side effects of CIPRO?”), or
    • your healthcare provider tells you to stop. This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to CIPRO. If this happens, CIPRO and other antibiotic medicines may not work in the future.
  • If you miss a dose of CIPRO Tablets or Oral Suspension, take it as soon as you remember. Do not take two doses at the same time, and do not take more than two doses in one day.
  • If you miss a dose of CIPRO XR, take it as soon as you remember. Do not take more than one dose in one day.
  • If you take too much, call your healthcare provider or get medical help immediately.

If you have been prescribed CIPRO Tablets, CIPRO Oral Suspension or CIPRO I.V. after being exposed to anthrax:

  • CIPRO Tablets, Oral Suspension and I.V. has been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
  • Take CIPRO exactly as prescribed by your healthcare provider. Do not stop taking CIPRO without talking with your healthcare provider. If you stop taking CIPRO too soon, it may not keep you from getting the anthrax disease.
  • Side effects may happen while you are taking CIPRO Tablets, Oral Suspension or I.V. When taking your CIPRO to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping CIPRO too soon are more important than the risks of side effects with CIPRO.
  • If you are pregnant, or plan to become pregnant while taking CIPRO, you and your healthcare provider should decide whether the benefits of taking CIPRO Tablets, Oral Suspension or I.V. for anthrax are more important than the risks.

What should I avoid while taking CIPRO?

  • CIPRO can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how CIPRO affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. CIPRO can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking CIPRO, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of CIPRO?

  • CIPRO can cause side effects that may be serious or even cause death. See “What is the most important information I should know about CIPRO?

Other serious side effects of CIPRO include:

  • Central Nervous System effects
    Seizures have been reported in people who take fluoroquinolone antibiotics including CIPRO. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking CIPRO will change your risk of having a seizure. Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of CIPRO. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
    • feel dizzy
    • seizures
    • hear voices, see things, or sense things that are not there (hallucinations)
    • feel restless
    • tremors
    • feel anxious or nervous
    • confusion
    • depression
    • trouble sleeping
    • nightmares
    • feel more suspicious (paranoia)
    • suicidal thoughts or acts
  • Serious allergic reactions
    Allergic reactions can happen in people taking fluoroquinolones, including CIPRO, even after only one dose. Stop taking CIPRO and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
    • hives
    • trouble breathing or swallowing
    • swelling of the lips, tongue, face
    • throat tightness, hoarseness
    • rapid heartbeat
    • faint
    • yellowing of the skin or eyes. Stop taking CIPRO and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to CIPRO (a liver problem).
  • Skin rash
    Skin rash may happen in people taking CIPRO even after only one dose. Stop taking CIPRO at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to CIPRO.
  • Serious heart rhythm changes (QT prolongation and torsade de pointes) Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. CIPRO may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
    • who are elderly
    • with a family history of prolonged QT interval
    • with low blood potassium (hypokalemia)
    • who take certain medicines to control heart rhythm (antiarrhythmics)
  • Intestine infection (Pseudomembranous colitis) Pseudomembranous colitis can happen with most antibiotics, including CIPRO. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.
  • Changes in sensation and possible nerve damage (Peripheral Neuropathy) Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including CIPRO. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
    • pain
    • burning
    • tingling
    • numbness
    • weakness
      CIPRO may need to be stopped to prevent permanent nerve damage.
  • Low blood sugar (hypoglycemia) People who take CIPRO and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance) can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with CIPRO. Your antibiotic medicine may need to be changed.
  • Sensitivity to sunlight (photosensitivity) See “What should I avoid while taking CIPRO?
  • Joint Problems
    Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child's healthcare provider if your child has any joint problems during or after treatment with CIPRO.
    The most common side effects of CIPRO include:

These are not all the possible side effects of CIPRO. Tell your healthcare provider about any side effect that bothers you, or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CIPRO?

  • CIPRO Tablets
    • Store CIPRO below 86°F (30°C)
  • CIPRO Oral Suspension
    • Store CIPRO Oral Suspension below 86°F (30°C) for up to 14 days
    • Do not freeze
    • After treatment has been completed, any unused oral suspension should be safely thrown away
  • CIPRO XR
    • Store CIPRO XR at 59°F to 86°F (15°C to 30°C )

Keep CIPRO and all medicines out of the reach of children.

General Information about CIPRO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIPRO for a condition for which it is not prescribed. Do not give CIPRO to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about CIPRO. If you would like more information about CIPRO, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIPRO that is written for healthcare professionals. For more information go to www.CIPRO.com or call 1-800-526-4099.

What are the ingredients in CIPRO?

  • CIPRO Tablets:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol
  • CIPRO Oral Suspension:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: The components of the suspension have the following compositions: Microcapsules-ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20. Diluent-medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor.
  • CIPRO XR:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide.
  • CIPRO I.V.:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: lactic acid as a solubilizing agent, hydrochloric acid for pH adjustment

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

MEDICATION GUIDE

CIPRO®
(Sip-row)
(ciprofloxacin hydrochloride) Tablets

CIPRO®
(Sip-row)
(ciprofloxacin) Oral Suspension

CIPRO® XR
(Sip-row)
(ciprofloxacin extended-release tablets)

CIPRO® I.V.
(Sip-row)
(ciprofloxacin) For Intravenous Infusion

Read the Medication Guide that comes with CIPRO® before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about CIPRO?

CIPRO belongs to a class of antibiotics called fluoroquinolones. CIPRO can cause side effects that may be serious or even cause death. If you get any of the following serious side effects, get medical help right away. Talk with your healthcare provider about whether you should continue to take CIPRO.

  • Tendon rupture or swelling of the tendon (tendinitis)
    • Tendons are tough cords of tissue that connect muscles to bones.
    • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites can happen in people of all ages who take fluoroquinolone antibiotics, including CIPRO. The risk of getting tendon problems is higher if you:
    • Swelling of the tendon (tendinitis) and tendon rupture (breakage) have also happened in patients who take fluoroquinolones who do not have the above risk factors.
    • Other reasons for tendon ruptures can include:
      • physical activity or exercise
      • kidney failure
      • tendon problems in the past, such as in people with rheumatoid arthritis (RA)
  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking CIPRO until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of CIPRO. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • Tendon rupture can happen while you are taking or after you have finished taking CIPRO. Tendon ruptures have happened up to several months after patients have finished taking their fluoroquinolone.
  • Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
    • hear or feel a snap or pop in a tendon area
    • bruising right after an injury in a tendon area
    • unable to move the affected area or bear weight
  • Worsening of myasthenia gravis (a disease which causes muscle weakness).
    Fluoroquinolones like CIPRO may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

See the section “What are the possible side effects of CIPRO?” for more information about side effects.

What is CIPRO?

CIPRO is a fluoroquinolone antibiotic medicine used to treat certain infections caused by certain germs called bacteria. Children less than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking CIPRO. CIPRO should not be used as the first choice of antibiotic medicine in children under 18 years of age. CIPRO Tablets, CIPRO Oral Suspension and CIPRO I.V. should not be used in children under 18 years old, except to treat specific serious infections, such as complicated urinary tract infections and to prevent anthrax disease after breathing the anthrax bacteria germ (inhalational exposure). It is not known if CIPRO XR is safe and works in children under 18 years of age. Sometimes infections are caused by viruses rather than by bacteria. Examples include viral infections in the sinuses and lungs, such as the common cold or flu. Antibiotics, including CIPRO, do not kill viruses. Call your healthcare provider if you think your condition is not getting better while you are taking CIPRO.

Who should not take CIPRO?

Do not take CIPRO if you:

  • have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or are allergic to any of the ingredients in CIPRO. Ask your healthcare provider if you are not sure. See the list of ingredients in CIPRO at the end of this Medication Guide.
  • also take a medicine called tizanidine (Zanaflex®). Serious side effects from tizanidine are likely to happen.

What should I tell my healthcare provider before taking CIPRO?

See “What is the most important information I should know about CIPRO?

Tell your healthcare provider about all your medical conditions, including if you:

  • have tendon problems
  • have a disease that causes muscle weakness (myasthenia gravis)
  • have central nervous system problems (such as epilepsy)
  • have nerve problems
  • have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
  • have a history of seizures
  • have kidney problems. You may need a lower dose of CIPRO if your kidneys do not work well.
  • have rheumatoid arthritis (RA) or other history of joint problems
  • have trouble swallowing pills
  • are pregnant or planning to become pregnant. It is not known if CIPRO will harm your unborn child.
  • are breast-feeding or planning to breast-feed. CIPRO passes into breast milk. You and your healthcare provider should decide whether you will take CIPRO or breast-feed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal and dietary supplements. CIPRO and other medicines can affect each other causing side effects. Especially tell your healthcare provider if you take:

  • an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take CIPRO or other fluoroquinolones may increase your risk of central nervous system effects and seizures. See “What are the possible side effects of CIPRO?
  • a blood thinner (warfarin, Coumadin®, Jantoven®)
  • tizanidine (Zanaflex®). You should not take CIPRO if you are already taking tizanidine. See “Who should not take CIPRO?
  • theophylline (Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
  • glyburide (Micronase®, Glynase®, Diabeta®, Glucovance®). See “What are the possible side effects of CIPRO?
  • phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin Sodium®, Prompt Penytoin Sodium®, Phenytek®)
  • products that contain caffeine
  • a medicine to control your heart rate or rhythm (antiarrhythmics) See “What are the possible side effects of CIPRO?
  • an anti-psychotic medicine
  • a tricyclic antidepressant
  • a water pill (diuretic)
  • a steroid medicine. Corticosteroids taken by mouth or by injection may increase the chance of tendon injury. See “What is the most important information I should know about CIPRO?
  • methotrexate (Trexall®)
  • Probenecid (Probalan®, Col-probenecid®)
  • Metoclopromide (Reglan®, Reglan ODT®)
  • Certain medicines may keep CIPRO Tablets, CIPRO Oral Suspension from working correctly.
    Take CIPRO Tablets and Oral Suspension either 2 hours before or 6 hours after taking these products:
    • an antacid, multivitamin, or other product that has magnesium, calcium, aluminum, iron, or zinc
    • sucralfate (Carafate®)
    • didanosine (Videx®, Videx EC®)

Ask your healthcare provider if you are not sure if any of your medicines are listed above.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take CIPRO?

  • Take CIPRO exactly as prescribed by your healthcare provider.
  • Take CIPRO Tablets in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • Take CIPRO Oral Suspension in the morning and evening at about the same time each day. Shake the CIPRO Oral Suspension bottle well each time before use for about 15 seconds to make sure the suspension is mixed well. Close the bottle completely after use.
  • Take CIPRO XR one time each day at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you can not swallow the tablet whole.
  • CIPRO I.V. is given to you by intravenous (I.V.) infusion into your vein, slowly, over 60 minutes, as prescribed by your healthcare provider.
  • CIPRO can be taken with or without food.
  • CIPRO should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products.
  • Drink plenty of fluids while taking CIPRO.
  • Do not skip any doses, or stop taking CIPRO even if you begin to feel better, until you finish your prescribed treatment, unless:
    • you have tendon effects (see “What is the most important information I should know about CIPRO?”),
    • you have a serious allergic reaction (see “What are the possible side effects of CIPRO?”), or
    • your healthcare provider tells you to stop. This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to CIPRO. If this happens, CIPRO and other antibiotic medicines may not work in the future.
  • If you miss a dose of CIPRO Tablets or Oral Suspension, take it as soon as you remember. Do not take two doses at the same time, and do not take more than two doses in one day.
  • If you miss a dose of CIPRO XR, take it as soon as you remember. Do not take more than one dose in one day.
  • If you take too much, call your healthcare provider or get medical help immediately.

If you have been prescribed CIPRO Tablets, CIPRO Oral Suspension or CIPRO I.V. after being exposed to anthrax:

  • CIPRO Tablets, Oral Suspension and I.V. has been approved to lessen the chance of getting anthrax disease or worsening of the disease after you are exposed to the anthrax bacteria germ.
  • Take CIPRO exactly as prescribed by your healthcare provider. Do not stop taking CIPRO without talking with your healthcare provider. If you stop taking CIPRO too soon, it may not keep you from getting the anthrax disease.
  • Side effects may happen while you are taking CIPRO Tablets, Oral Suspension or I.V. When taking your CIPRO to prevent anthrax infection, you and your healthcare provider should talk about whether the risks of stopping CIPRO too soon are more important than the risks of side effects with CIPRO.
  • If you are pregnant, or plan to become pregnant while taking CIPRO, you and your healthcare provider should decide whether the benefits of taking CIPRO Tablets, Oral Suspension or I.V. for anthrax are more important than the risks.

What should I avoid while taking CIPRO?

  • CIPRO can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how CIPRO affects you.
  • Avoid sunlamps, tanning beds, and try to limit your time in the sun. CIPRO can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while taking CIPRO, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of CIPRO?

  • CIPRO can cause side effects that may be serious or even cause death. See “What is the most important information I should know about CIPRO?

Other serious side effects of CIPRO include:

  • Central Nervous System effects
    Seizures have been reported in people who take fluoroquinolone antibiotics including CIPRO. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking CIPRO will change your risk of having a seizure. Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of CIPRO. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
    • feel dizzy
    • seizures
    • hear voices, see things, or sense things that are not there (hallucinations)
    • feel restless
    • tremors
    • feel anxious or nervous
    • confusion
    • depression
    • trouble sleeping
    • nightmares
    • feel more suspicious (paranoia)
    • suicidal thoughts or acts
  • Serious allergic reactions
    Allergic reactions can happen in people taking fluoroquinolones, including CIPRO, even after only one dose. Stop taking CIPRO and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:
    • hives
    • trouble breathing or swallowing
    • swelling of the lips, tongue, face
    • throat tightness, hoarseness
    • rapid heartbeat
    • faint
    • yellowing of the skin or eyes. Stop taking CIPRO and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to CIPRO (a liver problem).
  • Skin rash
    Skin rash may happen in people taking CIPRO even after only one dose. Stop taking CIPRO at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to CIPRO.
  • Serious heart rhythm changes (QT prolongation and torsade de pointes) Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. CIPRO may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are higher in people:
    • who are elderly
    • with a family history of prolonged QT interval
    • with low blood potassium (hypokalemia)
    • who take certain medicines to control heart rhythm (antiarrhythmics)
  • Intestine infection (Pseudomembranous colitis) Pseudomembranous colitis can happen with most antibiotics, including CIPRO. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.
  • Changes in sensation and possible nerve damage (Peripheral Neuropathy) Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including CIPRO. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
    • pain
    • burning
    • tingling
    • numbness
    • weakness
      CIPRO may need to be stopped to prevent permanent nerve damage.
  • Low blood sugar (hypoglycemia) People who take CIPRO and other fluoroquinolone medicines with the oral anti-diabetes medicine glyburide (Micronase, Glynase, Diabeta, Glucovance) can get low blood sugar (hypoglycemia) which can sometimes be severe. Tell your healthcare provider if you get low blood sugar with CIPRO. Your antibiotic medicine may need to be changed.
  • Sensitivity to sunlight (photosensitivity) See “What should I avoid while taking CIPRO?
  • Joint Problems
    Increased chance of problems with joints and tissues around joints in children under 18 years old. Tell your child's healthcare provider if your child has any joint problems during or after treatment with CIPRO.
    The most common side effects of CIPRO include:

These are not all the possible side effects of CIPRO. Tell your healthcare provider about any side effect that bothers you, or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store CIPRO?

  • CIPRO Tablets
    • Store CIPRO below 86°F (30°C)
  • CIPRO Oral Suspension
    • Store CIPRO Oral Suspension below 86°F (30°C) for up to 14 days
    • Do not freeze
    • After treatment has been completed, any unused oral suspension should be safely thrown away
  • CIPRO XR
    • Store CIPRO XR at 59°F to 86°F (15°C to 30°C )

Keep CIPRO and all medicines out of the reach of children.

General Information about CIPRO

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CIPRO for a condition for which it is not prescribed. Do not give CIPRO to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about CIPRO. If you would like more information about CIPRO, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIPRO that is written for healthcare professionals. For more information go to www.CIPRO.com or call 1-800-526-4099.

What are the ingredients in CIPRO?

  • CIPRO Tablets:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: cornstarch, microcrystalline cellulose, silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, and polyethylene glycol
  • CIPRO Oral Suspension:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: The components of the suspension have the following compositions: Microcapsules-ciprofloxacin, povidone, methacrylic acid copolymer, hypromellose, magnesium stearate, and Polysorbate 20. Diluent-medium-chain triglycerides, sucrose, lecithin, water, and strawberry flavor.
  • CIPRO XR:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: crospovidone, hypromellose, magnesium stearate, polyethylene glycol, silica colloidal anhydrous, succinic acid, and titanium dioxide.
  • CIPRO I.V.:
    • Active ingredient: ciprofloxacin
    • Inactive ingredients: lactic acid as a solubilizing agent, hydrochloric acid for pH adjustment

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 6/24/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Cipro Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CIPROFLOXACIN - ORAL

(SIP-roe-FLOX-a-sin)

COMMON BRAND NAME(S): Cipro

WARNING: This medication may rarely cause tendon damage (e.g., tendonitis, tendon rupture) during or after treatment. Your risk for tendon problems is greater if you are over 60 years of age, if you are taking corticosteroids (such as prednisone), or if you have a kidney, heart or lung transplant. Stop exercising, rest, and seek immediate medical attention if you develop joint/muscle/tendon pain or swelling.

Ciprofloxacin should not be used in patients with myasthenia gravis. It may cause the condition to become worse. Seek immediate medical attention if you develop muscle weakness or trouble breathing.

USES: This medication is used to treat a variety of bacterial infections. Ciprofloxacin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for virus infections (e.g., common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using ciprofloxacin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication may be taken with or without food, usually twice a day in the morning and evening or as directed by your doctor.

The dosage and length of treatment is based on your medical condition and response to treatment. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise.

Take this medication at least 2 hours before or 6 hours after taking other products that may bind to it, decreasing its effectiveness. Ask your pharmacist about the other products you take. Some examples include: quinapril, vitamins/minerals (including iron and zinc supplements), and products containing magnesium, aluminum, or calcium (such as antacids, didanosine solution, calcium supplements).

Calcium-rich foods, including dairy products (such as milk, yogurt) or calcium-enriched juice, can also decrease the effect of this medication. Take this medication at least 2 hours before or 6 hours after eating calcium-rich foods, unless you are eating these foods as part of a larger meal that contains other (non-calcium-rich) foods. These other foods decrease the calcium binding effect.

Ask your doctor or pharmacist about safely using nutritional supplements/replacements with this medication.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. It is important not to miss a dose. To help you remember and to keep the drug at a constant level, take it at the same times every day.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

Disclaimer

Cipro Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, diarrhea, dizziness, lightheadedness, headache, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: skin that sunburns more easily (sun sensitivity).

Ciprofloxacin may rarely cause serious nerve problems that may be reversible if identified and treated early. Seek immediate medical attention if you develop any of the following symptoms: pain/numbness/burning/tingling/weakness in any part of the body, changes in how you sense touch/pain/temperature/body position/vibration.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual bruising/bleeding, signs of a new infection (e.g., new/persistent fever, persistent sore throat), unusual change in the amount of urine, change in color of urine (red/pink urine), signs of liver problems (e.g., unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe/persistent headache, vision changes, shaking (tremors), seizures, severe dizziness, fainting, fast/irregular heartbeat, mental/mood changes (e.g., anxiety, confusion, hallucinations, depression, rare thoughts of suicide).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Cipro (ciprofloxacin) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking ciprofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics such as norfloxacin, gemifloxacin, levofloxacin, moxifloxacin, or ofloxacin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (e.g., recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, liver disease, myasthenia gravis, nervous system disorder (e.g., peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors, cerebral atherosclerosis).

Ciprofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using ciprofloxacin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ciprofloxacin safely.

This medication may rarely cause serious changes in blood sugar levels, especially if you have diabetes. Watch for symptoms of high blood sugar including increased thirst and urination. Also watch for symptoms of low blood sugar such as nervousness, shakiness, fast heartbeat, sweating, or hunger. Check your blood sugar regularly as directed by your doctor and report any changes. If you experience symptoms of low blood sugar, you may raise your blood sugar by using glucose tablets/gel or eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this drug in children because they may be more sensitive to its possible side effects (e.g., joint/tendon problems). Discuss the risks and benefits with the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to its side effects such as tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone) or heart problems. Discuss the risks and benefits with your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Cipro Consumer (continued)

DRUG INTERACTIONS: See also the How to Use section.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: live bacterial vaccines (e.g., typhoid, BCG), "blood thinners" (e.g., warfarin), corticosteroids (e.g., prednisone, hydrocortisone), cyclosporine, drugs removed from your body by certain liver enzymes (such as clozapine, duloxetine, phenytoin, ropinirole, tacrine), drugs for diabetes (e.g., glyburide, insulin), methotrexate, nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen), probenecid, sevelamer, strontium, tizanidine, theophylline, urinary alkalinizers (e.g., potassium/sodium citrate).

Many drugs besides ciprofloxacin may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, quinidine, procainamide, sotalol, certain macrolide antibiotics (e.g., erythromycin, clarithromycin), and certain antipsychotic medications (e.g., pimozide, thioridazine, ziprasidone), among others.

Also report the use of drugs that might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., chlorpromazine), or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas), eating large amounts of chocolate, or taking over-the-counter products that contain caffeine to keep you awake and alert. This drug may increase and/or prolong the effects of caffeine.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in those cases.

Laboratory and/or medical tests (e.g., kidney function, blood counts, cultures) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature below 86 degrees F (30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised December 2011. Copyright(c) 2011 First Databank, Inc.

Cipro Patient Information Including Side Effects

Brand Names: Cipro, Cipro XR, Proquin XR

Generic Name: ciprofloxacin (oral) (Pronunciation: SIP roe FLOX a sin)

What is ciprofloxacin (Cipro)?

Ciprofloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-o-KWIN-o-lones). Ciprofloxacin fights bacteria in the body.

Ciprofloxacin is used to treat different types of bacterial infections.

Ciprofloxacin may also be used for purposes not listed in this medication guide.

Cipro 100 mg

round, white, imprinted with CIPRO, 100

Cipro 250 mg

round, white, imprinted with CIPRO, 250

Cipro 500 mg

oblong, white, imprinted with CIPRO, 500

Cipro 750 mg

oblong, white, imprinted with CIPRO, 750

Cipro XR 1000 mg

oblong, white, imprinted with BAYER, C1000 QD

Cipro XR 500 mg

oblong, white, imprinted with BAYER, C500 QD

Ciprofloxacin 250 mg-APO

round, white, imprinted with APO, CIP 250

Ciprofloxacin 250 mg-BAR

round, white, imprinted with b 814, 250

Ciprofloxacin 250 mg-DRR

oval, white, imprinted with R, 126

Ciprofloxacin 250 mg-IVA

oval, white, imprinted with LOGO 5311, 250

Ciprofloxacin 250 mg-PAR

round, white, imprinted with G, CF 250

Ciprofloxacin 500 mg-APO

white, imprinted with APO, CIP500

Ciprofloxacin 500 mg-BAR

oblong, white, imprinted with b815, 500

Ciprofloxacin 500 mg-DRR

oval, white, imprinted with R, 127

Ciprofloxacin 500 mg-IVA

oval, white, imprinted with 500, LOGO 5312

Ciprofloxacin 500 mg-PAR

oblong, white, imprinted with G, CF500

Ciprofloxacin 500 mg-RAN

oblong, white, imprinted with RX710

Ciprofloxacin 500 mg-TEV

oblong, white, imprinted with 93, 0864

Ciprofloxacin 750 mg-APO

white, imprinted with APO, CIP750

Ciprofloxacin 750 mg-BAR

oblong, white, imprinted with b816, 750

Ciprofloxacin 750 mg-DRR

oblong, white, imprinted with R, 128

Ciprofloxacin 750 mg-IVA

oval, white, imprinted with Logo 5313, 750

Ciprofloxacin 750 mg-TEV

oblong, white, imprinted with 93, 0865

What are the possible side effects of ciprofloxacin (Cipro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ciprofloxacin and call your doctor at once if you have a serious side effect such as:

  • severe dizziness, fainting, fast or pounding heartbeats;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, unusual thoughts or behavior;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, weakness;
  • urinating less than usual or not at all;
  • easy bruising or bleeding;
  • numbness, tingling, or unusual pain anywhere in your body;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • nausea, vomiting;
  • dizziness or drowsiness;
  • blurred vision;
  • feeling nervous, anxious, or agitated; or
  • sleep problems (insomnia or nightmares).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Cipro (ciprofloxacin) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ciprofloxacin (Cipro)?

You should not use this medication if you are taking tizanidine (Zanaflex), if you have a history of myasthenia gravis, or if you are allergic to ciprofloxacin (Cipro) or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking ciprofloxacin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, diabetes, muscle weakness or trouble breathing, a history of seizures, low levels of potassium in your blood, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.

Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 6 hours before or 2 hours after you take ciprofloxacin.

Ciprofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. Stop taking ciprofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Side Effects Centers

Cipro Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking ciprofloxacin (Cipro)?

You should not use ciprofloxacin if:

  • you are also taking tizanidine (Zanaflex);
  • you have a history of myasthenia gravis; or
  • you are allergic to ciprofloxacin or similar medications such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

To make sure you can safely take ciprofloxacin, tell your doctor if you have any of these other conditions:

  • heart rhythm disorder, especially if you take quinidine (Quin-G), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace);
  • a history of allergic reaction to an antibiotic;
  • joint problems;
  • epilepsy or seizures;
  • kidney or liver disease;
  • diabetes;
  • muscle weakness or trouble breathing;
  • low levels of potassium in your blood (hypokalemia); or
  • a personal or family history of Long QT syndrome.

FDA pregnancy category C. It is not known whether ciprofloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Ciprofloxacin passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Ciprofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ciprofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

How should I take ciprofloxacin (Cipro)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Take ciprofloxacin with a full glass of water (8 ounces). Drink several extra glasses of fluid each day while you are taking ciprofloxacin. Ciprofloxacin may be taken with or without food, but take it at the same time each day.

Shake the oral suspension (liquid) for at least 15 seconds just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

When taking the oral liquid, swallow it without chewing the medicine beads you may notice in the liquid.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Do not take ciprofloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking ciprofloxacin. They could make the medication less effective.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Ciprofloxacin will not treat a viral infection such as the common cold or flu.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Side Effects Centers

Cipro Patient Information including If I Miss a Dose

What happens if I miss a dose (Cipro)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Cipro)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include seizures, urination problems, weakness, or blue lips with pale skin.

What should I avoid while taking ciprofloxacin (Cipro)?

You may be taking certain other medicines that should not be taken at the same time as ciprofloxacin. Avoid taking the following medicines within 6 hours before or 2 hours after you take ciprofloxacin. These other medicines can make ciprofloxacin much less effective when taken at the same time:

  • antacids that contain calcium, magnesium or aluminum (such as Tums, Mylanta, or Rolaids);
  • the ulcer medicine sucralfate (Carafate);
  • didanosine (Videx) powder or chewable tablets; or
  • vitamin or mineral supplements that contain calcium, iron, or zinc.

Avoid caffeine while you are taking ciprofloxacin, because the medication can make the effects of caffeine stronger.

Avoid exposure to sunlight or tanning beds. Ciprofloxacin can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Call your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking ciprofloxacin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Ciprofloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect ciprofloxacin (Cipro)?

Do not take ciprofloxacin together with tizanidine (Zanaflex).

Tell your doctor about all other medicines you use, especially:

  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • clozapine (Clozaril, FazaClo);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • glyburide (Micronase, Diabeta, Glynase);
  • methotrexate (Rheumatrex, Trexall);
  • metoclopramide (Reglan);
  • phenytoin (Dilantin);
  • probenecid (Benemid);
  • ropinirole (Requip);
  • theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl);
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others; or
  • steroid medication (prednisone and others).

This list is not complete and other drugs may interact with ciprofloxacin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about ciprofloxacin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 13.01. Revision date: 4/13/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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