Cefadroxil (Duricef)
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Cefadroxil (Duricef)

DURICEF®
(cefadroxil monohydrate, USP)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DURICEF® (cefadroxil) and other antibacterial drugs, DURICEF (cefadroxil) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

DRUG DESCRIPTION

DURICEF (cefadroxil) is a semisynthetic cephalosporin antibiotic intended for oral administration. It is a white to yellowish-white crystalline powder. It is soluble in water and it is acid- stable. It is chemically designated as 5-Thia-l-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7-[[amino(4-hydroxyphenyl)acetyl]amino]-3-methyl-8-oxo-, monohydrate[6R- [6α,7β(R*)]]-. It has the formula C16H17N3O5S•H20 and the molecular weight of 381.40. It has the following structural formula:

DURICEF (cefadroxil monohydrate) structural formula illustration

DURICEF (cefadroxil) film-coated tablets, 1 g, contain the following inactive ingredients: microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol, polysorbate 80, simethicone emulsion, and titanium dioxide.

DURICEF (cefadroxil) for Oral Suspension contains the following inactive ingredients: FD&C Yellow No. 6, flavors (natural and artificial), polysorbate 80, sodium benzoate, sucrose, and xanthan gum.

DURICEF (cefadroxil) capsules contain the following inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, and titanium dioxide.

What are the possible side effects of cefadroxil (Duricef)?

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

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding or bruising;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, swollen glands, rash or itching, joint pain,...

Read All Potential Side Effects and See Pictures of Duricef »

What are the precautions when taking cefadroxil (Duricef)?

Before taking cefadroxil, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporins; 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: kidney disease, intestinal disease (colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While...

Read All Potential Precautions of Duricef »

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DURICEF (cefadroxil) is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases:

Urinary tract infections caused by E. coli; P. mirabilis, and Klebsiella species.

Skin and skin structure infections caused by staphylococci and/or streptococci.

Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci).

Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. DURICEF (cefadroxil) is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the efficacy of DURICEF (cefadroxil) for the prophylaxis of subsequent rheumatic fever are not available.

Note: Culture and susceptibility tests should be initiated prior to and during therapy. Renal function studies should be performed when indicated.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DURICEF (cefadroxil) and other antibacterial drugs, DURICEF (cefadroxil) 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

DURICEF (cefadroxil) is acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.

Adults

Urinary Tract Infections: For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).

For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).

Skin and Skin Structure Infections: For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).

Pharyngitis and Tonsillitis: Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis-1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.

Children

For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of DURICEF (cefadroxil) should be administered for at least 10 days.

See chart for total daily dosage for children.

DAILY DOSAGE OF DURICEF® SUSPENSION
Child's Weight    
lbs kg 260 mg/5 mL 500 mg/5 mL
10 4.5 ½ tsp  
20 9.1 1 tsp  
30 13.6 1½ tsp  
40 18.2 2 tsp l tsp
50 22.7 2½ tsp 1¼ tsp
60 27.3 3 tsp 1½ tsp
70 & above 31.8+ - 2 tsp

Renal Impairment

In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of DURICEF (cefadroxil) and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 M2]) is 500 mg at the time intervals listed below.

Creatinine Clearances Dosage Interval
0-l0 mL/min 36 hours
10-25 mL/min 24 hours
25-50 mL/min 12 hours

Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

Reconstitution Directions for Oral Suspension
Bottle Size Reconstitution Directions
l00 mL Suspend in a total of 67 mL water.
Method: Tap bottle lightly to loosen powder. Add 67 mL of water in two portions. Shake well after each addition.
75 mL Suspend in a total of 51 mL water.
Method: Tap bottle lightly to loosen powder. Add 51 mL of water in two portions. Shake well after each addition.
50 mL Suspend in a total of 34 mL water.
Method: Tap bottle lightly to loosen powder.
  Add 34 mL of water in two portions.
Shake well after each addition.
After reconstitution, store in refrigerator. Shake well before using. Keep container tightly closed. Discard unused portion after 14 days.

HOW SUPPLIED

DURICEF® (cefadroxil monohydrate, USP) 500 mg Capsules: opaque, maroon and white hard gelatin capsules, imprinted with "PPP" and "784" on one end and with "DURICEF (cefadroxil) " and "500 mg" on the other end.

Capsules are supplied as follows:

N 0430-0780-19...................Bottle of 50

Store at controlled room temperature 15° - 30° C (59° - 86° F).

DURICEF® (cefadroxil) 1 gram Tablets: white to off white, top bisected, oval shaped, imprinted with "PPP" on one side of the bisect and "785" on the other side of the bisect. Tablets are supplied as follows:

N 0430-0781-19....................Bottle of 50

Store at controlled room temperature 15° - 30° C (59° - 86° F).

DURICEF® (cefadroxil) for Oral Suspension is orange-pineapple flavored, and is supplied as follows:

250mg/5mL................................N 0430-2782-15          50 mL Bottle

500 mg/5 mL N 0430-2782-17
N 0430-2783-16
N 0430-2783-17
100 mL Bottle
75 mL Bottle
100 mL Bottle

Prior to reconstitution: Store at controlled room temperature 15° - 30° C (59° - 86° F).

Manufactured by Bristol-Myers Squibb Co. Princeton, NJ 08543. For Warner Chilcott Company, Inc. Fajardo, PR 00738. Marketed by Warner Chilcott (US), Inc. Rockaway, NJ 07866. Revised April 2007. FDA Rev date: 6/5/2007

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Gastrointestinal

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment (see WARNINGS). Dyspepsia, nausea and vomiting have been reported rarely. Diarrhea has also occurred.

Hypersensitivity

Allergies (in the form of rash, urticaria, angioedema, and pruritus) have been observed. These reactions usually subsided upon discontinuation of the drug. Anaphylaxis has also been reported.

Other

Other reactions have included hepatic dysfunction including cholestasis and elevations in serum transaminase, genital pruritus, genital moniliasis, vaginitis, moderate transient neutropenia, fever. Agranulocytosis, thrombocytopenia, idiosyncratic hepatic failure, erythema multiforme, Stevens-Johnson syndrome, serum sickness, and arthralgia have been rarely reported.

In addition to the adverse reactions listed above which have been observed in patients treated with cefadroxil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:

Toxic epidermal necrolysis, abdominal pain, superinfection, renal dysfunction, toxic nephropathy, aplastic anemia, hemolytic anemia, hemorrhage, prolonged prothrombin time, positive Coombs' test, increased BUN, increased creatinine, elevated alkaline phosphatase, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT), elevated bilirubin, elevated LDH, eosinophilia, pancytopenia, neutropenia.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

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

DRUG INTERACTIONS

Drug/Laboratory Test Interactions

Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics. In hematologic studies or in transfusion cross-matching procedures when antiglobulin tests are performed on the minor side or in Coombs' testing of newborns whose mothers have received cephalosporin antibiotics before parturition, it should be recognized that a positive Coombs' test may be due to the drug.

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

BEFORE THERAPY WITH DURICEF (cefadroxil) IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFADROXTL, CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS. IF THIS PRODUCT IS TO BE GIVEN TO PENICILLIN-SENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS-SENSITIVITY AMONG BETA-LACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.

IF AN ALLERGIC REACTION TO DURICEF (cefadroxil) OCCURS, DISCONTINUE THE DRUG. SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, INTRAVENOUS FLUIDS, INTRAVENOUS ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including DURICEF (cefadroxil) , 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 CD AD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CD AD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CD AD has been reported to occur over two months after the administration of antibacterial agents.

If CD AD 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.

PRECAUTIONS

General

DURICEF (cefadroxil) should be used with caution in the presence of markedly impaired renal function (creatinine clearance rate of less than 50 mL/min/1.73 M2). (See DOSAGE AND ADMINISTRATION.) In patients with known or suspected renal impairment, careful clinical observation and appropriate laboratory studies should be made prior to and during therapy.

Prescribing DURICEF (cefadroxil) 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.

Prolonged use of DURICEF (cefadroxil) may result in the overgrowth of honsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.

DURICEF (cefadroxil) should be prescribed with caution in individuals with history of gastrointestinal disease particularly colitis.

Carcinogenesis, Mutagenesis and Impairment of Fertility

No long-term studies have been performed to determine carcinogenic potential. No genetic toxicity tests have been performed.

Pregnancy: Pregnancy Category B

Reproduction studies have been performed in mice and rats at doses up to 11 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cefadroxil monohydrate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery

DURICEF (cefadroxil) has not been studied for use during labor and delivery. Treatment should only be given if clearly needed.

Nursing Mothers

Caution should be exercised when cefadroxil monohydrate is administered to a nursing mother.

Pediatric Use

(See DOSAGE AND ADMINISTRATION.)

Geriatric Use

Of approximately 650 patients who received cefadroxil for the treatment of urinary tract infections in three clinical trials, 28% were 60 years and older, while 16% were 70 years and older. Of approximately 1,000 patients who received cefadroxil for the treatment of skin and skin structure infection in 14 clinical trials, 12% were 60 years and older while 4% were 70 years and over. No overall differences in safety were observed between the elderly patients in these studies and younger patients. Clinical studies of cefadroxil for the. treatment of pharyngitis or tonsillitis did not include sufficient numbers of patients 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience with cefadroxil has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Cefadroxil is substantially excreted by the kidney, and dosage adjustment is indicated for patients with renal impairment (see DOSAGE AND ADMINISTRATION: Renal Impairment). Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

A study of children under six years of age suggested that ingestion of less than 250 mg/kg of cephalosporins is not associated with significant outcomes. No action is required other than general support and observation. For amounts greater than 250 mg/kg, induce gastric emptying.

In five anuric patients, it was demonstrated that an average of 63% of a 1 g oral dose is extracted from the body during a 6-8 hour hemodialysis session.

CONTRAINDICATIONS

DURICEF (cefadroxil) is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

DURICEF (cefadroxil) is rapidly absorbed after oral administration. Following single doses of 500 mg and 1000 mg, average peak serum concentrations were approximately 16 and 28 |ag/mL, respectively. Measurable levels were present 12 hours after administration. Over 90% of the drug is excreted unchanged in the urine within 24 hours. Peak urine concentrations are approximately 1800 pg/mL during the period following a single 500 mg oral dose. Increases in dosage generally produce a proportionate increase in DURICEF (cefadroxil monohydrate, USP) urinary concentration. The urine antibiotic concentration, following a 1 g dose, was maintained well above the MIC of susceptible urinary pathogens for 20 to 22 hours.

Microbiology

In vitro tests demonstrate that the cephalosporins are bactericidal because of their inhibition of cell-wall synthesis. Cefadroxil has been shown to be active against the following organisms both in vitro and in clinical infections (see INDICATIONS):

Beta-hemolytic streptococci
Staphylococci,
including penicillinase-producing strains
Streptococcus (Diplococcus) pneumoniae

Escherichia coli

Proteus mirabilis

Klebsiella
species
Moraxella (Branhamella) catarrhalis

Note: Most strains of Entervcoccus faecalis (formerly Streptococcus faecalis) and Enterococcus faecium (formerly Streptococcus faecium) are resistant to DURICEF (cefadroxil) . It is not active against most strains of Enterobacter species, Morganella morganii (formerly Proteus morganii), and P. vulgaris. It has no activity against Pseudomonas species and Acinetobacter calcoaceticus (formerly Mima and Herellea species).

Susceptibility tests: Diffusion techniques

The use of antibiotic disk susceptibility test methods which measure zone diameter give an accurate estimation of antibiotic susceptibility. One such standard procedure1 which has been recommended for use with disks to test susceptibility of organisms to cefadroxil uses the cephalosporin class (cephalothin) disk. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for cefadroxil.

Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 µg cephalothin disk should be interpreted according to the following criteria:

Zone diameter (mm) Interpretation
≥ 18 (S) Susceptible
15-17 (I) Intermediate
< 14 (R) Resistant

A report of "Susceptible" indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of "intermediate susceptibility" suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of "Resistant" indicates that achievable concentrations of the antibiotic are unlikely to be ' inhibitory and other therapy should be selected.

Standardized procedures require the use of laboratory control organisms. The 30 µg cephalothin disk should give the following zone diameters:

Organism Zone Diameter (mm)
Staphylococcus aureus ATCC 25923 29-37
Escherichia coli ATCC 25922 17-22

Dilution Techniques

When using the NCCLS agar dilution or broth dilution (including microdilution) method2 or equivalent, a bacterial isolate may be considered susceptible if the MIC (minimum inhibitory concentration) value for cephalothin is 8 µg/mL or less. Organisms are considered resistant if the MIC is 32 µg/mL or greater. Organisms with an MIC value of less than 32 µg/mL but greater than 8 µg/mL are intermediate.

As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard cephalothin powder should give MIC values in the range of 0.12 µg/mL and 0.5 µg/mL for Staphylococcus aureus ATCC 29213. Vox Escherichia coli ATCC 25922, the MIC range should be between 4.0 µg/mL and 16.0 µg/mL. For Streptococcus faecalis ATCC 29212, the MIC range should be between 8.0 and 32.0 µg/mL.

REFERENCES

1. National Committee for Clinical Laboratory Standards, Approved Standard, Performance Standards for Antimicrobial Disk Susceptibility Test, 4th Edition, Vol. 10 (7): M2-A4, Villanova, PA, April, 1990.

2. National Committee for Clinical Laboratory Standards, Approved Standard: Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 2nd Edition, Vol. 10 (8): M7-A2, Villanova, PA, April, 1990.

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Patients should be counseled that antibacterial drugs including DURICEF (cefadroxil) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DURICEF (cefadroxil) 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 DURICEF (cefadroxil) or other antibacterial drugs in the future.

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.

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Patients should be counseled that antibacterial drugs including DURICEF (cefadroxil) should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When DURICEF (cefadroxil) 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 DURICEF (cefadroxil) or other antibacterial drugs in the future.

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.

Last reviewed on RxList: 3/18/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Duricef 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.

CEFADROXIL - ORAL

(SEF-a-DROX-il)

COMMON BRAND NAME(S): Duricef

USES: This medication is a cephalosporin-type antibiotic used to treat a wide variety of bacterial infections (e.g., strep throat, skin and urinary tract infections). It works by stopping the growth of bacteria.

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

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used before dental procedures in patients with artificial heart valves to prevent serious infection of the heart lining (bacterial endocarditis).

HOW TO USE: Take this medication by mouth usually once or twice a day, or as directed by your doctor. You may take this medicine with food if stomach upset occurs.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

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

Inform your doctor if your condition persists or worsens.

Disclaimer

Duricef Consumer (continued)

SIDE EFFECTS: Stomach upset, nausea, vomiting, diarrhea may occur. If any of these effects persist or worsen, notify 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 highly unlikely but very serious side effects occur: stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, new signs of infection (e.g., persistent sore throat or fever), easy bruising/bleeding, change in the amount of urine, mental/mood changes (such as confusion).

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 (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), 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 Duricef (cefadroxil) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking cefadroxil, tell your doctor or pharmacist if you are allergic to it; or to penicillins or other cephalosporins; 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: kidney disease, intestinal disease (colitis).

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Disclaimer

Duricef Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: live bacterial vaccines, probenecid.

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 medication may cause false positive results with certain diabetic urine testing products (cupric sulfate-type). This drug may also affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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. Canadian residents should call their local poison control center directly. Symptoms of overdose may include seizures.

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.

MISSED DOSE: If you miss a dose, use 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 between 59-86 degrees F (15-30 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 January 2011. Copyright(c) 2011 First Databank, Inc.

Duricef Patient Information Including Side Effects

Brand Names: Duricef

Generic Name: cefadroxil (Pronunciation: SEF a DROX il)

What is cefadroxil (Duricef)?

Cefadroxil is in a group of drugs called cephalosporin (SEF a low spor in) antibiotics. It works by fighting bacteria in your body.

Cefadroxil is used to treat many different types of infections caused by bacteria.

Cefadroxil may also be used for purposes other than those listed in this medication guide.

Cefadroxil 1 g-TEV

oval, white, imprinted with 9 3, 4059

Cefadroxil 500 mg-BAR

red/white, imprinted with C, 582

Cefadroxil 500 mg-IVA

white, imprinted with Zenith 500 mg, 4058

Cefadroxil 500 mg-TEV

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What are the possible side effects of cefadroxil (Duricef)?

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

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • unusual bleeding or bruising;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, swollen glands, rash or itching, joint pain, or general ill feeling;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath, urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, mild diarrhea;
  • stiff or tight muscles;
  • joint pain;
  • feeling restless or hyperactive;
  • unusual or unpleasant taste in your mouth;
  • mild itching or skin rash; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

What is the most important information I should know about cefadroxil (Duricef)?

Do not take this medication if you are allergic to cefadroxil, or to similar antibiotics, such as Ceftin, Cefzil, Keflex, Omnicef, and others.

Before taking this medication, tell your doctor if you are allergic to any drugs (especially penicillin). Also tell your doctor if you have kidney disease or a history of intestinal problems.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefadroxil will not treat a viral infection such as the common cold or flu.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Side Effects Centers

Duricef Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking cefadroxil (Duricef)?

Do not take this medication if you are allergic to cefadroxil or to other cephalosporin antibiotics, such as:

  • cefaclor (Raniclor);
  • cefazolin (Ancef);
  • cefdinir (Omnicef);
  • cefditoren (Spectracef);
  • cefpodoxime (Vantin);
  • cefprozil (Cefzil);
  • ceftibuten (Cedax);
  • cefuroxime (Ceftin);
  • cephalexin (Keflex); or
  • cephradine (Velosef); and others.

Before taking cefadroxil, tell your doctor if you are allergic to any drugs (especially penicillins), or if you have:

  • kidney disease; or
  • a history of intestinal problems, such as colitis.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cefadroxil.

The cefadroxil suspension (liquid) contains sucrose. Talk to your doctor before using this form of cefadroxil if you have diabetes.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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

How should I take cefadroxil (Duricef)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take this medicine with a full glass of water.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Cefadroxil will not treat a viral infection such as the common cold or flu.

Cefadroxil can be taken on an empty stomach or with food or milk if it causes stomach upset.

Shake the liquid form of cefadroxil well before measuring a dose. To ensure that you get a correct dose, measure the suspension with a dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

This medication can cause you to have false results with certain medical tests, including urine glucose (sugar) tests. Tell any doctor who treats you that you are using cefadroxil.

Store the tablets and capsules at room temperature away from moisture and heat.

Store cefadroxil oral liquid in the refrigerator. Do not allow it to freeze. Throw away any unused medication that is older than 14 days.

Side Effects Centers

Duricef Patient Information including If I Miss a Dose

What happens if I miss a dose (Duricef)?

Take the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Duricef)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a cefadroxil overdose are not known.

What should I avoid while taking cefadroxil (Duricef)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

What other drugs will affect cefadroxil (Duricef)?

There may be other drugs that can interact with cefadroxil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start taking a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about cefadroxil.


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: 5.03. Revision date: 12/15/2010.

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Side Effects Centers

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