Flagyl ER (Metronidazole Extended Release Tablets)
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Flagyl ER (Metronidazole Extended Release Tablets)

Flagyl® ER
(metronidazole) Extended Release Tablets

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flagyl ER (metronidazole extended release tablets) and other antibacterial drugs, Flagyl ER (metronidazole extended release tablets) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNING

Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS.)Unnecessary use of the drug should be avoided. Its use should be reserved for conditions described in the INDICATIONS AND USAGE section.

DRUG DESCRIPTION

Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 2-methyl-5nitroimidazole-1-ethanol, which has the following structural formula:

Flagyl® ER
 (metronidazole) Structural Formula Illustration

Flagyl ER 750 mg tablets contain 750 mg of metronidazole USP. Inactive ingredients include hypromellose, lactose, magnesium stearate, polyethylene glycol, poly (meth) acrylic acid ester copolymers, polysorbate 80, silicon dioxide, simethicone emulsion, talc, titanium dioxide, FD&C Blue No. 2 Aluminum Lake.

What are the possible side effects of metronidazole (Flagyl, Flagyl 375, Flagyl ER)?

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:

  • numbness or tingling in your hands or feet;
  • white patches or sores inside your mouth or on your lips;
  • pain or burning when you urinate;
  • diarrhea that is watery or bloody;
  • vision problems, pain behind your eyes;
  • trouble concentrating, slurred speech, mood or behavior changes,...

Read All Potential Side Effects and See Pictures of Flagyl ER »

What are the precautions when taking metronidazole extended release tablets (Flagyl ER)?

Before taking metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazoles such as tinidazole; 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: liver problems, nervous system disorders (e.g., seizures), blood disorders, Crohn's disease.

Avoid alcoholic beverages while taking this medication and for at least 3 days after finishing this medicine because severe stomach upset, nausea, vomiting, headache and flushing may occur.

This drug may make you dizzy. Do not drive, use machinery, or do any activity...

Read All Potential Precautions of Flagyl ER »

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Bacterial Vaginosis (BV). Flagyl ER (metronidazole extended release tablets) 750 mg tablets are indicated in the treatment of women with BV.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flagyl ER (metronidazole extended release tablets) and other antibacterial drugs, Flagyl ER (metronidazole extended release tablets) 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

Bacterial Vaginosis

Seven-day course of treatment—750 mg once daily by mouth for seven consecutive days.

Flagyl ER (metronidazole extended release tablets) 750 mg tablets should be taken under fasting conditions, at least one hour before or two hours after meals.

The optimum extended-release characteristics of Flagyl ER (metronidazole extended release tablets) 750 mg are obtained when the drug is taken under fasting conditions. (See CLINICAL PHARMACOLOGY - Pharmacokinetics.)

Pregnant patients should not be treated during the first trimester. (See CONTRAINDICATIONS and PRECAUTIONS.)

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels6 and toxicity is recommended.

The dose of metronidazole should not be specifically reduced in anuric patients because accumulated metabolites may be rapidly removed by dialysis.

In elderly patients, the pharmacokinetics of metronidazole may be altered and therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

HOW SUPPLIED

Flagyl ER (metronidazole extended release tablets) 750 mg tablets are oval, blue, film coated, with SEARLE and 1961 embossed on one side and FLAGYL and ER on the other side, supplied as:

NDC Number Size
0025–1961–30 Bottle of 30

Storage and Stability

Store in a dry place at 25°C (77°F); excursions permitted to 15°– 30°C (59°–86°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container with a child-resistant closure.

REFERENCES

6. Ralph ED, Kirby WMM. Bioassay of metronidazole with either anaerobic or aerobic incubation. J Infect Dis 1975; 132:587–591 or Gulaid et al. Determination of metronidazole and its major metabolites in biological fluids by high pressure liquid chromatography. Br J Clin Pharmacol 1978; 6:430–432.

Manufactured by: MOVA Pharmaceutical Corporation Caguas, PR 00725. Distributed by GD Searle LLC., Division of Pfizer Inc., NY, NY 10017. Revised August 2010

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

In two multicenter clinical trials, a total of 270 patients received 750 mg Flagyl ER (metronidazole extended release tablets) tablets orally once daily for 7 days, and 287 were treated with a comparator agent administered intravaginally once daily for 7 days. (See Clinical Studies.)4,5

Most adverse events were described as being of mild or moderate severity. Among patients taking Flagyl ER (metronidazole extended release tablets) who reported headaches, 10% considered them severe, and less than 2% of reported episodes of nausea were considered severe. Metallic taste was reported by 9% of patients taking Flagyl ER (metronidazole extended release tablets) .

Adverse events reported at ≥ 2% incidence for either treatment group, irrespective of treatment causality, are summarized in the table below.

Adverse Events ( ≥ 2% Incidence Rate)—Irrespective of Treatment Causality

  Flagyl ER 7 days
(N=267)
Vaginal Preparation
(N=285)
Headache 48 (18%) 44 (15%)
Vaginitis 39 (15%) 32 (12%)
Nausea 28 (10%) 8 (3%)
Taste Perversion (metallic taste) 23 (9%) 1 (0%)
Infection Bacterial 19 (7%) 17 (6%)
Influenza-like Symptoms 17 (6%) 20 (7%)
Pruritus Genital 14 (5%) 25 (9%)
Abdominal Pain 10 (4%) 13 (5%)
Dizziness 11 (4%) 3 (1%)
Diarrhea 11 (4%) 3 (1%)
Upper Respiratory Tract Infection 11 (4%) 10 (4%)
Rhinitis 12 (4%) 10 (4%)
Sinusitis 7 (3%) 6 (2%)
Urine Abnormal 7 (3%) 4 (1%)
Pharyngitis 8 (3%) 4 (1%)
Dysmenorrhea 9 (3%) 7 (2%)
Moniliasis 9 (3%) 8 (3%)
Mouth Dry 5 (2%) 2 (1%)
Urinary Tract Infection 6 (2%) 16 (6%)

Vulvovaginal candidiasis is a recognized consequence of treatment with many anti-infective agents. In these multicenter clinical trials, there were no statistically significant differences in the incidence rates of yeast vaginitis for groups of patients treated with Flagyl ER (metronidazole extended release tablets) or the vaginal comparator.

The following reactions have also been reported during treatment with metronidazole:

Central Nervous System

The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Since persistent peripheral neuropathy has been reported in some patients receiving prolonged administration of metronidazole, patients should be specifically warned about these reactions and should be told to stop the drug and report immediately to their physicians if any neurologic symptoms occur. In addition, patients have reported dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia. (See WARNINGS.)

Gastrointestinal

The most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea reported by about 12% of patients, sometimes accompanied by headache, anorexia, and occasionally vomiting, diarrhea, epigastric distress, and abdominal cramping. Constipation has also been reported.

Furry tongue, glossitis, and stomatitis have occurred; these may be associated with a sudden overgrowth of Candida which may occur during therapy. Rare cases of pancreatitis, which generally abated on withdrawal of the drug, have been reported.

Hematopoietic

Reversible neutropenia (leukopenia); rarely, reversible thrombocytopenia.

Cardiovascular

Flattening of the T-wave may be seen in electrocardiographic tracings.

Hypersensitivity

Urticaria, erythematous rash, Stevens-Johnson Syndrome, toxic epidermal necrolysis, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever.

Renal

Dysuria, cystitis, polyuria, incontinence, and a sense of pelvic pressure. Instances of darkened urine have been reported by approximately one patient in 100,000. Although the pigment which is probably responsible for this phenomenon has not been positively identified, it is almost certainly a metabolite of metronidazole and seems to have no clinical significance.

Other

Proliferation of Candida in the vagina, dyspareunia, decrease of libido, proctitis, and fleeting joint pains sometimes resembling “serum sickness.” If patients receiving metronidazole drink alcoholic beverages, they may experience abdominal distress, nausea, vomiting, flushing, or headache. A modification of the taste of alcoholic beverages has also been reported.

Patients with Crohn's disease are known to have an increased incidence of gastrointestinal and certain extraintestinal cancers. There have been some reports in the medical literature of breast and colon cancer in Crohn's disease patients who have been treated with metronidazole at high doses for extended periods of time. A cause and effect relationship has not been established. Crohn's disease is not an approved indication for Flagyl ER 750 mg tablets.

Read the Flagyl ER (metronidazole extended release tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Metronidazole has been reported to potentiate the anticoagulant effect of warfarin and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. This possible drug interaction should be considered when metronidazole is prescribed for patients on this type of anticoagulant therapy.

The simultaneous administration of drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma levels; impaired clearance of phenytoin has been reported.

The simultaneous administration of drugs that decrease microsomal liver enzyme activity, such as cimetidine, may prolong the half-life and decrease plasma clearance of metronidazole. In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.

Alcoholic beverages should not be consumed during metronidazole therapy and for at least three days afterward because abdominal cramps, nausea, vomiting, headaches, and flushing may occur.

Psychotic reactions have been reported in alcoholic patients who are using metronidazole and disulfiram concurrently. Metronidazole should not be given to patients who have taken disulfiram within the last 2 weeks.

Drug/Laboratory test interactions

Metronidazole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. Values of zero may be observed. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide adenine dinucleotide (NAD+⇔NADH). Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7.

REFERENCES

4. Integrated clinical and statistical report for the treatment of bacterial vaginosis with metronidazole modified release tablet— a dose duration study. G.D. Searle & Co., Protocol No. N13-95-02-015; Report No. N13-96-06-015, 19 Nov 1996.

5. Integrated clinical and statistical report for the treatment of bacterial vaginosis with metronidazole modified release tablet. G.D. Searle & Co., Protocol No. N13-95-02-017; Report No. N13-96-06-017, 11 Nov 1996.

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Central and Peripheral Nervous System Effects

Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.

PRECAUTIONS

General

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole and requires treatment with a candidacidal agent.

Prescribing Flagyl ER (metronidazole extended release tablets) 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.

Laboratory tests

Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of or history of blood dyscrasia. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies. Total and differential leukocyte counts should be made before and after re-treatments.

Carcinogenesis, mutagenesis, impairment of fertility

Pulmonary tumors have been observed in all six reported studies in the mouse, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only).

Malignant liver tumors were increased in male mice treated at approximately 1500 mg/m². This dose is approximately 3 times the recommended dose.

Malignant lymphomas and pulmonary neoplasms are also increased with lifetime feeding of the drug to mice (published data).

Mammary and hepatic tumors were increased among female rats administered oral metronidazole compared to concurrent controls.

Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative.

Metronidazole has shown mutagenic activity in in vitro assay systems including the Ames test. Studies in mammals in vivo have failed to demonstrate a potential for genetic damage. Fertility studies have been performed in mice at doses up to six times the maximum recommended human dose based on mg/m² and have revealed no evidence of impaired fertility.

Pregnancy

Teratogenic effects - Pregnancy Category B

Flagyl ER has not been studied in pregnant women. Since metronidazole crosses the placental barrier and enters the fetal circulation rapidly, it should not be administered to pregnant patients during the first trimester. No fetotoxicity was observed when metronidazole was administered orally to pregnant mice at 60 mg/ m²/day, which is approximately 10% of the human dose when expressed as mg/m². However, in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. The relationship of these findings to the drug is unknown. There are, however, no adequate and well-controlled studies in pregnant women. (See CONTRAINDICATIONS.)

Because animal reproduction studies are not always predictive of human response, and because metronidazole is a carcinogen in rodents, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

Since metronidazole is secreted in human milk in concentrations similar to those found in plasma, and since tumors were increased in rats and mice treated with metronidazole, 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.

Geriatric use

Decreased renal function does not alter the single-dose pharmacokinetics of metronidazole. However, plasma clearance of metronidazole is decreased in patients with decreased liver function. Therefore, in elderly patients, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

Pediatric use

Safety and effectiveness of this dosage form of metronidazole in pediatric patients have not been established.

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia.

Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 g to 10.4 g every other day.

Treatment

There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.

CONTRAINDICATIONS

Flagyl ER (metronidazole extended release tablets) 750 mg tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.

Flagyl ER, like other formulations of metronidazole-containing products, is contraindicated during the first trimester of pregnancy. (See PRECAUTIONS.)

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms, with an average elimination half-life in healthy humans of 8 hours.

The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. The metabolites that appear in the urine result primarily from side-chain oxidation [1(βhydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-ylacetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Renal clearance of metronidazole is approximately 10 mL/ min/1.73m2.1

Flagyl ER 750 mg tablets contain 750 mg of metronidazole in an extended release formulation which allows for once-daily dosing. The steady state pharmacokinetics were determined in 24 healthy adult female subjects with a mean ± SD age of 28.8 ± 8.8 years (range: 19–46).2 The pharmacokinetic parameters of metronidazole after administration of Flagyl ER (metronidazole extended release tablets) 750 mg under fed and fasting conditions are summarized in the following table.

Steady State Pharmacokinetic Parameters of Metronidazole after 750 mg of Flagyl ER (metronidazole extended release tablets) Given Once a Day for 7 Days

Parameter Flagyl ER 750 mg daily
Mean ± SD (N=24)
fed fasted
AUC(0–24) (μg•hr/mL) 211 ± 60.0 198 ± 75.3
Cmax (μg/mL) 19.4 ± 4.7 12.5 ± 4.8
Cmin (μg/mL) 3.4 ± 2.0 4.2 ± 2.2
Tmax (hrs) 4.6 ± 2.4 6.8 ± 2.8
T¤ (hrs) 7.4 ± 1.6 8.7 ± 2.2

Relative to the fasting state, the rate of metronidazole absorption from the extended release tablet is increased in the fed state resulting in alteration of the extended release characteristics.

Decreased renal function does not alter the single-dose pharmacokinetics of metronidazole. However, plasma clearance of metronidazole is decreased in patients with decreased liver function.

Microbiology

Metronidazole exerts an antimicrobial effect in an anaerobic environment by the following possible mechanism: Once metronidazole enters the organism, the drug is reduced by intra-cellular electron transport proteins. Because of this alteration to the metronidazole molecule, a concentration gradient is maintained which promotes the drug's intracellular transport. Presumably, free radicals are formed which, in turn, react with cellular components resulting in death of the microorganism.

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

Metronidazole exhibits in vitro minimal inhibitory concentrations (MIC's) of 8 μg/mL or less against most ( ≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of metronidazole in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.

Gram-positive anaerobes

Clostridium species
Eubacterium
species
Peptococcus
niger
Peptostreptococcus
species

Gram-negative anaerobes

Bacteroides fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus)
Fusobacterium
species
Prevotella
species (P. bivia, P. buccae, P. disiens)
Porphyromonas
species

Protozoal parasites

Entamoeba histolytica
Trichomonas
vaginalis

Metronidazole has shown minimal to no activity against clinically relevant facultative anaerobes or obligate aerobes. Metronidazole has minimal activity against Lactobacillus spp and other aerobic microorganisms commonly isolated from the vaginal tract.

Susceptibility Tests

Dilution techniques

Quantitative methods that are used to determine minimum inhibitory concentrations provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. For anaerobic bacteria, the susceptibility to metronidazole can be determined by the reference agar dilution method or by alternate standardized test methods.3 The MIC values obtained should be interpreted according to the following criteria:

MIC (μg/mL) Interpretation
≤ 8 Susceptible (S)
16 Intermediate (I)
≥ 32 Resistant (R)

For protozoal parasites: Standardized tests do not exist for use in clinical microbiology laboratories.

A report of “Susceptible” indicates that the pathogen is likely to be inhibited by usually achievable concentrations of the antimicrobial compound in the blood. 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 usually achievable concentrations of the antimicrobial compound in the blood are unlikely to be inhibitory and other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms that are used to control the technical aspects of the laboratory procedures. Standard metronidazole powder should provide the following MIC values:

Microorganism MIC (μg/mL)
Bacteroides fragilis ATCC 25285 0.25–1.0
Bacteroides thetaiotaomicron ATCC 29741 0.5–2.0

Clinical Studies

BV is a clinical syndrome that results from a replacement of the normal, Lactobacillus-dominant flora with several other organisms including Gardnerella vaginalis, Mobiluncus spp, Mycoplasma hominis and anaerobes (Peptostreptococcus spp and Bacteroides spp).

Flagyl ER (metronidazole extended release tablets) was studied in patients with BV in two randomized, multicenter, well-controlled, investigator blind clinical trials.4,5 A total of 557 otherwise healthy nonpregnant patients with BV were randomized to treatment with Flagyl ER (metronidazole extended release tablets) once a day for 7 days (n=270) or 2% clindamycin vaginal cream one applicator full (5 grams) once a day for 7 days (n=287).

The primary efficacy endpoint for each treatment regimen was defined as clinical cure assessed at 28–32 days post-therapy. Clinical cure was defined as a return to normal of the vaginal pH ( ≤ 4.5), absence of a “fishy” amine odor, and absence of clue cells.

The study results are presented in the table below:

Clinical Cure Rates at One Month

  Flagyl ER
% (n/N)
2% clindamycin cream
% (n/N)
Study 1 61% (77/126) 59% (80/135)
Study 2 62% (74/119)* 43% (50/117)
*p < 0.05 versus clindamycin cream

At one month post-therapy the pH of the vagina returned to normal earlier and in a greater percentage of patients in the Flagyl ER (metronidazole extended release tablets) treatment group when compared to the 2% clindamycin vaginal cream group; 72% vs 65%, respectively. Likewise, Flagyl ER (metronidazole extended release tablets) restored the normal Lactobacillus-predominant vaginal flora in a larger percentage of patients at one month post-therapy when compared to the 2% clindamycin treated group; 74% vs 63%, respectively.

REFERENCES

1. Salas-Herrera IG, Pearson RM, Johnston A, and Turner P. Concentration of metronidazole in cervical mucus and serum after single and repeated oral doses. J Antimicrobial Chemotherapy 1991; 28:283–289.

2. Metronidazole modified-release tablet multiple-dose bioequivalency study (fed/fasting). G.D. Searle & Co., Protocol No. S13-94-02-014; Report No. S13-95-06-014, 11 July 1995.

3. National Committee for Clinical Laboratory Standards, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria—Third Edition. Approved Standard NCCLS Document M11-A3, Vol. 13, No. 26, NCCLS, Villanova, PA, December, 1993.

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Alcoholic beverages should be avoided while taking metronidazole and for at least three days afterward. (See DRUG INTERACTIONS.)

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

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Alcoholic beverages should be avoided while taking metronidazole and for at least three days afterward. (See DRUG INTERACTIONS.)

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

Last reviewed on RxList: 9/15/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Flagyl ER 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.

METRONIDAZOLE SUSTAINED-ACTION - ORAL

(MET-roe-NYE-da-zole)

COMMON BRAND NAME(S): Flagyl ER

USES: This form of metronidazole is used for vaginal infections. It belongs to a class of antibiotics known as nitroimidazoles. It works by stopping the growth of bacteria and protozoa.

This antibiotic only treats bacterial and protozoal 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 for other infections.

HOW TO USE: Take this medication by mouth once daily or as directed by your doctor. To help this drug be absorbed by your body, it is best to take this on an empty stomach at least one hour before or two hours after a meal.

Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

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 the medication too early may allow bacteria/protozoa to continue to grow, which may result in a relapse of the infection.

Inform your doctor if your condition persists or worsens.

Disclaimer

Flagyl ER Consumer (continued)

SIDE EFFECTS: Dizziness, headache, diarrhea, nausea, stomach pain, loss of appetite, constipation, changes in taste, furry tongue, and dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This drug may cause urine to darken in color. This is harmless.

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: unsteadiness, seizures, mental/mood changes (such as confusion), numbness/tingling of hands/feet, painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: eye pain, severe/persistent headache, stiff/painful neck, sudden vision changes, sore throat, persistent fever, unusual bleeding/bruising, severe stomach pain, persistent nausea/vomiting.

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 very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Flagyl ER (metronidazole extended release tablets) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazoles such as tinidazole; 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: liver problems, nervous system disorders (e.g., seizures), blood disorders, Crohn's disease.

Avoid alcoholic beverages while taking this medication and for at least 3 days after finishing this medicine because severe stomach upset, nausea, vomiting, headache and flushing may occur.

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.

The elderly may be at greater risk for side effects while using this drug.

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. Discuss the risks and benefits with your doctor before breast-feeding.

Disclaimer

Flagyl ER Consumer (continued)

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

This drug should not be used with the following medications because very serious interactions may occur: alcohol-containing products (e.g., cough and cold syrups, aftershave), amprenavir oral solution, disulfiram, lopinavir/ritonavir oral solution.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting metronidazole.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), busulfan, cimetidine, fluorouracil, lithium, mebendazole, live vaccines, drugs for seizures (e.g., phenobarbital, phenytoin).

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 interfere with certain laboratory tests (including liver function tests, blood triglyceride levels), possibly causing false test results. 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 nausea, vomiting, severe dizziness, and seizures.

NOTES: Do not share this medication with others.

Treatment of certain infections (trichomoniasis) may require that sexual partners be treated as well to avoid re-infection. During therapy, refrain from sexual intercourse or always use a condom.

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., blood counts) should be performed from time to time 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 at 77 degrees F (25 degrees C) away from moisture and sunlight. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. 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 September 2011. Copyright(c) 2011 First Databank, Inc.

Flagyl ER Patient Information Including Side Effects

Brand Names: Flagyl, Flagyl 375, Flagyl ER

Generic Name: metronidazole (Pronunciation: me troe NI da zole)

What is metronidazole (Flagyl ER)?

Metronidazole is an antibiotic. It fights bacteria in your body.

Metronidazole is used to treat bacterial infections of the vagina, stomach, skin, joints, and respiratory tract. This medication will not treat a vaginal yeast infection.

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

Flagyl 375 mg

gray/green, imprinted with FLAGYL, 375mg

Flagyl 500 mg

oblong, blue, imprinted with 500, FLAGYL

Flagyl ER 750 mg

elliptical, blue, imprinted with SEARLE 1961, FLAGYL ER

Metronidazole 250 mg-DAN

round, white, imprinted with DAN, 5540

Metronidazole 250 mg-MUT

round, white, imprinted with MP 45

Metronidazole 250 mg-SID

round, white, imprinted with SL 333

Metronidazole 250 mg-TEV

round, white, imprinted with 93, 851

Metronidazole 250 mg-WAT

round, white, imprinted with 5540, DAN

Metronidazole 500 mg-MUT

oval, white, imprinted with MP 46

Metronidazole 500 mg-SCH

round, white, imprinted with 5552, DAN DAN

Metronidazole 500 mg-TEV

oblong, white, imprinted with 93 93, 852

Metronidazole 500 mg-WAT

round, white, imprinted with 5552, DAN DAN

Metronidazole 500mg-SID

oblong, white, imprinted with SL 334

What are the possible side effects of metronidazole (Flagyl ER)?

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:

  • numbness or tingling in your hands or feet;
  • white patches or sores inside your mouth or on your lips;
  • pain or burning when you urinate;
  • diarrhea that is watery or bloody;
  • vision problems, pain behind your eyes;
  • trouble concentrating, slurred speech, mood or behavior changes, tremors, muscle twitching, seizure (convulsions);
  • fever, chills, muscle pain, confusion, headache, sore throat, neck stiffness, increased sensitivity to light, drowsiness, nausea and vomiting; 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:

  • stomach pain, diarrhea;
  • dizziness, loss of balance;
  • vaginal itching or discharge;
  • dry mouth or unpleasant metallic taste;
  • cough, sneezing, runny or stuffy nose; or
  • swollen or sore tongue.

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 Flagyl ER (metronidazole extended release tablets) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about metronidazole (Flagyl ER)?

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. Metronidazole will not treat a viral infection such as the common cold or flu.

Do not drink alcohol while you are taking metronidazole and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Side Effects Centers

Flagyl ER Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking metronidazole (Flagyl ER)?

You should not use this medication if you are allergic to metronidazole, or if you are in the first trimester of pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Before taking metronidazole, tell your doctor if you are allergic to any drugs, or if you have:

  • liver disease;
  • a stomach or intestinal disease such as Crohn's disease;
  • a blood cell disorder such as anemia (lack of red blood cells) or leukopenia (lack of white blood cells);
  • epilepsy or other seizure disorder; or
  • nerve disorders.

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

Metronidazole can pass 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.

How should I take metronidazole (Flagyl ER)?

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 the extended-release metronidazole tablet (Flagyl ER) on an empty stomach, at least 1 hour before or 2 hours after eating a meal.

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.

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. Metronidazole will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using metronidazole.

Store at room temperature away from moisture and heat.

Side Effects Centers

Flagyl ER Patient Information including If I Miss a Dose

What happens if I miss a dose (Flagyl ER)?

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 (Flagyl ER)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, dizziness, loss of balance or coordination, numbness and tingling, or seizures (convulsions).

What should I avoid while taking metronidazole (Flagyl ER)?

Do not drink alcohol while you are taking metronidazole and for at least 3 days after you stop taking it. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting.

Check the labels of any medicines or food products you use to make sure they do not contain alcohol.

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 metronidazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What other drugs will affect metronidazole (Flagyl ER)?

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

  • cimetidine (Tagamet);
  • seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
  • a blood thinner such as warfarin (Coumadin, Jantoven);
  • lithium (Lithobid, Eskalith, others); or
  • disulfiram (Antabuse).

This list is not complete and other drugs may interact with metronidazole. 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 metronidazole.


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: 10.01. Revision date: 2/14/2011.

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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Side Effects Centers

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