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Flagyl ER (Tablet, Film Coated, Extended Release)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/176

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PredicateObject
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Flagyl ER (Tablet, Film Coated, Extended Release)
dailymed-instance:dosage
Bacterial Vaginosis: Seven-day course of treatment���750 mg once daily by mouth for seven consecutive days. Flagyl ER 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 750 mg are obtained when the drug is taken under fasting conditions. Pregnant patients should not be treated during the first trimester. 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 levelsand 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.
dailymed-instance:descripti...
Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 2-methyl-5-nitroimidazole-1-ethanol, which has the following structural formula: 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.
dailymed-instance:clinicalP...
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-(��hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Renal clearance of metronidazole is approximately 10 mL/ min/1.73m. 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).The pharmacokinetic parameters of metronidazole after administration of Flagyl ER 750 mg under fed and fasting conditions are summarized in the following table. 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.<br/>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��g/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 speciesEubacterium speciesPeptococcus nigerPeptostreptococcus species Gram-negative anaerobes:Bacteroides fragilis group (B. fragilis, B. distasonis, B. ovatus, B. thetaiotaomicron, B. vulgatus)Fusobacterium speciesPrevotella species (P. bivia, P. buccae, P. disiens)Porphyromonas species Protozoal parasites:Entamoeba histolyticaTrichomonas 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.<br/>Susceptibility Tests:<br/>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.The MIC values obtained should be interpreted according to the following criteria: 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:
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dailymed-instance:supply
Flagyl ER 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<br/>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.
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WARNING: Metronidazole has been shown to be carcinogenic in mice and rats.Unnecessary use of the drug should be avoided.Its use should be reserved for conditions described in the INDICATIONS AND USAGE section below.
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dailymed-instance:overdosag...
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.<br/>Treatment: There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
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Metronidazole
dailymed-instance:fullName
Flagyl ER (Tablet, Film Coated, Extended Release)
dailymed-instance:adverseRe...
In two multicenter clinical trials, a total of 270 patients received 750 mg Flagyl ER tablets orally once daily for 7 days, and 287 were treated with a comparator agent administered intravaginally once daily for 7 days. Most adverse events were described as being of mild or moderate severity. Among patients taking Flagyl ER 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. Adverse events reported at���2% incidence for either treatment group, irrespective of treatment causality, are summarized in the table below. 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 or the vaginal comparator. The following reactions have also been reported during treatment with metronidazole: Central Nervous System: Two serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures 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, irritability, depression, weakness, and insomnia. 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, 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.
dailymed-instance:indicatio...
Bacterial Vaginosis (BV): Flagyl ER 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 and other antibacterial drugs, Flagyl ER 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 informationare 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.
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Flagyl ER