Flagyl Er
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Questions & Answers
Side Effects & Adverse Reactions
Cases of encephalopathy and peripheral neuropathy (including optic neuropathy) have been reported with metronidazole.
Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. CNS lesions seen on MRI have been described in reports of encephalopathy. CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole. CNS lesions seen on MRI have also been described as reversible.
Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity.
Convulsive seizures have been reported in patients treated with metronidazole.
Cases of aseptic meningitis have been reported with metronidazole. Symptoms can occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued.
The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy (see ADVERSE REACTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
FLAGYL ER 750 mg tablets are indicated in the treatment of BV in non-pregnant women.
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 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.
History
There is currently no drug history available for this drug.
Other Information
FLAGYL metronidazole extended release tablets is an oral formulation of the synthetic nitroimidazole antimicrobial agent, 2-methyl-5-nitro-1H-imidazole-1-ethanol, which has the following structural formula:
FLAGYL (metronidazole) extended release tablets, 750 mg (indicated below as FLAGYL ER) 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.
Sources
Flagyl Er Manufacturers
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G.d. Searle Llc Division Of Pfizer Inc
![Flagyl Er (Metronidazole) Tablet, Film Coated, Extended Release [G.d. Searle Llc Division Of Pfizer Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Flagyl Er | G.d. Searle Llc Division Of Pfizer Inc
Bacterial Vaginosis750 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 (See CLINICAL PHARMACOLOGY, Absorption).
FLAGYL ER tablets should not be split, chewed, or crushed.
Dosage Adjustments Patients Undergoing HemodialysisHemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from a hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient's clinical situation (see CLINICAL PHARMACOLOGY).
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