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Flagyl ER (Metronidazole) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Bacterial Vaginosis (BV)

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.

DOSAGE AND ADMINISTRATION

Bacterial Vaginosis

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 (See CLINICAL PHARMACOLOGY, Absorption).

FLAGYL ER tablets should not be split, chewed, or crushed.

Dosage Adjustments

Patients Undergoing Hemodialysis

Hemodialysis 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).

HOW SUPPLIED

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

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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