Flagyl ER (Metronidazole) - Indications and Dosage

INDICATIONS AND USAGE

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 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 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—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 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.