Metronidazole

Indications

INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets, USP are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets, USP are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Sexual Partners. T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Trichomoniasis In the Female: One-day treatment − two grams of metronidazole tablets, given either as a single dose or in two divided doses of one gram each, given in the same day. Seven-day course of treatment − 250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears and signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen. The dosage regimen should be individualized.

Contraindications

CONTRAINDICATIONS Hypersensitivity Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives. In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see PRECAUTIONS ). Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently.

Warnings and precautions

WARNINGS Hypersensitivity Reactions Hypersensitivity reactions including severe cutaneous adverse reactions (SCARs) can be serious and potentially life threatening (see ADVERSE REACTIONS ). Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole. Symptoms can be serious and potentially life threatening.

Pregnancy

Pregnancy: Teratogenic Effects: There are no adequate and well controlled studies of metronidazole in pregnant women. There are published data from case-control studies, cohort studies, and 2 meta-analyses that include more than 5000 pregnant women who used metronidazole during pregnancy. Many studies included first trimester exposures.

Storage and supply

HOW SUPPLIED Metronidazole Tablets USP, 500 mg are white to off-white, oval shaped, biconvex, film coated tablets debossed with '851' on one side and plain on other side and are supplied as follows: NDC 82868-014-14 in bottles of 14 tablets with child-resistant closure NDC 82868-014-20 in bottles of 20 tablets with child-resistant closure NDC 82868…

Source: Metronidazole (Metronidazole) — US FDA prescribing information, 2026-01-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.