METRONIDAMED

What it is

METRONIDAMED is an intravaginal dosage form of the synthetic antibacterial agent metronidazole, a member of the imidazole class of antibacterial agents. The vaginal gel formulation contains metronidazole 0.75% w/w, with each 5 g applicator containing approximately 37.5 mg of metronidazole.

Approved indications

— Symptomatic bacterial vaginosis (formerly referred to as *Haemophilus vaginalis* vaginitis, *Gardnerella vaginalis* vaginitis, non-specific vaginitis, *Corynebacterium vaginale* vaginitis or anaerobic vaginosis).

Dosing overview

The recommended dose is one applicator full of METRONIDAMED (approximately 5 g containing approximately 37.5 mg of metronidazole) intravaginally once a day, at bedtime, for 5 days.

Key safety warnings

Approximately 6–10% of patients treated with METRONIDAMED developed symptomatic *Candida* vaginitis during or immediately after therapy. METRONIDAMED contains ingredients that may cause burning and irritation of the eye; in the event of accidental contact with the eye, rinse the eye with copious amounts of cool tap water. Some patients treated with oral or intravenous metronidazole have been reported to have convulsive seizures or peripheral neuropathy characterised mainly by numbness or paraesthesia of an extremity. While the occurrence of serious neurological symptoms with METRONIDAMED is unlikely, the appearance of abnormal neurological signs should prompt discontinuation of therapy. METRONIDAMED should be administered with caution to patients with central nervous system diseases. Cases of severe hepatotoxicity or acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome, have been reported with products containing metronidazole for systemic use. In this population, metronidazole should be used after careful benefit–risk assessment and if no alternative treatment is available. Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until baseline values are reached. If liver function tests become markedly elevated during treatment, the medicine should be discontinued.

Contraindications

METRONIDAMED is contraindicated for patients with a prior history of hypersensitivity to metronidazole, hydroxybenzoates, other ingredients of the formulation or other nitroimidazole derivatives.

PBS listing

The 200 mg tablet is listed with 2 PBS items under unrestricted access, with an ex-manufacturer price of A$2.50. The 400 mg tablet is listed with 2 PBS items under restricted access, with an ex-manufacturer price of A$3.27. The latest schedule date is 2026-05-01.

Regulatory history

METRONIDAMED was first approved on 28 March 2000. METRONIDAMED metronidazole 200 mg and 400 mg tablets were registered on the ARTG on 2024-07-11 under licence category RE.