ROZEX

What it is

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

Approved indications

— Treatment of symptomatic bacterial vaginosis.

Dosing overview

The recommended dose is one applicator full of ROZEX (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 ROZEX developed symptomatic Candida vaginitis during or immediately after therapy, which may be due to known or previously unrecognised vulvovaginal candidiasis presenting with more prominent symptoms during therapy. 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, although the occurrence of serious neurological symptoms with ROZEX is unlikely. ROZEX should be administered with caution to patients with central nervous system diseases. Cases of severe hepatotoxicity or acute hepatic failure with fatal outcomes and very rapid onset after treatment initiation have been reported in patients with Cockayne syndrome treated with metronidazole products for systemic use. In this population, metronidazole should be used after careful benefit–risk assessment and if no alternative treatment is available, with liver function tests performed prior to, throughout and after treatment until liver function is within normal ranges, and discontinuation if liver function tests become markedly elevated. Some patients treated with oral metronidazole have been observed to have mild transient leukopenia, and ROZEX should be administered with caution to patients with evidence of or a history of blood dyscrasia. ROZEX contains ingredients that may cause burning and irritation of the eye, and in the event of accidental contact with the eye, the eye should be rinsed with copious amounts of cool tap water.

Contraindications

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

Regulatory history

ROZEX metronidazole 7.5 mg/g gel was first listed on the ARTG on 9 September 1991. ROZEX received initial approval on 28 March 2000.