FLAGYL

What it is

Flagyl S is an oral suspension containing metronidazole benzoate 320 mg per 5 mL, equivalent to 200 mg of metronidazole per 5 mL. It is presented as a white or cream suspension with a slight yellow tinge and an odour of orange and lemon.

Approved indications

— Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of bacteroides, and other species such as fusobacteria, eubacteria, clostridia and anaerobic streptococci. — Oral treatment of urogenital trichomoniasis in the female and in the male. — Treatment of bacterial vaginosis. — Treatment of all forms of amoebiasis, including intestinal and extraintestinal disease and that of symptomless cyst passers. — Treatment of giardiasis. — Treatment of acute ulcerative gingivitis.

Dosing overview

For anaerobic infections in adults and children over 12 years, the dose is 400 mg three times daily for 7 days. For urogenital trichomoniasis in adults, a single 2 g dose or 200 mg three times daily for 7 days may be used. For bacterial vaginosis, the dose is 2 g daily or 400 mg three times daily, either for 1 or 7 days. For giardiasis, adults receive 2 g daily for 3 days. For acute ulcerative gingivitis in adults, the dose is 200 mg three times daily for 3 days. The dose should be taken at least one hour before a meal. A maximum of 2.4 g should not be exceeded during a 24 hour period.

Key safety warnings

Alcoholic beverages and drugs containing alcohol should not be consumed by patients being treated with metronidazole as nausea, vomiting, abdominal cramps, headaches, tachycardia and flushing may occur. Patients treated with metronidazole have been reported to develop posterior reversible encephalopathy syndrome (PRES). If patients present with symptoms such as headache, altered mental status, seizures and visual disturbances, a radiological procedure such as MRI should be performed. If PRES is diagnosed, adequate blood pressure control and immediate discontinuation of metronidazole is advised. Cases of severe bullous skin reactions such as Stevens Johnson syndrome, toxic epidermal necrolysis, acute generalised exanthematous pustulosis and Drug reaction with eosinophilia and systemic symptoms have been reported with metronidazole. If symptoms or signs are present, metronidazole treatment must be immediately discontinued. If metronidazole is to be administered for more than 10 days, it is recommended that haematological tests, especially total and differential leucocyte counts, be carried out regularly and that patients be monitored for peripheral or central neuropathy. If leucopenia or abnormal neurological signs occur, the drug should be discontinued immediately. Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system diseases due to the risk of neurological damage. Patients should be warned about the potential for confusion, dizziness, hallucinations, convulsions or transient visual disorders and advised not to drive or operate machinery if these symptoms occur. Cases of suicidal ideation with or without depression have been reported during treatment with metronidazole. Patients should be advised to discontinue treatment and contact their healthcare provider immediately if they experience psychiatric symptoms during treatment.

Contraindications

Patients with evidence of or a history of blood dyscrasias should not receive the drug. Active organic disease of the central nervous system is a contraindication. Hypersensitivity to metronidazole and other imidazoles is a contraindication. Patients with Cockayne Syndrome must not receive metronidazole, as severe irreversible hepatotoxicity and acute liver failure with fatal outcomes have been reported after initiation of metronidazole in these patients.

PBS listing

Flagyl oral suspension containing metronidazole benzoate 320 mg per 5 mL in 100 mL bottles is listed on the PBS with 2 items, unrestricted restriction, at an ex-manufacturer price of A$10.03.

Regulatory history

Flagyl S was first approved on 21 October 1991.