Source: European Medicines Agency (EU) Revision Year: 2020
For the topical treatment of Rosacea (inflammatory papulopustules rosacea related).
Not recommended as clinical trials have not been undertaken.
Cutaneous use.
Apply a thin film of the gel to the affected facial areas twice daily for four weeks. Treatment may be continued for a further four weeks if necessary.
Metronidazole should be applied in a thin layer to the affected areas of the skin twice daily, morning and evening. Areas to be treated should be washed with a mild cleanser before application. Patients may use non comedogenic and non astringent cosmetics after application of metronidazole. The dosage does not need to be adjusted for elderly patients. Metronidazole is not recommended for use in children due to a lack of data on safety and efficacy. The average period of treatment varies according countries. It is usually of three to four months. The recommended duration of treatment should not be exceeded. However, if a clear benefit has been demonstrated continued therapy for a further three to four months period may be considered by the prescribing physician depending upon the severity of the condition. In clinical studies, topical metronidazole therapy for rosacea has been continued for up to 2 years. In the absence of a clear clinical improvement, therapy should be stopped.
No data exist about overdose in humans. Acute oral toxicity studies with topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5g of finished product per kilogram body weight, the highest dose used. This dose is equivalent to the oral intake of 12 tubes of 30 g packaging Metrosa 0.75% Gel or more than 7 tubes of the 50 g packaging of Metrosa 0.75% Gel for an adult weighing 72 kg, and 2 tubes of the 30 g packaging of Metrosa 0.75% Gel and more than 1 tube of the 50 g packaging for a child weighing 12 kg.
Overdosage is not to be expected with this preparation. Any excess gel may be removed by washing with warm water. Appropriate gastric emptying may be used, if considered necessary, should accidental ingestion occur.
5 years.
Shelf life after first opening is 3 months.
Do not refrigerate or freeze.
Aluminium tube, fitted with a polyethylene (HDPE) screw cap.
Not all pack sizes are marketed.
No special requirements.
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