Presentation and Status in Health Basket
Adults: Rozex gel 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 Rozex gel.
Elderly: The dosage recommended in the elderly is the same as that recommended in adults.
Children: Not recommended. Safety and efficacy have not been established.
Rosacea with inflamed papules, pustules, erythema.
Contraindicated in individuals with a history of hypersensitivity to Metronidazole, or other ingredients of the formulation.
Contact with mucous membranes should be avoided. Rozex gel has been reported to cause lacrimation of the eyes, therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs patients should be directed to use the medication less frequently or discontinue use temporarily and to seek medical advice if necessary. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of, blood dyscrasia. Exposure of treated sites to ultraviolet (e.g. solarium, sun-lamp) or strong sunlight (including sun-bathing) should be avoided during use of metronidazole. Metronidazole transforms into inactive metabolite due to UV exposure, therefore its efficacy decreases significantly. Phototoxic side- effects haven’t been reported in clinical trials in relation to metronidazole. Unnecessary and prolonged use of this medication should be avoided. Evidence suggests that metronidazole is carcinogenic in certain animal species. There is no evidence to date of a carcinogenic effect in human. This product contains propylene glycol that may cause skin irritation. This product contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reactions (possibly delayed).
Because of the minimal absorption of metronidazole and consequently its insignificant plasma concentration after topical administration, the adverse experiences reported with the oral form of the drug have not been reported with Rozex gel. Adverse reactions reported with Rozex gel have been only local and mild. Dry skin, redness or other signs of skin irritation not present before therapy, stinging or burning of the skin, watering of eyes.
For full details see prescribing information.
Interaction with systemic medication is unlikely because absorption of metronidazole following cutaneous application of Rozex gel is low. Nevertheless, it should be mentioned that disulfiram-like reactions have been reported in a small number of patients taking metronidazole and alcohol concomitantly. Oral metronidazole has been reported to potentiate the effect of warfarin and other coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin is not known. However, very rare cases of modification of the INR values have been reported with concomitant use of Rozex and coumarin anticoagulants.
Pregnancy and Lactation
There is no experience to date with the use of Rozex gel in pregnancy. In case of oral administration, metronidazole crosses the placental barrier and rapidly enters the foetal circulation. No foetotoxicity was observed after oral metronidazole in either rats or mice. However because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents this drug should be used in pregnancy only if clearly needed. After oral administration, Metronidazole is excreted in breast milk in concentrations similar to those found in the plasma, Metronidazole blood levels from topical administration are significantly lower than those achieved after oral administration. A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
No data exists about overdose in humans. Acute oral toxicity studies with a topical gel formulation containing 0.75% w/w metronidazole in rats have shown no toxic action with doses of up to 5 g of finished product per kilogram body weight, the highest dose used. This dose is equivalent to the oral intake of 12 tubes of 30g packaging Rozex gel for an adult weighing 72 kg, and 2 tubes of gel for a child weighing 12 kg.