Metronidazole

INDICATIONS AND USAGE METRONIDAZOLE CREAM is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

DOSAGE AND ADMINISTRATION Areas to be treated should be cleansed before application of METRONIDAZOLE CREAM . Apply and rub in a thin film of METRONIDAZOLE CREAM once daily to entire affected area(s). Patients may use cosmetics after application of METRONIDAZOLE CREAM .

CONTRAINDICATIONS METRONIDAZOLE CREAM is contraindicated in those patients with a history of hypersensitivity to metronidazole or to any other ingredient in this formulation.

Drug Interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when METRONIDAZOLE CREAM is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption. (See CLINICAL PHARMACOLOGY , Pharmacokinetics . )

Pregnancy: Teratogenic Effects: There are no adequate and well-controlled studies with the use of METRONIDAZOLE CREAM in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral administration of metronidazole to rats or mice at 200 and 20 times, respectively, the expected clinical dose. However, oral metronidazole has shown carcinogenic activity in rodents. Because animal reproduction studies are not always predictive of human response, METRONIDAZOLE CREAM should be used during pregnancy only if clearly needed.

Nursing Mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels taken after topical metronidazole application are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother and the risk to the infant.

ADVERSE REACTIONS Safety data from 302 patients who used METRONIDAZOLE CREAM (n=200) or vehicle control (n=102) once daily in clinical trials and experienced an adverse event considered to be treatment related include: application site reaction ( METRONIDAZOLE CREAM 1, vehicle 1), condition aggravated ( METRONIDAZOLE CREAM 1, vehicle 0), paresthesia ( METRONIDAZOLE CREAM 0, vehicle 1), acne ( METRONIDAZOLE CREAM 1, vehicle 0), dry skin ( METRONIDAZOLE CREAM 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity. Two patients treated with METRONIDAZOLE CREAM once daily discontinued treatment because of adverse events: one for a severe flare of comedonal acne and one for rosacea aggravated. Additional clinical adverse effects reported spontaneously since the drug was marketed are uncommon and include tingling or numbness of extremities, allergic reactions, skin and eye irritation, rash, headache, nausea and dry mouth. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .