Noritate

Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

Noritate 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 Noritate 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 Noritate 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, Noritate should be used during pregnancy only if clearly needed.

Safety data from 302 patients who used Noritate (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 ( Noritate 1, vehicle 1), condition aggravated ( Noritate 1, vehicle 0), paresthesia ( Noritate 0, vehicle 1), acne ( Noritate 1, vehicle 0), dry skin ( Noritate 0, vehicle 2). The majority of adverse reactions were mild to moderate in severity.