NORITATE

Noritate ® (metronidazole cream) Cream, 1%, contains metronidazole USP. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole-1-ethanol. The molecular formula for metronidazole is C 6 H 9 N 3 O 3 . It has the following structural formula: Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has a solubility in water of 10 mg/mL at 20°C. Metronidazole is a member of the imidazole class of antibacterial agents and is classified as an antiprotozoal and antibacterial agent. Noritate is an emollient cream; each gram contains 10 mg micronized metronidazole USP, in a base of glycerin USP, glyceryl monostearate NF, methylparaben NF, propylparaben NF, purified water USP, stearic acid NF and trolamine NF. Noritate Chemical Structure

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

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

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

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. Two patients treated with Noritate 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 Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 .)

Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F).