Noritate

(Metronidazole)

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Noritate Prescribing Information

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:

When a one gram dose of

Noritate Cream, 1%,

was applied in a single application to the face of 16 healthy volunteers, low concentrations of metronidazole were detected in the plasma of 7 of the volunteers. The mean±SD C_maxof metronidazole was 27.6±7.3 ng/mL, which is about 1% of the value reported for a single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (T_max) in the volunteers with detectable metronidazole was 8-12 hours after topical application.

Pharmacodynamics:

The mechanisms by which metronidazole acts in reducing inflammatory lesions of rosacea are unknown.

Clinical Studies:

Safety and efficacy of

Noritate

were evaluated in two randomized vehicle-controlled clinical studies for the treatment of rosacea, which excluded patients who had nodules, moderate or severe rhinophyma, dense telangiectases, plaque-like facial edema or ocular involvement and those who had a history of not responding to metronidazole therapy for rosacea. Of the patients included in the efficacy database (n=416), there were 142 men and 274 women. Endpoint efficacy data comparisons for patients treated with daily

Noritate

or vehicle applications are listed below.

Inflammatory Lesion Counts and Erythema Severity Scores in Two Clinical Trials for Rosacea
	Noritate				Vehicle
	Study 1		Study 2		Study 1		Study 2
	N	Result	N	Result	N	Result	N	Result
Papules + Pustules Count
Baseline	89	15	92	19	50	18	49	17
Week 10	80	7*	82	8	45	15	41	12
Reduction		49%*		58%*		17%		30%
Papules Count
Baseline	89	13	92	17	50	15	49	15
Week 10	80	7*	82	7	45	12	41	11
Reduction		41%*		55%*		14%		28%
Erythema Score
Baseline	89	2.2	92	2.3	50	2.2	49	2.2
Week 10	80	1.3*	82	1.4*	45	1.7	40	1.8
Reduction		42%*		40%*		25%		19%

*Statistically significant differences between

Noritate

and vehicle groups with p≤0.05. Erythema scores: 0=none, 1=mild, 2=moderate and 3=severe.

Safety Studies:

Studies of contact sensitization (n=258), phototoxicity (n=21), and photocontact sensitization (n=29) of

Noritate

were conducted. No evidence of sensitization or phototoxicity was seen in these studies.

Pharmacokinetics:

When a one gram dose of

Noritate Cream, 1%,

Noritate^® (metronidazole cream) Cream, 1%,

contains metronidazole USP. Chemically, metronidazole is 2-methyl-5-nitro-1

-imidazole-1-ethanol. The molecular formula for metronidazole is C₆H₉N₃O₃. 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.

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