Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Metronidazole topical cream, 0.75% is white to off-white homogeneous cream, free from lumps, free from gritty particles and foreign matter without phase separation and is supplied as follows: 45 gram aluminum tube NDC 68788-8552-4 Storage conditions: Store at 20°C to 25°C (68ºF to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68788-8552-4 Metronidazole Topical Cream, 0.75% Rx only 45 g Viona Relabeled By: Preferred Pharmaceuticals Inc. Metronidazole Topical Cream 0.75%
- HOW SUPPLIED Metronidazole topical cream, 0.75% is white to off-white homogeneous cream, free from lumps, free from gritty particles and foreign matter without phase separation and is supplied as follows: 45 gram aluminum tube NDC 68788-8552-4 Storage conditions: Store at 20°C to 25°C (68ºF to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68788-8552-4 Metronidazole Topical Cream, 0.75% Rx only 45 g Viona Relabeled By: Preferred Pharmaceuticals Inc. Metronidazole Topical Cream 0.75%
Overview
Metronidazole topical cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of benzyl alcohol, emulsifying wax, glycerin, isopropyl palmitate, purified water, sorbitol solution, lactic acid and sodium hydroxide to adjust pH. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H -imidazole-1-ethanol. The molecular formula is C 6 H 9 N 3 O 3 and molecular weight is 171.15. Metronidazole is represented by the following structural formula: Image
Indications & Usage
Metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Dosage & Administration
Apply and rub in a thin layer of metronidazole topical cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of metronidazole topical cream.
Warnings & Precautions
No warnings available yet.
Contraindications
Metronidazole topical cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
Adverse Reactions
In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea. To report SUSPECTED ADVERSE REACTIONS, contact Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
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