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----------Metronidazole Topical Cream 0.75%
FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)
Vitazol™ Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
INDICATIONS AND USAGE:
Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.
Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.
Information for patients:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
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.
Carcinogenesis, mutagenesis, impairment of fertility:
Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.
Teratogenic effects: Pregnancy category B
After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of 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.
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.
DOSAGE AND ADMINISTRATION:
Apply and rub in a thin layer of Vitazol™ 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 Vitazol™ Metronidazole Topical Cream.
Vitazol™ Metronidazole Topical Cream, 0.75% is supplied in a 60 g tube - NDC 49908-100-60.
FOR TOPICAL USE ONLY - NOT FOR OPHTHALMIC USE. RX only NDC 49908-100-60
Revised: 12/2009 Rochester Pharmaceuticals
Reproduced with permission of U.S. National Library of Medicine
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