Rosadan Gel
Generic name:metronidazole
Dosage form: topical gel
Drug class:Topical anti-rosacea agents
Medically reviewed by Drugs.com. Last updated on Oct 22, 2021.
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FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)
Rx Only
Rosadan Gel Description
Rosadan® (metronidazole) Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent.
Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:
Rosadan Gel - Clinical Pharmacology
Bioavailability studies on the topical administration of 1 gram of Rosadan® (metronidazole) Gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which Rosadan® (metronidazole) Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
Indications and Usage for Rosadan Gel
Rosadan® (metronidazole) Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
Contraindications
Rosadan® (metronidazole) Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.
