국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
Rebel Distributors Corp
METRONIDAZOLE
METRONIDAZOLE 7.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Metronidazole topical gel USP, 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole topical gel USP, 0.75%, is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation. Safety and effectiveness in pediatric patients have not been established.
Metronidazole topical gel USP, 0.75%, is supplied as the following: NDC 42254-069-45: 45 g aluminum tube Storage conditions: Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 04584 Rev. 2 10/08 Manufactured by TOLMAR Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540
Abbreviated New Drug Application
METRONIDAZOLE- METRONIDAZOLE GEL REBEL DISTRIBUTORS CORP ---------- METRONIDAZOLE TOPICAL GEL USP, 0.75% Rx only FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE) DESCRIPTION Metronidazole topical gel USP, 0.75%, contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer 940, NF; edetate disodium, USP; methylparaben, NF; propylene glycol, USP; propylparaben, NF; purified water, USP; and sodium hydroxide, NF. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1_H_-imidazole-1-ethanol and has the following structure: CLINICAL PHARMACOLOGY Bioavailability studies on the topical administration of 1 gram of metronidazole topical gel USP, 0.75%, (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 metronidazole topical gel USP, 0.75%, acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. INDICATIONS & USAGE Metronidazole topical gel USP, 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. CONTRAINDICATIONS Metronidazole topical gel USP, 0.75%, is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation. PRECAUTIONS General: Metronidazol 전체 문서 읽기