Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
Prasco Laboratories
METRONIDAZOLE
METRONIDAZOLE 7.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole Topical Lotion is contraindicated in individuals with a history of hypersensitivity to metronidazole or to other ingredients of the formulation.
Metronidazole Topical Lotion, 0.75% is supplied in the following size: 2 fl. oz. (59 mL) plastic bottle – NDC 66993-961-59 Store at controlled room temperature 68° - 77°F (20° - 25°C). Protect from freezing. Marketed By: Prasco Laboratories Mason, OH 45040 USA Made in Canada P53362-0 Revised: January 2017
New Drug Application Authorized Generic
METRONIDAZOLE- METRONIDAZOLE LOTION PRASCO LABORATORIES ---------- METRONIDAZOLE TOPICAL LOTION, 0.75% RX ONLY FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE) DESCRIPTION Metronidazole Topical Lotion contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75% w/w) in a lotion consisting of benzyl alcohol, carbomer 941, cyclomethicone, glycerin, glyceryl stearate, light mineral oil, PEG-100 stearate, polyethylene glycol 400, potassium sorbate, purified water, steareth-21, stearyl alcohol, and sodium hydroxide and/or lactic acid to adjust pH. Metronidazole is an imidazole and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1_H_-imidazole-1-ethanol. The molecular formula is C H N O and molecular weight is 171.16. Metronidazole is represented by the following structural formula: CLINICAL PHARMACOLOGY The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect. _PHARMACOKINETICS:_ Absorption of metronidazole after topical application of Metronidazole Topical Lotion is less complete and more prolonged than after oral administration. Detectable plasma levels were found in all subjects following the administration of a 1 gram dose of Metronidazole Topical Lotion (containing 7.5 mg of metronidazole) applied every morning and evening for 4 days to the faces of 8 patients. The highest concentration (96 ng/mL) seen following the morning dose on Day 5 was approximately 80 times lower than the peak concentrations produced by a single 250 mg tablet of metronidazole. The mean (± SD) AUC after twice daily administration was 962 ± 373 ng.hr/mL. INDICATIONS AND USAGE 6 9 3 3 0-24 Metronidazole Topical Lotion is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. CLINICAL STUDIES A controlled clinical study was conducted in 144 patients with moderate to severe rosacea, in which Metronidazole Topical Lotion was compared with its Przeczytaj cały dokument