Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
Fougera Pharmaceuticals Inc.
METRONIDAZOLE
METRONIDAZOLE 7.5 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. Metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.
Metronidazole Gel USP 0.75% is supplied as follows: 45 gram tube NDC 0168-0275-45 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I2275D R07/13 #87
Abbreviated New Drug Application
METRONIDAZOLE- METRONIDAZOLE GEL FOUGERA PHARMACEUTICALS INC. ---------- METRONIDAZOLE GEL USP 0.75% FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. RX ONLY INDICATIONS AND USAGE Metronidazole gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea. DOSAGE AND ADMINISTRATION Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel. CONTRAINDICATIONS Metronidazole gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation. PRECAUTIONS: GENERAL: Metronidazole gel 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. DRUG INTERACTIONS: Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin 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. Metronidazole has shown evidence of mutagenic activity in several _in vitro_ bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberration Prečítajte si celý dokument