País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
Aidarex Pharmaceuticals LLC
METRONIDAZOLE
METRONIDAZOLE 500 mg
ORAL
PRESCRIPTION DRUG
Symptomatic Trichomoniasis Metronidazole tablets USP are indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis Metronidazole tablets USP are indicated in the treatment of asymptomatic females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatment of Asymptomatic Consorts T. vaginalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture
Metronidazole tablets USP, 500 mg are available as oblong, scored, white compressed tablets debossed with “WPI” on one side and “39” - “70” on the other side and are packaged in bottles of 14, 20, 21 and 30. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed by: Watson Pharma, Inc. Parsippany, NJ 07054 USA Repackaged By : Aidarex Pharmaceuticals LLC, Corona, CA 92880 Revised: April 2013
Abbreviated New Drug Application
METRONIDAZOLE- METRONIDAZOLE TABLET AIDAREX PHARMACEUTICALS LLC ---------- METRONIDAZOLE TABLETS USP 250 MG AND 500 MG REVISED: APRIL 2013 RX ONLY To reduce the development of drug-resistant bacteria and maintain the effectiveness of metronidazole tablets USP and other antibacterial drugs, metronidazole tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. WARNING Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS.) Unnecessary use of the drug should be avoided. Its use should be reserved for the conditions described in the INDICATIONS AND USAGE section below. DESCRIPTION Metronidazole is an oral synthetic antiprotozoal and antibacterial agent, 1-(β-hydroxyethyl)-2-methyl-5- nitroimidazole, which has the following structural formula: Metronidazole 250 mg and 500 mg tablets USP, for oral administration, contain the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, lactose (anhydrous), microcrystalline cellulose, sodium starch glycolate, and stearic acid. CLINICAL PHARMACOLOGY Disposition of metronidazole in the body is similar for both oral and intravenous dosage forms, with an average elimination half-life in healthy humans of eight hours. The major route of elimination of metronidazole and its metabolites is via the urine (60 to 80% of the dose), with fecal excretion accounting for 6 to 15% of the dose. The metabolites that appear in the urine result primarily from side- chain oxidation [1-(ß-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole- 1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Renal clearance of metronidazole is approximately 10 mL/min/1.73 m . Metronidazole is the major component appearing in the plasma, with lesser quantities of the 2- 2 hydroxymethyl metabolite also being present. Less than 20% of the circulating metronidazole is bound to plasma proteins. Both the par Llegiu el document complet