País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)
H.J. Harkins Company, Inc.
METRONIDAZOLE
METRONIDAZOLE 250 mg
ORAL
PRESCRIPTION DRUG
Metronidazole is 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). Metronidazole is 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. 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 or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there
Metronidazole Tablets USP: 250 mg - White, round, convex, unscored tablets debossed on one side with PLIVA 333 . Available in bottles of 100, 250 and 500. 500 mg - White, oblong, convex, unscored tablets debossed on one side with PLIVA 334 . Available in bottles of 100 and 500. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. ______________________________________________________________________________ 1. Proposed standard: PSM-11-Proposed Reference Dilution Procedure for Antimicrobic Susceptibility Testing of Anaerobic Bacteria, National Committee for Clinical Laboratory Standards; and Sutter, et al.: Collaborative Evaluation of a Proposed Reference Dilution Method of Susceptibility Testing of Anaerobic Bacteria, Antimicrob. Agents Chemother. 16:495-502 (Oct.) 1979; and Tally, et al.: In Vitro Activity of Thienamycin, Antimicrob. Agents Chemother. 14:436-438 (Sept.) 1978. 2. Ralph, E.D., and Kirby, W.M.M.: Bioassay of Metronidazole With Either Anaerobic or Aerobic Incubation, J. Infect. Dis. 132:587-591 (Nov.) 1975; or Gulaid, et al.: Determination of Metronidazole and Its Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography, Br. J. Clin. Pharmacol. 6:430-432, 1978. Rx only Manufactured in Poland By: PLIVA Krakow Pharmaceutical Company S.A. Krakow, Poland Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 11001717 Iss. 9/2010 Repacked by: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444
Abbreviated New Drug Application
METRONIDAZOLE - METRONIDAZOLE TABLET H.J. HARKINS COMPANY, INC. ---------- METRONIDAZOLE TABLETS USP WARNING: Metronidazole has been shown to be carcinogenic in mice and rats. (See PRECAUTIONS.) Unnecessary use of this 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: Each tablet for oral administration contains 250 mg or 500 mg of metronidazole. Inactive ingredients include microcrystalline cellulose, crospovidone, colloidal silicon dioxide and hydrogenated vegetable oil. 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-(β-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- hydroxymethyl metabolite also being present. Less than 20% of the circulating metronidazole is bound to plasma proteins. Both the parent compound and the metabolite possess _in vitro_ bactericidal activity against most strains of anaerobic bacteria and _in vitro _trichomonacidal activity. Metronidazole appears in cerebrospinal fluid, saliva, and human milk in concentrations similar to those found in plasma. Bactericidal concentrations of metronidazole have also been detected in pus from hepatic absce Leer el documento completo