METRONIDAZOLE tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

METRONIDAZOLE (UNII: 140QMO216E) (METRONIDAZOLE - UNII:140QMO216E)

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

METRONIDAZOLE

Sammensetning:

METRONIDAZOLE 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Metronidazole Tablets USP: 250 mg - White, round, convex, unscored tablets debossed on one side with PLIVA 333 . Available in bottles of 21, 28 and 30. 500 mg - White, oblong, convex, unscored tablets debossed on one side with PLIVA 334 . Available in bottles of 14, 15, 16, 20, 21, 28, 30 and 56. 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 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METRONIDAZOLE- METRONIDAZOLE TABLET
REBEL DISTRIBUTORS CORP
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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 abscesses