METRONIDAZOLE tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

MedVantx, Inc.

INN (International Nazwa):

METRONIDAZOLE

Skład:

METRONIDAZOLE 500 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Metronidazole, USP 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, USP 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 t

Podsumowanie produktu:

Metronidazole tablets USP are available as follows: 250 mg - White, round, convex tablets debossed “PLIVA 333 ” on one side and unscored on the other side. Available in bottles of 100, 250 and 500. 500 mg - White, oblong, convex tablets debossed “PLIVA 334 ”  on one side and unscored on the other side. 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. Manufactured In Czech Republic By: TEVA CZECH INDUSTRIES s.r.o. Opava-Komarov, Czech Republic Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. A 6/2011

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

METRONIDAZOLE- METRONIDAZOLE TABLET
MEDVANTX, INC.
----------
METRONIDAZOLE TABLETS USP
333
334
Rev. A 6/2011
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of metronidazole
and other antibacterial drugs, metronidazole 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, USP is an oral synthetic antiprotozoal and
antibacterial agent, 1-(β-hydroxyethyl)-2-
methyl-5-nitroimidazole, which has the following structural formula:
C6H9N3O3 M.W. 171.15
Each tablet for oral administration contains 250 mg or 500 mg of
metronidazole, USP. 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
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 i