Metronidazole (Page 4 of 4)
For amebic liver abscess
500 mg or 750 mg orally three times daily for 5 to 10 days.
Pediatric Patients
35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.
Anaerobic Bacterial Infections
In the treatment of most serious anaerobic infections, the intravenous form of metronidazole is usually administered initially.
The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.
The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.
Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels2 and toxicity is recommended.
The dose of metronidazole should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.
HOW SUPPLIED
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.
Storage and Stability
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.
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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
PRINCIPAL DISPLAY PANEL
Metronidazole Tablets USP, 500 mg 100 Tablets Label Text
NDC 50111-334- 01
METRONIDAZOLE
Tablets USP
500 mg
Rx only
100 TABLETS
TEVA
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Labeler — MedVantx, Inc. (806427725) |
Registrant — Pliva Inc. (824750777) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Blenheim Pharmacal, Inc. | 171434587 | REPACK (66116-601) |
Revised: 07/2012 MedVantx, Inc.
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