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.

______________________________________________________________________________

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 500mg Tablets #14
(click image for full-size original)

Metronidazole Tablets USP, 500 mg 100 Tablets Label Text

NDC 50111-334- 01
METRONIDAZOLE
Tablets USP
500 mg

Rx only

100 TABLETS

TEVA

METRONIDAZOLE
metronidazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-601(NDC:50111-334)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
SILICON DIOXIDE
HYDROGENATED COTTONSEED OIL
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong) Size 16mm
Flavor Imprint Code PLIVA;334
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-601-14 14 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070033 09/30/1990
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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