Metronidazole (Page 3 of 3)

OVERDOSAGE

Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia.

Oral metronidazole has been studied as a radiation sensitizer in the treatment of malignant tumors. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.

Treatment

There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.

DOSAGE AND ADMINISTRATION

In elderly patients, the pharmacokinetics of metronidazole may be altered, and, therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

Trichomoniasis

In the Female

One-day treatment— two grams of metronidazole, given either as a single dose or in two divided doses of one gram each given in the same day.

Seven-day course of treatment— 250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears, signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen.

The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.

Pregnant patients should not be treated during the first trimester. (See CONTRAINDICATIONS.) In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy).

When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after retreatment.

In the Male

Treatment should beindividualized as for the female.

Amebiasis

Adults

For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.

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 250 mg are 11/32״ , unscored, round, white to off-white tablets imprinted DAN and 5540 supplied in:

NDC 54868-0108-2 Bottles of 10
NDC 54868-0108-8 Bottles of 14
NDC 54868-0108-3 Bottles of 20
NDC 54868-0108-1 Bottles of 21
NDC 54868-0108-6 Bottles of 30
NDC 54868-0108-7 Bottles of 100

Metronidazole Tablets USP 500 mg are 17/32״ , scored, round, white to off-white tablets imprinted DAN and 5552 supplied in:

NDC 54868-0158-3 Bottles of 10
NDC 54868-0158-1 Bottles of 14
NDC 54868-0158-5 Bottles of 20
NDC 54868-0158-0 Bottles of 21
NDC 54868-0158-8 Bottles of 30
NDC 54868-0158-6 Bottles of 40
NDC54868-0158-2 Bottles of 4

Dispense in a well-closed, light-resistant container with child-resistant closure.

Store below 86°F (30°C).

Protect from light.

  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.

Relabeling and Repackaging by:

Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL

Metronidazole Tablets USP

250 mg

image of 250 mg package label
(click image for full-size original)

Metronidazole Tablets USP

500 mg

image of 500 mg package label
(click image for full-size original)
METRONIDAZOLE metronidazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0108(NDC:0591-5540)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METRONIDAZOLE (METRONIDAZOLE) METRONIDAZOLE 250 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (White to off-whtie) Score no score
Shape ROUND Size 9mm
Flavor Imprint Code DAN;5540
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0108-1 21 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0108-2 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0108-3 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-0108-6 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-0108-7 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:54868-0108-8 14 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018764 10/17/1996
METRONIDAZOLE metronidazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-0158(NDC:0591-5552)
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
SILICON DIOXIDE
CROSPOVIDONE
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color white (White to off-white) Score 2 pieces
Shape ROUND Size 14mm
Flavor Imprint Code DAN;5552
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-0158-0 21 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-0158-1 14 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-0158-3 10 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-0158-5 20 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-0158-6 40 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
6 NDC:54868-0158-8 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
7 NDC:54868-0158-2 4 TABLET (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018764 04/24/1995
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-0108), relabel (54868-0158), repack (54868-0108), repack (54868-0158)

Revised: 07/2013 Physicians Total Care, Inc.

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