Metronidazole (Page 4 of 4)

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

DOSAGE AND ADMINISTRATION

Trichomoniasis:
In the Female:
One-day treatment − two grams of metronidazole tablets, 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 and 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 for 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 re-treatment.

In the Male: Treatment should be individualized as it is 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, intravenous 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.

Dosage Adjustment

Patients with Severe Hepatic Impairment

For patients with severe hepatic impairment (Child-Pugh C), the dose of metronidazole tablets should be reduced by 50% (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients Undergoing Hemodialysis:

Hemodialysis removes significant amounts of metronidazole and its metabolites from systemic circulation. The clearance of metronidazole will depend on the type of dialysis membrane used, the duration of the dialysis session, and other factors. If the administration of metronidazole cannot be separated from the hemodialysis session, supplementation of metronidazole dosage following the hemodialysis session should be considered, depending on the patient’s clinical situation (see CLINICAL PHARMACOLOGY).

HOW SUPPLIED

Product: 50090-4494

NDC: 50090-4494-0 4 TABLET in a BOTTLE

NDC: 50090-4494-3 14 TABLET in a BOTTLE

NDC: 50090-4494-4 21 TABLET in a BOTTLE

NDC: 50090-4494-6 28 TABLET in a BOTTLE

NDC: 50090-4494-9 20 TABLET in a BOTTLE

Storage and Stability: Store below 77°F (25°C) and protect from light.

Manufactured By:

Appco Pharma LLC

Piscataway, New Jersey 08854, USA.

Manufactured For:

Heritage Pharmaceuticals Inc.

East Brunswick, NJ 08816, USA.

1-866-901-DRUG (3784)

Revised: 04/2018 200192

METRONIDAZOLE

Label ImageLabel Image
METRONIDAZOLE metronidazole tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4494(NDC:23155-652)
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
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
SILICON DIOXIDE
COTTONSEED OIL
Product Characteristics
Color WHITE (White to Off-White) Score no score
Shape OVAL (Oval) Size 16mm
Flavor Imprint Code MCR;105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4494-0 4 TABLET in 1 BOTTLE None
2 NDC:50090-4494-3 14 TABLET in 1 BOTTLE None
3 NDC:50090-4494-4 21 TABLET in 1 BOTTLE None
4 NDC:50090-4494-6 28 TABLET in 1 BOTTLE None
5 NDC:50090-4494-9 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205245 11/29/2017
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4494), REPACK (50090-4494)

Revised: 09/2019 A-S Medication Solutions

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