trimethobenzamide hydrochloride

FDA Drug Profile — Tigan

Drug Details

Generic Name
trimethobenzamide hydrochloride
Brand Names
Tigan
Application Number
NDA017530
Sponsor
Par Health USA, LLC
NDC Codes
1
Dosage Forms
INJECTION
Routes
INTRAMUSCULAR
Active Ingredients
TRIMETHOBENZAMIDE HYDROCHLORIDE

Indications and Usage

INDICATIONS Tigan® is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

Warnings

WARNINGS Tigan® may produce drowsiness. Patients should not operate motor vehicles or other dangerous machinery until their individual responses have been determined. Usage in Pregnancy Trimethobenzamide hydrochloride was studied in reproduction experiments in rats and rabbits and no teratogenicity was suggested. The only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg and 100 mg/kg and increased resorptions in rabbits receiving 100 mg/kg. In each study these adverse effects were attributed to one or two dams. The relevance to humans is not known. Since there is no adequate experience in pregnant or lactating women who have received this drug, safety in pregnancy or in nursing mothers has not been established. Usage with Alcohol Concomitant use of alcohol with Tigan® may result in an adverse drug interaction.