trimethobenzamide hydrochloride
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.