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
1 INDICATIONS AND USAGE Trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. Limitation of Use: Trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects, and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment. Trimethobenzamide hydrochloride capsules are an antiemetic indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. ( 1 ) Limitation of Use: • Trimethobenzamide hydrochloride capsules are not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (CNS) effects and the risk of exacerbation of the underlying disease in pediatric patients with Reye's syndrome or other hepatic impairment. ( 1 , 8.4 )