Trimethobenzamide Hydrochloride

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 )

Trimethobenzamide hydrochloride capsules are contraindicated in patients with known hypersensitivity to trimethobenzamide [see Adverse Reactions ( 6 )] . Known hypersensitivity to trimethobenzamide ( 4 )

Acute Dystonic Reactions and Other Extrapyramidal Symptoms (EPS) : Depending on the severity of symptoms, reduce the dosage or discontinue the drug. Treat acute dystonic reactions with anticholinergics. Avoid trimethobenzamide hydrochloride capsules in patients receiving other drugs that are likely to cause EPS. ( 5.1 , 7.2 ) Masking of Other Serious Disorders : EPS and other CNS symptoms in patients treated with trimethobenzamide hydrochloride capsules may be confused with CNS signs of undiagnosed primary disease (e.g., encephalopathy, metabolic imbalance, Reye's Syndrome).

If CNS symptoms occur, evaluate the risks and benefits of continuing trimethobenzamide hydrochloride capsules. ( 5.2 , 7.2 ) Other CNS Reactions : Coma, depression of mood, disorientation, and seizures have been reported. The recent use of other drugs that cause CNS depression or EPS symptoms may also increase the risk; consider reducing the dosage or discontinuing the drug. ( 5.3 , 7.1 , 7.2 ) Hepatotoxicity : Avoid use in patients whose signs and symptoms suggest the presence of hepatic impairment.