Trimethobenzamide hydrochloride

Trimethobenzamide hydrochloride capsules are indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.

The recommended adult dosage is 300 mg orally three or four times daily. ( 2.1) Geriatric patients and/or patients with renal impairment (creatinine clearance 70 mL/min/1.73m 2or less): Reduce the daily dosage by increasing the dosing interval; monitor renal function. ( 2.2, 8.5, 8.6) Select the lowest effective daily dosage and adjust as needed based upon therapeutic response and tolerability.

The following adverse reactions from voluntary reports or clinical studies have been reported with trimethobenzamide. Because many of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

Alcohol:May cause drowsiness; avoid concomitant use. ( 7.1) Other Drugs that Cause CNS Depression or EPS:Either trimethobenzamide hydrochloride capsules or the other interacting drug should be chosen, depending on the importance of the drug to the patient. If CNS-acting drugs cannot be avoided, monitor patients for CNS adverse reactions.

Trimethobenzamide Hydrochloride Capsules, USP are available as a capsule for oral use with an size 1 , two-piece purple opaque cap and purple opaque body, hard gelatin capsules, printed in white with HP on cap and in white with 180 on body, filled with white to off-white granular powder. Each capsule contains 300 mg of trimethobenzamide hydrochloride.