Application Nr Approved Date Route Status External Links
ANDA076546 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Trimethobenzamide Hydrochloride TRIMETHOBENZAMIDE HYDROCHLORIDE ZINC538509

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