Aprepitant

Product manufactured by Sandoz Inc

Application Nr Approved Date Route Status External Links
ANDA090999 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Aprepitant Is A Substance P/neurokinin 1 (Nk 1 ) Receptor Antagonist, Indicated: • In Combination With Other Antiemetic Agents For Prevention Of : • Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Of Highly Emetogenic Cancer Chemotherapy (Hec) Including High-Dose Cisplatin ( 1.1 ) • Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy (Mec) ( 1.1 ) • For Prevention Of Postoperative Nausea And Vomiting (Ponv) In Adults ( 1.2 ) Limitations Of Use ( 1.3 ) • Aprepitant Capsules Have Not Been Studied For Treatment Of Established Nausea And Vomiting. • Chronic Continuous Administration Of Aprepitant Capsules Are Not Recommended. 1.1 Prevention Of Chemotherapy Induced Nausea And Vomiting (Cinv) Aprepitant Capsules, In Combination With Other Antiemetic Agents, Are Indicated For The Prevention Of: • Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Of Highly Emetogenic Cancer Chemotherapy (Hec) Including High-Dose Cisplatin. • Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy (Mec). Pediatric Use Information Is Approved For Merck Sharp & Dohme Corp.’s Emend ® (Aprepitant) Capsules. However, Due To Merck Sharp & Dohme Corp’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Information. 1.2 Prevention Of Postoperative Nausea And Vomiting (Ponv) Aprepitant Capsules Are Indicated In Adults For The Prevention Of Postoperative Nausea And Vomiting. 1.3 Limitations Of Use • Aprepitant Capsules Have Not Been Studied For The Treatment Of Established Nausea And Vomiting. • Chronic Continuous Administration Of Aprepitant Capsules Is Not Recommended Because It Has Not Been Studied, And Because The Drug Interaction Profile May Change During Chronic Continuous Use.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Aprepitant APREPITANT ZINC27428713

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