Application Nr Approved Date Route Status External Links
ANDA206396 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Palonosetron Hydrochloride Injection Is Indicated In Adults For Prevention Of: ● Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy (mec). ● Acute Nausea And Vomiting Associated With Initial And Repeat Courses Highly Emetogenic Cancer Chemotherapy (hec). ● Postoperative Nausea And Vomiting (ponv) For Up To 24 Hours Following Surgery. Efficacy Beyond 24 Hours Has Not Been Demonstrated. As With Other Antiemetics, Routine Prophylaxis Is Not Recommended In Patients In Whom There Is Little Expectation That Nausea And/or Vomiting Will Occur Postoperatively. In Patients Where Nausea And Vomiting Must Be Avoided During The Postoperative Period, Palonosetron Hydrochloride Is Recommended Even Where The Incidence Of Postoperative Nausea And/or Vomiting Is Low. Palonosetron Hydrochloride Injection Is Indicated In Pediatric Patients 1 Month To Less Than 17 Years Of Age For Prevention Of: ● Acute Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy, Including Highly Emetogenic Cancer Chemotherapy. Palonosetron Hydrochloride Is A Serotonin-3 (5-Ht 3 ) Receptor Antagonist Indicated In: Adults For Prevention Of : Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Of Moderately Emetogenic Cancer Chemotherapy (mec). ( 1 ) Acute Nausea And Vomiting Associated With Initial And Repeat Courses Of Highly Emetogenic Cancer Chemotherapy (hec). ( 1 ) Postoperative Nausea And Vomiting (ponv) For Up To 24 Hours Following Surgery. Efficacy Beyond 24 Hours Has Not Been Demonstrated ( 1 ) Pediatric Patients Aged 1 Month To Less Than 17 Years For Prevention Of: Acute Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy, Including Highly Emetogenic Cancer Chemotherapy (hec). ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Palonosetron Hydrochloride PALONOSETRON HYDROCHLORIDE ZINC3795819

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