Application Nr Approved Date Route Status External Links
ANDA205870 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 A Serotonin-3 (5-Ht 3 ) Receptor Antagonist Indicated In Adults For: Moderately Emetogenic Cancer Chemotherapy -- Prevention Of Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses ( 1.1 ) Highly Emetogenic Cancer Chemotherapy -- Prevention Of Acute Nausea And Vomiting Associated With Initial And Repeat Courses ( 1.1 ) Prevention Of Postoperative Nausea And Vomiting (ponv) For Up To 24 Hours Following Surgery. Efficacy Beyond 24 Hours Has Not Been Demonstrated ( 1.3 ) Palonosetron Hydrochloride Injection Is Indicated In 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 ( 1.2 ) 1.1 Chemotherapy-Induced Nausea And Vomiting In Adults Palonosetron Hydrochloride Injection Is Indicated For: Moderately Emetogenic Cancer Chemotherapy -- Prevention Of Acute And Delayed Nausea And Vomiting Associated With Initial And Repeat Courses Highly Emetogenic Cancer Chemotherapy -- Prevention Of Acute Nausea And Vomiting Associated With Initial And Repeat Courses 1.2 Chemotherapy-Induced Nausea And Vomiting In Pediatric Patients Aged 1 Month To Less Than 17 Years Palonosetron Hydrochloride Injection Is Indicated For Prevention Of Acute Nausea And Vomiting Associated With Initial And Repeat Courses Of Emetogenic Cancer Chemotherapy, Including Highly Emetogenic Cancer Chemotherapy. 1.3 Postoperative Nausea And Vomiting In Adults Palonosetron Hydrochloride Injection Is Indicated For Prevention Of 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 Injection Is Recommended Even Where The Incidence Of Postoperative Nausea And/or Vomiting Is Low.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

Comments