PALONOSETRON injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Palonosetron Hydrochloride (UNII: 23310D4I19) (palonosetron - UNII:5D06587D6R)

Available from:

Dr.Reddy's Laboratories Limited

INN (International Name):

Palonosetron Hydrochloride

Composition:

palonosetron 0.05 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 repea

Product summary:

Palonosetron hydrochloride injection is supplied as a sterile, clear and colorless solution: Storage

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PALONOSETRON- PALONOSETRON INJECTION, SOLUTION
DR.REDDY'S LABORATORIES LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PALONOSETRON HYDROCHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
PALONOSETRON HYDROCHLORIDE
INJECTION.
PALONOSETRON HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Palonosetron hydrochloride injection is a serotonin-3 (5-HT ) 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)
DOSAGE AND ADMINISTRATION
Chemotherapy-Induced Nausea and Vomiting (2.1)
*
Age
Dose
Infusion Time
Adults
0.25 MG as a single dose
Infuse over 30 SECONDS beginning approximately 30
minutes before the start of chemotherapy
Pediatrics
(1 month to less
than 17 years)
20 MICROGRAMS PER
KILOGRAM (maximum 1.5 mg) as a single
dose
Infuse over 15 MINUTES beginning approximately 30
minutes before the start of chemotherapy
Postoperative Nausea and Vomiting (2.1)
The recommended adult dosage is 0.075 mg as a single intravenous dose
administered over 10 seconds immediately
before the induction of anesthesia.
DOSAGE FORMS AND STRENGTHS
Inje ction:
0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial (3)
0.075 mg palonosetron in 1.5 mL (0.05 mg/mL) single-dose vial (3)
CONTRAINDICATIONS
Hypersensitivity to palonosetron or any of its components (4)
WARN