PALONOSETRON HYDROCHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PALONOSETRON HYDROCHLORIDE (UNII: 23310D4I19) (PALONOSETRON - UNII:5D06587D6R)

Available from:

Sandoz Inc

INN (International Name):

PALONOSETRON HYDROCHLORIDE

Composition:

PALONOSETRON 0.25 mg in 5 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Palonosetron 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 is recommended even where the incidence of postoperative nausea and/or vomiting is low. Palonosetron HCl 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 chemoth

Product summary:

Palonosetron HCl injection is supplied as a sterile, clear and colorless solution: NDC 0781-3312-75: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose vial individually packaged in a carton. Storage

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PALONOSETRON HYDROCHLORIDE- PALONOSETRON HYDROCHLORIDE INJECTION,
SOLUTION
SANDOZ INC
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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 HCL INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Palonosetron 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
*Note different dosing units in pediatrics
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
Injection: 0.25 mg palonosetron in 5 mL (0.05 mg/mL) in a single-dose
vial. ( 3)
CONTRAINDICATIONS
Hypersensitivity to palonosetron or any of its components. ( 4)
WARNINGS AND PRECAUTIONS
Hypersensitivity react