ONDANSETRON injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

ONDANSETRON HYDROCHLORIDE (UNII: NMH84OZK2B) (ONDANSETRON - UNII:4AF302ESOS)

Disponível em:

West-Ward Pharmaceuticals Corp

DCI (Denominação Comum Internacional):

ONDANSETRON HYDROCHLORIDE

Composição:

ONDANSETRON 2 mg in 1 mL

Via de administração:

INTRAMUSCULAR

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Ondansetron Injection, USP is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. Ondansetron is approved for patients aged 6 months and older. Ondansetron Injection, USP is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/‌or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection, USP is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection, USP and experience nausea and/or vomiting postoperatively, Ondansetron Injection, USP may be given to prevent further episodes. Ondansetron Injection, USP is approved for patients aged 1 month and older. Ondansetron injection is contraindica

Resumo do produto:

Ondansetron Injection, USP 2 mg/mL, is supplied as follows: NDC 0143-9891-25  2 mL single dose vials (Carton of 25) NDC 0143-9890-01 20 mL multi dose vial (Carton of 1) NDC 0143-9890-10 20 mL multi dose vial (Carton of 10) Storage: Store vials between 20° to 25ºC (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

ONDANSETRON- ONDANSETRON INJECTION
WEST-WARD PHARMACEUTICALS CORP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON INJECTION, USP SAFELY AND
E FFE C TIVE LY.
SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON INJECTION, USP
ONDANSETRON INJECTION, USP FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ondansetron Injection, USP is a 5-HT receptor antagonist indicated for
the prevention of:
• nausea and vomiting associated with initial and repeat courses of
emetogenic cancer chemotherapy. (1.1)
• postoperative nausea and/or vomiting. (1.2)
DOSAGE AND ADMINISTRATION
Prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy (2.1):
Dilution of Ondansetron Injection, USP in 50 mL of 5% Dextrose
Injection or 0.9% Sodium Chloride Injection is
required before administration to adult and pediatric patients.
Adults and pediatric patients 6 months of age and older: The
recommended dosage is 0.15 mg/kg per dose for 3 doses
(maximum of 16 mg per dose), infused intravenously over 15 minutes.
Administer the first dose 30 minutes before the start of chemotherapy
and subsequent doses 4 and 8 hours after the
first dose.
Prevention of postoperative nausea and/or vomiting (2.2):
Dilution of Ondansetron Injection, USP is not required before
administration to adult and pediatric patients.
See full prescribing information for the recommended dosage and
administration instructions for adult and pediatric
patients 1 month of age and older.
Patients with severe hepatic impairment (2.3):
Do not exceed a total daily dose of 8 mg.
DOSAGE FORMS AND STRENGTHS
Ondansetron Injection (2 mg/mL): 2 mL single dose vial and 20 mL
multiple dose vials. (3)
CONTRAINDICATIONS
• Patients known to have hypersensitivity (e.g., anaphylaxis) to
this product or any of its components. (4)
• Concomitant use of apomorphine. (4, 7.2)
WARNINGS AND PRECAUTIONS
• Hypersensitivity reactions includ