ONDANSETRON- ondansetron hydrochloride injection, solution

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Fresenius Kabi USA, LLC

INN (Isem Internazzjonali):

ONDANSETRON HYDROCHLORIDE

Kompożizzjoni:

ONDANSETRON 4 mg in 2 mL

Rotta amministrattiva:

INTRAVENOUS

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Ondansetron Injection 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 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 is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection and experience nausea and/or vomiting postoperatively, Ondansetron Injection may be given to prevent further episodes. Ondansetron is approved for patients aged 1 month and older. Ondansetron Injection is contraindicated for patients known to have hypersensi

Sommarju tal-prodott:

Ondansetron Injection, USP 2 mg/mL is available as: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Product may also be stored in a refrigerator 2°C to 8°C (36°F to 46°F). Protect from light. DO NOT DILUTE FOR IV PUSH. Do NOT place syringe on a Sterile Field.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

ONDANSETRON - ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ONDANSETRON INJECTION, USP.
ONDANSETRON INJECTION FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1991
RX ONLY
RECENT MAJOR CHANGES
Warnings and Precautions, Myocardial Ischemia (5.4)
10/2021
INDICATIONS AND USAGE
Ondansetron Injection 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 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):
Do not administer a full prefilled syringe (4 mg dose) to pediatric
patients less than 40 kg as this
exceeds the recommended dose.
Dilution of Ondansetron Injection 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, USP (2 mg/mL): 2 mL Prefilled disposable
single-use syringe (3)
CONTRAINDICATIONS
Patients known to