ONDANSETRON- ondansetron hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cardinal Health

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [see Clinical Studies (14.1)]. Ondansetron injection, USP 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 [see Clinical Studies (14.3)]. Ondansetron injection, USP

Product summary:

Ondansetron Injection USP, 4 mg/2 mL (2 mg/mL), is supplied as follows: Overbagged with 5 x Ondansetron Injection USP, 4 mg/2 mL (2 mg/mL) 2 mL Single-dose Vials, NDC 55154-8329-5 The vial stopper is not made with natural rubber latex. Store between 2° and 30°C (36° and 86°F). Protect from light. Protect from freezing. Retain in carton until time of use.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON- ONDANSETRON HYDROCHLORIDE INJECTION, SOLUTION
CARDINAL HEALTH
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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.
ONDANSETRON INJECTION, USP FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.3) 09/2014
INDICATIONS AND USAGE
Ondansetron injection, USP is a 5-HT receptor antagonist indicated:
•
•
DOSAGE AND ADMINISTRATION
Prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy (2.1):
•
Prevention of Postoperative Nausea and/or Vomiting (2.2):
POPULATION
AGE
DOSAGE OF ONDANSETRON
INJECTION
INTRAVENOUS INFUSION RATE
Adults
> 12 yrs
4 mg x 1
over 2 to 5 min
Pe diatrics
(> 40 kg)
1 mo. to 12 yrs
4 mg x 1
over 2 to 5 min
Pe diatrics
(≤ 40 kg)
1 mo. to 12 yrs
0.1 mg/kg x 1
over 2 to 5 min
•
DOSAGE FORMS AND STRENGTHS
Ondansetron injection (2 mg/mL): 2 mL single dose vial. (3)
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Chemotherapy-Induced Nausea and Vomiting –
•
3
Prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy.
(1.1)
Prevention of postoperative nausea and/or vomiting. (1.2)
Adults and Pediatric patients (6 months to 18 years): Three 0.15 mg/kg
doses, up to a maximum of 16 mg per dose,
infused intravenously over 15 minutes. The first dose should be
administered 30 minutes before the start of
chemotherapy. Subsequent doses are administered 4 and 8 hours after
the first dose.
In patients with severe hepatic impairment, a total daily dose of 8 mg
should not be exceeded. (2.4)
Patients known to have hypersensitivity (e.g., anaphylaxis) to this
product or any of its components. (4)
Concomitant use of apomorphine. (4)
Hypersensitivity reactions including anaphylaxis and bronchospasm,
have been r