ONDANSETRON HYDROCHLORIDE- 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:

INTRAMUSCULAR

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 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 is approved for patients aged 1 month

Product summary:

Ondansetron Injection, USP, 2 mg/mL, is supplied as follows: Unit of Sale Concentration Each NDC 0409-4755-01 Carton of 5 4 mg/2 mL (2 mg/mL) NDC 0409-4755-11 2 mL Single-Use Vials NDC 0409-4755-02 Carton of 10 4 mg/2 mL (2 mg/mL) NDC 0409-4755-12 2 mL Single-Use Vials NDC 0409-4755-03 Carton of 25 4 mg/2 mL (2 mg/mL) NDC 0409-4755-18 2 mL Single-Use Vials NDC 0409-4759-01 Carton of 1 40 mg/20 mL (2 mg/mL) NDC 0409-4759-01 20 mL Multi-dose Vials Storage: Store at 20 to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Product may also be stored in a refrigerator, 2 to 8°C (36 to 46°F). Retain in carton until time of use. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON HYDROCHLORIDE- 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 SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ONDANSETRON.
ONDANSETRON INJECTION, USP FOR INTRAVENOUS OR INTRAMUSCULAR USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.3) 9/2014
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):
PO PULATIO N
AG E
ONDANSETRON
INJECTION, USP
DO SAG E
INTRAVENOUS
INFUSION RATE
Adults
>12 yrs
4 mg x 1
over 2 - 5 min
Pe diatrics
(>40 kg)
1 mo. – 12 yrs
4 mg x 1
over 2 - 5 min
Pe diatrics
(≤40 kg)
1 mo. – 12 yrs
0.1 mg/kg x 1
over 2 - 5 min
•
DOSAGE FORMS AND STRENGTHS
Ondansetron Injection, USP (2 mg/mL): 2 mL single dose vial and 20 mL
multidose vials. (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 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 reported in patients who have
exhibited hypersensitiv