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:

Heritage Pharmaceuticals Inc.

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 2 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [see Clinical Studies (14.1)] . 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 [see Clinical Studies (14.3)] . Ondansetron is approved for patients aged 1 month and older. Ondansetron In

Product summary:

Ondansetron Injection, USP, 2 mg/mL, is supplied as follows: NDC 23155-377-31                20-mL multidose vials (Singles) Storage: Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled  Room Temperature]. Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON HYDROCHLORIDE - ONDANSETRON HYDROCHLORIDE INJECTION,
SOLUTION
HERITAGE PHARMACEUTICALS INC.
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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 INJECTION, USP
ONDANSETRON INJECTION, USP FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Serotonin Syndrome (5.3) 09/2014
INDICATIONS AND USAGE
Ondansetron Injection is a 5-HT receptor antagonist indicated:
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)
DOSAGE AND ADMINISTRATION
Prevention of nausea and vomiting associated with initial and repeat
courses of emetogenic cancer chemotherapy (2.1):
• 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.
Prevention of postoperative nausea and/or vomiting (2.2):
PO PULATIO N
AG E
DOSAGE OF ONDANSETRON INJECTION
INTRAVENOUS INFUSION RATE
Adults
> 12 yrs
4 mg x 1
over 2 - 5 min
Pediatrics (> 40 kg)
1 mo. – 12 yrs
4 mg x 1
over 2 - 5 min
Pediatrics (≤ 40 kg)
1 mo. – 12 yrs
0.1 mg/kg x 1
over 2 - 5 min
In patients with severe hepatic impairment, a total daily dose of 8 mg
should not be exceeded. (2.4)
DOSAGE FORMS AND STRENGTHS
Ondansetron Injection (2 mg/mL): 20 mL multidose 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)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions including anaphylaxis and bronchospasm,
have been reported in patients who have exhibited
hypersensitivity to other selective 5-HT receptor antagonists. (5