ZOFRAN- ondansetron hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Novartis Pharmaceuticals Corporation

INN (International Name):

ONDANSETRON

Composition:

ONDANSETRON 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ZOFRAN is indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 - initial and repeat courses of moderately emetogenic cancer chemotherapy - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen ZOFRAN is also indicated for the prevention of postoperative nausea and/or vomiting. ZOFRAN is contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see Adverse Reactions (6.2)] - receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness Risk Summary Published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude conclusions about the safety of ondansetron use in pre

Product summary:

ZOFRAN Tablets Store between 2°C and 30°C (36°F and 86°F). Protect from light. Dispense in tight, light-resistant container as defined in the USP. Store between 2°C and 30°C (36°F and 86°F). Protect from light. Dispense in tight, light-resistant container as defined in the USP. ZOFRAN ODT Orally Disintegrating Tablets Store between 2°C and 30°C (36°F and 86°F). ZOFRAN Oral Solution Store upright between 15°C and 30°C (59°F and 86°F). Protect from light. Store bottles upright in cartons.

Authorization status:

New Drug Application

Summary of Product characteristics

ZOFRAN- ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOFRAN TABLETS,
ZOFRAN ODT, AND ZOFRAN ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR ZOFRAN TABLETS, ZOFRAN ODT, AND ZOFRAN ORAL SOLUTION.
ZOFRAN (ONDANSETRON HYDROCHLORIDE) TABLETS, FOR ORAL USE
ZOFRAN ODT (ONDANSETRON) ORALLY DISINTEGRATING TABLETS
ZOFRAN (ONDANSETRON HYDROCHLORIDE) ORAL SOLUTION
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Myocardial Ischemia (5.4)
10/2021
INDICATIONS AND USAGE
ZOFRAN is a 5-HT receptor antagonist indicated for the prevention of:
nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin
greater than or equal to 50 mg/m . (1)
nausea and vomiting associated with initial and repeat courses of
moderately emetogenic cancer
chemotherapy. (1)
nausea and vomiting associated with radiotherapy in patients receiving
either total body irradiation,
single high-dose fraction to the abdomen, or daily fractions to the
abdomen. (1)
postoperative nausea and/or vomiting. (1)
DOSAGE AND ADMINISTRATION
See full prescribing information for the recommended dosage in adults
and pediatrics. (2)
Patients with severe hepatic impairment: do not exceed a total daily
dose of 8 mg. (2.2, 8.6)
DOSAGE FORMS AND STRENGTHS
Tablets: 4 mg and 8 mg. (3)
ODT Orally Disintegrating Tablets: 4 mg and 8 mg. (3)
Oral Solution: 4 mg/5 mL. (3)
CONTRAINDICATIONS
Patients known to have hypersensitivity (e.g., anaphylaxis) to
ondansetron or any components of the
formulation. (4)
Concomitant use of apomorphine. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions, Including Anaphylaxis and Bronchospasm:
Discontinue ZOFRAN if
suspected. Monitor and treat promptly per standard of care until signs
and symptoms resolve. (5.1)
QT Interval Prolongation and Torsade de Pointes: Avoid ZOFRAN in
patients with congenital long QT
syndrome