ONDANSETRON HYDROCHLORIDE tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Bryant Ranch Prepack

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Ondansetron tablets are 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 Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron tablets are 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

Ringkasan produk:

NDC: 63629-8111-1: 20 Tablets in a BOTTLE NDC: 63629-8111-2: 30 Tablets in a BOTTLE

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ONDANSETRON TABLETS.
ONDANSETRON TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Myocardial Ischemia (5.4) 10/2021
INDICATIONS AND USAGE
Ondansetron tablets are 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, 8 mg, and 24 mg. (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 ondansetron 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 ondansetron in
patients with congenital long QT
syndrome; monitor with electrocardiograms (ECGs) if concomitant
electrolyte abnormalities, cardiac
failure or arrhythmias, or use of other QT prolonging drugs. (5.2)
Serotonin Syndrome: Reported with 5-HT receptor antagonists alone but
particularly wi