ONDANSETRON tablet, orally disintegrating

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

RPK Pharmaceuticals, Inc.

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

Product: 53002-0591 NDC: 53002-0591-1 3 TABLET, ORALLY DISINTEGRATING in a BLISTER PACK NDC: 53002-0591-2 6 TABLET, ORALLY DISINTEGRATING in a BLISTER PACK NDC: 53002-0591-3 10 TABLET, ORALLY DISINTEGRATING in a BLISTER PACK NDC: 53002-0591-4 30 TABLET, ORALLY DISINTEGRATING in a BLISTER PACK

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ONDANSETRON - ONDANSETRON TABLET, ORALLY DISINTEGRATING
RPK PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON ORALLY
DISINTEGRATING TABLETS, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
ONDANSETRON ORALLY DISINTEGRATING TABLETS.
ONDANSETRON ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Warnings and Precautions, Myocardial Ischemia (5.4) 10/2021
INDICATIONS AND USAGE
Ondansetron orally disintegrating 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
Orally Disintegrating Tablets: 4 mg and 8 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)
Seroton