ONDANSETRON tablet, orally disintegrating

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Sandoz Inc

INN (International Nazwa):

ONDANSETRON

Skład:

ONDANSETRON 4 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Ondansetron orally disintegrating tablets are indicated for the prevention of nausea and vomiting associated with: Ondansetron orally disintegrating tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is contraindicated in patients: Risk Summary Available data do not reliably inform the association of ondansetron and adverse fetal outcomes. Published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation [see Data ]. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see Data ]. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimat

Podsumowanie produktu:

Ondansetron orally disintegrating tablets, USP equivalent to 4 mg of (ondansetron base), are white to off white, round, flat, beveled edged tablets, debossed with “SZ” on one side and “342” on the other side, and are supplied as follows: Ondansetron orally disintegrating tablets, USP equivalent to 8 mg of (ondansetron base), are white to off white, round, flat, beveled edged tablets, debossed with “SZ” on one side and “343” on the other side, and are supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
SANDOZ 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ondansetron is a 5-HT receptor antagonist indicated for the prevention
of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions in adults for the:
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nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin ≥50 mg/m . (1)
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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)
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)
Orally Disintegrating Tablets: 4 mg and 8 mg (3)
Patients known to have hypersensitivity (e.g., anaphylaxis) to
ondansetron or any components of the formulation. (4)
Concomitant use of apomorphine. (4)
_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 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