ONDANSETRON HYDROCHLORIDE tablet, film coated ONDANSETRON tablet, orally disintegrating

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Sun Pharmaceutical Industries, Inc.

INN (Algemene Internationale Benaming):

ONDANSETRON HYDROCHLORIDE

Samenstelling:

ONDANSETRON 4 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Ondansetron 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. Ondansetron is also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron 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 o

Product samenvatting:

Ondansetron Tablets Bottles: Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from light. Dispense in tight, light-resistant container as defined in the USP. Unit dose packs: Store at 20° to 25°C (68° to 77°F) (See USP Controlled Room Temperature). Protect from light. Store blisters in cartons. Ondansetron Orally Disintegrating Tablets   Store between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ONDANSETRON HYDROCHLORIDE - ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
ONDANSETRON - ONDANSETRON TABLET, ORALLY DISINTEGRATING
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON
HYDROCHLORIDE TABLETS, AND ONDANSETRON ORALLY DISINTEGRATING TABLETS
SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ONDANSETRON
HYDROCHLORIDE
TABLETS, AND ONDANSETRON ORALLY DISINTEGRATING TABLETS.
ONDANSETRON HYDROCHLORIDE TABLETS, FOR ORAL USE
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 is a 5-HT receptor antagonist indicated for the prevention
of: (1)
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)
CONTRAINDICATIONS
Patients known to have hypersensitivity (e.g., anaphylaxis) to
ondansetron or any components of the
formulation. (4) (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 ond