ONDANSETRON- ondansetron tablet, orally disintegrating

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

NuCare Pharmaceuticals,Inc.

INN (Διεθνής Όνομα):

ONDANSETRON

Σύνθεση:

ONDANSETRON 8 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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/m 2 . - 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 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 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 incon

Περίληψη προϊόντος:

8 mg (ondansetron HCl USP (dihydrate) equivalent to 8 mg of ondansetron), are yellow, oval, standard convex, film-coated tablets with ‘8’ on one side and ‘G1’ logo on the other side in. NDC 68071-1547-1 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

ONDANSETRON- ONDANSETRON TABLET, ORALLY DISINTEGRATING
NUCARE PHARMACEUTICALS,INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ONDANSETRON TABLETS AND
ONDANSETRON ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING
INFORMATION FOR ONDANSETRON TABLETS AND ONDANSETRON ORALLY
DISINTEGRATING TABLETS.
ONDANSETRON TABLETS, FOR ORAL USE
ONDANSETRON ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
Ondansetron 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)
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 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)
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