ONDANSETRON tablet, film coated

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

PD-Rx Pharmaceuticals, Inc.

INN (International Nazwa):

ONDANSETRON HYDROCHLORIDE

Skład:

ONDANSETRON 8 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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/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 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 th

Podsumowanie produktu:

Ondansetron Tablets, USP 8 mg (ondansetron hydrochloride, 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: Bottles of 6 tablets (NDC 43063-770-06). Bottles: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

ONDANSETRON- ONDANSETRON TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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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 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)
Serotonin Syndrome: Reported with 5-HT3 receptor antagonists alone but
part