ONDANSETRON HYDROCHLORIDE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

RedPharm Drug, Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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/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 tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron 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. 8.1 Pregnancy 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 fet

Каталог на резюме:

Ondansetron Tablets USP, 4 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘91’ on the other side. Bottles of 30 NDC 57237-075-30 Ondansetron Tablets USP, 8 mg are yellow colored, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘92’ on the other side. Bottles of 30 NDC 57237-076-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
REDPHARM DRUG, INC.
----------
ONDANSETRON
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
INDICATIONS AND USAGE
Ondansetron tablets are a 5-HT3 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/m2. (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)
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
particularly
with concomitant use of serotonergic drugs. If such symptoms occur,
discontinue
ondansetron