ONDANSETRON HYDROCHLORIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddy's Laboratories Limited

INN (International Name):

ONDANSETRON HYDROCHLORIDE

Composition:

ONDANSETRON 4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 . highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . - initial and repeat courses of moderately emetogenic cancer chemotherapy. 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 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 co

Product summary:

Ondansetron Tablets Ondansetron Tablets Ondansetron tablets USP, 4 mg (ondansetron hydrochloride USP, equivalent to 4 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “153” on other side and are supplied in bottles of 30, 100, 500, unit-dose packages of 100 (10 x 10) and unit-dose packages of 3 (1 x 3).   Bottles of 30 NDC 55111-153-30 Bottles of 100 NDC 55111-153-01 Bottles of 500 NDC 55111-153-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-153-78 Unit Dose Packages of 3 (1 x 3) NDC 55111-153-13   Ondansetron tablets USP, 8 mg (ondansetron hydrochloride USP, equivalent to 8 mg of ondansetron) are yellow, round, biconvex, film coated tablets debossed “R” on one side and “154” on other side and are supplied in bottles of 30, 100, 500, unit-dose packages of 100 (10 x 10) and unit-dose packages of 3 (1 x 3).   Bottles of 30 NDC 55111-154-30 Bottles of 100 NDC 55111-154-01 Bottles of 500 NDC 55111-154-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-154-78 Unit Dose Packages of 3 (1 x 3) NDC 55111-154-13   Ondansetron tablets USP, 16 mg (ondansetron hydrochloride USP, equivalent to 16 mg of ondansetron) are white, round, biconvex, film coated tablets debossed “R” on one side and “155” on other side and are supplied in bottles of 30, 500 and unit-dose packages of 100 (10 x 10).   Bottles of 30 NDC 55111-155-30 Bottles of 500 NDC 55111-155-05 Unit-dose packages of 100 (10x10) NDC 55111-155-78   Ondansetron tablets USP, 24 mg (ondansetron hydrochloride USP, equivalent to 24 mg of ondansetron) are pink, round, biconvex, film coated tablets debossed “R” on one side and “156” on other side and are supplied in bottles of 30, 500, unit-dose packages of 100 (10 x 10) and unit-dose packages of 1 (1 x 1).   Bottles of 30 NDC 55111-156-30 Bottles of 500 NDC 55111-156-05 Unit Dose Packages of 100 (10 x 10) NDC 55111-156-78 Unit Dose Packages of 1 (1 x 1) NDC 55111-156-11   Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Dispense in tight container as defined in the USP. Store blisters in cartons.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ONDANSETRON HYDROCHLORIDE- ONDANSETRON HYDROCHLORIDE TABLET, FILM
COATED
DR. REDDY'S LABORATORIES LIMITED
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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 tablets are 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, 8 mg, 16 mg and 24 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 ondansetron
tablets 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-HT receptor antagonists alone but