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:

Major Pharmaceuticals

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: Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. Ondansetron is contraindicated in patients: 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 of ondansetron use in pregnancy (see Data ). Available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. Reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area (BSA), respectively (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

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. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6551-61 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. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-6552-61 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
MAJOR PHARMACEUTICALS
----------
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:
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Tablets: 4 mg, 8 mg, 16 mg and 24 mg (3)
CONTRAINDICATIONS
3.
4.
WARNINGS AND PRECAUTIONS
6.
7.
8.
9.
10.
ADVERSE REACTIONS
The most common adverse reactions in adults for the:
4.
5.
6.
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT DR. REDDY'S
LABORATORIES INC., AT 1-888-
375-3784 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 5/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Dosage in Hepatic Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypersensitivity Reactions
5.2 QT Prolongation
5.3 Serotonin Syndrome
5.4 Myocardial Ischemia
5.5 Masking of Progressive Ileus and Gastric Distension
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Serotonergic Drugs
7.2 Drugs Affecting Cytochrome P-450 Enzymes
7.3 Tramadol
7.4 Chemotherapy
3
nausea and vomiting associated with highly emetogenic cancer
chemotherapy, including cisplatin
greater than or equal to 50 mg/m (1)
2
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)
See full