Drug Catalog - Product Detail
ONDANSETRON HYDROCHLORIDE TB 4MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45963-0538-30 | ACTAVIS | 30 | 4MG | TABLET |
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Description
DESCRIPTION The active ingredient in ondansetron tablets is ondansetron hydrochloride (HCl) as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT 3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The empirical formula is C 18 H 19 N 3 O•HCl•2H 2 O, representing a molecular weight of 365.9. Ondansetron HCl dihydrate is a white to off-white powder that is soluble in water and normal saline. Each 4 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron. Each 8 mg ondansetron tablet, USP for oral administration contains ondansetron hydrochloride, USP equivalent to 8 mg of ondansetron. Each tablet also contains the inactive ingredients croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide, triacetin, and iron oxide yellow (8 mg tablet only). Product meets USP Dissolution Test #3. MM1
How Supplied
HOW SUPPLIED Ondansetron tablets, USP 4 mg (ondansetron hydrochloride, USP equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with "4" on one side and “NO” on another side. They are supplied as follows: NDC 45963-538-30 Bottles of 30 tablets Ondansetron tablets, USP 8 mg (ondansetron hydrochloride, USP equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with "8" on one side and "NO" on the other side. They are supplied as follows: NDC 45963-539-30 Bottles of 30 tablets Store at 20° - 25°C (68° - 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.
Indications & Usage
INDICATIONS & USAGE Prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy, including cisplatin ≥ 50 mg/m 2 . Prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Prevention of 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. Prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. In patients where nausea and/or vomiting must be avoided postoperatively, ondansetron tablets are recommended even where the incidence of postoperative nausea and/or vomiting is low.
Dosage and Administration
DOSAGE & ADMINISTRATION Prevention of Nausea and Vomiting Associated With Highly Emetogenic Cancer Chemotherapy The recommended adult oral dosage of ondansetron tablets is 24 mg given as three 8-mg tablets administered 30 minutes before the start of single-day highly emetogenic chemotherapy, including cisplatin ≥ 50 mg/m 2 . Multiday, single-dose administration of a 24 mg dosage has not been studied. Pediatric Use There is no experience with the use of a 24 mg dosage in pediatric patients. Geriatric Use The dosage recommendation is the same as for the general population. Prevention of Nausea and Vomiting Associated With Moderately Emetogenic Cancer Chemotherapy The recommended adult oral dosage is one 8-mg ondansetron tablet given twice a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with a subsequent dose 8 hours after the first dose. One 8-mg ondansetron tablet should be administered twice a day (every 12 hours) for 1 to 2 days after completion of chemotherapy. Pediatric Use For pediatric patients 12 years of age and older, the dosage is the same as for adults. For pediatric patients 4 through 11 years of age, the dosage is one 4-mg ondansetron tablet or one 4-mg given 3 times a day. The first dose should be administered 30 minutes before the start of emetogenic chemotherapy, with subsequent doses 4 and 8 hours after the first dose. One 4-mg ondansetron tablet should be administered 3 times a day (every 8 hours) for 1 to 2 days after completion of chemotherapy. Geriatric Use The dosage is the same as for the general population. Prevention of Nausea and Vomiting Associated With Radiotherapy, Either Total Body Irradiation, or Single High-Dose Fraction or Daily Fractions to the Abdomen The recommended oral dosage is one 8-mg ondansetron tablet given 3 times a day. For total body irradiation , one 8-mg ondansetron tablet should be administered 1 to 2 hours before each fraction of radiotherapy administered each day. For single high-dose fraction radiotherapy to the abdomen , one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for 1 to 2 days after completion of radiotherapy. For daily fractionated radiotherapy to the abdomen , one 8-mg ondansetron tablet should be administered 1 to 2 hours before radiotherapy, with subsequent doses every 8 hours after the first dose for each day radiotherapy is given. Pediatric Use There is no experience with the use of ondansetron tablet in the prevention of radiation-induced nausea and vomiting in pediatric patients. Geriatric Use The dosage recommendation is the same as for the general population. Postoperative Nausea and Vomiting The recommended dosage is 16 mg given as two 8-mg ondansetron tablets 1 hour before induction of anesthesia. Pediatric Use There is no experience with the use of ondansetron tablets in the prevention of postoperative nausea and vomiting in pediatric patients. Geriatric Use The dosage is the same as for the general population. Dosage Adjustment for Patients With Impaired Renal Function The dosage recommendation is the same as for the general population. There is no experience beyond first-day administration of ondansetron. Dosage Adjustment for Patients With Impaired Hepatic Function In patients with severe hepatic impairment (Child-Pugh 2 score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life. In such patients, a total daily dose of 8 mg should not be exceeded.