ONDANSETRON HYDROCHLORIDE (Page 5 of 5)

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 three 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 tablets, in the prevention of radiation-induced nausea and vomiting in pediatric patients.

Geriatric Use: The dosage 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-Pugh² 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.

HOW SUPPLIED

Ondansetron tablets, 4 mg (ondansetron HCl dihydrate equivalent to 4 mg of ondansetron), are white, oval, film-coated tablets engraved with “130” on one side and plain on the other in unit dose packs of 100 (10×10) tablets (NDC 62756-130- 02) and bottles of 30 tablets (NDC 62756-130-01).

Ondansetron tablets, 8 mg (ondansetron HCl dihydrate equivalent to 8 mg of ondansetron), are yellow, oval, film-coated tablets engraved with “131” on one side and plain on the other in unit dose packs of 100 (10×10) tablets (NDC 62756-131-02) and bottles of 30 tablets (NDC 62756-131-01).

Bottles: Store at 20° — 25°C (68° — 77°F). (See USP Controlled Room Temperature). Protect from light. Dispense in tight, light-resistant container as defined in the USP.

Unit dose packs: Store at 20° — 25°C (68° — 77°F). (See USP Controlled Room Temperature). Protect from light. Store blisters in cartons.

REFERENCE

1. Britto MR, Hussey EK, Mydlow P, et al. Effect of enzyme inducers on ondansetron (OND) metabolism in humans. Clin Pharmacol Ther 1997;61:228.

2. Pugh RNH, Murray-Lyon IM, Dawson JL, Pietroni MC, Williams R. Transection of the oesophagus for bleeding oesophageal varices. Brit J Surg 1973;60:646-649.

3. Villikka K, Kivisto KT, Neuvonen PJ. The effect of rifampin on the pharmacokinetics of oral and intravenous ondansetron. Clin Pharmacol Ther 1999;65:377-381.

4. De Witte JL, Schoenmaekers B, Sessler DI, et al. Anesth Analg 2001;92:1319-1321.

5. Arcioni R, della Rocca M, Romanò R, et al. Anesth Analg 2002;94:1553-1557.

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Acme Plaza, Andheri-Kurla Road,
Andheri (East), Mumbai-400 059, India.

Distributed by:
CARACO PHARMACEUTICAL LABORATORIES LTD.
DETROIT, MI 48202.

And Relabeled By:

Dispensing Solutions Inc.
3000 West Warner Ave
Santa Ana, CA 92704
United States

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55045-3729-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55045-3817-03

ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55045-3729(NDC:62756-130) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONDANSETRON HYDROCHLORIDE (ONDANSETRON) ONDANSETRON 4 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSES TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400

Product Characteristics Color white Score no score Shape OVAL Size 10mm Flavor Imprint Code 130 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55045-3729-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077050 06/25/2007

ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55045-3817(NDC:62756-131) Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ONDANSETRON HYDROCHLORIDE (ONDANSETRON) ONDANSETRON 8 mg

Inactive Ingredients Ingredient Name Strength ANHYDROUS LACTOSE CELLULOSE, MICROCRYSTALLINE STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSES TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400

Product Characteristics Color white Score no score Shape OVAL Size 10mm Flavor Imprint Code 130 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:55045-3817-3 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077050 06/25/2007

Labeler — Dispensing Solutions, Inc. (066070785)

Registrant — PSS World Medical, Inc. (101822682)

Establishment
Name	Address	ID/FEI	Operations
Dispensing Solutions, Inc.		066070785	relabel (55045-3817), repack (55045-3817)

Revised: 11/2013 Dispensing Solutions, Inc.