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:

NDC 54868-5801-2 Bottles of 10
NDC 54868-5801-1 Bottles of 15
NDC 54868-5801-4 Bottles of 20
NDC 54868-5801-0 Bottles of 30
NDC 54868-5801-3 Bottles of 60

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:

NDC 54868-5738-0NDC 54868-5738-2NDC 54868-5738-3 Bottles of 10Bottles of 15Bottles of 20
NDC 54868-5738-1 Bottles of 30

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.

PJPI0111
ISS. 09/2006

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 4 mg

Ondansetron Hydrochloride Tablets
4 mg
Rx only

Ondansetron tablets-4mg package label
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — Label — 8 mg

Ondansetron Hydrochloride Tablets
8 mg
Rx only

Ondansetron tablets-8mg package label
(click image for full-size original)

ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5801(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:54868-5801-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5801-1 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-5801-2 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-5801-3 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:54868-5801-4 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077050 07/30/2007
ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5738(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
POLYSORBATE 80
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score no score
Shape OVAL Size 13mm
Flavor Imprint Code 131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5738-0 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:54868-5738-1 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:54868-5738-2 15 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:54868-5738-3 20 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077050 12/29/2006
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-5801), relabel (54868-5738), repack (54868-5801), repack (54868-5738)

Revised: 02/2013 Physicians Total Care, Inc.

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