Ondansetron Hydrochloride (Page 3 of 3)

DRUG ABUSE AND DEPENDENCE

Animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

OVERDOSAGE

There is no specific antidote for ondansetron overdose. Patients should be managed with appropriate supportive therapy. Individual intravenous doses as large as 150 mg and total daily intravenous doses as large as 252 mg have been inadvertently administered without significant adverse events. These doses are more than 10 times the recommended daily dose.
In addition to the adverse events listed above, the following events have been described in the setting of ondansetron overdose: “Sudden blindness” (amaurosis) of 2 to 3 minutes’ duration plus severe constipation occurred in 1 patient that was administered 72 mg of ondansetron intravenously as a single dose. Hypotension (and faintness) occurred in a patient that took 48 mg of ondansetron tablets. Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed. In all instances, the events resolved completely.

DOSAGE AND 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/m². 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 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 tablets 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-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 USP, 4 mg are white to off-white, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘91’ on the other side.
Bottles of 30 NDC 65862-187-30
Bottles of 500 NDC 65862-187-05
Bottles of 1000 NDC 65862-187-99
1 x 3 Unit-dose Tablets NDC 65862-187-03
10 x 10 Unit-dose Tablets NDC 65862-187-10
Ondansetron Tablets USP, 8 mg are yellow colored, oval shaped, film-coated tablets debossed with ‘F’ on one side and ‘92’ on the other side.
Bottles of 30 NDC 65862-188-30
Bottles of 500 NDC 65862-188-05
Bottles of 1000 NDC 65862-188-99
1 x 3 Unit-dose Tablets NDC 65862-188-03
10 x 10 Unit-dose Tablets NDC 65862-188-10
Ondansetron Tablets USP, 24 mg are pink colored, oval shaped, film-coated tablets debossed with ‘C’ on one side and ‘71’ on the other side.
Unit-dose Packs of 1 Tablet NDC 65862-189-11
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light.

REFERENCES

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 for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 072, India
Revised: 10/2011

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 4 mg (500 Tablet Bottle)

NDC 65862-187-05
Ondansetron Tablets, USP
4 mg
Rx only 500 Tablets
AUROBINDO

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Revised: 11/2011 MedVantx, Inc.