Ondansetron (Page 6 of 6)

14.2 Radiation-Induced Nausea and Vomiting

Total Body Irradiation

In a randomized, placebo-controlled, double-blind trial in 20 patients, 8 mg of ondansetron administered 1.5 hours before each fraction of radiotherapy for 4 days was significantly more effective than placebo in preventing vomiting induced by total body irradiation. Total body irradiation consisted of 11 fractions (120 cGy per fraction) over 4 days for a total of 1,320 cGy. Patients received 3 fractions for 3 days, then 2 fractions on Day 4.

Single High-Dose Fraction Radiotherapy

In an active-controlled, double-blind trial in 105 patients receiving single high-dose radiotherapy (800 to 1,000 cGy) over an anterior or posterior field size of greater than or equal to 80 cm2 to the abdomen, ondansetron was significantly more effective than metoclopramide with respect to complete control of emesis (0 emetic episodes). Patients received the first dose of ondansetron (8 mg) or metoclopramide (10 mg) 1 to 2 hours before radiotherapy. If radiotherapy was given in the morning, 8 mg of ondansetron or 10 mg of metoclopramide was administered in the late afternoon and repeated again before bedtime. If radiotherapy was given in the afternoon, patients took 8 mg of ondansetron or 10 mg of metoclopramide only once before bedtime. Patients continued the doses of oral medication three times daily for 3 days.

Daily Fractionated Radiotherapy

In an active-controlled, double-blind trial in 135 patients receiving a 1- to 4-week course of fractionated radiotherapy (180 cGy doses) over a field size of greater than or equal to 100 cm2 to the abdomen, ondansetron was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes). Patients received the first dose of ondansetron (8 mg) or prochlorperazine (10 mg) 1 to 2 hours before the first daily radiotherapy fraction, with subsequent 8-mg doses approximately every 8 hours on each day of radiotherapy.

14.3 Postoperative Nausea and Vomiting

In two placebo-controlled, double-blind trials (one conducted in the US and the other outside the US) in 865 females undergoing inpatient surgical procedures, ondansetron 16 mg as a single dose or placebo was administered one hour before the induction of general balanced anesthesia (barbiturate, opioid, nitrous oxide, neuromuscular blockade, and supplemental isoflurane or enflurane), ondansetron tablets was significantly more effective than placebo in preventing postoperative nausea and vomiting.

No trials have been performed in males.

16 HOW SUPPLIED/STORAGE AND HANDLING

Ondansetron Oral Solution USP, 4 mg/5mL, a clear, colorless to light yellow liquid with a characteristic strawberry odor, contains 5 mg of ondansetron hydrochloride dihydrate equivalent to 4 mg of ondansetron per 5 mL in bottles of 50 mL with child-resistant closures (NDC 51672-4091-3).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Store bottles upright in cartons.

17 PATIENT COUNSELING INFORMATION

QT Prolongation

Inform patients that ondansetron may cause serious cardiac arrhythmias such as QT prolongation. Instruct patients to tell their healthcare provider right away if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.

Hypersensitivity Reactions

Inform patients that ondansetron may cause hypersensitivity reactions, some as severe as anaphylaxis and bronchospasm. Instruct patients to immediately report any signs and symptoms of hypersensitivity reactions, including fever, chills, rash, or breathing problems to their healthcare provider.

Masking of Progressive Ileus and Gastric Distension

Inform patients following abdominal surgery or those with chemotherapy-induced nausea and vomiting that ondansetron may mask signs and symptoms of bowel obstruction. Instruct patients to immediately report any signs or symptoms consistent with a potential bowel obstruction to their healthcare provider.

Drug Interactions

  • Instruct the patient to report the use of all medications, especially apomorphine, to their healthcare provider. Concomitant use of apomorphine and ondansetron may cause a significant drop in blood pressure and loss of consciousness.
  • Advise patients of the possibility of serotonin syndrome with concomitant use of ondansetron and another serotonergic agent such as medications to treat depression and migraines. Advise patients to seek immediate medical attention if the following symptoms occur: changes in mental status, autonomic instability, neuromuscular symptoms with or without gastrointestinal symptoms.

Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761
Dist. by: Taro Pharmaceuticals U.S.A., Inc. , Hawthorne, NY 10532
Revised: May, 2019

70016-0519-8
549

PRINCIPAL DISPLAY PANEL — 50 mL Bottle Carton

50 mL

NDC 51672-4091 -3

Ondansetron
Oral SolutionUSP, 4 mg/5 mL

Rx only

TARO

PRINCIPAL DISPLAY PANEL -- 50 mL Bottle Carton
(click image for full-size original)
ONDANSETRON ondansetron hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4091
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ondansetron hydrochloride (ondansetron) ondansetron 4 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
water
sodium benzoate
trisodium citrate dihydrate
sucralose
Product Characteristics
Color Score
Shape Size
Flavor STRAWBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51672-4091-3 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (51672-4091-3)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077009 11/30/2007
Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Operations
Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE (51672-4091)

Revised: 06/2019 Taro Pharmaceuticals U.S.A., Inc.

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