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 tablets 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 tablets was significantly more effective than metoclopramide with respect to complete control of emesis (0 emetic episodes). Patients received the first dose of ondansetron tablets (8 mg) or metoclopramide (10 mg) 1 to 2 hours before radiotherapy. If radiotherapy was given in the morning, 8 mg of ondansetron tablets 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 tablets 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 tablets was significantly more effective than prochlorperazine with respect to complete control of emesis (0 emetic episodes). Patients received the first dose of ondansetron tablets (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 2 placebo-controlled, double-blind trials (one conducted in the US and the other outside the US) in 865 females undergoing inpatient surgical procedures, ondansetron tablets 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 Tablets

Ondansetron Tablets USP, 4 mg (ondansetron hydrochloride dihydrate 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 63304-458-30 Bottles of 30

Ondansetron Tablets USP, 8 mg (ondansetron hydrochloride dihydrate 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 63304-459-30 Bottles of 30

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

QT Prolongation

Inform patients that ondansetron tablets 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 tablets 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 tablets 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 tablets 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 tablets 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.

Distributed by:

Sun Pharmaceutical Industries, Inc.

Cranbury, NJ 08512 USA

Manufactured by:

Natco Pharma Limited

Kothur- 509 228, India

Revised: 01/2019

346169

Package/Label Display Panel

PDP-4mg
(click image for full-size original)

Package/Label Display Panel

PDP-8mg
(click image for full-size original)
ONDANSETRON
ondansetron tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-458
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 10mm
Flavor Imprint Code 4;NO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-458-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077851 06/25/2007
ONDANSETRON
ondansetron tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-459
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
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, CORN
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 12mm
Flavor Imprint Code 8;NO
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-459-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077851 06/25/2007
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Natco Pharma Limited-Pharma Division 918588174 MANUFACTURE (63304-458), MANUFACTURE (63304-459)

Revised: 09/2019 Sun Pharmaceutical Industries, Inc.

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