Ondansetron Hydrochloride: Package Insert and Label Information (Page 4 of 4)
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 cm
2 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 cm
2 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 2 placebo-controlled, double-blind trials (one conducted in the U.S. and the other outside the U.S.) 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 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 57237-075-30
Blister Pack of 30 NDC 58118-7500-8
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 57237-076-30
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.
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 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.
Distributed by:
Rising Health, LLC
Saddle Brook, NJ 07663
Made in India
Repackaged by:
Clinical Solutions Wholesale
Franklin, TN 37067
Code: TS/DRUGS/19/1993
Revised: 11/2017
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 4 mg (30 count Blister Pack)
| ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated | ||||||||||||||||||
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| Labeler — Clinical Solutions Wholesale, LLC (078710347) |
| Registrant — Clinical Solutions Wholesale, LLC (078710347) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Clinical Solutions Wholesale, LLC | 078710347 | repack (58118-7500) | |
Revised: 09/2020 Clinical Solutions Wholesale, LLC
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