Ondansetron Hydrochloride (Page 5 of 5)

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 Tablets USP, 4 mg (ondansetron hydrochloride USP dihydrate equivalent to 4 mg of ondansetron), are yellow, film coated oval convex tablets debossed with “TARO” on one side and “OND4” on the other side.

Daily Unit dose of 3	NDC 51672-4108-8
Bottle of 30	NDC 51672-4108-6
Unit dose 100	NDC 51672-4108-0

Ondansetron Tablets USP, 8 mg (ondansetron hydrochloride USP dihydrate equivalent to 8 mg of ondansetron), are white, film coated oval convex tablets debossed with “TARO” on one side and “OND8” on the other side.

Daily Unit dose of 3	NDC 51672-4109-8
Bottle of 30	NDC 51672-4109-6
Unit dose 100	NDC 51672-4109-0

Ondansetron Tablets USP, 24 mg (ondansetron hydrochloride USP dihydrate equivalent to 24 mg of ondansetron), are pink, film coated oval convex tablets debossed with “TARO” on one side and “OND24” on the other side.

Daily Unit dose of 1

NDC 51672-4110-5

Bottles: Store at 20˚ to 25˚C (68˚ to 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˚ to 25˚C (68˚ to 77˚F) [see USP Controlled Room Temperature]. Protect from light. Store blisters 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: February, 2018

PRINCIPAL DISPLAY PANEL — 4 mg Tablet Bottle Label

NDC 51672-4108-6

30 Tablets

Ondansetron Tablets USP,

4 mg*

TARO

Rx only

PRINCIPAL DISPLAY PANEL — 8 mg Tablet Bottle Label

NDC 51672-4109-6

30 Tablets

Ondansetron Tablets USP,

8 mg *

TARO

Rx only

PRINCIPAL DISPLAY PANEL — 24 mg Tablet Bottle Carton

NDC 51672-4110-5

1 Tablet
1 Unit Dose Tablet

Ondansetron Tablet USP,

24 mg*

Rx only

Keep this and all medications out of the reach of children.

TARO

ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4108 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 lactose, unspecified form magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified polyethylene glycol, unspecified starch, corn talc titanium dioxide ferric oxide yellow

Product Characteristics Color YELLOW Score 2 pieces Shape OVAL (convex) Size 10mm Flavor Imprint Code TARO;OND4 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51672-4108-8 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4108-8) 2 NDC:51672-4108-6 30 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:51672-4108-0 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 100 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4108-0)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077729 03/28/2011

ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4109 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 lactose, unspecified form magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified polyethylene glycol, unspecified talc titanium dioxide

Product Characteristics Color WHITE Score 2 pieces Shape OVAL (convex) Size 13mm Flavor Imprint Code TARO;OND8 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51672-4109-8 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 3 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4109-8) 2 NDC:51672-4109-6 30 TABLET, FILM COATED in 1 BOTTLE None 3 NDC:51672-4109-0 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 100 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4109-0)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077729 03/28/2011

ONDANSETRON HYDROCHLORIDE ondansetron hydrochloride tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51672-4110 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ondansetron Hydrochloride (Ondansetron) Ondansetron 24 mg

Inactive Ingredients Ingredient Name Strength lactose, unspecified form magnesium stearate microcrystalline cellulose polyvinyl alcohol, unspecified polyethylene glycol, unspecified talc titanium dioxide FD&C blue no. 2 aluminum oxide ferric oxide red

Product Characteristics Color PINK Score 2 pieces Shape OVAL (convex) Size 13mm Flavor Imprint Code TARO;OND24 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:51672-4110-5 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK 1 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (51672-4110-5)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077729 03/28/2011

Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceutical Industries, Ltd.		600072078	MANUFACTURE (51672-4108), MANUFACTURE (51672-4109), MANUFACTURE (51672-4110)

Revised: 02/2018 Taro Pharmaceuticals U.S.A., Inc.