GastroGard® (omeprazole) Oral Paste for Equine Ulcers

Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Merial Limited
Code Source: 50604-3704
Route of Administration: ORAL

GASTROGARD

Generic: omeprazole

Ingredients:

• omeprazole omeprazole : Active ingredient - basis of strength - 370 mg in 1 g

Package Description:

• 6.15 g in 1 SYRINGE, PLASTIC
• 6.15 g in 1 SYRINGE, PLASTIC

Oral Paste for Horses and Foals

NADA 141-123, Approved by FDA

Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Chemical name: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl]sulfinyl]-1 H -benzimidazole. Empirical formula: C 17 H 19 N 3 O 3 S. Molecular weight: 345.42. Structural formula:

Chemical Structure

How Supplied

GastroGard (omeprazole) Paste for horses contains 37% w/w omeprazole and is available in an adjustable-dose syringe. Each syringe contains 2.28 g of omeprazole. Syringes are calibrated according to body weight and are available in boxes of 7 units or 72 units.

Storage Conditions

Indications

For treatment and prevention of recurrence of gastric ulcers in horses and foals 4 weeks of age and older.

Dosage Regimen

For treatment of gastric ulcers, GastroGard Paste should be administered orally once-a-day for 4 weeks at the recommended dosage of 1.8 mg omeprazole/lb body weight (4 mg/kg). For the prevention of recurrence of gastric ulcers, continue treatment for at least an additional 4 weeks by administering GastroGard Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).

Directions For Use

GastroGard Paste for horses is recommended for use in horses and foals 4 weeks of age and older. The contents of one syringe will dose a 1250 lb (568 kg) horse at the rate of 1.8 mg omeprazole/lb body weight (4 mg/kg). For treatment of gastric ulcers, each weight marking on the syringe plunger will deliver sufficient omeprazole to treat 250 lb (114 kg) body weight. For prevention of recurrence of gastric ulcers, each weight marking will deliver sufficient omeprazole to dose 500 lb (227 kg) body weight. To deliver GastroGard Paste at the treatment dose rate of 1.8 mg omeprazole/lb body weight (4 mg/kg), set the syringe plunger to the appropriate weight marking according to the horse's weight in pounds. To deliver GastroGard Paste at the dose rate of 0.9 mg/lb (2 mg/kg) to prevent recurrence of ulcers, set the syringe plunger to the weight marking corresponding to half of the horse's weight in pounds. To set the syringe plunger, unlock the knurled ring by rotating it 1/4 turn. Slide the knurled ring along the plunger shaft so that the side nearest the barrel is at the appropriate notch. Rotate the plunger ring 1/4 turn to lock it in place and ensure it is locked. Make sure the horse's mouth contains no feed. Remove the cover from the tip of the syringe, and insert the syringe into the horse's mouth at the interdental space. Depress the plunger until stopped by the knurled ring. The dose should be deposited on the back of the tongue or deep into the cheek pouch. Care should be taken to ensure that the horse consumes the complete dose. Treated animals should be observed briefly after administration to ensure that part of the dose is not lost or rejected. If any of the dose is lost, redosing is recommended. If, after dosing, the syringe is not completely empty, it may be reused on following days until emptied. Replace the cap after each use.

Warning

Do not use in horses intended for human consumption. Keep this and all drugs out of the reach of children. In case of ingestion, contact a physician. Physicians may contact a poison control center for advice concerning accidental ingestion.

Adverse Reactions

In efficacy trials, when the drug was administered at 1.8 mg omeprazole/lb (4 mg/kg) body weight daily for 28 days and 0.9 mg omeprazole/lb (2 mg/kg) body weight daily for 30 additional days, no adverse reactions were observed.

Precautions

The safety of GastroGard Paste has not been determined in pregnant or lactating mares.

Clinical Pharmacology

Efficacy

Dose Confirmation: GastroGard (omeprazole) Paste, administered to provide omeprazole at 1.8 mg/lb (4 mg/kg) daily for 28 days, effectively healed or reduced the severity of gastric ulcers in 92% of omeprazole-treated horses. In comparison, 32% of controls exhibited healed or less severe ulcers. Horses enrolled in this study were healthy animals confirmed to have gastric ulcers by gastroscopy. Subsequent daily administration of GastroGard Paste to provide omeprazole at 0.9 mg/lb (2 mg/kg) for 30 days prevented recurrence of gastric ulcers in 84% of treated horses, whereas ulcers recurred or became more severe in horses removed from omeprazole treatment.

Safety

GastroGard Paste was well tolerated in the following controlled efficacy and safety studies. In field trials involving 139 horses, including foals as young as one month of age, no adverse reactions attributable to omeprazole treatment were noted. In a placebo controlled adult horse safety study, horses received 20 mg/kg/day omeprazole (5? the recommended dose) for 90 days. No treatment related adverse effects were observed. In a placebo controlled tolerance study, adult horses were treated with GastroGard Paste at a dosage of 40 mg/kg/day (10? the recommended dose) for 21 days. No treatment related adverse effects were observed. A placebo controlled foal safety study evaluated the safety of omeprazole at doses of 4, 12 or 20 mg/kg (1, 3 or 5?) once daily for 91 days. Foals ranged in age from 66 to 110 days at study initiation. Gamma glutamyltransferase (GGT) levels were significantly elevated in horses treated at exaggerated doses of 20 mg/kg (5? the recommended dose). Mean stomach to body weight ratio was higher for foals in the 3? and 5? groups than for controls; however, no abnormalities of the stomach were evident on histological examination.

Reproductive Safety

In a male reproductive safety study, 10 stallions received GastroGard Paste at 12 mg/kg/day (3? the recommended dose) for 70 days. No treatment related adverse effects on semen quality or breeding behavior were observed. A safety study in breeding mares has not been conducted.

For More Information

Please call 1-888-637-4251. Marketed by: Merial Limited, Duluth, GA 30096-4640, U.S.A. Made in Brazil ® GastroGard is a registered trademark of the AstraZeneca Group of Companies. ©2011 Merial. All rights reserved. Rev. 05-2011

PRINCIPAL DISPLAY PANEL - 72 Syringe Shipping Label

READ PACKAGE INSERT FOR FURTHER INSTRUCTIONS AND IMPORTANT INFORMATION.
GastroGard ^®
(omeprazole) Oral Paste for Equine Ulcers
For Treatment and Prevention of
Recurrence of Equine Gastric Ulcers
CAUTION : Federal (USA) law restricts this drug to use by or
on the order of a licensed veterinarian.
Store at 68 °F - 77°F (20-25°C).
Excursions between 59 °F - 86°F (15-30°C) are permitted.
® GastroGard is a
registered trademark of
the AstraZeneca Group
of Companies.
©2011 Merial.
All rights reserved.
CONTENTS: 72 Syringes Individually Wrapped
Lot No & Exp Date
Product 3661172
Marketed by:
Merial Limited,
Duluth, GA 30096-4640, U.S.A.
Made in Brazil
1829/02
36611
Rev. 05-2011
MERIAL

PRINCIPAL DISPLAY PANEL - 72 Syringe Shipping Label