Equine & Livestock

Oral Paste for Horses and Foals • Approved by FDA under NADA # 141-123 Brief Summary: This information is not comprehensive. Before using Gastrogard ® (omeprazole) Paste, please consult the product insert for full prescribing information. The product insert may be obtained from your veterinarian or by visiting www.gastrogard.com. Caution • Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. How Supplied • GASTROGARD (omeprazole) Paste for horses contains 37% w/w omeprazole and is available in an adjustable-dose syringe. Each syringe contains 2.28g of omeprazole. Syringes are calibrated according to body weight. 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 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 at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg). Directions For Use • GASTROGARD 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 plung- er 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 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 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. • 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. • The safety of GASTROGARD has not been determined in pregnant or lactating mares. 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. • To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS, or online at www.fda.gov/reportanimalae. Efficacy • Dose Confirmation: GASTROGARD, 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 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. • Clinical Field Trials: GASTROGARD administered at 1.8 mg/lb (4 mg/kg) daily for 28 days healed or reduced the severity of gastric ulcers in 99% of omeprazole-treated horses. In comparison, 32.4% of control horses had healed ulcers or ulcers which were reduced in severity. These trials included horses of various breeds and under different management conditions, and included horses in race or show training, pleasure horses, and foals as young as one month. Horses enrolled in the efficacy trials were healthy animals confirmed to have gastric ulcers by gastroscopy. In these field trials, horses readily accepted GASTROGARD. There were no drug related adverse reactions. In the clinical trials, GASTROGARD was used concomitantly with other therapies, which included: anthelmintics, antibiotics, non-steroidal and steroidal anti- inflammatory agents, diuretics, tranquilizers and vaccines. • Management Considerations: Safety • GASTROGARD 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 (5x 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 at a dosage of 40 mg/kg/day (10x 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 5x) 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 (5x the recommended dose). Reproductive Safety • In a male reproductive safety study, 10 stallions received GASTROGARD at 12 mg/kg/ day (3x 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: Boehringer Ingelheim Animal Health USA Inc., Duluth, GA 30096, U.S.A. Made in Brazil GASTROGARD ® is a registered trademark of Boehringer Ingelheim Animal Health USA Inc. All rights reserved. ©2020 Boehringer Ingelheim Animal Health USA Inc. US-EQU-0242-2022 Rev. 07-2020 Reference: Product Insert 147528-002 Revised 05/2019 NOW AVAILABLE! Contact your Covetrus representative to order: (855) 724-3461 northamerica.covetrus.com Bionote is proud to add Equine SAA, Equine Progesterone and Foal IgG biomarker tests to its line of quantitative, in-clinic biomarker tests. Each offers fast, crucial insight to help equine veterinarians practice medicine like they have always wanted to by providing their best quality of care without time and cost barriers. These university-validated tests provide quantitative biomarker levels in minutes in-stable or in-clinic. Take the Reins in Your Equine Care C M Y CM MY CY CMY K ai1694620307503_BIOA10220_Equine_Ads_7.875x5_03.pdf 1 9/13/23 10:51 AM

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