Omeprazole

For the prevention of gastric ulcers in horses.

UlcerGard®

Horses and Foals (4 Weeks of Age and Older)

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

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. The safety of GastroGard Paste has not been determined in pregnant or lactating mares.

GastroGard®

Horses and foals 4 weeks of age and older

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

Gastrobim™

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

FDA application 200-842

For the prevention of gastric ulcers in horses.

Ulcergard® (omeprazole) Oral Paste for Horses

Clinical Pharmacology Mechanism of Action: Omeprazole is a gastric acid pump inhibitor that regulates the final step in hydrogen ion production and blocks gastric acid secretion regardless of the stimulus. Omeprazole irreversibly binds to the gastric parietal cell's H+, K+ ATPase enzyme which pumps hydrogen ions into the lumen of the stomach in exchange for potassium ions. Since omeprazole accumulates in the cell cannaliculi and is irreversibly bound to the effect site, the plasma concentration at steady state is not directly related to the amount that is bound to the enzyme. The relationship between omeprazole action and plasma concentration is a function of the rate-limiting process of H+, K+ ATPase activity/turnover. Once all of the enzyme becomes bound, acid secretion resumes only after new H+, K+ ATPase is synthesized in the parietal cell (i.e., the rate of new enzyme synthesis exceeds the rate of inhibition). Pharmacodynamics: In a study of pharmacodynamic effects using horses with gastric cannulae, secretion of gastric acid was inhibited in horses given 4 mg omeprazole/kg/day. After the expected maximum suppression of gastric acid secretion was reached (5 days), the actual secretion of gastric acid was reduced by 99%, 95% and 90% at 8, 16, and 24 hours, respectively. Pharmacokinetics: In a pharmacokinetic study involving thirteen healthy, mixed breed horses (8 female, 5 male) receiving multiple doses of omeprazole paste (1.8 mg/lb once daily for fifteen days) in either a fed or fasted state, there was no evidence of drug accumulation in the plasma when comparing the extent of systemic exposure (AUC0-∞). When comparing the individual bioavailability data (AUC0-∞, Cmax, and Tmax measurements) across the study days, there was great inter- and intrasubject variability in the rate and extent of product absorption. Also, the extent of omeprazole absorption in horses was reduced by approximately 67% in the presence of food. This is evidenced by the observation that the mean AUC0-∞ values measured during the fifth day of omeprazole therapy when the animals were fasted for 24 hours was approximately three times greater than the AUC estimated after the first and fifteenth doses when the horses were fed hay ad libitum and sweet feed (grain) twice daily. Prandial status did not affect the rate of drug elimination. The terminal half-life estimates (N=38) ranged from approximately one-half to eight hours.

FDA application 200-842

Not for use in humans. Keep this and all medications out of the reach of children. In case of ingestion by humans, contact a physician. Do not use in horses intended for human consumption. PrimeGuard is intended for use in healthy horses. If you notice any signs of illness prior to or during the use of this product, consult your veterinarian for appropriate diagnosis and treatment recommendations.

Vetr PrimeGuard (37% omeprazole oral paste)

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. Keep Gastrobim Paste in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

FDA application 200-842

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.

GASTROGARD® (omeprazole) Oral Paste for Equine Ulcers

Not for use in humans. Keep this and all medications out of the reach of children. In case of ingestion by humans, contact a physician. Do not use in horses intended for human consumption. To obtain product information call 1-888-637-4251.

Ulcergard® (omeprazole) Oral Paste for Horses

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. Contact Information To report suspected adverse drug experiences, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. 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

FDA application 200-842

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.

GASTROGARD® (omeprazole) Oral Paste for Equine Ulcers

The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. Horses over 1,200 lb body weight should receive two doses per day.

Oral

UlcerGard®

Horses and Foals (4 Weeks of Age and Older)

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).

Oral

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. The safety of GastroGard Paste has not been determined in pregnant or lactating mares.

GastroGard®

Horses and foals 4 weeks of age and older

For treatment of gastric ulcers, Gastrobim™ 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 Gastrobim™ Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).

Oral

Gastrobim™

Directions For Use Gastrobim 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 Gastrobim 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 Gastrobim 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: 1) While holding plunger, turn the knurled ring on the plunger ¼ turn to the left and slide the knurled ring along the plunger shaft so that the side nearest the barrel is at the appropriate weight marking, aligning the arrow on the ring to the line between the weight number and “lbs.” on the plunger, as shown in the pictogram. 2) Lock the ring in place by making ¼ turn to the right. Ensure it is locked (it should no longer slide). 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.

ORAL

FDA application 200-842

Dosage Regimen For treatment of gastric ulcers, Gastrobim 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 Gastrobim Paste at the recommended daily maintenance dose of 0.9 mg/lb (2 mg/kg).

ORAL

FDA application 200-842

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).

ORAL

GASTROGARD® (omeprazole) Oral Paste for Equine Ulcers

Each syringe contains 4 individual daily doses for horses weighing 600-1200 lbs. Please refer to the following dosage chart for help in determining the correct dose for your horse. ULCERGARD® DOSAGE CHART HORSE WEIGHT DOSE * Less than 600 lbs. Consult a veterinarian 600-1,200 lbs. 1 dose per day over 1,200 lbs. 2doses once per day *Duration of 8 or 28 days

ORAL

Ulcergard® (omeprazole) Oral Paste for Horses

The minimum recommended dosage is 1 mg/kg per day (0.45 mg/lb) or 1/4 syringe. When given once daily during the stressful period, ULCERGARD has been shown to effectively prevent stomach ulcers in horses. This effect was tested in horses exposed to stressful conditions for either 8 or 28 days.

ORAL

Ulcergard® (omeprazole) Oral Paste for Horses