GASTROGARD- omeprazole paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

omeprazole (UNII: KG60484QX9) (omeprazole - UNII:KG60484QX9)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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

Product summary:

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.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

GASTROGARD- OMEPRAZOLE PASTE
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
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GASTROGARD
(OMEPRAZOLE) ORAL PASTE FOR EQUINE ULCERS
ORAL PASTE FOR HORSES AND FOALS
Approved by FDA under NADA # 141-123
CAUTION
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DES CRIPTION
Chemical name: 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)
methyl] sulfinyl]-1H-
benzimidazole. Empirical formula: C
H N O S. Molecular weight: 345.42. Structural formula:
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
Store at 68°F – 77°F (20-25°C). Excursions between 59°F –
86°F (15-30°C) are permitted.
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).
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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),
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