GASTROGARD- omeprazole paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Merial, Inc.

INN (International Name):

omeprazole

Composition:

omeprazole 370 mg in 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Caution Indications

Product summary:

How Supplied

Authorization status:

New Animal Drug Application

Summary of Product characteristics

GASTROGARD- OMEPRAZOLE PASTE
MERIAL, INC.
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GASTROGARD
(OMEPRAZOLE) ORAL PASTE FOR EQUINE ULCERS
NADA 141-123, Approved by the FDA
ORAL PASTE FOR HORSES AND FOALS
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CAUTION
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DES CRIPTION
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HOW SUPPLIED
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STORAGE CONDITIONS
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INDICATIONS
•
DOSAGE REGIMEN
•
®
NADA 141-123, Approved by FDA
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
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:
17
19
3
3
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.
Store at 68°F – 77°F (20-25°C). Excursions between 59°F –
86°F (15-30°C) are permitted.
For treatment and prevention of recurrence of gastric ulcers in 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
DIRECTIONS FOR USE
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•
•
•
•
•
WARNING
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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).
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 treatmen