Gastazole 370mg/g Oral Paste for Horses Pack of 7 Syringes

Gastazole: omeprazole for horses with gastric ulcers

Omeprazole is a proton pump inhibitor. It suppresses gastric acid secretion by inhibiting the H+/K+-ATPase enzyme system, the acid (proton) pump within the stomach lining. Because this is the final step in acid secretion, omeprazole blocks secretion irrespective of the stimulus. The full effect on the inhibition of acid secretion is reached by five days after the first administration.

Gastazole is given by mouth once a day from a pre-filled syringe with 100kg dose divisions on the plunger. Your vet will set the course: a treatment course is 28 days at the higher dose followed by 28 days at the lower dose, and the lower dose can also be used for prevention.

Key features of Gastazole 370mg/g Oral Paste for Horses:

• Active ingredient: omeprazole 370mg per g of paste.
• For treatment and prevention of gastric ulcers in horses.
• 7 pre-filled syringes: 7.57g of paste in each.
• One syringe treats a 700kg horse at 4mg omeprazole per kg.
• Once-daily dosing by mouth.
• For foals from four weeks of age and weighing over 75kg, adult horses and breeding stallions.

Managing the causes of gastric ulcers

Stress (including high performance training and competition), feeding, management and husbandry practices may be associated with the development of gastric ulceration in horses. Alongside treatment, consider ways to reduce stress, reduce fasting and increase your horse's intake of roughage and access to grazing, and talk to your vet about changes to training and management. See our equine care range and other vet medicines.

Always follow the directions and dosage given to you by your prescriber.

Dosage

For oral use in horses, including foals from four weeks of age and weighing over 75 kg, and breeding stallions.

Treatment of gastric ulcers: one administration per day during 28 consecutive days at the dose rate of 4 mg omeprazole per kg body weight followed immediately by a dosage regimen of one administration per day during 28 consecutive days at the dose rate of 1 mg omeprazole per kg body weight, to reduce the recurrence of gastric ulcers during treatment.

Should recurrence occur, re-treatment at a dose rate of 4 mg omeprazole per kg body weight is recommended.

It is recommended to associate the treatment with changes of husbandry and training practices.

Prevention of gastric ulcers: one administration per day at the dose rate of 1 mg omeprazole per kg body weight.

Do not use in animals under 4 weeks of age or weighing less than 75 kg bodyweight.

Using the syringe

To ensure a correct dosage, body weight should be determined as accurately as possible.

At 4 mg omeprazole/kg: set the syringe plunger to the appropriate dose division for the horse's weight. Each 100 kg dose division on the syringe plunger delivers sufficient omeprazole to treat 100 kg body weight. The contents of one syringe will treat a 700 kg horse at the rate of 4 mg omeprazole per kg body weight.

At 1 mg omeprazole/kg: set the syringe plunger to the dose division equivalent to one quarter of the horse's body weight. At this dose, each 100 kg dose division on the syringe plunger will deliver sufficient omeprazole to treat 400 kg body weight. For example, to treat a horse weighing 400 kg, set the plunger to 100 kg.

Replace cap after use.

Before use

Do not use in cases of hypersensitivity to the active substance or to any of the excipient(s).

Special precautions for use in horses:

• Stress (including high performance training and competition), feeding, management and husbandry practices may be associated with the development of gastric ulceration in horses. Individuals responsible for the well-being of horses should consider reducing the ulcerogenic challenge by modifying husbandry practices to achieve one or more of the following: reduced stress, reduced fasting, increased intake of roughage and access to grazing.
• The product should not be used in animals under 4 weeks of age or weighing less than 75 kg bodyweight.

Precautions for the person giving the paste:

• As this product may cause irritation and hypersensitivity reactions, avoid direct contact with skin and eyes.
• People with known hypersensitivity to omeprazole and/or sesame should avoid contact with the veterinary medicinal product.
• Personal protective equipment consisting of impervious gloves should be worn when handling the veterinary medicinal product.
• Do not eat or drink when handling and administering the product.
• Wash hands or any exposed skin after use.
• The dosing syringe should be returned to the original packaging and suitably stored to prevent access by children.
• In case of contact with eyes, wash immediately with clean running water and seek medical advice, and show the package leaflet or the label to the physician if symptoms persist.
• Persons developing a reaction after contact with the product should avoid handling the product in future.

Pregnancy and lactation: Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic effect. The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species. The use is not recommended during pregnancy and lactation.

Interactions: Omeprazole may delay the elimination of warfarin. Omeprazole may potentially alter benzodiazepine metabolism and prolong CNS effects. Clarithromycin may increase levels of omeprazole. Omeprazole may reduce cyclosporine metabolism. Omeprazole may decrease absorption of drugs requiring decreased gastric pH for optimal absorption (ketoconazole, itraconazole, iron, ampicillin esters). No other interaction with medicines routinely used in the treatment of horses is expected, although interaction with drugs metabolised by liver enzymes cannot be excluded.

Withdrawal period: Meat and offal: 1 day. Not authorised for use in mares producing milk for human consumption.

Adverse reactions and overdose

Adverse reactions: None known. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system.

Overdose: No undesirable effects related to treatment were observed following daily use for 91 days at omeprazole dosages up to 20 mg/kg in adult horses and in foals older than 2 months. No undesirable effects related to treatment (in particular no adverse effect on the semen quality or reproductive behaviour) were observed following daily use for 71 days at an omeprazole dosage of 12 mg/kg in breeding stallions. No undesirable effects related to treatment were observed following daily use for 21 days at an omeprazole dosage of 40 mg/kg in adult horses.

Storage and disposal

• Do not store above 25ºC. Replace cap after use.
• Shelf life after opening the immediate packaging: 28 days.
• Medicines should not be disposed of via wastewater. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Active ingredient: Omeprazole 370 mg per g.

Other ingredients: Ferric Oxide Yellow (E172) 2 mg per g, Ethanolamine, Potassium sorbate, Cassia Oil, Sodium Stearate, Calcium Stearate, Castor Oil Hydrogenated, Propylene Glycol Dicaprylocaprate, Sesame Oil Refined.

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We cannot guarantee the Patient Information Leaflet is accurate and is for reference only.