Equine Bute Paste 1L Anti-inflammatory, analgesic and antipyretic oral paste for the relief of painful musculoskeletal conditions.

ACTIVE CONSTITUENTS

Phenylbutazone 200mg/mL as an Oral Paste

PACK SIZE

1 Litre pail

INDICATIONS

Anti-inflammatory, analgesic and antipyretic oral paste for the relief of painful musculoskeletal conditions in horses.

Phenylbutazone is used for its anti-inflammatory, analgesic and antipyretic activity in the treatment of bone and joint inflammation, musculoskeletal disorders, soft tissue inflammation, such as tendonitis, acute tenosynovitis, capsulitis and bursitis and acute and chronic laminitis. Clinical response to the drug can be seen within a few hours of oral dosage, while optimum effects occur approximately 12 hours post administration.

PHARMACOLOGY

Phenylbutazone is a nonsteroidal anti-inflammatory drug (NSAID) with antipyretic and analgesic activity. It binds irreversibly to the enzyme cyclooxygenase, inhibiting its activity in the biosynthesis of prostaglandins. Prostaglandins are the primary mediators of the inflammatory response causing tissue swelling and inflammation, pain, and fever. Further production of prostaglandin cannot occur until new enzyme is synthesized; resulting in a reduced concentration of prostaglandins at inflammatory sites, and reduced inflammatory responses.

Phenylbutazone is well absorbed following oral administration. The drug is distributed throughout the body, with highest levels being attained in the liver, lungs, heart, kidneys, and plasma. Phenylbutazone is up to 95% plasma protein bound. The increased vascular permeability to plasma proteins during an inflammatory process results in concentration of phenylbutazone in the inflammatory exudate.

The serum half-life of phenylbutazone is dose dependent, ranging in the horse from 3.5 hours at a dose of 2g/450kg to 6 hours at a dose of 8g/450kg. Therapeutic efficacy may last for more than 24 hours, due probably to the irreversible binding of the drug to cyclooxygenase.

Phenylbutazone is almost completely metabolised in the horse. The principal metabolites are oxyphenbutazone, with a pharmacological effect similar to phenylbutazone, and the pharmacologically inactive -hydroxyphenylbutazone. The first of the metabolites to be excreted is -hydroxyphenylbutazone which can be detected in urine up to 18 hours post administration. Oxyphenbutazone may be detected for at least 96 hours in the horse following a single oral dose

DOSAGE AND ADMINISTRATION

For oral use only. This product is contraindicated in animals with cardiac, renal or hepatic disorders, blood dyscrasias or preexisting gastrointestinal ulceration.

Horses - Administer orally prior to feeding. 4.4 mg/kg (10mL/450 kg) bodyweight twice daily for the first day; 2.2 mg/kg (5 mL/450 kg) bodyweight twice daily for the next four days; 2.2mg/kg (5 mL/450 kg) once daily on alternate days or as directed by a veterinarian. Maximum daily dose should not exceed 4 grams (20 mL).

Ponies - Administer orally prior to feeding. 2.2 mg/kg (2.5mL/225 kg) bodyweight twice daily for four days; 2.2 mg/kg (2.5 mL/225 kg) once daily on alternate days or as directed by a veterinarian.

Do not exceed the recommended dose, as ponies exhibit an increased sensitivity to the toxic effects of phenylbutazone.

PRECAUTIONS

Phenylbutazone should not be combined with other NSAIDs or other highly protein bound drugs, such as digoxin, warfarin, and sulfonamides. Potential adverse effects of phenylbutazone include anorexia, depression, colic, weight loss, ventral oedema, oral and gastrointestinal lesions including ulcers, and renal papillary necrosis. Ponies exhibit an increased sensitivity to the toxic effects of phenylbutazone. If any of these signs occur discontinue treatment immediately.

MEAT WITHHOLDING PERIOD

NOT TO BE USED in horses intended for human consumption.

NEW ZEALAND INFORMATION

It is a legal requirement that this product is not used in any animal producing or intended to produce food for human consumption.

RACING/EVENT WITHHOLDING PERIOD

If used in performance animals, the regulations of the relevant authorities regarding medication should be observed.

FIRST AID

If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126 or in New Zealand 0800 764 766.

DISPOSAL

Dispose of empty container by wrapping with paper and putting in garbage.

STORAGE

Store below 25°C (Air conditioning). Protect from light.

REGISTRATION

APVMA Approval No. 63283/45232 (Australia)

ACVM No. A10324 (New Zealand)

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