Butazocare flavour 1g granules in sachet POM

Clinical particulars
Target species
Horses and ponies (non-food producing).
Indications for use, specifying the target species
For the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of phenylbutazone can offer relief. Examples of conditions normally considered suitable for treatment with phenylbutazone include lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis, and in the reduction of post-surgical soft tissue reaction.
Contraindications
Do not use in animals suffering from cardiac, hepatic or renal disease; where there is the possibility of gastrointestinal ulceration or bleeding; or where there is evidence of a blood dyscrasia.
Do not use in animals suffering from gastrointestinal diseases.
Do not use in animals with haemorrhagic diathesis.
Do not use in cases of known hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
The clinical effect of phenylbutazone can be evident for at least three days following cessation of administration. This should be borne in mind when examining horses for soundness
Special precautions for use
Special precautions for use in animals
Use in any animal under six weeks of age, or in aged animals, may involve additional risks. If such use cannot be avoided, animals may require a reduced dosage and special clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a risk of increased toxicity. It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered. Response to long-term therapy should be monitored at regular intervals by a veterinary practitioner. NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections, appropriate concurrent antimicrobial therapy should be instigated. The therapeutic index of phenylbutazone is low. Do not exceed the stated dose or the duration of treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may cause hypersensitivity (allergic) reactions in those sensitised to phenylbutazone, either via skin contact or accidental inhalation. People with known hypersensitivity to phenylbutazone, should avoid contact with this product. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes, or difficulty breathing, are more serious symptoms and require urgent medical attention.This product can be irritating to the skin and the eyes. Avoid contact with the eyes. In case of accidental eye contact, irrigate eyes with plenty of clean water. If irritation persists seek medical advice. Wash any exposed skin and hands after use. Care should be taken to avoid ingesting the powder. In the event of accidental ingestion, seek medical advice and show the product packaging to the physician.
Adverse reactions (frequency and seriousness)
In common with other NSAIDs that inhibit prostaglandin synthesis, there may be gastric and/or renal intolerance. This is usually associated with overdosage and such events are rare. Recovery is usual on cessation of treatment and following the initiation of supportive symptomatic therapy (see 4.10 for further information).
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
- inappetence
- apathy
- colic
- weight loss
- diarrhoea
- gastrointestinal bleeding
- intestinal protein loss which can result in hypoproteinemia
- sodium and potassium loss which can result in oedema
- thrombocytopenia
- leucopenia
- hematopoietic dysfunction
- anemia
- increased aminotransferase levels
Use during pregnancy, lactation or lay
Phenylbutazone crosses the placenta and passes into milk in lactating animals. Use during pregnancy should be avoided whenever possible, particularly during the first trimester
Interaction with other medicinal products and other forms of interaction
Phenylbutazone may be highly bound to plasma proteins and compete with other highly bound drugs (e.g. sulfonamides) to produce an increase in non-bound pharmacologically active concentrations which can lead to toxic effects.
Phenylbutazone induces enzymatic activity and thus affect plasma levels and efficacy of other drugs.
Due to inhibition of renal prostaglandin synthesis, efficacy of diuretics are reduced. Elimination of penicillin is reduced.
Adverse reactions caused by phenylbutazone are exacerbated by concurrent administration of glucocorticoids, other non-steroidal antiphlogistics, or anticoagulants.
Do not administer with other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other.
Amounts to be administered and administration route
For oral administration.
The dosage should be adjusted according to the individual animal's response, but the following may be taken as a guide:
Horses 450 kg (1000 lb) body weight: the contents of two sachets to be administered twice on day 1 of treatment (equivalent to 8.8 mg/kg/day) followed by the contents of one sachet twice daily for four days (4.4 mg/kg/day), then one sachet daily, or on alternate days, sufficient to keep the horse comfortable (2.2 mg/kg/day).
Ponies 225 kg (500 lb) body weight, one sachet (4.4 mg/kg) on alternate days.
Discontinue treatment if no response is evident after four to five days treatment.
For ease of administration mix the powder with a small quantity of feed.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdosing may result in gastric and large intestinal ulceration and general enteropathy. Renal papillary damage may also occur with impaired renal function. Subcutaneous oedema, especially under the jaw may become evident due to plasma protein loss.
There is no specific antidote. If signs of possible overdosage occur, treat the animal symptomatically.
Acute overdosing may result in central nervous symptoms (seizures, excitations), haematuria acidosis. If signs of overdose are observed treatment with phenylbutazone is to be discontinued.
The therapeutic index of phenylbutazone is low.
Withdrawal period(s)
Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.
Pharmacological particulars
Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, non-steroids.
ATC vet code: QM01AA01
Pharmacodynamic properties
Phenylbutazone acts by inhibiting the production of prostaglandins. Prostaglandins possess a wide variety of physiological properties, including those involved in the production of pain, inflammation and pyrexia. The main metabolite, oxyphenbutazone, possesses similar pharmacological properties
Pharmacokinetic particulars
Phenylbutazone is generally well absorbed following oral administration. The rate, but not the extent, of absorption may be affected due to binding of phenylbutazone to food and the contents of the gastrointestinal tract.
Pharmaceutical particulars
List of excipients
Cellulose microcrystalline, Ethylcellulose, Hypromellose, Magnesium stearate, Sucrose, Peppermint flavour
Major incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Sachets of a paper/polyethylene outer layer and aluminium/polyethylene inner layer in packs of 32 and 100 sachets. Each sachet contains 2 g Butazocare powder. The sachets are packaged in a carton. Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.