Bute
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Introduction
1. Equipalazone 1g Oral Paste
2. Equipalazone 1g Oral Powder
3. Equipalazone 200mg/ml Solution for Injection
4. Phenylbutazone 100mg tablets
5. Phenylbutazone 200mg tablets
6. Pro-Dynam Oral Powder
Presentation
1. Equipalazone 1g Oral Paste
Palatable paste for oral administration, containing per unit dose:
1 g Phenylbutazone
Preservatives:
0.006 g Sodium Methyl Parahydroxybenzoate
0.0015 g Sodium Propyl Parahydroxybenzoate
2. Equipalazone 1g Oral Powder
Free flowing white/cream powder for oral administration, containing 1 g micro-encapsulated Phenylbutazone per sachet.
Preservative: Sodium Paracombin 0.15 % w/w
3. Equipalazone 200mg/ml Solution for Injection
A sterile aqueous solution for injection, containing Phenylbutazone 200 mg/ml.
Preservative: Benzyl Alcohol 1.5 % v/v
4. Phenylbutazone 100mg tablets
Red sugar coated tablets containing Phenylbutazone PhEur 100 mg.
5. Phenylbutazone 200mg tablets
White sugar coated tablets containing: Phenylbutazone PhEur 200 mg.
6. Pro-Dynam Oral Powder
A fine white odourless powder for oral administration presented in sachets, each 5 g sachet containing 1 g phenylbutazone in a palatable base.
Uses
1. Equipalazone 1g Oral Paste
Equipalazone 1 g Oral Paste is indicated in the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of Phenylbutazone can offer relief, for example, in lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis.
2. Equipalazone 1g Oral Powder
Equipalazone 1 g Oral Powder is indicated in the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of Phenylbutazone can offer relief, for example, in lameness associated with osteoarthritic conditions, acute and chronic laminitis, bursitis and carpitis, and in the reduction of post-surgical soft tissue reaction.
3. Equipalazone 200mg/ml Solution for Injection
Equipalazone 200 mg/ml Solution for Injection is indicated in the treatment of musculoskeletal disorders in horses and ponies where the anti-inflammatory and analgesic properties of Phenylbutazone can offer relief against inflammation, pain and lameness.
4. Phenylbutazone 100mg tablets
Indicated in dogs of 5–20 kg bodyweight for the treatment of osteoarthritis, acute musculo-skeletal trauma including spondylitis, bursitis and inflammation of ligaments, rheumatoid and other arthritic diseases.
5. Phenylbutazone 200mg tablets
Indicated in dogs of 20 kg and over for the treatment of osteoarthritis, acute musculo-skeletal trauma including spondylitis, bursitis and inflammation of ligaments, rheumatoid and other arthritic diseases.
6. Pro-Dynam Oral Powder
Pro-Dynam is a non-steroidal anti-inflammatory drug (NSAID) for use in horses. Pro-Dynam is indicated for the treatment of musculoskeletal conditions where relief from pain and a reduction in the associated inflammation is required, e.g. in lameness associated with osteoarthritic conditions, bursitis, laminitis and soft tissue inflammation, particularly where continued mobility is considered desirable.
It is also of value in limiting post surgical inflammation, myositis and other soft tissue inflammation.
Pro-Dynam can be used as an anti-pyretic where this is considered advisable, e.g. in viral respiratory infections.
Dosage & administration
1. Equipalazone 1g Oral Paste
Each marked division (2 turns of the ring) is equivalent to 1 unit dose (i.e. 1 g Phenylbutazone).
Horses: 450 kg (1000 lbs) bodyweight:
2 unit doses twice on day one (equivalent to 8.8 mg/kg/day), 1 unit dose twice daily for four days (4.4 mg/kg/day) followed by 1 unit dose daily or on alternate days (2.2 mg/kg/day), sufficient to keep the animal comfortable.
Ponies: 225 kg (500 lbs) bodyweight:
1 unit dose (4.4 mg/kg) on alternate days.
Remove cap from nozzle, turn ring to required dosage and express as near to the back of the tongue as possible. Replace cap after use.
Adjust dose according to bodyweight.
Discontinue treatment if no response is evident after four to five days treatment.
2. Equipalazone 1g Oral Powder
Dependent on individual response, but as a guide:
Horses: 450 kg (1000 lb) bodyweight:
Two sachets to be administered twice on day one (equivalent to 8.8 mg/kg/day) followed by 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) bodyweight:
One sachet (4.4 mg/kg/day) on alternate days.
Adjust dose according to bodyweight.
Discontinue treatment if no response is evident after four to five days treatment.
For ease of administration, Equipalazone 1 g Oral Powder may be mixed with a small quantity of bran or oats.
3. Equipalazone 200mg/ml Solution for Injection
Horses: 450 kg (1000 lb) bodyweight:
Maximum 10 ml (4.4 mg Phenylbutazone/kg).
Ponies: 225 kg (500 lb) bodyweight:
Maximum 5 ml (4.4 mg Phenylbutazone/kg)
Equipalazone 200 mg/ml Solution for Injection should be administered by slow intravenous injection as a single dose, which may be followed if necessary by oral Phenylbutazone therapy commencing 24 hours after the injection.
In acute cases and in hospitalised animals, Equipalazone 200 mg/ml Solution for Injection may be administered once daily for not more than five consecutive days.
4. Phenylbutazone 100mg tablets & 5. Phenylbutazone 200mg tablets
20 mg/kg daily for 7 days preferably in divided doses every 8 or 12 hours, followed by 10 mg/kg daily for 7 days preferably in divided doses every 8 or 12 hours. Phenylbutazone 100 mg should not be administered to dogs of less than 5 kg bodyweight. Dogs weighing 5–10 kg should be given one Phenylbutazone 100 mg tablet daily for 7 days only. The 5 mg/kg dose for the second week is not appropriate as tablets should be administered whole. Where it is not possible to divide the daily dose, dogs should be monitored closely for signs of adverse reactions.
The tablets should be administered whole with or immediately after food. In older dogs suffering chronic musculo-skeletal disease the course of treatment at the lower dose may be extended but the patient must be regularly monitored for any possible adverse effects.
In the case of trauma, if symptoms persist after the initial two week course of treatment the diagnosis should be reassessed.
6. Pro-Dynam Oral Powder
Pro-Dynam should be administered by mouth.
For each 450 kg (1000 lbs) bodyweight the following dosage guide should be used according to individual response:
Day 1
Two sachets twice daily (equivalent to 4.4 mg/kg on each occasion).
Day 2–4
One sachet twice daily (equivalent to 2.2 mg/kg on each occasion) followed by one sachet daily (2.2 mg/kg daily) or on alternate days as required.
If no response is evident after 4–5 days, discontinue treatment.
Hay may delay the absorption of phenylbutazone and so the onset of a clinical effect. It is advisable not to feed hay immediately prior to, or during the administration of Pro-Dynam.
For ease of administration Pro-Dynam may be mixed with a quantity of bran or oats.
Price comparison
Contra-indications, warnings, etc.
1. Equipalazone 1g Oral Paste, 2. Equipalazone 1g Oral Powder & 3. Equipalazone 200mg/ml Solution for Injection
Treated horses may never be slaughtered for human consumption.
The therapeutic index of Phenylbutazone is low.
Do not exceed the stated dose or the duration of treatment.
Use is contraindicated 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 or hypersensitivity to the product.
Do not administer other NSAIDs concurrently or within 24 hours of each other.
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.
Use in animals less than six weeks of age, or in aged animals, may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a risk of increased renal toxicity.
Concurrent administration of potentially nephrotoxic drugs should be avoided.
It is preferable that NSAIDs which inhibit prostaglandin synthesis are not administered to animals undergoing general anaesthesia until fully recovered.
Use during pregnancy should be avoided whenever possible, particularly during the first trimester.
Operator warnings: The product should be handled with care at all times to reduce the risk of accidental ingestion or skin contact. If accidental skin or eye contact occurs, the site should be washed immediately with water. If the product is ingested, seek medical advice immediately and show the product packaging.
Advice to doctors: gastric lavage (emesis in children) should be performed urgently. Charcoal haemoperfusion has also been shown to be beneficial. Treatment should then be administered symptomatically.
General precautions: For animal treatment only.
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.
Withdrawal period: Do not use in animals intended for human consumption.
4. Phenylbutazone 100mg tablets & 5. Phenylbutazone 200mg tablets
Contra-indications, warnings, etc
If any of this product is accidentally swallowed, go at once to the Accident and Emergency (Casualty) department of a hospital and show the container to the doctor or nurse on duty.
Pet owners should return any unused tablets to their Veterinary Surgery for disposal.
Only to be dispensed by veterinarians, in secure child resistant containers.
Disposal:
Dispose of any unused product or containers in accordance with guidance from your local waste regulation authority, eg the local regional office of the Environment Agency or SEPA.
End user should be advised that any remaining after the course of treatment should be returned to the veterinary surgery.
Do not exceed the stated dose or the duration of treatment.
Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.
Do not administer other NSAIDs concurrently or within 24 hours of each other.
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs which can lead to toxic effects.
NSAID's can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections, appropriate antimicrobial therapy should be instigated.
Not to be used in cats.
Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be avoided.
In suspected cases of renal or hepatic dysfunction an EDTA and clotted blood sample should be taken in order that relevant haematological and biochemical assays can be carried out prior to commencement of treatment.
Treatment should be discontinued in animals developing gastro-intestinal symptoms or vascular disorders.
It is preferable that NSAID's which inhibit prostaglandin synthesis are not administered to animals undergoing anaesthesia until fully recovered.
6. Pro-Dynam Oral Powder
For animal treatment only.
Do not use in horses intended for human consumption.
Do not exceed the stated dose as the therapeutic index of phenylbutazone is low.
Use is contraindicated 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 or hypersensitivity to the product.
Do not administer other NSAIDs or glucocorticoids concurrently or within 24 hours of each other.
Use in any animal less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful management.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of increased renal toxicity.
Concurrent administration of potential nephrotoxic drugs should be avoided.
Phenylbutazone is extensively bound to plasma proteins. It may displace other drugs that are highly protein bound, (e.g. some sulphonamides, warfarin) or it may itself be displaced to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.
Concurrent therapy with other therapeutic agents should be undertaken with caution due to the risk of metabolic interactions. Phenylbutazone may interfere with the metabolism of other drugs, e.g. warfarin, barbiturates, with resultant toxicity.
There is evidence to indicate that the pharmacokinetics of penicillin products may be affected by concurrent administration of products containing phenylbutazone, with a possible reduction of therapeutic efficacy, since tissue penetration may be reduced. The distribution of other drugs given concurrently may also be affected.
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.
Although no adverse effects of phenylbutazone on the foetus or maintenance of pregnancy have been reported during field use, no definitive safety studies have been carried out in the mare. Foetotoxic effects of phenylbutazone have been recorded in experimental animal species at high dose levels. Phenylbutazone does not readily cross the blood milk barrier.
If the administration of phenylbutazone to pregnant or lactating mares is considered essential, the potential benefits should be weighed against the potential hazard to the mare and/or foal. Avoid use around time of parturition.
Operator warnings
Avoid contact with the eyes. In case of accidental eye contact, irrigate eyes with plenty of clean water. If irritation persists seek medical advice.
Care should be taken to avoid inhaling or ingesting the powder. In the event of accidental inhalation or ingestion seek medical advice and show the product packaging.
Wash hands after use.
Keep out of the reach of children.
Pharmaceutical precautions
1. Equipalazone 1g Oral Paste & 2. Equipalazone 1g Oral Powder
Do not store above 25°C. Keep out of the reach and sight of children.
Any contents remaining later than 28 days after the first opening should be discarded.
Disposal: Dispose of any unused product and empty containers in accordance with guidance from your national waste regulation authority.
3. Equipalazone 200mg/ml Solution for Injection
Store between +2 and +8°C. Protect from light. Keep out of the reach and sight of children.
Once the vial is broached, following withdrawal of the first dose use the product within 28 days. Discard unused material.
Disposal: Dispose of any unused product and empty containers in accordance with guidance from your national waste regulation authority.
4. Phenylbutazone 100mg tablets & 5. Phenylbutazone 200mg tablets
Keep out of the reach of children.
Store in a dry place below 25°C.
6. Pro-Dynam Oral Powder
Any unused product or waste material should be disposed of in accordance with national requirements.
Packaging quantities
1. Equipalazone 1g Oral Paste
Dial-a-dose syringes containing 6 unit doses.
2. Equipalazone 1g Oral Powder
Boxes of 32 and 100 sachets.
3. Equipalazone 200mg/ml Solution for Injection
Multidose vials of 50 ml.
4. Phenylbutazone 100mg tablets
Containers of 500 and 1000 Tablets.
5. Phenylbutazone 200mg tablets
Containers of 500 and 1000 Tablets.
6. Pro-Dynam Oral Powder
Boxes of 100 × 5 g sachets, each sachet containing 1 g phenylbutazone.
Further information
1. Equipalazone 1g Oral Paste, 2. Equipalazone 1g Oral Powder & 3. Equipalazone 200mg/ml Solution for Injection
The clinical effect of Phenylbutazone can be evident for at least 3 days following cessation of administration. This should be borne in mind when examining the horse for soundness.
Some authorities (including the Jockey Club) regard Phenylbutazone as a "prohibited substance" under the rules of competition. Therefore, use of this product in a competition horse should be in accordance with the recommendations/advice of the relevant competition authorities.
To be supplied only on veterinary prescription.
Veterinary medicinal product authorised for use in UK and Ireland.
4. Phenylbutazone 100mg tablets
For dogs weighing more than 20kg the use of Phenylbutazone 200mg is indicated.
5. Phenylbutazone 200mg tablets
For dogs weighing less than 20 kg and more than 5 kg, the use of Phenylbutazone 100 mg is indicated.
6. Pro-Dynam Oral Powder
The clinical effects of phenylbutazone can be evident for at least three days following cessation of therapy. This should be borne in mind when examining horses for soundness.
Some equestrian authorities regard phenylbutazone as a `prohibited substance' within their rules.
Disclaimer
This site has been created by www.MedicAnimal.com for information purposes only. MedicAnimal is a proud retailer of Bute but is not affiliated with or related to the manufacturer of Bute and the contents of this site are neither sponsored or endorsed by the manufacturer of Bute.