Pro-Dynam Oral Powder (pack of 100)-Hyperdrug

Presentation A fine white odourless powder for oral administration presented in sachets, each 5 g sachet containing 1 g phenylbutazone in a palatable base. Uses 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 and administration 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. Contra-indications, warnings, etc 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 Any unused product or waste material should be disposed of in accordance with national requirements. Legal category POM-V Packaging Quantities Boxes of 100 × 5 g sachets, each sachet containing 1 g phenylbutazone. Further information 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.

Contra-indications, warnings, etc For animal treatment only. Do not use in horses intended for human consumption. The therapeutic index of phenylbutazone is low. 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, and 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 has 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. Care should be taken to avoid inhaling the powder. Wash hands after use. Keep out of the reach of children. Pharmaceutical precautions Nil.