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|Drug Name and Strength||Trilostane 60mg|
|Indication||Treatment of pituitary dependent and adrenal dependent hyperadrenocorticism (Cushing syndrome) in dogs.|
|Contraindications||Administration to animals with primary hepatic disease and/or renal insufficiency, or to pregnant or lactating bitches or any animals intended for breeding. The 60 mg capsule is contraindicated in animals weighing less than 10 kg. This product is contraindicated in dogs weighing less than 3 kg.|
|Actions||Trilostane is a 4α,5-epoxysteroid, and inhibits the action of the enzyme 3β-hydroxysteroid dehydrogenase, which is important in steroid synthesis. Vetoryl has the potential to block all steroid hormones, i.e. cortisol, aldosterone and androgens. Signs of aldosterone inhibition (increased blood potassium, urea and creatinine) do not become apparent in most Cushingoid dogs on trilostane therapy at the appropriate dosage. Vetoryl has the potential to block oestrogen, progesterone and testosterone, so should not be used in pregnant or breeding animals. Vetoryl is metabolised and excreted by the liver and kidneys.|
|Warnings||Do not swallow. Wash hands after use.|
|Precautions||An accurate diagnosis of hyperadrenocorticism is essential. As most cases of hyperadrenocorticism are diagnosed in dogs between the ages of 10 and 15 years, other pathological processes are frequently present. It is particularly important to screen animals for primary hepatic disease and renal insufficiency, as the product is contraindicated in these cases. The presence of diabetes mellitus and hyperadrenocorticism together requires specific monitoring. If a dog has previously been treated with mitotane, its adrenal function will have been reduced. Experience in the field suggests that an interval of at least one month should elapse between cessation of mitotane and the introduction of trilostane. Close monitoring of adrenal function is advised, as dogs may be more susceptible to the effects of trilostane. The product should be used with extreme caution in dogs with pre-existing anaemia, as further reductions in packed cell volume and haemoglobin may occur. Regular monitoring should be undertaken.Trilostane may decrease testosterone synthesis and has antiprogesterone properties. The possibility of interactions with other medicinal products has not been specifically studied. Given that hyperadrenocorticism tends to occur in older dogs, many will be receiving concurrent medication. The risk of hyperkalaemia developing should be considered if trilostane is used in conjunction with potassium sparing diuretics or angiotensin converting enzyme (ACE) inhibitors. The concurrent use of such drugs should be subject to a risk:benefit analysis by the veterinary surgeon, as there have been a few reports of deaths (including sudden death) in dogs when treated concurrently with trilostane and an ACE inhibitor. A sudden reduction in serum cortisol may cause malaise and weakness, or may unmask arthritis or dermatoses. Caution should be used in treating animals which show symptoms of arthritis with therapies such as nonsteroidal anti-inflammatory drugs (NSAIDs), which may also potentiate or precipitate renal disease or exacerbate existing problems that aged hyperadrenocorticoid dogs may have. Concomitant use of NSAIDs and other anti-inflammatories with trilostane has not been specifically studied. Therapies for osteoarthritis that are less likely than NSAIDs to cause renal injury should be considered in dogs receiving trilostane.Product is harmful if swallowed. Do not swallow. Wash hands after use. Do not handle the capsules if pregnant or if trying to conceive. Trilostane may decrease testosterone synthesis and has anti-progesterone properties. Women who are pregnant or are intending to become pregnant should avoid handling the capsules. People with known hypersensitivity to trilostane or any of the excipients should avoid contact with the product. The content of the capsules may cause skin and eye irritation and sensitisation. Do not divide or open capsules.First Aid If poisoning occurs, contact a Poisons Information Centre. Phone Australia 131 126. Wash hands with soap and water following accidental exposure and after use. In the event of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician. In the event of accidental breakage of the capsules and contact of the granules with eyes or skin, wash immediately with plenty of water. If irritation persists, seek medical advice.Disposal Dispose of empty containers by wrapping with paper and putting in garbage.|
|Dosage and Administration||Administer orally, once daily, with food. The starting dose is approximately 2 mg/kg, based on available combinations of capsule sizes. Titrate the dose according to individual response as determined by monitoring.If a dose increase is required, use combinations of capsule sizes to slowly increase the once daily dose. A wide range of capsule sizes enables optimum dosing for the individual dog. Administer the lowest dose necessary to control the clinical signs. Ultimately, if symptoms are not adequately controlled for an entire 24 hour inter-dose period, consider increasing the daily dose by up to 50% and dividing it equally between morning and evening doses. Do not divide or open capsules. A small number of animals may require doses significantly in excess of 10 mg/kg bodyweight/day; in these situations, appropriate additional monitoring should be implemented. 10 mg capsules should be used in dogs that require particularly small doses of trilostane, and to assist with dosage requirements. Only complete blister strips should be dispensed. General directions. When there is no apparent response to treatment, the diagnosis should be re-evaluated. Dose increases may be necessary. Do not divide or open capsules. Monitoring. Samples should be taken for biochemical tests (including electrolyte levels) and an ACTH stimulation test before treatment, at 10 days, four weeks, 12 weeks and then every three months, after initial diagnosis and after each dose adjustment. It is imperative that ACTH stimulation tests are performed four to six hours after dosing to enable accurate interpretation of results. Regular assessment of the clinical progress of the disease should also be made at each of the above time points.In the event of a nonstimulatory ACTH stimulation test during monitoring, treatment should be stopped for seven days and then restarted at a lower dose. Repeat the ACTH stimulation test after a further 14 days. If the result is still nonstimulatory, stop treatment until clinical signs of hyperadrenocorticism recur. Repeat the ACTH stimulation test one month after restarting treatment.Dogs should be monitored at regular intervals for primary hepatic disease, renal disease, and for diabetes mellitus. Subsequent close monitoring during treatment should be carried out. Particular attention should be paid to liver enzymes, electrolytes, urea and creatinine.|
|Storage||Store below 30°C (room temperature). Keep the blister strips in the carton.|
|MSDS (external link)||Vetoryl Capsules 60mg MSDS|
|Label (external link)||Vetoryl Capsules 60mg Label|