Trilostane

Trilostane is useful in Cushing's syndrome & primary hyperaldosteronism. It reversibly inhibits ß hydroxysteroid dehydrogenase/delta 5-4 isomerase in the adrenal cortex; the resulting inhibition of the synthesis of mineralocorticoids and glucocorticoids may be useful in Cushing's syndrome. It has minor role in post-menopausal breast cancer that has relapsed following initial estrogen antagonist therapy.

Trilostane is primarily indicated in conditions like Cushing's syndrome, Post-menopausal breast cancer (with glucocorticoid therapy), Primary hyperaldosteronism, and can also be given in adjunctive therapy as an alternative drug of choice in Adrenal cortical hyperfunction, Prophylaxis of macrocytic anemias.

Trilostane is contraindicated in conditions like Pregnancy, Breast feeding.

The symptomatic adverse reactions produced by Trilostane are more or less tolerable and if they become severe, they can be treated symptomatically, these include Rashes, Flushing, Tingling, Mouth swelling, Granulocytopenia (rarely).

Hypoadrenocorticism can develop at any dose of VETORYL Capsules. In some cases, it may take months for adrenal function to return and some dogs never regain adequate adrenal function. All dogs should undergo a thorough history and physical examination before initiation of therapy with VETORYL Capsules. Other conditions, such as primary hepatic and/or renal disease should be considered when the patient is exhibiting signs of illness in addition to signs of hyperadrenocorticism (e.g. vomiting, diarrhea, poor/reduced appetite, weight loss, and lethargy). Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of VETORYL Capsules should be considered. Owners should be advised to discontinue therapy immediately and contact their veterinarian if signs of potential drug toxicity are observed (see INFORMATION FOR DOG OWNERS, DOSAGE AND ADMINISTRATION, PRECAUTIONS, ADVERSE REACTIONS, ANIMAL SAFETY and POST-APPROVAL EXPERIENCE). In case of overdosage, symptomatic treatment of hypoadrenocorticism with corticosteroids, mineralocorticoids and intravenous fluids may be required. Angiotensin converting enzyme (ACE) inhibitors should be used with caution with VETORYL Capsules, as both drugs have aldosterone-lowering effects which may be additive, impairing the patient’s ability to maintain normal electrolytes, blood volume and renal perfusion. Potassium sparing diuretics (e.g. spironolactone) should not be used with VETORYL Capsules as both drugs have the potential to inhibit aldosterone, increasing the likelihood of hyperkalemia. HUMAN WARNINGS: Keep out of reach of children. Not for human use. Wash hands after use. Do not empty capsule contents and do not attempt to divide the capsules. Do not handle the capsules if pregnant or if trying to conceive. Trilostane is associated with teratogenic effects and early pregnancy loss in laboratory animals. In the event of accidental ingestion/overdose, seek medical advice immediately and take the labeled container with you.

Hypoadrenocorticism can develop at any dose of VETORYL Capsules. In some cases, it may take months for adrenal function to return and some dogs never regain adequate adrenal function. All dogs should undergo a thorough history and physical examination before initiation of therapy with VETORYL Capsules. Other conditions, such as primary hepatic and/or renal disease should be considered when the patient is exhibiting signs of illness in addition to signs of hyperadrenocorticism (e.g. vomiting, diarrhea, poor/reduced appetite, weight loss, and lethargy). Appropriate laboratory tests to establish hematological and serum biochemical baseline data prior to, and periodically during, administration of VETORYL Capsules should be considered. Owners should be advised to discontinue therapy immediately and contact their veterinarian if signs of potential drug toxicity are observed (see INFORMATION FOR DOG OWNERS, DOSAGE AND ADMINISTRATION, PRECAUTIONS, ADVERSE REACTIONS, ANIMAL SAFETY and POST-APPROVAL EXPERIENCE). In case of overdosage, symptomatic treatment of hypoadrenocorticism with corticosteroids, mineralocorticoids and intravenous fluids may be required. Angiotensin converting enzyme (ACE) inhibitors should be used with caution with VETORYL Capsules, as both drugs have aldosterone-lowering effects which may be additive, impairing the patient’s ability to maintain normal electrolytes, blood volume and renal perfusion. Potassium sparing diuretics (e.g. spironolactone) should not be used with VETORYL Capsules as both drugs have the potential to inhibit aldosterone, increasing the likelihood of hyperkalemia. HUMAN WARNINGS: Keep out of reach of children. Not for human use. Wash hands after use. Do not empty capsule contents and do not attempt to divide the capsules. Do not handle the capsules if pregnant or if trying to conceive. Trilostane is associated with teratogenic effects and early pregnancy loss in laboratory animals. In the event of accidental ingestion/overdose, seek medical advice immediately and take the labeled container with you.

Scraped Dose — Always provide the Client Information Sheet with prescription (see INFORMATION FOR DOG OWNERS ). 1. Starting dose The starting dose for the treatment of hyperadrenocorticism in dogs is 1-3 mg/lb (2.2-6.7 mg/kg) once a day. Start with the lowest possible dose based on body weight and available combinations of capsule sizes. VETORYL Capsules should be administered with food. 2. Action at 10-14 day evaluation (Table 1) After approximately 10-14 days at this dose, re-examine the dog and conduct a 4-6 hour post-dosing ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). If physical examination is acceptable, take action according to Table 1. Owners should be instructed to stop therapy and contact their veterinarian immediately in the event of adverse reactions such as vomiting, diarrhea, lethargy, poor/reduced appetite, weakness, collapse or any other unusual developments. If these clinical signs are observed, conduct an ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). Table 1: Action at 10-14 day evaluation *Combinations of capsule sizes should be used to slowly increase the once daily dose. 3. Individual dose adjustments and close monitoring are essential Re-examine and conduct an ACTH stimulation test and serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function) 10-14 days after every dose alteration. Care must be taken during dose increases to monitor the dog’s clinical signs. Once daily administration is recommended. However, if clinical signs are not controlled for the full day, twice daily dosing may be needed. To switch from a once daily dose to a twice daily dose, the total daily dose should be divided into 2 portions given 12 hours apart. It is not necessary for the portions to be equal. If applicable, the larger dose should be administered in the morning and the smaller dose in the evening. For example, a dog receiving 90 mg would receive 60 mg in the morning, and 30 mg in evening. 4. Long term monitoring Once an optimum dose of VETORYL Capsules has been reached, re-examine the dog at 30 days, 90 days and every 3 months thereafter. At a minimum, this monitoring should include: ● A thorough history and physical examination. ● An ACTH stimulation test (conducted 4-6 hours after VETORYL Capsule administration) - a post-ACTH stimulation test resulting in a cortisol of < 1.45 µg/dL (< 40 nmol/L), with or without electrolyte abnormalities, may precede the development of clinical signs of hypoadrenocorticism. ● Serum biochemical tests (with particular attention to electrolytes, and renal and hepatic function). Good control is indicated by favorable clinical signs as well as post-ACTH serum cortisol of 1.45-9.1 µg/dL (40-250 nmol/L). If the ACTH stimulation test is < 1.45 µg/dL (< 40 nmol/L) and/or if electrolyte imbalances characteristic of hypoadrenocorticism (hyperkalemia and hyponatremia) are found, VETORYL Capsules should be temporarily discontinued until recurrence of clinical signs consistent with hyperadrenocorticism and ACTH stimulation test results return to normal (1.45-9.1 µg/dL or 40-250 nmol/L). VETORYL Capsules may then be re-introduced at a lower dose.

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

No data regarding the interactions of Trilostane was found.

No storage information is recorded for this medicine yet.