Vetoryl: Product Information

VETORYL- trilostane capsule
Dechra Veterinary Products

Adrenocortical suppressant for oral use in dogs only.

CAUTION:

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION:

VETORYL Capsules are available in 6 sizes (5, 10, 20, 30, 60 and 120 mg) for oral administration based on body weight. Trilostane (4α,5α-epoxy-17β-hydroxy-3-oxoandrostane-2α-carbonitrile) is an orally active synthetic steroid analogue that selectively inhibits 3 β-hydroxysteroid dehydrogenase in the adrenal cortex, thereby inhibiting the conversion of pregnenolone to progesterone. This inhibition blocks production of glucocorticoids and to a lesser extent, mineralocorticoids and sex hormones while steroid precursor levels increase. The structural formula is:

Chemical Structure
(click image for full-size original)

INDICATIONS:

VETORYL Capsules are indicated for the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism in dogs.

DOSAGE AND ADMINISTRATION:

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
Post-ACTH serum cortisol Action
µg/dL nmol/L
*
Combinations of capsule sizes should be used to slowly increase the once daily dose.
< 1.45 < 40 Stop treatment. Re-start at a decreased dose
1.45 to 5.4 40 to 150 Continue on same dose
> 5.4 to 9.1 > 150 to 250 EITHER: Continue on current dose if clinical signs are well controlledOR: Increase dose if clinical signs of hyperadrenocorticism are still evident *
> 9.1 > 250 Increase initial 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.

CONTRAINDICATIONS:

The use of VETORYL Capsules is contraindicated in dogs that have demonstrated hypersensitivity to trilostane.

Do not use VETORYL Capsules in animals with primary hepatic disease or renal insufficiency (See WARNINGS and PRECAUTIONS).

Do not use in pregnant dogs. Studies conducted with trilostane in laboratory animals have shown teratogenic effects and early pregnancy loss.

WARNINGS:

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.

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