Dechra
VETORYL® (trilostane)
CAPSULES
5 mg, 10 mg, 30 mg, 60 mg and 120 mg strengths
Adrenocortical suppressant for oral use in dogs only.
BRIEF SUMMARY (For Full Prescribing Information, see package insert.)
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: VETORYL Capsules are an orally active synthetic steroid analogue that blocks production of hormones produced in the adrenal cortex of dogs.
INDICATION: VETORYL Capsules are indicated for the treatment of pituitary- and adrenal- dependent hyperadrenocorticism in dogs.
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. Do not use in pregnant dogs. Studies conducted with trilostane in laboratory animals have shown teratogenic effects and early pregnancy loss.
WARNINGS: 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.
PRECAUTIONS: Hypoadrenocorticism can develop at any dose of VETORYL Capsules. A small percentage of dogs may develop corticosteroid nwithdrawal syndrome within 10 days of starting treatment. Mitotane (o,p’-DDD) treatment will reduce adrenal function. Experience in foreign markets suggests that when mitotane therapy is stopped, an interval of at least one month should elapse before the introduction of VETORYL Capsules. The use of VETORYL
Capsules will not affect the adrenal tumor itself. Adrenalectomy should be considered as an option for cases that are good surgical candidates. The safe use of this drug has not been evaluated in lactating dogs and males intended for breeding.
ADVERSE REACTIONS: The most common adverse reactions reported are poor/reduced appetite, vomiting, lethargy/dullness, diarrhea, elevated liver enzymes, elevated potassium with or without elevated sodium, elevated BUN, decreased Na/K ratio, weakness, elevated creatinine, shaking, and renal insufficiency. Occasionally, more serious reactions, including severe depression, hemorrhagic diarrhea, collapse, hypoadrenocortical crisis or adrenal necrosis/rupture may occur, and may result in death.
Distributed by:
Dechra Veterinary Products 7015 College Boulevard, Suite 525 Overland Park, KS 66211
VETORYL is a trademark of Dechra Ltd. © 2015, Dechra Ltd.
NADA 141-291, Approved by FDA
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