Vetoryl

• Dechra Veterinary Products

Vetoryl Capsules are indicated for the treatment of pituitary-dependent hyperadrenocorticism in dogs.

Vetoryl Capsules are indicated for the treatment of hyperadrenocorticism due to adrenocortical tumor in dogs.

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.

Eighty-three dogs with hyperadrenocorticism were enrolled in a multi-center US field study. Additionally, 30 dogs with hyperadrenocorticism were enrolled in two UK field studies. Results from these studies demonstrated that treatment with Vetoryl Capsules resulted in an improvement in clinical signs (decreased thirst, decreased frequency of urination, decreased panting, and improvement of appetite and activity). Improvement in post-ACTH cortisol levels occurred in most cases within 14 days of starting Vetoryl Capsules therapy.

In these three studies, there were a total of 10 dogs diagnosed with hyperadrenocorticism due to an adrenal tumor or due to concurrent pituitary and adrenal tumors. Evaluation of these cases failed to demonstrate a difference in clinical, endocrine, or biochemical response when compared to cases of pituitary-dependent hyperadrenocorticism.

In a laboratory study, Vetoryl Capsules were administered to 8 healthy 6 month old Beagles per group at 0X (empty capsules), 1X, 3X, and 5X the maximum starting dose of 6.7 mg/kg twice daily for 90 days. Three animals in the 3X group (receiving 20.1 mg/kg twice daily) and five animals in the 5X group (receiving 33.5 mg/kg twice daily) died between Days 23 and 46. They showed one or more of the following clinical signs: decreased appetite, decreased activity, weight loss, dehydration, soft stool, slight muscle tremors, diarrhea, lateral recumbency, and staggering gait. Bloodwork showed hyponatremia, hyperkalemia, and azotemia, consistent with hypoadrenocortical crisis. Post-mortem findings included epithelial necrosis or cystic dilation of duodenal mucosal crypts, gastric mucosal or thymic hemorrhage, atrial thrombosis, pyelitis and cystitis, and inflammation of the lungs.

ACTH stimulated cortisol release was reduced in all dogs treated with Vetoryl Capsules. The dogs in the 3X and 5X groups had decreased activity. The 5X dogs had less weight gain than the other groups. The 3X and 5X dogs had lower sodium, albumin, total protein, and cholesterol compared to the control dogs. The 5X dogs had lower mean corpuscular volume than the controls. There was a dose dependent increase in amylase. Post-mortem findings included dose dependent adrenal cortical hypertrophy.

Vetoryl Capsules are available in 10, 30 and 60 mg strengths, packaged in aluminum foil blister cards of 10 capsules, with 3 cards per carton.

Vetoryl Capsules 10 mg     NDC 17033-110-30
Vetoryl Capsules 30 mg     NDC 17033-130-30
Vetoryl Capsules 60 mg     NDC 17033-160-30

NADA 141-291, Approved by FDA.

Distributed by:
Dechra Veterinary Products
7015 College Boulevard
Suite 525
Overland Park, KS 66211

Vetoryl is a trademark of Dechra Ltd
© 2008, Dechra Ltd

PM PLT243

Vetoryl® (trilostane) CAPSULES

Vetoryl (pronounced "vet-or-ill") Capsules
Generic name: trilostane ("try-low-stain")

This summary contains important information about Vetoryl Capsules. You should read this information before you start giving your dog Vetoryl Capsules and review it each time the prescription is refilled. This sheet is provided only as a summary and does not take the place of instructions from your veterinarian. Talk to your veterinarian if you do not understand any of this information or if you want to know more about Vetoryl Capsules.

What are Vetoryl Capsules?

Vetoryl Capsules contain an adrenosuppressant drug that is used to treat hyperadrenocorticism in dogs. Vetoryl Capsules are a prescription drug for dogs.

Hyperadrenocorticism (also known as Cushing's disease) is a condition in which excess levels of the hormone cortisol are produced. Cortisol is normally released from the adrenal gland into the bloodstream at times of stress. In dogs with hyperadrenocorticism, the level of cortisol produced is excessive and, if left untreated, becomes incapacitating.

Characteristic signs are:

• Passing large quantities of urine
• Frequent urination and possible incontinence
• Excessive drinking
• Ravenous appetite
• Lethargy or decreased activity
• Excessive panting
• Pot belly
• Thin skin
• Hair loss or recurrent skin diseases
• Muscle wasting

Your dog may not necessarily display all of these signs.

What kind of results can I expect when my dog is on Vetoryl Capsules?

Although Vetoryl Capsules ARE NOT A CURE for hyperadrenocorticism, the product can control the clinical signs:

• Response varies from dog to dog.
• Improvement can be seen in most dogs within a few weeks.
• If Vetoryl Capsules are discontinued or not given as directed, excess cortisol production can resume and the signs of hyperadrenocorticism can return.

Which dogs should not take Vetoryl Capsules?

Your dog should not be given Vetoryl Capsules if he/she:

• Has kidney or liver disease.
• Takes certain medications. Vetoryl Capsules should be used with caution with several medications used to treat heart disease (some diuretics and ACE inhibitors).
• Is pregnant.

Tell your veterinarian about all medicines you have given your dog in the past, and any medicines that you are planning to give with Vetoryl Capsules. This should include other medicines that you can get without a prescription. Your veterinarian may want to check that all of your dog's medicines can be given together.

What should I know about giving Vetoryl Capsules to my dog?

• Vetoryl Capsules should be given according to your veterinarian's instructions. Your veterinarian will tell you the number of Vetoryl Capsules that is right for your dog.
• Administer capsules with food.
• Keep out of reach of children. Not for human use.
• Do not open capsules and do not attempt to split or divide capsules.
• Wash hands after use.
• Do not handle the capsules if pregnant or trying to become pregnant. Studies in laboratory animals have produced birth defects and early pregnancy loss. In the event of accidental ingestion/overdose, seek medical advice immediately and take the labeled container with you.

What should I talk to my veterinarian about before giving Vetoryl Capsules?

Talk to your veterinarian about:

• What tests might be done before Vetoryl Capsules are prescribed.
• How often your dog may need to be examined by your veterinarian.
• The risks and benefits of using Vetoryl Capsules.

Tell your veterinarian if your dog has ever had the following medical problems:

• Liver disease
• Kidney disease

Tell your veterinarian about:

• Any other medical problems or allergies that your dog has now or has had.
• If your dog is pregnant, nursing or if you plan to breed your dog.
• Any medications your dog is taking, including over-the-counter products and nutritional supplements.

What are the possible side effects that may occur in my dog during therapy?

Vetoryl Capsules, like other drugs, may cause some side effects. Serious, but rare side effects have been reported in dogs taking Vetoryl Capsules. Serious side effects can occur with or without warning and, in rare situations, result in death.

Side effects generally involve an over suppression of the adrenal glands (hypoadrenocorticism, also known as Addison's Disease). Look for the following side effects that may indicate your dog is having a problem with Vetoryl Capsules or may have another medical problem:

• Depression, lethargy or decrease in activity.
• Change in bowel movements (such as diarrhea or loose stools).
• Vomiting.
• Stops eating or loses all interest in food.

As Vetoryl Capsules control the hyperadrenocorticism, there should be a decrease in food and water consumption to normal levels. There should also be resolution of excess urination. If, however, there is a dramatic decrease in appetite or the dog stops drinking water, it could be an indication of a side effect requiring treatment.

It is important to stop therapy and contact your veterinarian immediately if you think your dog has a medical problem or side effect from Vetoryl Capsule therapy. If you have additional questions about possible side effects, talk to your veterinarian.

What do I do in case my dog takes more than the prescribed amount of Vetoryl Capsules?

Contact your veterinarian immediately if your dog takes more than the prescribed amount of Vetoryl Capsules.

What else should I know about Vetoryl Capsules?

This sheet provides a summary of information about Vetoryl Capsules. If you have any questions or concerns about Vetoryl Capsules, or hyperadrenocorticism, talk to your veterinarian.

As with all prescribed medicines, Vetoryl Capsules should only be given to the dog for which it was prescribed.

It is important to periodically discuss your dog's response to Vetoryl Capsules at regular checkups. Your veterinarian will determine if your dog is responding as expected and if your dog should continue receiving Vetoryl Capsules.

Distributed by:
Dechra Veterinary Products
7015 College Boulevard
Suite 525
Overland Park, KS 66211

Vetoryl is a trademark of Dechra Ltd
© 2008, Dechra Ltd

10
mg

Vetoryl® CAPSULES

(trilostane)

30 Capsules

CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

NADA 141-291, Approved by FDA.

Dechra