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In the event of an adverse reaction the NSAID should be discontinued and an alternative method of pain management used. Trilostane may decrease testosterone and progesterone synthesis.

Women who are pregnant or are intending to become pregnant should avoid handling the capsules. The content of the capsules may cause skin and eye irritation and sensitisation. Do not divide or open capsules. In the event of accidental breakage of the capsules and contact of the granules with eye or skin, wash immediately with plenty of water.

If irritation persists, seek medical advice. In the event of accidental ingestion, seek medical advice immediately and take the labelled container with you. Although all adverse reactions are not reported, the following information is based on voluntary post-approval drug experience reporting.

It is generally recognized that this results in significant under-reporting. The adverse events listed here reflect reporting and not necessarily causality. Foreign market experience: The most serious events were death, adrenal necrosis, hypoadrenocorticism electrolyte alterations, weakness, collapse, anorexia, lethargy, vomiting, diarrhea, and azotemia , and corticosteroid withdrawal syndrome weakness, lethargy, anorexia, and weight loss.

Additional adverse events included: In some cases death has been reported as an outcome of the adverse events listed. Serious adverse reactions associated with this drug can occur without warning and, in rare situations, result in death. This inhibition blocks production of glucocorticoids and to a lesser extent, mineralocorticoids and sex hormones while steroid precursor levels increase.

Pharmacokinetic data in dogs have demonstrated large inter-individual variability. Trilostane absorption is enhanced by food administration. In healthy dogs, mean maximal plasma concentrations occur 1.

There is no evidence that trilostane or its major metabolite, ketotrilostane, accumulate with time. Of the dogs with hyperadrenocorticism that were enrolled in Phase 1 of an 84 day multi-center US field study, dogs were included in the effectiveness assessment.

Additionally, dogs could be assessed from the three UK field studies. Results of 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.

By day 84 of Phase 1 of the US field study, In these three studies, there were a total of 21 dogs diagnosed with hyperadrenocorticism due to either an adrenal tumor or 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. A control group received empty gelatine capsules only. Serum concentrations of sodium and chloride decreased between days 7 and 28 in all treated dogs and red blood cell counts decreased in treated male dogs.

These were considered to be pharmacological effects. Three animals in the 3X group receiving They showed one or more of the following clinical signs: 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.

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 hypertrophy in all treated dogs, including dogs in the 1X group.

Dogs ranged from years and weighed kg. In both phases of the US field study, the following adverse reactions most of which were mild and transient were seen:. Owners should be advised to discontinue Vetoryl Capsules and contact their veterinarian immediately if signs of intolerance are observed.

Owners should be advised of the importance of periodic follow-up for all dogs during administration of Vetoryl Capsules. Trilostane absorption is enhanced by administration with food. In healthy dogs, maximal plasma levels of trilostane occur within 1.

There is no accumulation of trilostane or its metabolites over time. 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.

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. Three animals in the 3X group receiving They showed one or more of the following clinical signs: 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. 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. Distributed by: 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. Vetoryl Capsules contain an adrenosuppressant drug that is used to treat hyperadrenocorticism in dogs.

Vetoryl Capsules are a prescription drug for dogs. 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.

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.

What should I talk to my veterinarian about before giving Vetoryl Capsules? 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. Look for the following side effects that may indicate your dog is having a problem with Vetoryl Capsules or may have another medical problem:.

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. This sheet provides a summary of information about Vetoryl Capsules.

Give this medication exactly as directed by your veterinarian. Give this medication with food. Do not open capsules and do not attempt to split or divide capsules.

Wash your hands after use. Do not handle the capsules if you are pregnant or trying to become pregnant. If you do not understand the directions ask the pharmacist or veterinarian to explain them to you. Keep this medication away from children and other pets.

Vetoryl capsules should be given with food. Do not open capsules and do not attempt to split or divide capsule. Speak with your veterinarian to help you determine the correct dosage for your dog. X X Horses: X X Storage: Should be stored at room temperature. Keep out of reach of children. What happens if I miss a dose: Give the missed dose as soon as you remember.

However, if is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed.

Do not give a double dose of the medication. What happens if I overdose the pet: Seek emergency veterinary medical treatment.

Symptoms of Vetoryl overdose may include lethargy, weakness, vomiting, or collapse. What should I avoid while using Vetoryl: Do not give Vetoryl to dogs with kidney or liver disease. Do not give to pregnant or nursing dogs or dogs intended for breeding. Do not touch Vetoryl capsules if you are pregnant or trying to become pregnant.

Possible side effects of Vetoryl: If any of the following serious side effects occur, stop giving Vetoryl and seek emergency veterinary medical attention; an allergic reaction difficulty breathing; swelling of the lips, tongue or face; hives , severe depression, bloody diarrhea, collapse, or other severe reactions.

Other less serious side effects such as unexpected decrease in appetite, vomiting, diarrhea, and lethargy may occur. Other side effects may also occur.

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