DESCRIPTION:

Vetoryl 120 mg Capsules

Vetroryl (Trilostane) Capsules are indicated for the treatment of pituitary-dependent hyperadrenocorticism (Cushing's Syndrome) in dogs.

For oral use in dogs only

CAUTION:

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

DESCRIPTION:

Truprofen is a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid class that includes ibuprofen, naproxen, and ketoprofen.

INDICATIONS:

To control hypercortisolism associated with pituitary-dependent and adrenal- dependent hyperadrenocorticism in dogs.

DOSAGE AND ADMINISTRATION:

The starting dose of Vetoryl Capsules is 2.2 - 6.7 mg/kg (1.0 - 3.0 mg/lb) orally once a day based on body weight and capsule size (see Table 1). Vetoryl Capsules should be administered with food. Table 1: Starting Dose Weight range (kg) Weight range (lb) Starting dose (mg) ONCE DAILY â‰¥ 1.7 to < 4.5 â‰¥ 3.8 to < 10 10 â‰¥ 4.5 to < 10 â‰¥ 10 to < 22 30 â‰¥ 10 to < 20 â‰¥ 22 to < 44 60 â‰¥ 20 to < 40 â‰¥ 44 to < 88 120 â‰¥ 40 to < 60* â‰¥ 88 to < 132* 180 * Dogs over 60 kg (132 pounds) should be administered the appropriate combination of capsules. After approximately 10-14 days at this dose, re-examine the dog and conduct a 4-6 hour post-dosing ACTH stimulation test, and take action according to Table 2. Table 2: Action after ACTH evaluation Post ACTH serum cortisol Action (refer to “Adjusting the Dose”) nmol/L µg/dL < 40 < 1.45 Stop treatment until ACTH results show stimulation (return to normal). Re-start at a decreased dose. 40 to 150 1.45 to 5.4 EITHER: If electrolytes are normal, continue on same dose. OR: If electrolytes are abnormal, stop treatment until electrolytes return to normal. Re-start at decreased dose. > 150 to 250 > 5.4 to 9.1 EITHER: If clinical signs are well controlled, continue on current dose. OR: If clinical signs of hyperadrenocorticism are still evident, increase dose. > 250 > 9.1 Increase initial dose. Adjusting the Dose: Individual dose adjustments and close monitoring are essential. Once daily administration is recommended. Combinations of capsule sizes should be used to increase and decrease the dose. The dose should be slowly increased. The once daily dose should not be increased by more than two times (double) the previous dose. Dogs requiring a decrease in dose following temporary cessation of treatment should be restarted on half the previous dose. 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, increase the total daily dose by 1/3 to 1/2 and divide the total amount into 2 doses given 12 hours apart. A small percentage of animals may require doses significantly in excess of 10 mg/kg/day. In these situations appropriate additional monitoring for adverse events should be implemented as the safety of doses > 10 mg/kg/day has not been fully evaluated. A small number of dogs do not respond to Vetoryl capsules and alternate therapy should be considered.

CONTRAINDICATIONS:

Do not use in animals weighing less than 1.7 kg. Do not divide capsules. Do not use in dogs suffering from primary hepatic disease or renal insufficiency. Do not use in pregnant or nursing bitches or any animals intended for breeding. The use of Vetoryl capsules is contraindicated in dogs that have demonstrated hypersensitivity to trilostane.

WARNINGS:

Keep out of reach of children. Not for human use. 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.

PRECAUTIONS:

The most common adverse reactions reported are poor/reduced appetite, vomiting, lethargy/dullness, diarrhea and weakness. Occasionally, more serious reactions, including severe depression, hemorrhagic diarrhea, collapse, hypoadrenocortical crisis or adrenal necrosis/rupture may occur, and may result in death. 107 dogs were treated in Phase 1 of a 13 centre, open label, 84 day study in the US. Dogs ranged from 6-16 years and weighed 3-54 kg. 91 dogs continued into Phase 2 for a further 91-529 days (mean 348 days). During Phase 1 (up to day 84 of Vetoryl treatment), adverse events were observed in 93 dogs (87%); during Phase 2 adverse events were observed in 88 dogs (96%). In both phases of the US field study, the following adverse reactions (most of which were mild and transient) were seen:

INFORMATION FOR DOG OWNERS:

Be aware that the following side effects may indicate that your dog is having a problem with Vetoryl capsules: â—� Stops eating or loses interest in food. â—� Vomiting. â—� Change in bowel movement (such as diarrhea or loose stools). â—� Depression, lethargy or decreased activity. As Vetoryl capsules control the hyperadrenocoticism, there should be a decrease in food and water consumption to normal levels.

STORAGE:

Store between 15°C and 30°C.