Percorten V

The active ingredient in PERCORTEN-V is desoxycorticosterone pivalate (DOCP). It is a mineralocorticoid hormone and an analog of desoxycorticosterone. It is white, odorless, and stable in air. It is practically insoluble in water, sparingly soluble in acetone, slightly soluble in methanol, ether and vegetable oils. The molecular weight is 414.58. It is designated chemically as 21 (2,2-dimethyl-1-oxopropoxy)-pregn-4-ene3,20-dione. The empirical formula is C26H38O4 and the structural formula is:

PERCORTEN-V is a white aqueous suspension. Each ml contains 25 mg desoxycorticosterone pivalate. Inactive ingredients are water for injection, methylcellulose, sodium carboxymethylcellulose, polysorbate 80, sodium chloride, and thimerosal.

In a laboratory study the safety of PERCORTEN-V was established in five month old Beagle dogs. PERCORTEN-V was administered IM to 24 Beagles at 0, 2.2, 6.6 or 11 mg/kg of body weight daily over a consecutive 3-day period every 28 days (equivalent to a cumulative monthly dosage of 0, 6.6,19.8 or 33 mg/kg) for 6 months. This resulted in no mortality or any significant effects on body weight, food consumption, and ophthalmic observations at any dose level. However, polyuria and polydipsia were noted and creatinine concentration decreased (14-89 mg/dl) in the 1X, 3X and 5X groups. Histopathological changes were only observed in the kidneys when PERCORTEN-V was administered at ≥ 6.6 mg/kg. The primary renal lesion consisted of glomerulonephropathy seen in all males at ≥ 6.6 mg/kg, in one female at 6.6 mg/kg, and in all females at 11 mg/kg. Other possible treatment related lesions in the kidney, observed sporadically in the 6.6 and 11.0 mg/kg groups, were tubular hyperplasia, inflammation and tubular dilatation. Glomerulonephropathy may possibly be attributed to the pharmacological effects of the drug although there were no clinical measurements assessed in this study. In conclusion, PERCORTEN-V was well tolerated, when administered at 2.2 mg/kg on three consecutive days in every 28-day period for six months.

Multiple-Dose Vials, 4 ml, each ml containing 25 mg desoxycorticosterone pivalate (DOCP),

10.5 mg methylcellulose, 3 mg sodium carboxymethylcellulose, 1 mg polysorbate 80, and 8 mg sodium chloride with 0.002% thimerosal added as preservative in water for injection. Packed one vial per carton.

1. Canine and Feline Endocrinology and Reproduction. Second Edition, E. C. Feldman and R. W. Nelson, W. B. Saunders Co., New York, 1996.

2. Textbook of Veterinary Internal Medicine. Fourth Edition, S. J. Ettinger and E. C. Feldman editors, W. B. Saunders Co., New York, 1995.

3. Toxicity of desoxycorticosterone pivalate given at high doses to clinically normal Beagles for six months, E. Chow, W. R. Campbell, J. C. Turnier, R. C. Lynn and K. L. Pavkov, Am. J. Vet. Res. 54(11):1954-1961, 1993.

Manufactured for:       Novartis Animal Health US, Inc.

      Greensboro, NC 27408, USA

NADA # 141-029, Approved by FDA.

©2001 Novartis       NAH/PER/VI/4        07/07

PERCORTEN-V is a registered trademark of Novartis AG.

Package Label – 25 mg/ml 

Percorten® - V

(desoxycorticosterone pivalate)

Injectable Suspension

For veterinary use only

25 mg/ml

NOVARTIS

ANIMAL HEALTH