Zycortal

Information from Dechra:

For subcutaneous use in dogs only 

Mineralocorticoid

 CAUTION: Federal law (U.S.A.) restricts this drug to use by or on the order of a licensed veterinarian. 

DESCRIPTION: Desoxycorticosterone pivalate is a mineralocorticoid hormone. Chemically, desoxycorticosterone pivalate is 21-(2,2-dimethyl-1-oxopropoxy)-pregn-4-ene-3,20-dione. The structural formula is: Molecular Formula: C26H38O4 ZYCORTAL Suspension is a white aqueous suspension. Each milliliter contains 25 mg of desoxycorticosterone pivalate. Inactive ingredients are 10.5 mg methylcellulose, 3 mg sodium carboxymethylcellulose, 1 mg polysorbate 60, 8 mg sodium chloride, 1 mg chlorocresol and water for injection (to 100%).

 INDICATION: For use as replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison’s disease). 

DOSAGE AND ADMINISTRATION: Prior to each use, thoroughly shake the vial to resuspend the product. ZYCORTAL Suspension replaces the mineralocorticoid hormones only. Dogs with combined glucocorticoid and mineralocorticoid deficiency should also be treated with prednisone or prednisolone at an initial dosage of 0.2-0.4 mg/kg/day (0.1-0.2 mg/lb/day). ZYCORTAL Suspension is intended for long-term administration at intervals and doses dependent upon individual response. Tailor the dose of ZYCORTAL Suspension and the concurrently administered glucocorticoid replacement therapy to the individual dog based on clinical response and normalization of Na+ and K+ concentrations.

CONTRAINDICATIONS: Do not use ZYCORTAL Suspension in dogs that have previously had a hypersensitivity reaction to desoxycorticosterone pivalate. 

WARNINGS: Use ZYCORTAL Suspension with caution in dogs with congestive heart disease, edema, severe renal disease or primary hepatic failure. Desoxycorticosterone pivalate may cause polyuria, polydipsia, increased blood volume, edema and cardiac enlargement. Excessive weight gain may indicate fluid retention secondary to sodium retention. Do not use desoxycorticosterone pivalate in pregnant dogs. 

HUMAN WARNINGS: Not for human use. Keep this and all drugs out of the reach of children. Consult a physician in case of accidental human exposure. 

PRECAUTIONS: Any dog presenting with severe hypovolemia, dehydration, pre-renal azotemia and inadequate tissue perfusion (“Addisonian crisis”) must be rehydrated with intravenous fluid (saline) therapy before starting treatment with ZYCORTAL Suspension. The effectiveness of ZYCORTAL Suspension may be reduced if potassium-sparing diuretics, such as spironolactone, are administered concurrently. 

ADVERSE REACTIONS: In controlled clinical field studies, one hundred fifty-two dogs were included in the field safety analysis. Polyuria, Polydipsia,  Depression/lethargy, Inappropriate urination, Alopecia, Decreased appetite/anorexia, Panting , Vomiting, Diarrhea, Shaking/trembling, Polyphagia ,  Urinary tract infection , Urinary incontinence,  Restlessness, Urticaria/facial edema.