Desoxycortone

Indications

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. Initial dose of ZYCORTAL Suspension: The initial dose is 2.2 mg/kg (1 mg/lb) body weight, administered by subcutaneous injection. Interim monitoring visit: Re-evaluate the dog and measure the serum sodium/potassium ratio (Na + /K + ratio) approximately 10 days after the first dose, which is the time to maximum concentration (T max ) of desoxycorticosterone (see

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. Adverse reactions are summarized in Table 2. Table 2: Percentage of Dogs with Adverse Reactions in the Field Study Adverse Reaction ZYCORTAL Suspension (n = 113 dogs) Active Control (n = 39 dogs) Polyuria 15.0% (17) 12.8% (5) Polydipsia 13.3% (15) 15.4% (6) Depression/lethargy 9.7% (11) 2.6% (1) Inappropriate urination 8.0% (9) 10.3% (4) Alopecia 5.3% (6) 5.1% (2) Decreased appetite/anorexia 4.4% (5) 2.6% (1) Panting 3.5% (4) 0.0% (0) Vomiting 3.5% (4) 0.0% (0) Diarrhea 2.7% (3) 7.7% (3) Shaking/trembling 2.7% (3) 2.6% (1) Polyphagia 1.8% (2) 2.6% (1) Urinary tract infection 1.8% (2) 0.0% (0) Urinary incontinence 0.9% (1) 2.6% (1) Restlessness 0.9% (1) 2.6% (1) Urticaria/facial edema 0.0% (0) 5.1% (2) One dog with a pre-existing Grade III/VI heart murmur developed congestive heart failure 17 days after the first administration of ZYCORTAL Suspension and was removed from the study. Post-Approval Experience (2020) The following adverse events are based on post approval adverse drug experience reporting for ZYCORTAL Suspension. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events in dogs are listed in decreasing order of reporting frequency: Injection site pain, lethargy, vomiting, polydipsia, anorexia, polyuria, diarrhea, weight gain, alopecia, anaphylaxis, collapse, and anemia. Death or euthanasia has been associated with some of the adverse events listed above. To report suspected adverse events, for technical assistance or to obtain a copy of the safety data sheet (SDS), contact Dechra at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact the FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

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: C 26 H 38 O 4 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%). Chemical Structure

Storage

Store at controlled room temperature 25°C (77°F) with excursions between 15-30°C (59-86°F) permitted. Do not freeze. Use within 120 days of first puncture.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming desoxycortone as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.