Zycortal Injectable 25mg/mL 4 mL Bottle

Dosing:

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 (Tmax ) of desoxycorticosterone (see CLINICAL PHARMACOLOGY). If the dog's clinical signs have worsened or not resolved, adjust the dose of prednisone/prednisolone and/or investigate other causes of the clinical signs.

Second dose of Zycortal^® Suspension:

At approximately 25 days after the first dose, re-evaluate the dog and repeat the Na+/K+ ratio.

• If the dog is both clinically normal and has a normal Na+/K+ ratio on Day 25, adjust the dose based on the Day 10 Na+/K+ ratio using the guidelines in Table 1, below.
• If the dog is clinically normal and has a Na+/K+ ratio > 32 on Day 25, either adjust the dose based on the Day 10 Na+/K+ ratio according to Table 1 or delay the dose (see Prolonging the dosing interval).
• If the dog is either not clinically normal or if the Na+/K+ ratio is abnormal on Day 25, adjust the dose of prednisone/prednisolone or Zycortal^® Suspension (see Subsequent doses and long-term management).

Cautions:

For use in dogs only. Not for human use. Keep this and all medications out of the reach of children. Consult a physician in case of accidental human exposure. Do not use Zycortal Suspension in pregnant or lactating dogs. Do not use Zycortal Suspension in dogs that have previously had a hypersensitivity reaction to desoxycorticosterone pivalate.