1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zycortal 25 mg/ml prolonged-release injectable suspension for dogs
  2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Desoxycortone pivalate 25 mg/ml Excipients: Chlorocresol 1 mg/ml For the full list of excipients, see section 6.1.
  3. PHARMACEUTICAL FORM Prolonged-release injectable suspension. Opaque white suspension.
  4. CLINICAL PARTICULARS 4.1 Target species Dogs. 4.2 Therapeutic indications specified for the different target species for replacement therapy for mineralocorticoid deficiency in dogs with primary hypoadrenocorticism (Addison’s disease). 4.3 Contraindications Do not use in case of hypersensitivity to the active substance or to any of the excipients. 4.4 Special precautions for each target species Before starting treatment with the veterinary medicinal product, it is important that Addison’s disease be definitively diagnosed. Any dog with severe hypovolemia, dehydration, pre-renal azotemia, and inadequate tissue perfusion (known as “Addisonian crisis”) must be rehydrated with intravenous fluid therapy (saline) before starting treatment with the veterinary medicinal product. 4.5 Special precautions for use in animals Administer with caution in dogs with congestive heart failure, severe renal disease, primary hepatic insufficiency, or edema. Special precautions are to be taken by the person administering the veterinary medicinal product to animals. Avoid contact with eyes and skin. In case of accidental spillage on the skin or eyes, wash the affected area with water. If irritation occurs, seek medical advice immediately, and provide the doctor with the product leaflet or label. This veterinary medicinal product may cause pain and swelling at the injection site if accidentally self-administered. This veterinary medicinal product may cause adverse reactions on the male reproductive organs and consequently affect fertility. This veterinary medicinal product may cause adverse reactions to the development of unborn children and newborns. Pregnant and breastfeeding women should not administer this veterinary medicinal product. In case of accidental self-injection, seek medical advice immediately, and provide the doctor with the product leaflet or label. 4.6 Adverse reactions (frequency and seriousness) Very common adverse reactions in a clinical trial were polydipsia and polyuria. Unusual urination, lethargy, alopecia, dyspnea, vomiting, decreased appetite, anorexia, reduced activity, depression, diarrhea, polyphagia, tremors, fatigue, and urinary tract infections were common adverse reactions in a clinical trial. Pain at the injection site has been reported as an uncommon adverse reaction after administration of Zycortal in spontaneous reports after market release. Pancreatic disorders have been reported rarely in spontaneous reports after market release and following the use of Zycortal. Concomitant administration of glucocorticoids may contribute to these signs. The following classification defines the frequency of adverse reactions:
  • very common (more than 1 in 10 treated animals showing adverse reactions)
  • common (more than 1 but less than 10 animals in 100 treated animals)
  • uncommon (more than 1 but less than 10 animals in 1,000 treated animals)
  • rare (more than 1 but less than 10 animals in 10,000 treated animals)
  • very rare (less than 1 animal in 10,000 treated animals, including isolated reports). 4.7 Use during pregnancy, lactation, or lay The safety of the veterinary medicinal product has not been established during reproduction, pregnancy or lactation. Therefore, it is used only after the responsible veterinary surgeon’s benefit/risk assessment. 4.8 Interaction with other medicinal products and other forms of interaction Administer with caution when Zycortal is used concurrently with veterinary medicinal products that affect serum concentrations of sodium or potassium or cellular transport of sodium or potassium; for example, trimethoprim, amphotericin B, digoxin or insulin. 4.9 Dosage and route of administration Subcutaneous administration. Before use, shake the vial carefully to resuspend the veterinary medicinal product. Use an appropriately graduated syringe to apply the volume with the required dose accurately. This is especially important when injecting small volumes. Zycortal only replaces mineralocorticoid hormones. Dogs with combined glucocorticoid and mineralocorticoid deficiency should also receive a glucocorticoid, such as prednisolone, in accordance with current scientific knowledge. Zycortal is intended for long-term application at intervals and doses depending on individual response. Adjust the dose of Zycortal and concurrently administered glucocorticoid replacement therapy for each dog based on clinical response and normalization of serum Na+ and K+ concentrations. Initial dose of Zycortal: The initial dose is 2.2 mg/kg body weight, administered by subcutaneous injection. Intermediate observation visit: Reassess the dog’s condition 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 desoxycortone). If the dog’s clinical signs have worsened or not subsided, adjust the glucocorticoid dose and/or look for other causes of clinical signs. Second dose of Zycortal: Approximately 25 days after the first dose, reassess the dog’s condition and measure the Na+/K+ ratio.  If the dog is clinically normal and has a normal Na+/K+ ratio (i.e. from 27 to 32) on Day 25, adjust the dose based on the Na+/K+ ratio on Day 10, using the guidelines in Table 1 below.  If the dog is clinically normal and has a Na+/K+ ratio > 32 on Day 25, adjust the dose based on the Na+/K+ ratio on Day 10 according to Table 1, or delay the dose (see Extending the dosing interval).  If the dog is not clinically normal, or if the Na+/K+ ratio is abnormal on Day 25, adjust the dose of glucocorticoid or Zycortal (see Subsequent doses and long-term treatment).


Ratio of Na⁺/K⁺ on Day 10 Action
Do not apply Dose 2 on Day 10
≥ 34 Reduce the dose to: 2.0 mg/kg body weight
32 to < 34 Reduce the dose to: 2.1 mg/kg body weight
27 to < 32 Continue with 2.2 mg/kg body weight
≥ 24 to < 27 Increase the dose to: 2.3 mg/kg body weight
< 24 Increase the dose to: 2.4 mg/kg body weight


Extending the dosing interval: If the dog is in a clinically normal state and the Na⁺/K⁺ ratio on Day 25 is > 32, it may be possible to extend the dosing interval instead of adjusting the dose, as described in Table 1. Evaluate electrolytes every 5-9 days until the Na⁺/K⁺ ratio is < 32, and then apply 2.2 mg/kg Zycortal. Subsequent doses and long-term treatment: Once the optimal dose and dosing interval are determined, maintain the same treatment regimen. If the dog develops unusual clinical signs or serum concentrations of Na+ or K+, use the following guidelines for subsequent doses:  Clinical signs of polyuria/polydipsia: First, reduce the glucocorticoid dose. If polyuria/polydipsia persists and the Na+/K+ ratio is >32, reduce the Zycortal dose without changing the dosing interval.  Clinical signs of depression, lethargy, vomiting, diarrhea, or weakness: Increase the glucocorticoid dose.  Hyperkalemia, hyponatremia, or a Na+/K+ ratio < 27: Reduce the Zycortal dosing interval by 2-3 days or increase the dose.  Hypokalemia, hypernatremia, or a Na+/K+ ratio > 32: Reduce the Zycortal dose. Consider temporarily increasing the glucocorticoid dose before a stressful situation. In the clinical trial, the average final dose of desoxycortone pivalate was 1.9 mg/kg (range 1.2-2.5 mg/kg), and the average final dosing interval was 38.7 ± 12.7 days (range 20-99 days), with most dogs having a dosing interval between 20 and 46 days.

4.10 Overdose (symptoms, emergency measures, antidotes), if necessary When administered to dogs at doses three to five times higher than the recommended dose, injection site reactions have been characterized by erythema and edema. As expected from the pharmacodynamic effects, increasing doses of desoxycortone are associated with a dose-related tendency for increased serum sodium and decreased blood urea nitrogen, serum potassium, and specific gravity of urine. Polyuria and polydipsia may be observed. Hypertension has been observed in dogs receiving 20 mg/kg desoxycortone pivalate. There is no specific antidote. In case of overdose symptoms, treat the dog symptomatically and reduce the subsequent doses.

4.11 Withdrawal period Not applicable.

  1. Pharmacological properties Pharmacotherapeutic group: Corticosteroids for systemic use, mineralocorticoids ATCvet code: QH02AA03

5.1 Pharmacodynamic properties Desoxycortone is a corticosteroid with primarily mineralocorticoid activity similar to aldosterone. In the kidneys, desoxycortone causes the retention of sodium and chloride ions and the excretion of hydrogen and potassium ions, creating an osmotic gradient. The osmotic gradient helps in water reabsorption from renal tubules leading to increased extracellular fluid volume, which increases blood volume, improves venous return to the heart, and increases cardiac output.

5.2 Pharmacokinetic properties Following subcutaneous administration of desoxycortone pivalate at a dose of 11 mg/kg body weight (five times higher than the recommended dose), the plasma half-life (mean ± standard deviation) is approximately 17 ± 7 days, with a maximum concentration (Cmax) of 13.2 ± 5 ng/ml and time to maximum concentration (Tmax) of 10 ± 3.5 days.

  1. Pharmaceutical particulars 6.1 List of excipients Methylcellulose Sodium carboxymethylcellulose Polysorbate 60 Sodium chloride Cholesterol Water for injections

6.2 Main incompatibilities In the absence of data on compatibility, this veterinary medicinal product should not be mixed with other veterinary medicinal products.


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