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ACTIVE INGREDIENT | Desoxycortone pivalate 25 mg/ml |
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ANIMALS | Dogs |
FORM | Suspension |
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Ratio of Na⁺/K⁺ on Day 10 | Action |
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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.
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.
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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