Target species
Dogs (male)
Indications for use for each target species
Treatment of benign prostatic hypertrophy (BPH) in male dogs.
Contraindications
None.
Special warnings
In dogs with BPH associated with prostatitis, the product can be administered concurrently with antimicrobials.
Special precautions for use
Special precautions for safe use in the target species:
A transient reduction of plasma cortisol concentration may occur; this may continue for several weeks after administration. Appropriate monitoring should be implemented in dogs under stress (e.g. postoperative) or those with hypoadrenocorticism. The response to an ACTH stimulation test may also be suppressed for several weeks after administration of osaterone.
Use with caution in dogs with a history of liver disease, as safety of use of the product in these dogs has not been thoroughly investigated, and as treatment of some dogs with liver disease has resulted in reversible elevation of ALT and ALP in clinical trials.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Wash hands after administration.
In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.
A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease in FSH, LH and testosterone, reversible after 16 days. There was no clinical effect.
In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child-bearing age should avoid contact with, or wear disposable gloves, when administering the product.
Adverse events
Dogs (male):
Very common (>1 animal / 10 animals treated): | Increased appetite1 Hypocortisolaemia1 |
Common (1 to 10 animals / 100 animals treated): | Behavioural disorders (e.g., hyperactivity, decreased activity or more social behaviour)1 |
Uncommon (1 to 10 animals / 1,000 animals treated): | Vomiting and/or diarrhoea1 Polydipsia1, lethargy1 Polyuria1 Mammary hyperplasia |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Decreased appetite1 Galactorrhoea2 Changes in hair coat (e.g., hair loss or hair modification)1 |
2 Associated with mammary hyperplasia.
In clinical trials, treatment with the veterinary medicinal product was not discontinued and all dogs recovered without any specific therapy. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Amounts to be administered and administration route
For oral use.
Administer 0.25 – 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:
Dog's weight | YPOZANE Tablets to be administered | Number of tablets per day | Treatment duration |
3 to 7.5 kg* | 1.875 mg tablet | 1 Tablet | 7 days |
7.5 to 15 kg | 3.75 mg tablet |
15 to 30 kg | 7.5 mg tablet |
30 to 60 kg | 15 mg tablet |
*No data are available for dogs less than 3 kg bodyweight.
Tablets can be given either directly into the mouth or with food. The maximum dose should not be exceeded.
The onset of clinical response to treatment is usually seen within 2 weeks. The clinical response persists for at least 5 months after treatment.
Re-evaluation by the veterinarian should take place 5 months after treatment or earlier if clinical signs recur. A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the product. If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
An overdose study (up to 1.25 mg/kg bodyweight for 10 days, repeated one month later) did not show undesirable effects except for a decrease of cortisol plasma concentration.