Target species
Cats
Indications for use for each target species
For body weight gain in cats experiencing poor appetite or unintended weight loss resulting from chronic medical conditions (see pharmacodynamics).
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
This veterinary medicinal product does not treat the underlying chronic medical conditions but is intended to provide supportive therapy.
The efficacy in cats less than 6 years old or with less than 2 kg body weight has not been evaluated.
The efficacy of the veterinary medicinal product has not been established for more than 90 days. Therefore, when the treatment is administered for a longer duration, the response to treatment should be monitored.
Special precautions for use
Special precautions for safe use in the target species:
The veterinary medicinal product has been shown to increase serum glucose levels in cats, with highly variable effects on individual cats. However, in non-diabetic cats homeostatic mechanisms adapt to maintain blood glucose levels within normal ranges after a few days. Use in cats with diabetes mellitus has not been evaluated. In cases of diabetes mellitus, use only according to the benefit/risk assessment by the responsible veterinarian.
Use with caution in cats with hypotension as the veterinary medicinal product caused decreased heart rate and blood pressure for up to 4 hours following dose administration to healthy cats. These effects were reversed by human interaction followed by feeding of the cat.
Use with caution in cats with hypersomatotropism (acromegaly).
Use with caution in cats with hepatic dysfunction as capromorelin is metabolised in the liver.
The safety in cats less than 10 months old or with less than 2 kg body weight has not been evaluated.
The safety of the veterinary medicinal product for a treatment period of more than 90 days in cats with chronic medical conditions has not been evaluated. Therefore, when the treatment is administered for a longer duration, cats should be monitored.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Ingestion by children may cause mild and reversible signs of abdominal pain, lethargy, lightheadedness, palpitation, low back pain, feeling warm and increased perspiration. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
This veterinary medicinal product contains parabens and povidone, which may cause allergic reactions. People with known hypersensitivity to these substances should administer the veterinary medicinal product with caution.
This veterinary medicinal product may cause eye and skin irritation. Contact with the eyes, skin and mucous membranes should be avoided. Wash hands after use. In case of accidental eye or skin contact, rinse the affected area immediately with plenty of fresh water. If irritation persists, seek medical advice and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Cats
Very common (>1 animal / 10 animals treated): | Hypersalivation1 |
Common (1 to 10 animals / 100 animals treated): | Diarrhoea, Vomiting Anaemia Skin lesions (on the mouth and chin) Dehydration, Lethargy |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Bradycardia, Hypotension |
1At the time of dosing and resolved within few minutes.
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 the national competent authority via the national reporting system. See also section 16 of the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during reproduction, pregnancy and lactation in the target species. Laboratory studies in rats have shown evidence of teratogenic effects. Do not use in breeding, pregnant and lactating cats.
Interaction with other medicinal products and other forms of interaction
None known.
Administration routes and dosage
Oral use.
The recommended dose is 2 mg/kg body weight which is equivalent to 0.1 ml/kg body weight. The veterinary medicinal product is to be administered once daily directly into the mouth.
To administer the veterinary medicinal product:
- Remove the cap, insert the dosing syringe, invert the bottle, withdraw the appropriate amount of solution using a ml scale syringe.
- Return the bottle to the upright position, remove the syringe, replace the cap tightly.
- Administer the solution into the cat’s mouth.
- Rinse the syringe and the plunger with water and leave apart to dry.
Duration of treatment will depend on the response observed to treatment. Long-term administration of the veterinary medicinal product is likely needed as chronic medical conditions tend to be progressive in nature and weight loss is expected to continue if not treated.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
After administration of the veterinary medicinal product up to 5 times the recommended dose for 6 months to young healthy cats the following adverse reactions were observed: Non-progressive increases in triglyceride levels were noted in male cats. Increase in liver to brain weight ratio was observed and liver vacuolation was noted in two animals (one in the 3x and one in the 5x group). One male cat in the 5x group was observed with hyperglycaemia and glucosuria. Other adverse reactions observed were consistent with those mentioned in adverse events.
Capromorelin increased serum growth hormone concentrations in healthy cats at a dosage of 6 mg/kg body weight. The effect was highest after the first dose and was attenuated on subsequent days.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.