Felimazole Oral
Active substance
ATC code
Species
Cats
Indications
For the stabilisation of hyperthyroidism prior to surgical thyroidectomy. For the long-term treatment of feline hyperthyroidism.
Dose to be administered and administration route
Oral use.
For the stabilisation of feline hyperthyroidism prior to surgical thyroidectomy and for the long-term treatment of feline hyperthyroidism, the recommended starting dose is 5 mg per day (1 ml of the veterinary medicinal product).
Wherever possible, the total daily dose should be divided into two equal doses and administered morning and evening.
If, for reasons of compliance, once daily dosing is preferable, then this is acceptable, although the twice-daily dose may be more efficacious in the short term.
In order to administer the dose accurately, use the syringe provided in the package. The syringe fits on the bottle and is graduated in 0.25 mg increments up to 5 mg. Withdraw the required dose and administer the veterinary medicinal product directly into the cat’s mouth.
Haematology, biochemistry and serum total T4 should be assessed before initiating treatment and after 3 weeks, 6 weeks, 10 weeks, 20 weeks, and thereafter every 3 months. At each of the recommended monitoring intervals, the dose should be titrated to effect according to the total T4 and to clinical response to treatment. Dose adjustments should be made in increments of 2.5 mg (0.5 ml of the veterinary medicinal product) and the aim should be to achieve the lowest possible dose rate. In cats that require particularly small dose adjustments, increments of 1.25 mg of thiamazole (0.25 ml of the veterinary medicinal product) can be used.
If more than 10 mg per day is required (2 ml of the veterinary medicinal product) animals should be monitored particularly carefully.
The dose administered should not exceed 20 mg/day (4 ml of the veterinary medicinal product).
For long-term treatment of hyperthyroidism, the animal should be treated for life.
Adverse reactions
Adverse reactions have been reported following long-term control of hyperthyroidism. In many cases signs may be mild and transitory and not a reason for withdrawal of treatment. The more serious effects are mainly reversible when medication is stopped and, in these cases, treatment should be stopped immediately and alternative therapy considered, following a suitable period for recovery.
Uncommon (1 to 10 animals / 1,000 animals treated): | Vomiting[1], Anorexia1, Inappetence1, Lethargy1 Pruritus1,[2], Excoriation1,2 Prolonged bleeding1,[3],[4] Icterus1,4, Hepatopathy1 Eosinophilia1, Lymphocytosis1, Neutropenia1, Lymphopenia1, Leucopenia1 (slight), Agranulocytosis1 Thrombocytopenia1,[5],6, Haemolytic anaemia1 |
Rare (1 to 10 animals / 10,000 animals treated): | Autoimmune disorder (serum anti-nuclear antibodies) |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Lymphadenopathy5, Anaemia5 |
6 Occurs uncommonly as a haematological abnormality and rarely as an immunological side effect.
Following long-term treatment with thiamazole in rodents, an increased risk of neoplasia in the thyroid gland has been shown to occur, but no evidence is available in cats.
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.
Dispensing
POM-V
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