Atopica 25mg Capsules

The mean recommended dose of Ciclosporin is 5 mg/kg body weight according to the following scheme. For a dog weighing 4 to < 7.5 kg one capsule of the veterinary medicinal product. The veterinary medicinal product will initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case within 4 weeks. If no response is obtained within the first 8 weeks, the treatment should be stopped. Once the clinical signs of atopic dermatitis are satisfactorily controlled, the preparation can then be given every other day as a maintenance dose. The veterinarian should perform a clinical assessment at regular intervals and adjust the frequency of administration to the clinical response obtained. In some cases where the clinical signs are controlled with every-other-day dosing, the veterinarian can decide to give the veterinary medicinal product every 3 to 4 days. Adjunct treatment (e.g. medicated shampoos, fatty acids) may be considered before reducing the dosing interval. Treatment may be stopped when the clinical signs are controlled. Upon recurrence of clinical signs, treatment should be resumed at daily dosing, and in certain cases repeated treatment courses may be required. The veterinary medicinal product should be given at least 2 hours before or after feeding. Insert the capsule directly into the dogs mouth.

Ciclosporin 25.00 mg, tocopherol (E-307) 0.25 mg, Iron oxide black (E-172) 0.105 mg, Titanium dioxide (E-171) 2.12 mg, Carminic acid (E-120) < 1.00g, Carminic acid (E-120), Corn oil-mono-di-triglycerides, Ethanol (E-1510), Gelatine (E-441), Glycerol (E-422), Macrogolglycerol hydroxystearate, Propylene glycol (E-1520), Titanium dioxide (E-171).

Do not use in cases of hypersensitivity to ciclosporin or one of the excipients. For all capsule strengths, do not use in dogs less than six months of age or less than 4 kg in weight. Do not use in cases with a history of malignant disorders or progressive malignant disorders. Do not vaccinate with a live vaccine during treatment or within a two-week interval before or after treatment. Clinical signs of atopic dermatitis such as pruritus and skin inflammation are not specific for this disease and therefore other causes of dermatitis such as ectoparasitic infestations, other allergies which cause dermatological signs (e.g. flea allergic dermatitis or food allergy) or bacterial and fungal infections should be ruled out before treatment is started. It is good practice to treat flea infestations before and during treatment of atopic dermatitis. It is recommended to clear bacterial and fungal infections before administeringthe veterinary medicinal product. However, infections occurring during treatment are not necessarily a reason for drug withdrawal, unless the infection is severe. A complete clinical examination should be performed before treatment. As ciclosporin inhibits T-lymphocytes and though it does not induce tumors, it may lead to increased incidences of clinically apparent malignancy. Lymphadenopathy observed on treatment with ciclosporin should be regularly monitored. In laboratory animals, ciclosporin is liable to affect the circulating levels of insulin and to cause an increase in glycaemia. In the presence of suggestive signs of diabetes mellitus, the effect of treatment on glycaemia must be monitored. The use of ciclosporin is not recommended in diabetic dogs. Closely monitor creatinine levels in dogs with severe renal insufficiency. Particular attention must be paid to vaccination. Treatment with the veterinary medicinal product may interfere with vaccination efficacy. In the case of inactivated vaccines, it is not recommended to vaccinate during treatment or within a two-week interval before or after administration of the product. The occurrence of adverse reactions is uncommon. The most frequently observed undesirable effects are gastrointestinal disturbances such as vomiting, mucoid or soft faeces and diarrhoea. They are mild and transient and generally do not require the cessation of the treatment. Other undesirable effects may be observed infrequently: lethargy or hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin reactions such as verruciform lesions or change of hair coat, red and swollen pinnae, muscle weakness or muscle cramps. These effects generally resolve spontaneously after treatment is stopped.