Description

Pharmacological properties: Cyclosporine is a cyclic polypeptide made up of 11 amino acids that acts specifically and reversibly on T lymphocytes. Pharmacodynamic properties: Cyclosporine exerts an anti-inflammatory and antipruritic effect in the treatment of atopic dermatitis. Cyclosporine has been shown to preferentially inhibit T cell activation during antigenic stimulation, affecting the production of IL 2 and other T cell-derived cytokines. Cyclosporine also has the ability to inhibit antigenic function of the skin immune system. . It also blocks the uptake and activation of eosinophils, the production of cytokines by keratinocytes, the functions of Langerhans cells, the degranulation of mast cells and therefore the release of histamine and proinflammatory cytokines. Cyclosporine does not depress hematopoiesis, and has no effect on phagocytic cell function. Interactions and incompatibilities: • Several substances competitively inhibit or induce enzymes involved in cyclosporine metabolism, particularly cytochrome P450 (CYP 3A 4). In some clinically justified cases, it may be necessary to adjust the dose of Atopica®. • Ketoconazole at 5-10 mg/kg increases the concentration of cyclosporine in the blood up to 5-fold, which is considered clinically relevant. During concomitant use of ketoconazole and cyclosporine, and in the case where the dog is treated daily, doubling the treatment interval should be considered as a practical measure by the veterinarian. • Macrolides such as erythromycin can double cyclosporine plasma levels. • Certain inducers of cyctochrome P450, anticonvulsants and antibiotics (eg trimethoprim/sulfadimidine) may reduce the plasma concentration of ciclosporin. • Cyclosporine is a substrate and an inhibitor of the P-glycoprotein transporter MDR1. Therefore, co-administration of cyclosporine with P-glycoprotein substrates such as macrocyclic lactones (eg ivermectin and milbemycin) could reduce the efflux of these active substances from blood-brain barrier cells, potentially having resulting in signs of CNS toxicity. • Cyclosporine can increase the nephrotoxicity of aminoglycoside antibiotics and trimethoprim. Therefore, its concomitant use is not recommended. In case of vaccination, see the points “Contraindications” and “Special precautions”. Indications and target species: Dog: Treatment of chronic atopic dermatitis. Atopica® 25 mg: Dogs from 4 to 7,5 kg. Atopica® 50 mg: Dogs from 7,5 to 36 kg. Atopica® 100 mg: Dogs from 15 to 55 kg. Contraindications: • Do not use in cases of hypersensitivity to cyclosporine or to any of the excipients. • For any concentration of the capsules, do not use in dogs less than six months of age or less than 2 kg in weight. • Do not use in animals with a clinical history of malignant tumors. • Do not vaccinate with a live vaccine during treatment or during the two weeks before or after treatment. (See also the points “Special precautions” and “Interactions and incompatibilities”). Side effects: • The most frequently observed adverse reactions are gastrointestinal disturbances such as vomiting, mucous or loose stools, and diarrhoea. They are mild and transient and generally do not require discontinuation of treatment. • Other adverse reactions that may be seen less frequently include: lethargy or hyperactivity, anorexia, mild to moderate gingival hyperplasia, skin reactions such as warty lesions or coat changes, redness and swelling of the pinna, weakness or muscle cramps. These reactions remit spontaneously after discontinue treatment. For animals with malignant tumors, consult the points "Contraindications" and "Special precautions". • If you notice any other adverse effect, please report it to your veterinarian. Route of administration:: Oral. Atopica® should be given at least 2 hours before or after meals. Insert the capsule directly into the dog's mouth. Posology: Dogs: The average recommended dose of cyclosporine is 5 mg/kg of body weight according to the following schedule: Dog weight* Number of capsules administered to achieve the recommended dose 4 to <7,5 kg 1 Atopica® 25 mg capsule 7,5 to <15 kg 1 Atopica® 50 mg capsule 15 to <29 kg 1 Atopica® 100 mg capsule 29 to <36 kg 1 Atopica® 100 mg capsule 1 Atopica® 50 mg capsule 36 to <55 kg 2 Atopica® 100 mg capsules * For higher weights, proceed according to the average recommended dose. • Initially Atopica® will be administered daily until satisfactory clinical improvement is seen. This usually happens within 4 weeks. If there is no improvement during the first 8 weeks, treatment should be stopped. • Once the clinical symptoms of atopic dermatitis have been satisfactorily controlled, the product can be given every other day as a maintenance dose. The veterinarian must make clinical controls at regular intervals and adjust the frequency of administration to the clinical response obtained. • In cases where symptoms are controlled with alternate day administration, the veterinarian may decide to give Atopica® every 3 to 4 days. • Before reducing the treatment interval, consideration should be given to giving additional treatment (eg medicated shampoos, fatty acids). • Treatment can be stopped when clinical symptoms have been controlled. If clinical symptoms reappear, treatment can be resumed at a daily dose, in some cases several courses of treatment will be necessary. Special precautions: In animals: • The clinical symptoms of atopic dermatitis, such as itching and inflammation of the skin, are not specific to this disease and therefore, before starting treatment, other causes of dermatitis should be ruled out, such as infestations by ectoparasites, other allergies that cause dermatological symptoms ( eg flea allergy dermatitis or food allergy) or infections bacterial and fungal. It is good practice to treat flea infestations before and during atopic dermatitis treatment. • It is recommended to eliminate bacterial and fungal infections before administering Atopica®. However, the occurrence of infections during treatment is not necessarily a reason to stop treatment, unless the infection is severe. • Given that cyclosporine inhibits T lymphocytes, it can cause a decrease in the immune response in malignant tumor processes, so a complete clinical examination must be carried out before starting treatment. Lymphadenopathy observed during ciclosporin treatment should be monitored regularly. • In laboratory animals it has been observed that cyclosporine is capable of affecting circulating insulin levels and causing an increase in blood glucose. In the presence of signs suggestive of diabetes mellitus, the effect of treatment on glycaemia should be monitored. • The use of cyclosporine in diabetic dogs is not recommended. • In animals with severe renal insufficiency, creatinine levels should be closely monitored. • Treatment with Atopica® may interfere with the efficacy of the vaccination. In the case of inactivated vaccines, vaccination is not recommended during treatment or within two weeks before or after administration of the product. In the case of live vaccines, see also the point "Contraindications". • The concomitant use of other immunosuppressive agents is not recommended. In person: • Wash hands after administration. • In case of accidental ingestion of the capsule or its contents, see a doctor immediately and show him the package leaflet or the label. Wait time:: Not applicable. Conservation mode:: Do not store above 25 °C. Store in the blister. Keep the blister in the outer carton packaging.