Oral soft capsule for the control of atopic dermatitis in dogs
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Description and Composition
Soft capsule of 4 strengths are available:
ATOPICA contains 10 mg, 25 mg, 50 mg or 100 mg Cyclosporine A per capsule.
List of excipients:
Tocopherol (E-307), iron oxide black (E 172), titanium dioxide (E 171), Carminic acid, excip. ad sol..
ATOPICA contains Cyclosporine A, an immunomodulator. Cyclosporine has anti-inflammatory and anti-pruritic activities in atopic dermatitis. Cyclosporine acts specifically and reversibly on T-lymphocytes and inhibits the antigen-triggered release of lymphokines by activated T-cells. It also inhibits eosinophil recruitment and activation, keratinocyte cytokine production, Langerhans' cell functions, degranulation of mastocytes and therefore release of histamine and pro inflammatory cytokines. Cyclosporine does not depress hemopoiesis and has no effect on the function of phagocytic cells.
Treatment of chronic manifestations of atopic dermatitis in dogs.
Atopic dermatitis is one of the most common allergic skin diseases in dogs and is caused by allergens such as house dust mites or pollens which stimulate an exaggerated immune response in atopic dogs. The disease is chronic, recurrent and requires lifelong management. Cyclosporine selectively acts on the immune cells involved in the allergic reaction. Cyclosporine reduces the inflammation and itching associated with atopic dermatitis.
Dosage and Administration
ATOPICA 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, ATOPICA can then be given every other day as a maintenance dose. In some cases where the clinical signs are controlled with every-other-day dosing, ATOPICA may be given every 3 to 4 days. Dose adjustment should only be carried out in consultation with your veterinarian.
Your veterinarian will perform a clinical assessment at regular intervals and adjust the frequency of administration up or down according to the clinical response obtained. 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, if advised to do so by your veterinarian. Upon recurrence of clinical signs, treatment should be resumed at daily dosing, and, as atopic dermatitis is a chronic disease, repeated treatment courses may be required.
ATOPICA should be given at least 2 hours before or after feeding as bioavailability is better in fasted animals.
Insert the capsule directly into the dog’s mouth.
Special Precautions, Warnings and Undesirable Effects
Do not use in cases of hypersensitivity to Cyclosporine or one of the excipients.
For all capsule strengths, do not use in dogs less than six months of age or less than 2 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.
The occurrence of adverse reactions is uncommon. Gastrointestinal disturbances such as vomiting, mucoid or soft faeces and diarrhoea may occur. They are mild and transient and generally do not require the cessation of the treatment.
Other undesirable effects are rare and may include 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.
If you notice any serious effects or other effects not mentioned above, please inform your veterinarian.
Special precautions for use
Clinical signs of atopic dermatitis such as itching 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 administering ATOPICA. However, infections occurring during treatment are not necessarily a reason for drug withdrawal, unless the infection is severe.
Your veterinarian will carry out a complete clinical examination before treatment. As Cyclosporine inhibits T-lymphocytes and though it does not induce tumors, it may lead to increased incidences of clinically apparent malignancy. If lymphadenopathy (enlargement of the lymph glands) is observed during treatment, this should be regularly monitored.
Cyclosporine may affect the circulating levels of insulin. In dogs with signs suggestive of diabetes mellitus, glucose levels must be monitored. The use of ATOPICA is not recommended in diabetic dogs.
Creatinine levels should be closely monitored in dogs with severe renal insufficiency.
Treatment with ATOPICA may interfere with vaccination efficacy. It is not recommended to vaccinate during treatment or within a two-week interval before or after administration of the product.
It is not recommended to use other immunosuppressive agents concomitantly.
Use during pregnancy or lactation
The safety of ATOPICA has not been studied in breeding male dogs nor in pregnant or lactating female dogs. Cyclosporine passes the placenta barrier and is excreted via milk, therefore the treatment of lactating bitches is not recommended. Your veterinarian should be advised if your dog is a breeding animal, so that a risk/benefit assessment can be made.
Interaction with other medicinal products and other forms of interaction
Various substances are known to competitively inhibit or induce the enzymes involved in the metabolism of Cyclosporine. In certain clinically justified cases, an adjustment of the dosage of ATOPICA may be required. The toxicity of some medications may be increased by administration with Cyclosporine. Consult your veterinarian prior to administering other products during ATOPICA therapy.
No undesirable effects beyond those that were seen under recommended treatment have been observed in the dog with a single oral dose of up to 6 times of what is recommended.
There is no specific antidote and in case of signs of overdose the dog should be treated symptomatically. The signs are reversible within 2 months following cessation of treatment.
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 of the capsule or its contents, seek medical advice immediately and show the package insert or the label to the physician.
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