Manufacturer/Label Information:
Atopica
Novarts
Product Type
Oral soft capsule for the treatment of chronic manifestations of atopic dermatitis in dogs
Description and Composition
Soft capsule of 4 strenghts 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..
Properties
ATOPICA contains Cyclosporine A (ATCvet code QL04A A01) a selective immunosuppressor. It is a cyclic polypeptide consisting of 11 amino acids with a molecular weight of 1203 Daltons which acts specifically and reversibly on T-lymphocytes. 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.
Indications
Treatment of chronic manifestations of atopic dermatitis in dogs
Dosage and Administration
The mean recommended dose rate of cyclosporin is 5 mg/kg body weight per day given according to the following scheme.
Body weight of the dog (kg) Number of capsules given to obtain the recommended dose
| Body weight of the dog (kg) |
Number of capsules given to obtain the recommended dose |
| 2 to <3 |
1 x 10mg |
| 3 to <4 |
2 x 10mg |
| 4 to <7.5 |
1 x 25mg |
| 7.5 to < 15 |
1 x 50mg |
| 15 to <29 |
1 x 100mg or 2 x50 mg |
| 29 to <36 |
3 x 50mg |
| 36-55 |
2 x 100mg |
ATOPICA will initially be given daily until a satisfactory clinical improvement is seen. This will generally be the case after 4 to 8 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 be given every second day. If the signs are then controlled with this dosing, ATOPICA can be then given every 3 to 4 days. The veterinary surgeon will adjust the frequency of administration to the response. 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. Treatments of up to several months have been shown to be well tolerated. ATOPICA should be given at least 2 hours before or after feeding. Insert the capsule directly into the dog's mouth.
Special Precautions, Warnings and Undesirable Effects
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
The most frequently observed undesirable effects include gastrointestinal disturbances such as vomiting, mucoid or soft stool and diarrhea. They are mild and transient and generally do not require the cessation of the treatment. Very rarely (muscle cramps, muscle weakness) anorexia, gingival hypertrophy, veruciform lesions or change of hair coat have been reported.The efficacy and safety of cyclosporine has neither been assessed in dogs aged less than 6 months weighing less than 2 kg nor in breeding dogs or pregnant or lactating bitches. It is recommended to clear bacterial and fungal infections before treatment with ATOPICA. But infections are not necessarily a reason for drug withdrawal if they occur during treatment. As cyclosporine inhibits T-lymphocytes, it may decrease the immune response in case of malignancy. A complete clinical examination should be performed before treatment. Lymphadenopathy observed on treatment with cyclosporine should be regularly monitored.
In contrast to humans, there is no evidence of cyclosporine kidney toxicity and increased blood pressure in dogs.
Various drugs are known to competitively inhibit or induce the enzymes involved in the metabolism of cyclosporin, in particular cytochrome P450 (CyP 3A 4). In clinically relevant cytochrome P450-mediated interactions an appropriate adjustment of ATOPICA dosage might be required. Ketoconazole is the only drug known to lead to a clinically relevant increase of the blood concentration of cyclosporin in dogs.
Formulation and Packages
Box containing 10 capsules in an aluminium/aluminium blister pack
Storage Recommendations and Shelf Life
3 years
Do not store above 25C. Capsules must be left in blister packs until required for use.
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