ATOPICA FOR CANINE ATOPIC DERMATITI
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Atopica┬« (Novartis) (Cyclosporin) A Treatment for Canine Atopic Dermatitis that selectively targets the allergic reaction. Oral medication with unique selective immunomodulating properties. Dramatically reduces skin lesions and effectively controls pruritis. Well tolerated and safe on vital organs. Advanced skin allergy relief. Engendered better rates of skin lesion improvement and remission than methylprednisolone in laboratory and clinical trials. Available in gel capsules. 


WHAT IS ATOPIC DERMATITIS?
Atopic dermatitis is a type of skin allergy in dogs, similar to the skin condition in humans. In dogs, it is the second most common form of allergy: an estimated 10% of the dog population are affected. A genetically inherited and normally lifelong disease, the first sign of atopic dermatitis usually occurs between 6 months and 3 years of age. Atopic dermatitis occurs when hypersensitive dogs come in contact with common allergens such as house dust mites, pollens and moulds. The main sign of atopic dermatitis is itching. Dogs will chew on their feet, rub their face on the carpet, and gnaw and scratch at their skin. These actions, in turn, worsen skin inflammation, and cause lesions, hair loss and dry, flaky skin. The situation is often further complicated by secondary bacterial and fungal infections. There are several treatments available for dogs to control the signs of atopic dermatitis, such as corticosteroids and antihistamines. But unfortunately, they have limitations and there is no cure.

WHAT IS ATOPICA®?
ATOPICA is the first medication specifically developed for the treatment of atopic dermatitis in dogs. ATOPICA is an oral medication (capsule) that has been proven safe and highly effective through the largest veterinary dermatology trial in history.

HOW DOES IT WORK?
ATOPICA works by inhibiting the function of cells responsible for the dog's allergic response. As a result, ATOPICA provides dramatic relief from the signs of atopic dermatitis, controlling itching and reducing skin inflammation and lesions. The improvement and tolerability seen with ATOPICA is similar to or better than that of corticosteroids, regarded until now as the most effective drug for atopic dermatitis.

WHAT ABOUT SAFETY?
Extensively tested, ATOPICA has been proven to control atopic dermatitis without the potentially severe long-term side effects associated with corticosteroids. ATOPlCA is deemed safe on vital functions and organs such as the kidneys, liver and adrenal glands. The most common side effects seen with ATOPICA are occasional vomiting and diarrhoea, which are normally mild and transient and do not require cessation of treatment.

WHAT TO EXPECT FROM TREATMENT
Improvement of the signs of atopy can be expected within 4 weeks after beginning full-dosage treatment with ATOPICA. Once a satisfactory clinical improvement is seen, the dosage may be tapered depending on how well your dog is responding.

HOW TO MONITOR YOUR DOG
You can greatly help your veterinarian in assessing response to therapy by observing the changes in your dog's scratching behaviour from the time of the first treatments with ATOPICA.

HOW TO DEAL WITH RELAPSES
Since atopic dermatitis is a chronic disease, unfortunately, relapses may occur. However, ATOPICA-treated dogs have lower relapse rates than dogs that have been treated with corticosteroids. If a relapse occurs after ATOPICA treatment has been stopped, a new round of treatment may be necessary.

WHAT ABOUT COST?
ATOPICA's cost can best be determined relative to the use of alternative, complementary treatments. Individual medications such as corticosteroids, antihistamines, topical shampoos and essential fatty acids may be less expensive but the cost of any combination of various medications and supportive therapy, as is usually required, can be offset by the use of ATOPICA alone. Moreover, if your dog responds satisfactorily, the dose and thus the cost of ATOPICA will be reduced over time. Your veterinarian will determine the treatment regime that is best for you and, more importantly, best to manage your dog's chronic disease.

Product Type
Oral soft capsule for the treatment of atopic dermatitis in dogs

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), edible red ink, excip. ad sol..

Properties
ATOPICA contains Cyclosporine A (ATCvet code QL04A A) a selective immunomodulator. 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 resting 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 atopic dermatitis in dogs

Dosage and Administration
The recommended dose of cyclosporin is 5 mg/kg body weight given according to the following scheme.

Body weight of the dog (kg) Number of capsules given to obtain the recommended dose 
2 1 x 10mg 
3 2 x 10mg 
4-7 1 x 25mg 
8-14 1 x 50mg 
15-28 1 x 100mg 
29-35 1 x 100mg + 1 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. ATOPICA can then be given every second day. Once the clinical signs of atopic dermatitis are satisfactorily controlled, ATOPICA can be given every 3 to 4 days. The veterinary surgeon will adjust the frequency of administration to the response. Treatment should continue unlimited to prevent a relapse. Treatments of up to several months have been shown to be effective and well tolerated. If no response is obtained within the first 8 weeks, the treatment should be stopped. ATOPICA should be given at least 2 hours before or after feeding. Insert the capsule directly into the dog's mouth.

Special Precautions and Warnings
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
Card envelope containing one blister pack made of an aluminium lidding foil and a coated aluminium bottom foil containing 10 capsules.

Storage Recommendations and Shelf Life
3 years
Do not store above 25C. Capsules must be left in blister packs until required for use. When a blister is opened, a characteristic smell is noticeable which is normal.