Atopica Capsules

Controls Atopic Dermatitis in Dogs

Novartis Atopica (cyclosporine) is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs body weight.

Atopic dermatitis is an allergic skin disease in dogs caused by immunological hypersensitivity to common allergens in the environment - like house dust. Atopic dermatitis often begins during the first two years of life. Dogs will groom excessively with licking or chewing the paws, abdomen or perineum. Ears may be red and hot, even without any scratching of them. Itching (pruritis) evenually dominates the dog's life and leads to areas of baldness and red skin. Secondary infections with yeast and/or bacteria is common.

Dosage and Administration:

The initial daily dose of ATOPICA is 5 mg/kg/day (3.3-6.7 mg/kg/day) as a single daily dose for 30 days. Following this initial daily treatment period, the dose of ATOPICA may be tapered by decreasing the frequency of dosing to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect. ATOPICA should be given at least one hour before or two hours after a meal. If a dose is missed, the next dose should be administered (without doubling) as soon as possible, but dosing should be no more frequent than once daily.

Federal Law restricts this drug to use by or on the order of a licensed veterinarian

ATOPICA Capsules contain cyclosporine and is available in 10, 25, 50, and 100 mg capsule strengths in color-coded packaging for oral administration to dogs.

Dose Administration

Contraindications:

ATOPICA is contraindicated for use in dogs with a history of malignant neoplasia.

Precautions:

Not for human use. Keep this and all drugs out of reach of children. For use only in dogs.

Gastrointestinal problems and gingival hyperplasia may occur at the initial recommended dose.

ATOPICA should be used with caution with drugs that affect the P-450 enzyme system. Simultaneous administration of ATOPICA with drugs that suppress the P-450 enzyme system, such as ketoconazole, may lead to increased plasma levels of cyclosporine.

The safety and effectiveness of ATOPICA has not been established in dogs less than 6 months of age or less than 4 lbs body weight. ATOPICA is not for use in breeding dogs, pregnant or lactating bitches.

Killed vaccines are recommended for dogs receiving ATOPICA because the impact of cyclosporine on the immune response to modified live vaccines is unknown.

Adverse Reactions:

Vomiting and diarrhea were the most common adverse reactions. In most cases, signs spontaneously resolve with continued dosing. In other cases, temporary dose modifications (brief interruption in dosing, divided dosing, or administration with a small amount of food) should be employed to resolve signs.

Persistent otitis externa, urinary tract infections, anorexia, gingival hyperplasia, lymphadenopathy and lethargy are the next most frequent adverse events. Gingival hyperplasia regressed with dose tapering.

Clinical Pharmacology:

Cyclosporine is a potent immunosuppressive agent that has been shown to work via suppression of T-helper and T-suppressor cells and inhibition of Interleukin-2. It does not impair the hematopoietic system or cell-mediated immunologic responses, A decrease in CD4 and CD8 cells was not seen in dogs receiving 20 mg/kg/day of cyclosporine for 56 days. ATOPICA is not a corticosteroid or an antihistamine.

Rx Medication Sold Only To Licensed Veterinarians & Pharmacies. Current License Must Be On File Prior To Shipping.