Atopica for Dogs

Description

Atopica for Dogs is a prescription medication specifically indicated for the control of atopic dermatitis in dogs. It contains cyclosporine USP Modified, an immunomodulating medication that targets the immune response involved in allergic skin inflammation.

Canine atopic dermatitis is a chronic allergic skin condition that can cause persistent itching, inflammation, and skin lesions. Atopica works at the source of the inflammatory response to help relieve itching and reduce skin lesions while providing an option for long-term management.

Atopica is intended for dogs at least 6 months of age and weighing at least 4 lb. Treatment begins with daily administration and may later be reduced to every-other-day or twice-weekly dosing when adequate control is maintained.

Uses & Benefits

• Controls canine atopic dermatitis
• Helps relieve itching associated with atopic dermatitis
• Helps reduce skin lesions
• Targets immune pathways involved in allergic inflammation
• Provides long-term management of chronic atopic dermatitis
• Non-steroidal treatment option
• Oral soft gelatin capsule formulation
• Convenient once-daily initial administration
• Allows tapered maintenance dosing when appropriate
• Some dogs can be maintained with every-other-day or twice-weekly dosing
• FDA-approved specifically for canine atopic dermatitis

How It Works

Atopica contains cyclosporine USP Modified, a systemic immunomodulating medication.

Cyclosporine inhibits activation of immune cells involved in the allergic inflammatory response. By modifying T-cell activity and associated inflammatory signaling, cyclosporine helps reduce the inflammation, itching, and skin lesions associated with canine atopic dermatitis.

Unlike corticosteroids, cyclosporine does not work through glucocorticoid activity and provides an alternative approach for long-term management of canine atopic dermatitis.

Indications

For use in dogs at least 6 months of age and weighing at least 4 lb for the control of:

• Canine atopic dermatitis / Allergic skin inflammation / Itching associated with atopic dermatitis / Skin lesions associated with atopic dermatitis

Ingredients

Active Ingredients:

• Cyclosporine USP Modified

Inactive Ingredients:

Atopica is supplied as a liquid-filled soft gelatin capsule

Directions

Administer orally exactly as prescribed by your veterinarian.

Atopica should be administered:

• At least 1 hour before a meal, or
• At least 2 hours after a meal

Capsules should be swallowed intact. Do not break or open the capsules. Wear gloves during administration and wash hands afterward.

Weight / Dosage

The initial recommended dose is approximately 5 mg/kg once daily.

Initial Treatment

• Administer once daily for 30 days.

Maintenance Treatment

Following the initial daily treatment period, dosing frequency may be reduced to:

• Every other day, or
• Twice weekly

Reduce dosing frequency until the minimum frequency that maintains the desired therapeutic effect is reached.

Manufacturer Weight-Based Dosing

• 4–6.5 lb: 10 mg
• 6.6–9 lb: 20 mg
• 9.1–16 lb: 25 mg
• 16.1–33 lb: 50 mg
• 33.1–64 lb: 100 mg
• 64.1–79 lb: 150 mg
• 79.1–121 lb: 200 mg

Administer exactly as prescribed by your veterinarian. Follow all dosing and administration instructions provided on the prescription label and by your veterinarian. Do not adjust the dose, frequency, route, or duration of administration unless directed by your veterinarian.

Cautions

• For animal use only.
• For use in dogs only.
• Federal law restricts this medication to use by or on the order of a licensed veterinarian.
• Do not use in dogs with a history of neoplasia.
• Do not use in dogs with known hypersensitivity to cyclosporine.
• Do not use in reproducing dogs.
• Cyclosporine is a systemic immunosuppressant and may increase susceptibility to infection and development of neoplasia.
• Use cautiously in dogs with diabetes mellitus.
• Use cautiously in dogs with renal insufficiency.
• Tell your veterinarian about all medications and supplements your dog receives.
• Capsules should not be broken or opened.
• Wear gloves during administration and wash hands afterward.
• Keep out of reach of children and other animals.

Possible Side Effects

The most commonly reported adverse effects associated with Atopica are:

• Vomiting / Diarrhea

Other possible side effects may include:

• Soft stools / Decreased appetite / Gingival hyperplasia / Muscle weakness or cramping / Changes in the hair coat

Gastrointestinal effects and gingival hyperplasia may occur, particularly during initial treatment.

Because cyclosporine affects immune function, treatment may increase susceptibility to infection and development of neoplasia. Contact your veterinarian if your dog develops persistent vomiting or diarrhea, significant appetite changes, unusual weakness, signs of infection, abnormal growths, or another unexpected or concerning reaction.

Precautions

• Safety and effectiveness have not been established in dogs younger than 6 months or weighing less than 4 lb
• Do not use in reproducing dogs
• Use cautiously in dogs with diabetes mellitus
• Use cautiously in dogs with renal insufficiency
• Monitor the dog's clinical response during treatment
• Tell your veterinarian about all medications and supplements the dog receives
• Use cautiously with medications that affect the cytochrome P-450 enzyme system
• Drug interactions may alter cyclosporine concentrations
• Because cyclosporine affects immune function, vaccination decisions should be discussed with the veterinarian
• Killed vaccines are recommended when vaccination is necessary during treatment
• Monitor for signs of infection or abnormal tissue growth during long-term therapy
• Do not break or open capsules
• Wear gloves during administration and wash hands afterward

Storage

Store and dispense Atopica in the original unit-dose container at controlled room temperature between 59°F and 77°F (15°C to 25°C). Keep the medication out of reach of children and animals.

Disposal

Dispose of unused or expired medication according to your veterinarian's, pharmacist's, or local medication disposal recommendations.
Do not open capsules before disposal. Do not give unused medication to another animal. Keep discarded medication and packaging where children and animals cannot access them.