Atopica Capsules for Dogs

ATOPICA^® is indicated for the control of atopic dermatitis in dogs weighing at least 4 pounds and at least 6 months of age.

ATOPICA^® is indicated for the control of atopic dermatitis in dogs weighing at least 4 pounds.

Do not use Atopica^® in dogs with a history of neoplasia, with a hypersensitivity to cyclosporine, or in reproducing dogs. Atopica^® is a systemic immunosuppressant that may increase susceptibility to infection and development of neoplasia. For use only in dogs. Capsules should not be broken or opened. Wear gloves during administration and wash hands after administration. Gastrointestinal problems and gingival hyperplasia may occur at the initial dose. Safety and effectiveness has not been established in dogs less than 6 months or 4 lbs. Use with caution in dogs with diabetes mellitus or renal insufficiency, and with drugs that affect the P-450 pathway. Killed vaccines are recommended. The most common adverse events are vomiting and diarrhea.

For full prescribing information, see Product Label.

This product contains a chemical on the Proposition 65 List.

Dogs

Cyclosporine (Modified)

Immunosuppressant

Atopica soft gelatin capsules (cyclosporine capsules) USP MODIFIED are supplied in packages of 15 unit-dose blisters, and are available in four strengths: 10 mg, 25 mg, 50 mg, and 100 mg.

Please ensure the selected product and quantity are appropriate for your pet, as recommended by your veterinarian. For current availability, please refer to the product selection above.

Atopica capsules should be given orally as directed by your veterinarian. Please consult your veterinarian before making any changes or discontinuing the prescribed dosing schedule. If you have questions about your pet’s prescribed dosing schedule (e.g., timing, interval), please contact your veterinarian.

The initial 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 twice weekly by your veterinarian based upon the 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.

Store within the original unit-dose container in a cool, dry place at a controlled room temperature between 59°F and 77°F. Keep this and all other medications in a secure location out of the reach of children and animals. Do not puncture foil and expose capsules until it is time for administration.

Exposure to extreme temperatures, light, or moisture can affect the integrity and effectiveness of medications. Always store this medication properly (e.g., away from the bathroom, kitchen sink, or other damp places).

The most common side effects of this medication are vomiting and diarrhea. These effects may be more likely to appear at the start of treatment (or following a dose change) and usually resolve over time.

Atopica (cyclosporine) is a systemic immunosuppressant that may increase susceptibility to infection and development of neoplasia (cancer or other abnormal tissue growth).

Contact your veterinarian immediately if your pet has swelling/overgrowth of the gums or if you notice any signs of an infection (e.g., fever, chills, frequent or painful urination).

The information provided above may not encompass all possible side effects. Please notify your veterinarian if your pet experiences any side effects, including those listed above, or if you notice anything unusual.

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

Capsules should not be broken or opened. Wear gloves during administration and wash hands after administration. In case of accidental ingestion, seek medical advice immediately and provide the package insert or the label to the physician.

Do not use Atopica in dogs with a history of neoplasia, with a hypersensitivity to cyclosporine, or in reproducing dogs.

Atopica may cause elevated levels of serum glucose and should be used with caution in dogs with diabetes mellitus. Since the effect of cyclosporine use on dogs with compromised renal function has not been studied, Atopica should be used with caution in dogs with renal insufficiency.

Do not administer this medication to animals with a known or suspected allergy/hypersensitivity to it (cyclosporine) or any of its ingredients. Allergic reactions to medications may occur. Please inform Vetsource and your veterinarian if your pet has any known sensitivities or allergies, especially to medications and supplements.

If your pet displays symptoms of an allergic reaction, discontinue therapy and call your veterinarian immediately or seek emergency veterinary attention. Symptoms may include (but are not limited to): swollen lips, tongue, face, or airways; difficulty breathing; agitation; profuse salivation; and widespread hives or itching.

This medication is classified as hazardous due to potential exposure risks in humans. Proper use of personal protective equipment (PPE), such as gloves, is recommended when handling this medication to minimize the risk of exposure.

Do not break, open, or otherwise manipulate capsules, as this will increase the risk of exposure. Wear gloves during administration and wash hands thoroughly with soap and water afterward (even if gloves are worn).

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

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

The following drugs* may have potential interactions with this medication: ACE inhibitors (e.g., benazepril), azole antifungals (e.g., ketoconazole), corticosteroids (e.g., dexamethasone, prednisone), digoxin, estriol, JAK inhibitors (e.g., oclacitinib), loop diuretics (e.g., furosemide), methotrexate, mycophenolate, NSAIDs, phenobarbital, sirolimus, spironolactone, sulfa antibiotics, telmisartan (Semintra), and warfarin.

*NOTE: This is not a comprehensive list of all possible interactions. As with all medications, please consult your veterinarian if you have any questions or concerns prior to use. Contact your veterinarian if your pet experiences any unusual reactions when multiple medications and/or supplements are given together.

Please ensure your veterinarian is aware of all medications, supplements, and over-the-counter (OTC) products that your pet is currently using. Your veterinarian may prescribe multiple medications, even if a potential drug interaction may occur. In these instances, your veterinarian may adjust the dosages or monitor your pet more closely.

If you are concerned that your pet has experienced an adverse reaction to this medication, please contact Elanco at 1-888-545-5973 or Vetsource Pet Owner Care at 877-738-4443.

If you have any reason to suspect accidental consumption or overdose, call your doctor/veterinarian or the appropriate poison control resource immediately.

The national toll-free Poison Help line, 1-800-222-1222, will connect you to your local poison center in case of emergency. This service is available nationwide and in most U.S. territories.

The ASPCA Animal Poison Control Center is available 24 hours a day, 365 days a year at 888-426-4435.

Pet Poison Helpline also provides a 24/7 animal poison control service at 855-764-7661.

All content, including the images and product description above, is intended for general informational purposes only and should not be considered a substitute for professional veterinary consultation, diagnosis, or treatment.

For additional information about this product and how it fits into your pet's individual treatment plan, please consult your veterinarian.