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FDA-Approved Cyclosporine Capsules for Dogs with Atopic Dermatitis
Product Description
Atopica (Cyclosporine Capsules) USP Modified is an FDA-approved prescription oral immunomodulating capsule for dogs weighing at least 4 lbs. It works by targeting the immune pathway responsible for atopic dermatitis, suppressing the overreaction that causes persistent itching and skin inflammation. Available in four weight-appropriate strengths, 10 mg, 25 mg, 50 mg, and 100 mg, each supplied in 15 unit-dose blister packs.
Benefits
- Targeted Immune Action: Suppresses T-helper and T-suppressor cells and inhibits interleukin-2, addressing allergic skin overreaction at its source.
- Not a Steroid: Moderates immune function without reducing blood cell production or phagocytic activity the way corticosteroids do.
- Clinically Proven Results: CADESI scores dropped 45% in treated dogs over 30 days versus a 9% worsening in placebo dogs across 265 study participants.
- Pruritus Improvement: Itching scores improved in 74% of treated dogs after 30 days, compared to only 24% in the placebo group.
- Dose Tapering Option: After 30 days, dosing can shift to every other day or twice weekly, reducing overall long-term exposure for your dog.
- Weight-Specific Sizing: Four capsule strengths are matched to weight ranges so each dog receives a full capsule at the right dose every time.
- Reversible Gum Changes: Gingival hyperplasia noted on daily dosing showed clear improvement once dogs moved to a less frequent maintenance schedule.
Ingredients
Active Ingredients
Cyclosporine
How to Use
Dosage & Administration Instructions
- Prescription Required: Federal law restricts Atopica to use by or on the order of a licensed veterinarian only.
- Dogs Only: These capsules are approved for oral use in dogs only; never give them to cats or any other animal species.
- Starting Dose: Administer 5 mg/kg once daily for 30 days using the weight-appropriate capsule strength from the product insert dose table.
- Empty Stomach Needed: Give at least one hour before a meal or two hours after to ensure consistent absorption and reliable therapeutic effect.
- GI Upset Adjustment: If vomiting occurs, the vet may suggest a brief pause, dose splitting, or temporary administration with a small amount of food.
- Taper After 30 Days: Once a good response is seen, the schedule gradually shifts to every other day and eventually to twice weekly.
- No Double Dosing: A missed dose should be given as soon as remembered, but never give two doses on the same day.
- Keep Capsules Whole: Do not break or open capsules; wear gloves when handling them and wash hands thoroughly with soap and water afterward.
- Killed Vaccines Only: During treatment, dogs should only receive killed vaccines as the effects on modified live vaccine responses are not yet fully known.
Disclaimer: This dosage information is provided by the manufacturer. Always consult your veterinarian before administering or adjusting any supplement for your pet.
Additional Information
Precautions
- Cancer History Contraindication: Do not use in any dog with a history of neoplasia, as this immunosuppressant may increase susceptibility to cancer development.
- Hypersensitivity Contraindication: Do not use in dogs with a known hypersensitivity to cyclosporine; anaphylaxis and allergic edema have been reported post-approval.
- Infection and Cancer Risk: As a systemic immunosuppressant, it may increase susceptibility to infections and the potential for neoplasia development or worsening.
- Breeding Dogs Excluded: Safety has not been established in breeding, pregnant, or nursing dogs; avoid use in these animals entirely.
- Age and Weight Limits: Dogs younger than 6 months or below 4 lbs fall outside the established safety and effectiveness data for this product.
- Drug Interaction Risk: Atopica is metabolised through the P-450 system; azole antifungals like ketoconazole can raise cyclosporine plasma levels noticeably.
- Diabetic Dogs Caution: Blood glucose may rise during treatment; diabetic dogs need close monitoring, and tapering or stopping may be required.
- Renal Insufficiency Caution: The effect of cyclosporine in dogs with kidney problems has not been studied; proceed carefully in dogs with renal insufficiency.
Possible Side Effects
- Vomiting: Reported in 30.9% of dogs in the field study; most cases resolved on their own as treatment continued over time.
- Diarrhea: Around 20% of study dogs experienced diarrhea, though it generally passed without major veterinary intervention being needed.
- Ear Infections: Persistent otitis externa was noted in roughly 6.8% of study dogs; new cases required separate otic treatment alongside Atopica therapy.
- Gum Overgrowth: Gingival hyperplasia was reported in 2.3% of dogs; it was dose-dependent and regressed after tapering to a lower maintenance frequency.
- Neoplasia Reports: Lymphoma and mast cell tumors have been reported post-approval; it is not confirmed whether these were pre-existing or developed during treatment.
- Diabetes Mellitus: Reported in post-approval experience; West Highland White Terriers are the most frequently reported breed for this side effect.
- Urinary Tract Infections: Reported in 3.8% of field study dogs; monitor for signs of urinary tract infection throughout the course of immunosuppressive therapy.
- Neurological Signs: Convulsions, muscle tremors, and ataxia have been reported post-approval; seek immediate veterinary care if any neurological signs develop.
Storage Information
- Room Temperature Storage: Store in the original unit-dose blister container at a controlled room temperature between 59-77°F (15-25°C) at all times.
- Keep Original Packaging: Capsules must stay in the original blister pack until administration; do not transfer to secondary containers or pill organizers.
- Secure Away from Others: Store in a location out of reach of children and all animals to prevent accidental ingestion of these immunosuppressive capsules.
Shipping & Return
We offer ground, express, and priority delivery; see our shipping policy for details.
For return instructions or product concerns, please refer to our detailed refund policy.
Prescription items are NON-RETURNABLE and NON-REFUNDABLE.
Frequently Asked Questions
Q1: What is Atopica cyclosporine used for in dogs?
Ans: Atopica is an FDA-approved prescription capsule for managing atopic dermatitis in dogs weighing at least 4 lbs. It targets the immune pathway causing allergic skin reactions, reducing persistent itching, inflammation, and lesions rather than just masking symptoms with steroids or antihistamines.
Q2: What is the correct Atopica cyclosporine dose for dogs?
Ans: The starting dose is 5 mg/kg given once daily for 30 days using the weight-appropriate capsule. After 30 days, the vet may taper to every other day, then twice weekly, finding the lowest frequency that keeps the condition under control long term.
Q3: Why must Atopica cyclosporine capsules be given on an empty stomach?
Ans: Food in the stomach interferes with how cyclosporine is absorbed in the gut. Giving the capsule at least one hour before eating or two hours after keeps absorption consistent. If vomiting is a concern, the vet may allow temporary administration with a small amount of food.
Q4: Can Atopica cyclosporine be used in dogs with a history of cancer?
Ans: No. Atopica is contraindicated in dogs with any prior history of neoplasia. As a systemic immunosuppressant, it may raise susceptibility to infections and cancer development. Post-approval reports have included lymphoma and mast cell tumor cases, though a direct causal link has not been confirmed.
Q5: Can my dog receive vaccines while taking Atopica cyclosporine?
Ans: Only killed vaccines are recommended during Atopica treatment. Dogs on cyclosporine at higher doses did not mount an antibody response to modified live vaccines, while all dogs responded normally to a killed rabies vaccine. Always discuss the vaccination schedule with your vet.