Atopica label

Atopica

Atopica Recall

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Side Effects & Adverse Reactions

ATOPICA (cyclosporine) is a potent systemic immunosuppressant that may increase the susceptibility to infection and the development of neoplasia.

Human Warnings:

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

Human Warnings:

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

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

ATOPICA is indicated for the control of atopic dermatitis in dogs weighing at least 4 lbs body weight.

History

There is currently no drug history available for this drug.

Other Information

ATOPICA (cyclosporine capsules, USP) MODIFIED is an oral form of cyclosporine that immediately forms a microemulsion in an aqueous environment. Cyclosporine, the active ingredient in ATOPICA, is a cyclic polypeptide, immune modulating agent consisting of 11 amino acids. It is produced as a metabolite by the fungal species Beauveria nivea.

Chemically, cyclosporine A is designated [R-[R*,R*-(E)]]-cyclic-(L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl-3-hydroxy-N, 4-dimethyl-L-2-amino-6-octenoyl-L- α -amino-butyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl). The structural formula is:

Cyclosporine structural formula

ATOPICA capsules contain cyclosporine formulated together with inactive ingredients.

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

Atopica Manufacturers

  • Atopica | Novartis Animal Health Us, Inc.
    No Recall

    Atopica | Novartis Animal Health Us, Inc.

    Atopica | Novartis Animal Health Us, Inc.

    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.

    Dog body
    weight (lbs) Dog body
    weight (kg) Dose
    5 mg/kg 4 – 6.5 lbs 2 – 2.9 kg 10 mg capsule 6.6 – 9 lbs 3 – 3.9 kg 2 x 10 mg capsule 9.1 – 16 lbs 4 – 7.9 kg 25 mg capsule 16.1 – 33 lbs 8 – 14.9 kg 50 mg capsule 33.1 – 64 lbs 15 – 28.9 kg 100 mg capsule 64.1 – 79 lbs 29 – 35.9 kg 100 mg capsule
    +50 mg capsule 79.1 – 121 lbs 36 - 55.9 kg 2 x 100 mg capsule