subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.522"
section_subject: "Cyclosporine."
cfr_reference: "21 CFR 520.522"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Specifications. (1) Each cyclosporine capsule, USP (MODIFIED) contains 10, 25, 50, or 100 milligrams (mg) cyclosporine.
(d)Conditions of use—(1) Dogs. Use capsules described in paragraph (a)(1) of this section as follow:
(i)Amount. Administer 5 mg per kilogram (mg/kg) of body weight given orally as a single daily dose for 30 days. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or two times a week, until a minimum frequency is reached which will maintain the desired therapeutic effect.
(ii)Indications for use. For the control of atopic dermatitis in dogs weighing at least 4 pounds.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2)Cats. Use the solution described in paragraph (a)(2) of this section as follow:
(i)Amount. Administer 7 mg/kg of body weight orally as a single daily dose for a minimum of 4 to 6 weeks or until resolution of clinical signs. Following this initial daily treatment period, the dosage may be tapered by decreasing the frequency of administration to every other day or twice weekly to maintain the desired therapeutic effect.
(ii)Indications for use. For the control of feline allergic dermatitis in cats at least 6 months of age and weighing at least 3 pounds.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.