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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 520 - Oral Dosage Form New Animal Drugs |
§ 520.2598 - Trilostane.
Latest version.
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§ 520.2598 Trilostane.
(a) Specifications. Each capsule contains 5, 10, 30, 60, or 120 milligrams (mg) trilostane.
(b) Sponsor. See No. 043264 in § 510.600 of this chapter.
(c) Conditions of use in dogs -
(1) Amount. The starting dose is 1.0 to 3.0 milligrams per pound (2.2 to 6.7 milligrams per kilogram) once a day.
(2) Indications for use. For the treatment of pituitary-dependent and adrenal-dependent hyperadrenocorticism . For treatment of hyperadrenocorticism due to adrenocortical tumor. in dogs.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[74 FR 21767, May 11, 2009, as amended at 74 FR 30464, June 26, 2009; 80 FR 53460, Sept. 4, 2015; 87 FR 58962, Sept. 29, 2022]