(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 treatment of pituitary-dependent hyperadrenocorticism. For treatment of hyperadrenocorticism due to adrenocortical tumor.

(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]