Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 520  /  Sec. 520.455 Clomipramine tablets.

(a) Specifications. Each tablet contains 5, 20, 40, or 80 milligrams (mg) clomipramine hydrochloride.

(b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.

(c) Conditions of use--(1) Amount. 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.

(1) Amount. 2 to 4 milligrams of clomipramine hydrochloride per kilogram (0.9 to 1.8 milligrams per pound) of body weight per day, administered as a single daily dose or divided twice daily.

(2) Indications for use. For use as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [64 FR 1762, Jan. 12, 1999, as amended at 72 FR 262, Jan. 4, 2007]