21 C.F.R. § 522.147 – Atipamezole.

(a) Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride.
(b) Sponsors. See Nos. 015914, 052483, 068504, 069043, and 086101 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs—(1) Amount. Administer 3,750 mcg/m ² intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m ² intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride.
(2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019; 88 FR 84700, Dec. 6, 2023; 89 FR 42357, May 15, 2024; 91 FR 41560, July 7, 2026]