Section 522.558 - Dexmedetomidine(a)Specifications. Each milliliter of solution contains:(1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or(2) 0.5 mg dexmedetomidine hydrochloride.(b)Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (1) Nos. 017033, 068504, 069043, and 086117 for use of product described in paragraph (a)(2) of this section.(2) No. 052483 for use of products described in paragraph (a) of this section.(c)Conditions of use - (1)Dogs - (i)Indications for use and amount.(A) For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms ([MICRO]g) per square meter (/m2) of body surface area by intravenous injection or 500 [MICRO]g/m2 of body surface area by intramuscular injection.(B) For use as a preanesthetic to general anesthesia, administer 125 [MICRO]g/m2 of body surface area or 375 [MICRO]g/m2 of body surface area by intramuscular injection.(ii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.(2)Cats -(i)Amount. 40 [MICRO]g/killogram by intramuscular injection.(ii)Indications for use. For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures; and as a preanesthetic to general anesthesia.(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, Mar. 13, 2015; 86 FR 57997, Oct. 20, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 27699, May 3, 2023; 88 FR 84701, Dec. 6, 2023 86 FR 57997, 10/20/2021; 87 FR 10969, 2/28/2022; 88 FR 27699, 5/3/2023; 88 FR 84701, 12/6/2023