§522.558. Dexmedetomidine.
21 C.F.R. § 522.558
Specifications. Each milliliter of solution contains:
0.1 milligrams (mg) dexmedetomidine hydrochloride; or
0.5 mg dexmedetomidine hydrochloride.
Sponsors. See sponsors in in § 510.600(c) of this chapter for use as in paragraph (c) of this section:
Nos. 017033, 068504, 069043, 086101, and 086117 for use of product described in paragraph (a)(2) of this section.
No. 052483 for use of products described in paragraph (a) of this section.
Conditions of use—
Dogs—
Indications for use and amount.
For use as a sedative and analgesic to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures, administer 375 micrograms (µg) per square meter (/m 2) of body surface area by intravenous injection or 500 µg/m 2 of body surface area by intramuscular injection.
For use as a preanesthetic to general anesthesia, administer 125 µg/m 2 of body surface area or 375 µg/m 2 of body surface area by intramuscular injection.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cats—
Amount. 40 µg/killogram by intramuscular injection.
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.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[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; 91 FR 5301, Feb. 6, 2026]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 91 FR 5301, Feb. 6, 2026]