Electronic Code of Federal Regulations

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

§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) No. 026637 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 (µg) per square meter (/m2) of body surface area by intravenous injection or 500 µg/m2 of body surface area by intramuscular injection.

(B) For use as a preanesthetic to general anesthesia, administer 125 µg/m2 of body surface area or 375 µg/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 µg/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]