21 Food and Drugs 6 2003-04-01 2003-04-01 false Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection. 522.1222b Section 522.1222b Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1222b Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection.

(a) Chemical name. Ketamine hydrochloride, (±),-2-(o-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride, with promazine hydrochloride, 10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride, and aminopentamide hydrogen sulfate.

(b) Specifications. The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity, 7.5 milligrams of promazine hydrochloride, and 0.0625 milligram of aminopentamide hydrogen sulfate, with 1:10,000 benzethonium chloride.

(c) Sponsor. See Code No. 000856 in § 510.600(c) of this chapter.

(d) Special considerations. Store in a cool place. Protect from light. Do not use if precipitate appears.

(e) Conditions of use. (1) It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery.

(2) It is administered intramuscularly at a recommended dose from 15 to 20 milligrams ketamine base per pound of body weight, depending on the effect desired.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 59342, Dec. 23, 1975, as amended at 42 FR 3838, Jan. 21, 1977; 53 FR 27851, July 25, 1988]