21 CFR Ch. I (4–1–02 Edition)

§ 522.2444 21 CFR Ch. I (4–1–02 Edition)

Applications for these uses need not in- dilution with sterile water for injec- clude effectiveness data as specified in tion. § 514.111 of this chapter, but may re- (b) Sponsor. See No. 061133 in quire bioequivalency and safety infor- § 510.600(c) of this chapter. mation. (c) Conditions of use. (1) It is used as [40 FR 25812, June 19, 1975, as amended at 49 an anesthetic for intravenous adminis- FR 8434, Mar. 7, 1984; 53 FR 23390, June 22, tration to dogs and cats during short to 1988; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, moderately long surgical procedures. June 30, 1997] (2) It is administered as follows: § 522.2444 Sodium thiopental implan- (i) For total anesthesia, it is given at tation or injectable dosage forms. approximately 10 to 12 milligrams per pound of body weight over a period of § 522.2444a Sodium thiopental for in- 3.5 to 5 minutes. jection. (ii) When preanesthetic medication is (a) Specifications. The drug contains used, it is important to wait at least an sodium thiopental sterile powder for hour before administering thiopental dilution with sterile water for injec- and sodium pentobarbital for injection, tion. and the dosage necessary for anes- (b) Sponsor. See No. 000856 in thesia is reduced. Usually 1⁄2 to 2⁄3 the § 510.600(c) of this chapter. normal amount is adequate. (c) Conditions of use. (1) It is used as (3) Federal law restricts this drug to an anesthetic for intravenous adminis- use by or on the order of a licensed vet- tration to dogs and cats during short to erinarian. moderately long surgical and other procedures. It is also used to induce an- [40 FR 13858, Mar. 27, 1975, as amended at 47 esthesia in dogs and cats which then FR 14149, Apr. 2, 1982; 66 FR 14073, Mar. 9, have surgical anesthesia maintained by 2001] use of a volatile anesthetic. (2) It is administered as follows: § 522.2470 Tiletamine hydrochloride and zolazepam hydrochloride for (i) For brief anesthesia (6 to 10 min- injection. utes) a dosage of 6 to 9 milligrams per pound of body weight is suggested. (a) Specifications. Tiletamine hydro- (ii) To obtain anesthesia of 15 to 25 chloride and zolazepam hydrochloride minutes duration the suggested dosage for injection when reconstituted with is 10 to 12 milligrams per pound of body sterile distilled water provides weight. tiletamine hydrochloride and (iii) Use of a preanesthetic tranquil- zolazepam hydrochloride equivalent to izer or morphine will decrease the dos- 50 milligrams of tiletamine base and 50 age of sodium thiopental required, pro- milligrams of zolazepam base per milli- vide for smoother induction and liter of solution. smoother recovery, and sometimes pro- (b) Sponsor. See No. 000031 in long the recovery period. If morphine is § 510.600(c) of this chapter. used as a preanesthetic agent the dose (c) Conditions of use—(1) Indications of the barbiturate can be reduced as for use. It is used for restraint or for much as 40 to 50 percent. When a tran- anesthesia combined with muscle re- quilizer is administered the barbitu- laxation in cats and in dogs for re- rate dosage can be reduced 10 to 25 percent. straint and minor procedures of short (3) Federal law restricts this drug to duration (30 minutes) requiring mild to use by or on the order of a licensed vet- moderate analgesia. erinarian. (2) Amount. Expressed as milligrams of the drug combination: § 522.2444b Sodium thiopental, sodium (i) In healthy dogs: An initial pentobarbital for injection. intramuscular dosage of 3 to 4.5 milli- (a) Specifications. Each gram of the grams per pound of body weight for di- drug contains 750 milligrams of sodium agnostic purposes; 4.5 to 6 milligrams thiopental and 250 milligrams of so- per pound of body weight for minor dium pentobarbital sterile powder for procedures of short duration such as

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