21 C.F.R. § 522.1704   Sodium pentobarbital injection.


Title 21 - Food and Drugs


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

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§ 522.1704   Sodium pentobarbital injection.

(a)(1) Specifications. Sodium pentobarbital injection is sterile and contains in each milliliter 64.8 milligrams of sodium pentobarbital.

(2) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(3) Conditions of use. (i) The drug is indicated for use as a general anesthetic in dogs and cats. Although it may be used as a general surgical anesthetic for horses, it is usually given at a lower dose to cause sedation and hypnosis and may be supplemented with a local anesthetic. It may also be used in dogs for the symptomatic treatment of strychnine poisoning.

(ii) The drug is administered intravenously “to effect”. For general surgical anesthesia, the usual dose is 11 to 13 milligrams per pound of body weight. For sedation, the usual dose is approximately 2 milligrams per pound of body weight. For relieving convulsive seizures in dogs, when caused by strychnine, the injection should be administered intravenously “to effect”. The drug may be given intraperitoneally if desired. However, the results of such injections are less uniform. When given intraperitoneally, it is administered at the same dosage level as for intravenous administration. The dose must be reduced for animals showing under-nourishment, toxemia, shock and similar conditions.

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

(b) [Reserved]

[40 FR 13858, Mar. 27, 1975, as amended at 45 FR 83483, Dec. 19, 1980; 52 FR 25212, July 6, 1987; 62 FR 61625, Nov. 19, 1997; 66 FR 23588, May 9, 2001]

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