yourstate.us
21 CFR 522.2470

§ 522.2470 Tiletamine and zolazepam.

United States · 21 CFR — Food and Drugs · Status: effective

Get this as JSONEmbed this
Cite this
Citation
21 CFR 522.2470, § 522.2470 Tiletamine and zolazepam, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87549
Permanent ID
ys:prov:87549@1
SHA-256
11eea7ca5c41f0c4ed248092ed1569d8af3d58b0b425365a4cf23c0dda439168

The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.

Full text

(a) Specifications. The drug is a sterile powder. Each milliliter of constituted solution contains tiletamine hydrochloride equivalent to 50 milligrams (mg) of tiletamine base and zolazepam hydrochloride equivalent to 50 mg of zolazepam base. (b) Sponsors. See Nos. 017033, 051311, and 054771 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Expressed as milligrams of the drug combination: (A) An initial intramuscular dosage of 3 to 4.5 milligrams per pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of body weight. (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body weight to effect for induction of anesthesia followed by maintenance with an inhalant anesthetic. (ii) Indications for use. (A) Intramuscular administration in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia. (B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 mg/lb of body weight is recommended for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg/lb of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg/lb of body weight. (ii) Indications for use. For restraint or for anesthesia combined with muscle relaxation. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.