CFR

522.2470—Tiletamine hydrochloride and zolazepam hydrochloride for injection.

(a) Specifications. Tiletamine hydrochloride and zolazepam hydrochloride for injection when reconstituted with sterile distilled water provides tiletamine hydrochloride and zolazepam hydrochloride equivalent to 50 milligrams of tiletamine base and 50 milligrams of zolazepam base per milliliter of solution.

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

(c) Conditions of use— (1) Indications for use. It is used for restraint or for anesthesia combined with muscle relaxation in cats and in dogs for restraint and minor procedures of short duration (30 minutes) requiring mild to moderate analgesia.

(2) Amount. Expressed as milligrams of the drug combination:

(i) In healthy dogs: An initial intramuscular dosage of 3 to 4.5 milligrams per pound of body weight for diagnostic purposes; 4.5 to 6 milligrams per pound 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 milligrams per pound of body weight. The maximum total safe dose is 13.6 milligrams per pound of body weight.

(ii) In healthy cats: An initial intramuscular dosage of 4.4 to 5.4 milligrams per pound 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 milligrams per pound 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 milligrams per pound 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 milligrams per pound of body weight.

(3) Limitations. Discard unused reconstituted solution after 48 hours. Not for use in dogs and cats with pancreatic disease, or with severe cardiac or pulmonary dysfunction. Not for use in pregnant animals. Not for use in cats suffering with renal insufficiency. The dosage should be reduced in geriatric dogs and cats. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[47 FR 15328, Apr. 9, 1982, as amended at 51 FR 24142, July 2, 1986; 67 FR 67521, Nov. 6, 2002]

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