21 CFR 522.2470 - Tiletamine hydrochloride and zolazepam hydrochloride for injection.

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There are 3 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 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.
[47 FR 15328, Apr. 9, 1982, as amended at 51 FR 24142, July 2, 1986; 67 FR 67521, Nov. 6, 2002]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558