CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.2582]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.2582 Triflupromazine.

(a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of triflupromazine hydrochloride.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Amount - (i) Dogs. Administer by intravenous injection at a dosage of 0.5 to 1 mg per pound of body weight daily, or by intramuscular injection at a dosage of 1 to 2 mg per pound of body weight daily.

(ii) Cats. Administer by intramuscular injection at a dosage of 2 to 4 mg per pound of body weight daily.

(iii) Horses. Administer by intravenous or intramuscular injection at a dosage of 10 to 15 mg per 100 pounds of body weight daily to a maximum dose of 100 mg.

(2) Indications for use. For use in dogs, cats, and horses to relieve anxiety and to help control psychomotor overactivity as well as to increase the tolerance of animals to pain and pruritus. The drug is indicated in various office and clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014]