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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Mar 22, 2024.

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

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR522.2483]



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. 522.2483 Triamcinolone.

(a) Specifications. Each milliliter of suspension contains 2 or 6 milligrams (mg) triamcinolone acetonide.

(b) Sponsors. See Nos. 000010 and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use - (1) Dogs and cats - (i) Amount - (A) Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as a single injection. For dermatologic disorders, administer 0.1 mg per pound (/lb) of body weight as a single injection. If symptoms recur, the dose may be repeated, or oral corticosteroid therapy may be instituted.

(B) Intralesional. Administer 1.2 to 1.8 mg, divided in several injections around the lesion, spaced 0.5 to 2.5 centimeters apart, depending on lesion size. At any one site, the dose injected should not exceed 0.6 mg. and should be well into the cutis to prevent rupture of the epidermis. When treating animals with multiple lesions, do not exceed a total dose of 6 mg.

(C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a single injection, depending on the size of the joint and severity of symptoms. After 3 or 4 days, repeat dosage if indicated. If initial results are inadequate or too transient, dosage may be increased, not to exceed 3 mg.

(ii) Indications for use. For the treatment of inflammation and related disorders, and the management and treatment of acute arthritis and allergic and dermatologic disorders.

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

(2) Horses - (i) Amount - (A) Intramuscular or subcutaneous. Administer 0.01 to 0.02 mg/lb of body weight as a single injection. Usual dose is 12 to 20 mg.

(B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a single injection, depending on the size of the joint and severity of symptoms. After 3 or 4 days, repeat dosage if indicated. If initial results are inadequate or too transient, dosage may be increased, not to exceed 18 mg.

(ii) Indications for use. For the treatment of inflammation and related disorders.

(iii) 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.

[75 FR 10167, Mar. 5, 2010, as amended at 78 FR 21060, Apr. 9, 2013; 80 FR 34279, June 16, 2015; 83 FR 48946, Sept. 28, 2018]

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