21 C.F.R. § 520.2481 Triamcinolone acetonide tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains either 0.5 milligram or 1.5 milligrams of the drug. (b) Sponsor. See Nos. 000010 and 053501 in §510.600(c) of this chapter. (c) NAS/NRC status. The conditions of use specified in this section are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information. (d) Conditions of use. (1) The drug is indicated for use in dogs and cats for its anti-inflammatory activity. (2) An initial daily dosage of 0.05 milligram per pound of body weight is usually sufficient to control symptoms, although up to 0.1 milligram per pound of body weight may be given daily if response to the smaller dose is inadequate. As soon as feasible, and in any case within 2 weeks, dosage should be reduced gradually to maintenance levels of 0.0125 to 0.025 milligram per pound of body weight per day. Therapy should be discontinued by a gradual reduction in dosage after the condition has been controlled for several days. Therapy may be initiated with a single dose of sterile triamcinolone acetonide suspension veterinary in which case the tablet dosage should be administered beginning 5 to 7 days after the injection or when symptoms reappear. (3) The labeling shall comply with the requirements of §510.410 of this chapter. (4) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13838, Mar. 27, 1975, as amended at 51 FR 26002, July 18, 1986; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2481 Triamcinolone acetonide tablets.
