21 C.F.R. § 520.540c Dexamethasone chewable tablets.
Title 21 - Food and Drugs
(a) Specifications. Each half-scored tablet contains 0.25 milligram of dexamethasone.1 (b) Sponsor. See No. 000069 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. 0.25 to 1.25 milligrams per day.1 (2) Indications for use. Supportive therapy in nonspecific dermatosis and inflammatory conditions in dogs.1 (3) Limitations. (i) Administer by free-choice feeding or crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved. (ii) Clinical and experimental data have demonstrated that corticosteriods administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. (iii) Do not use in viral infections. Anti-inflammatory action of corticosteriods may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy.1 (iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [44 FR 7130, Feb. 6, 1979, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.540c Dexamethasone chewable tablets.
