21 C.F.R. § 520.540b Dexamethasone tablets and boluses.
Title 21 - Food and Drugs
(a)(1) Specifications. Each bolus is half-scored and contains 10 milligrams of dexamethasone. (2) Sponsor. See No. 000061 in §510.600(c) of this chapter. (3) Conditions of use. (i) Dexamethasone bolus is indicated in cases where cattle and horses require additional steroid therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lamenesses, and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition. (ii) Administered orally, 5 to 10 milligrams for the first day, then 5 milligrams per day as required. (iii) Do not use in viral infections during the viremic stage. With bacterial infections, appropriate antibacterial therapy should be used. (iv) Do not use in animals with chronic nephritis and hypercorticalism (cushingoid syndrome), except for emergency therapy. (v) Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. (vi) Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (b)(1) Specifications. Each tablet contains 0.25 milligram of dexamethasone.1 (2) Sponsors. See Nos. 000061 and 061623 in §510.600(c) of this chapter. (3) Conditions of use—(i) Amount. Dogs: Administer orally at 0.25 to 1.25 milligrams per day for up to 7 days. Cats: 0.125 to 0.5 milligram per day for up to 7 days.1 (ii) Indications for use. In treatment of dogs and cats as an anti-inflammatory agent.1 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter. (iii) Limitations. (a) Clinical and experimental data have demonstrated that corticosteriods administered orally or by injection 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. (b) Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy.1 (c) Federal law restricts this drug to use by or on the order of a licensed veterinarian.1 [40 FR 26273, June 23, 1975, as amended at 44 FR 7130, Feb. 6, 1979; 50 FR 49372, Dec. 2, 1985; 52 FR 7832, Mar. 13, 1987; 55 FR 8461, Mar. 8, 1990; 66 FR 14073, Mar. 9, 2001; 68 FR 4914, Jan. 31, 2003; 70 FR 16934, Apr. 4, 2005]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.540b Dexamethasone tablets and boluses.
