21 C.F.R. § 520.1880 Prednisolone tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains 5 or 20 milligrams prednisolone. (b) Sponsor. See No. 061690 in §510.600(c)(2) of this chapter. (c) Special considerations. (1) Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate parturition followed by dystocia, fetal death, retained placenta, and metritis. (2) Do not use in viral infections. Systemic therapy with prednisolone is contraindicated in animals with peptic ulcer, corneal ulcer, and Cushingoid syndrome. The presence of diabetes, osteoporosis, predisposition to thrombophlebitis, hypertension, congestive heart failure, renal insufficiency, and active tuberculosis necessitates carefully controlled use. Some of the above conditions occur only rarely in dogs but should be kept in mind. (3) Anti-inflammatory action of corticosteroids may mask signs of infection. (d) Conditions of use—(1) Amount. Dogs: 2.5 milligrams per 4.5 kilograms (10 pounds) body weight per day. Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced until maintenance level is achieved. (2) Indications for use. For use in dogs as an anti-inflammatory agent. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 4718, Feb. 7, 1992, as amended at 60 FR 57832, Nov. 22, 1995; 63 FR 148, Jan. 5, 1998]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1880 Prednisolone tablets.
