CFR

520.1408—Methylprednisolone tablets.

(a) Specifications. Each table contains 1, 2, or 4 milligrams of methylprednisolone.

(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter for use of 1- and 4-milligram tablets; see No. 000010 for use of 1- and 2-milligram tablets.

(c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and found effective. NADA's for approval of drugs for these conditions of use need not include effectiveness data specified by § 514.111 of this chapter, but may require bioequivalency and safety information.

(d) Special consideration. (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 premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(2) Systemic therapy with methylprednisolone is contraindicated in animals with arrested tuberculosis, peptic ulcer, acute psychoses, or cushingoid syndrome. The presence of active tuberculosis, diabetes, osteoporosis, chronic psychotic reactions, predisposition to thrombophlebitis, hypertension, congestive heart failure, or renal insufficiency necessitates carefully controlled use of corticosteroids. Some of these conditions occur only rarely in dogs and cats but should be kept in mind.

(3) Anti-inflammatory action of corticosteroids may mask signs of infection.

(e) Conditions of use— (1) Amount. Dogs and cats: 5 to 15 pounds, 2 milligrams; 15 to 40 pounds, 2 to 4 milligrams; 40 to 80 pounds, 4 to 8 milligrams.

(2) Indications for use. For use in dogs and cats as an anti-inflammatory agent.

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

Code of Federal Regulations

[47 FR 52697, Nov. 23, 1982, as amended at 49 FR 20810, May 17, 1984; 50 FR 32844, Aug. 15, 1985; 53 FR 40727, Oct. 18, 1988; 62 FR 35076, June 30, 1997]

Tips