CFR

520.1409—Methylprednisolone, aspirin tablets.

(a) Specifications. Each tablet contains 0.5 milligram of methylprednisolone and 300 milligrams of aspirin.

(b) Sponsor. See No. 000009 in § 510.600(c) of this chapter.

(c) NAS/NRC status. The conditions of use have been NAS/NRC reviewed and found effective. New animal drug applications 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 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 premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(2) Systemic therapy with methylprednisolone is contraindicated in animals with tuberculosis, chronic nephritis, peptic ulcer, or Cushingoid syndrome. The presence of diabetes mellitus, osteoporosis, predisposition to thrombophlebitis, hypertension, congestive heart failure, or renal insufficiency necessitates carefully controlled use of corticosteroids.

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

(e) Conditions of use— (1) Amount. Dogs under 15 pounds, 1/4 to 1 tablet daily; 15 to 60 pounds, 1 to 2 tablets daily; 60 pounds and over, 2 tablets daily.

(2) Indications for use. As an anti-inflammatory and analgesic agent in dogs.

(3) Limitations. Administer total daily dose in divided doses 6 to 10 hours apart, with a light feeding. When response is attained, dosage should be gradually reduced until maintenance level is achieved. Do not administer to cats. Do not overdose. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[48 FR 21566, May 13, 1983]

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