CFR

522.1410—Sterile methylprednisolone acetate suspension.

(a) Specifications. Each milliliter of aqueous suspension contains 20 or 40 milligrams of methylprednisolone acetate. 1

Code of Federal Regulations

Footnote(s): 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, but may require bioequivalency and safety information.

(b) Sponsors. See Nos. 000009 and 000010 in § 510.600(c) 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 premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

(2) Systemic therapy with methylprednisolone acetate, as with other corticoids, is contraindicated in animals with arrested tuberculosis, peptic ulcer, and Cushing's syndrome. The presence of active tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency, predisposition to thrombophlebitis, hypertension, or congestive heart failure necessitates carefully controlled use of corticosteroids. Intrasynovial, intratendinous, or other injections of corticosteroids for local effect are contraindicated in the presence of acute infectious conditions. Exacerbation of pain, further loss of joint motion, with fever and malaise following injection may indicate that the condition has become septic. Appropriate antibacterial therapy should be instituted immediately.

(d) Conditions of use— (1) Amount— Dosage may be repeated when necessary, as follows: dogs—2 to 40 milligrams (up to 120 milligrams in extremely large breeds or dogs with severe involvement); cats—10 to 20 milligrams; horses—200 milligrams. 1

(ii) Intrasynovial. Dosage may be repeated when necessary, as follows: horses—40 to 240 milligrams; dogs—up to 20 milligrams. 1

(2) Indications for use. Treatment of inflammation and related disorders in dogs, cats, and horses; 1 treatment of allergic and dermatologic disorders in dogs and cats; and as supportive therapy to antibacterial treatment of severe infections in dogs and cats.

(3) Limitations. Not for use in horses intended for food. Not for human use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[43 FR 59058, Dec. 19, 1978, as amended at 51 FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, June 30, 1997]

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