CFR

522.1881—Sterile prednisolone acetate aqueous suspension.

(a) Specifications. Each milliliter of sterile aqueous suspension contains 25 milligrams of prednisolone acetate.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) NAS/NRC status. The conditions of use are NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified in § 514.111 of this chapter but may require bioequivalency and safety information.

(d) Conditions of use. (1) The drug is indicated in the treatment of dogs, cats, and horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and post-operatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition.

(2) The drug is administered to horses intra-articularly at a dosage level of 50 to 100 milligrams. The dose may be repeated when necessary. If no response is noted after 3 or 4 days, the possibility must be considered that the condition is unresponsive to prednisolone therapy. The drug is administered to dogs and cats intramuscularly at a dosage level of 10 to 50 milligrams. The dosage may be repeated when necessary. If the condition is of a chronic nature, an oral corticosteroid may be given as a maintenance dosage. The drug may be given intra-articularly to dogs and cats at a dosage level of 5 to 25 milligrams. The dose may be repeated when necessary after 7 days for two or three doses.

(3) The labeling shall comply with the requirements of § 510.410 of this chapter for corticosteroids.

(4) Not for use in horses intended for food.

(5) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[52 FR 23032, June 17, 1987]

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