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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1881


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.1881   Prednisolone acetate.

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

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

(c) Conditions of use—(1) Amount. The drug is administered to horses intra-articularly at a dosage level of 50 to 100 mg. The dose may be repeated when necessary. The drug is administered to dogs and cats intramuscularly at a dosage level of 10 to 50 mg. 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 mg. The dose may be repeated when necessary after 7 days for two or three doses.

(2) Indications for use. 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 postoperatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition.

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

[79 FR 16194, Mar. 25, 2014]

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