CFR

522.1884—Prednisolone sodium succinate injection.

(a) Chemical name. 11 beta, 17, 21-Trihydroxypregna-1, 4-diene-3, 20-dione 21-succinate sodium salt.

(b) Specifications. Each milliliter of prednisolone sodium succinate injection contains: Prednisolone sodium succinate equivalent in activity to 10, 20, or 50 milligrams of prednisolone.

(c) Sponsor. See No. 000009 in § 510.600(c) of this chapter for products containing 10, 20, and 50 milligrams equivalent prednisolone activity per milliliter for use in horses, dogs, and cats as provided in paragraphs (d)(1), (2) (i), (ii), and (iii) of this section.

(d) Conditions of use. (1) The drug is intended for the treatment of horses, dogs, and cats. 1

Code of Federal Regulations

Footnote(s): 1 These conditions are NAS/NRC reviewed and found 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.

(2) (i) The dosage for horses is 50 to 100 milligrams as an initial dose given intravenously over a period of one-half to 1 minute, or intramuscularly, and may be repeated in inflammatory, allergic, or other stress conditions at intervals of 12, 24, or 48 hours, depending upon the size of the animal, the severity of the condition and the response to treatment. 1

(ii) In dogs, the drug is administered intravenously at a range of 2.5 to 5 milligrams per pound of body weight as an initial dose followed by maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by the condition of the animal, for treatment of shock.

(iii) In dogs and cats, the drug may be given intramuscularly for treatment of inflammatory, allergic and less severe stress conditions, where immediate effect is not required, at 1 to 5 milligrams ranging upward to 30 to 50 milligrams in large breeds of dogs. Dosage may be repeated in 12 to 24 hours and continued for 3 to 5 days if necessary. If permanent corticosteroid effect is required oral therapy with prednisolone tablets may be substituted.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. 1

Code of Federal Regulations

[40 FR 13858, Mar. 27, 1975, as amended at 46 FR 13215, Feb. 20, 1981; 46 FR 33513, June 30, 1981; 52 FR 25212, July 6, 1987; 66 FR 23588, May 9, 2001]

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