21 CFR 522.1884 - Prednisolone sodium succinate injection.

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There are 2 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 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

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
[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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-02; vol. 79 # 127 - Wednesday, July 2, 2014
    1. 79 FR 37617 - New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 2, 2014.
      21 CFR Parts 510, 520, 522, 529, 556, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-07-02; vol. 79 # 127 - Wednesday, July 2, 2014
    1. 79 FR 37617 - New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 2, 2014.
      21 CFR Parts 510, 520, 522, 529, 556, and 558