21 CFR 522.540 - Dexamethasone.

Status message

There are 4 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.540 Dexamethasone.
(a)
(1) Specifications. Each milliliter of solution contains 2 milligrams (mg) dexamethasone.
(2) Sponsors. See sponsors in § 510.600(c) of this chapter:
(i) Nos. 000061, 000859, and 061623 for use as in paragraph (a)(3) of this section.
(ii) Sponsors. See Nos. 054925 and 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section.
(3) Conditions of use—
(i) Amount. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary, as follows:
(A) Dogs. 0.25 to 1 mg.
(B) Cats. 0.125 to 0.5 mg.
(C) Horses. 2.5 to 5 mg.
(D) Cattle. 5 to 20 mg, depending on the severity of the condition.
(ii) Indications for use. The drug is indicated:
(A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses;
(B) As an anti-inflammatory agent in dogs and cats.
(iii) Do not use in horses intended for human food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)
(1) Specifications. The drug is a sterile aqueous solution. Each milliliter contains either 2.0 milligrams of dexamethasone or 4.0 milligrams of dexamethasone sodium phosphate (equivalent to 3.0 milligrams dexamethasone).
(2) Sponsor. See number in § 510.600(c) of this chapter as follows:
(i) No. 061623 for use of 2.0 milligrams dexamethasone or 4.0 milligrams dexamethasone sodium phosphate injections.
(ii) No. 000402 for use of 2.0 milligrams dexamethasone or 4.0 milligrams dexamethasone sodium phosphate injections.
(3) Conditions of use.
(i) The drug is used in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis, as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.
(ii) The drug is administered intravenously at 0.25 to 1 milligram initially. The dose may be repeated for 3 to 5 days or until a response is noted. If continued treatment is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days.
(iii) 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.
(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)
(1) Specifications. The drug is a sterile aqueous solution. Each milliliter contains 2.0 milligrams of dexamethasone or 4.0 milligrams of dexamethasone sodium phosphate (equivalent to 3.0 milligrams of dexamethasone).
(2) Sponsor. See Nos. 000402 and 061623 in § 510.600(c) of this chapter.
(3) Conditions of use.
(i) The drug is used as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.
(ii) The drug is administered intravenously at a dosage of 2.5 to 5.0 milligrams. If permanent corticosteroid effect is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days. 1
(iii) 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.
(iv) Not for use in horses intended for food.
(v) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)
(1) Specifications. The drug is a sterile aqueous solution. Each milliliter contains 2.0 milligrams of dexamethasone or 4.0 milligrams of dexamethasone sodium phosphate (equivalent to 3.0 milligrams of dexamethasone).
(2) Sponsors. See the following numbers in § 510.600(c) of this chapter:
(i) Nos. 000069 and 000859 for intravenous or intramuscular use of 2.0 milligrams dexamethasone injection.
(ii) No. 000069 for intravenous use of 2.0 milligrams dexamethasone injection.
(3) Conditions of use.
(i) The drug is used as an anti-inflammatory agent in dogs, cats, and horses.
(ii) It is administered intravenously or intramuscularly as follows: dogs—0.25 to 1 milligram; cats—0.125 to 0.5 milligram; horses—2.5 to 5 milligrams.
(iii) Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.
(iv) Not for use in horses intended for food.
(v) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)
(1) Specifications. The drug is a sterile aqueous solution. Each milliliter contains 4.0 milligrams of dexamethasone sodium phosphate (equivalent to 3 milligrams of dexamethasone).
(2) Sponsor. See No. 000859 in § 510.600(c) of this chapter.
(3) Conditions of use.
(i) The drug is given for glucocorticoid and anti-inflammatory effect in dogs and horses.
(ii) Administer intravenously as follows: Dogs—0.25 to 1 milligram initially; may be repeated for 3 to 5 days or until response is noted. Horses—2.5 to 5 milligrams. If permanent glucocorticoid effect is required, oral therapy may be substituted. When therapy is to be withdrawn after prolonged use, the daily dose should be reduced gradually over several days.
(iii) Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.
(iv) Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Except when used for emergency therapy, the product is contraindicated in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers.
(v) Not for use in horses intended for food.
(vi) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[41 FR 28265, July 9, 1976]
Editorial Note:
For Federal Register citations affecting § 522.540, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

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.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558