[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.542]

[Page 231-232]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.542  Dexamethasone-21-isonicotinate suspension.

    (a) Specifications. Each milliliter of sterile suspension contains 1 
milligram of dexamethasone-21-isonicotinate.

[[Page 232]]

    (b) Sponsor. No. 000010 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in the treatment of 
various inflammatory conditions associated with the musculoskeletal 
system in dogs, cats, and horses.
    (2) It is recommended for intramuscular administration as follows: 
Dogs--0.25 to 1 milligram; cats--0.125 to 0.5 milligram; horses--5 to 20 
milligrams. Dosage may be repeated.
    (3) Clinical and experimental data have demonstrated that 
corticosteriods 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 
following by dystocia, fetal death, retained placenta, and metritis.
    (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.

[42 FR 37543, July 22, 1977, as amended at 47 FR 14703, Apr. 6, 1982]