[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.535]

[Page 228]
 
                        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. 522.535  Desoxycorticosterone pivalate.

    (a) Specifications. Each milliliter of sterile aqueous suspension 
contains 25 milligrams of desoxycorticosterone pivalate.
    (b) Sponsor. See No. 058198 in Sec. 510.600(c) of this chapter.
    (c) [Reserved]
    (d) Conditions of use--(1) Dogs--(i) Amount. Dosage requirements are 
variable and must be individualized on the basis of the response of the 
patient to therapy. Initial dose of 1 milligram per pound (0.45 
kilogram) of body weight every 25 days, intramuscularly. Usual dose is 
0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
    (ii) Indications for use. For use as replacement therapy for the 
mineralocorticoid deficit in dogs with primary adrenocortical 
insufficiency.
    (iii) Limitations. For intramuscular use only. Do not use in 
pregnant dogs, dogs suffering from congestive heart disease, severe 
renal disease, or edema. Federal law restricts this drug to use by or on 
the order of a licensed veterinarian.
    (2) [Reserved]

[63 FR 13122, Mar. 18, 1998]