21 C.F.R. § 522.535 Desoxycorticosterone pivalate.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of sterile aqueous suspension contains 25 milligrams of desoxycorticosterone pivalate. (b) Sponsor. See No. 058198 in §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]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.535 Desoxycorticosterone pivalate.
