522.480—Repository corticotropin injection.
(a)
(1) Specifications.
The drug conforms to repository corticotropin injection U.S.P. It contains 40 or 80 U.S.C. (I.U.) units per cubic centimeter.
(3) Special considerations.
The drug should be refrigerated. With prolonged use supplement daily diet with potassium chloride at one gram for small animals and from 5 to 10 grams for large animals.
(4) Conditions of use.
(i)
It is used as an intramuscular or subcutaneous injection in cattle and small animals for stimulation of the adrenal cortex where there is a general deficiency of corticotropin (ACTH). It is also a therapeutic agent for primary bovine ketosis.
(ii)
It is administered to cattle initially at 200 to 600 units followed by a dose daily or every other day of 200 to 300 units and to small animals at one unit per pound of body weight to be repeated as indicated.
(b)
(1) Specifications.
The drug conforms to respository corticotropin injection U.S.P. It contains 40 or 80 U.S.P. units per milliliter.
(3) Conditions of use.
(i)
For intramuscular injection in dogs as a diagnostic aid to test for adrenal dysfunction. For intramuscular or subcutaneous injection in dogs and cats for stimulation of the adrenal cortex where there is a general deficiency of ACTH.
(ii)
For diagnostic use: Administer at one unit per pound of body weight intramuscularly. For therapeutic use: Administer at one unit per pound of body weight intramuscularly or subcutaneously, initially, to be repeated as indicated.
(c) National Academy of Sciences/National Reserach Council (NAS/NRC) status.
The therapeutic indication for use has been reviewed by NAS/NRC and found to be effective. Applications for this use need not include effectiveness data as specified in § 514.111 of this chapter, but may require bioequivalency and safety information.