21 C.F.R. § 522.44 Sterile sodium acetazolamide.
Title 21 - Food and Drugs
(a) Specifications. Sterile sodium acetazolamide contains acetazolamide sodium complying with United States Pharmacopeia as a sterile powder with directions for reconstituting the product with sterile distilled water to furnish a product having a concentration of 100 milligrams acetazolamide activity per milliliter. (b) Sponsor. See No. 010042 in §510.600(c) of this chapter. (c) Conditions of use. (1) It is used as an aid in the treatment of dogs with mild congestive heart failure and for rapid reduction of intraocular pressure.1 1 These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by §514.111 of this chapter, but may require bioequivalency and safety information. (2) It is administered intramuscularly or intraperitoneally to dogs at a level of 5 to 15 milligrams per pound of body weight daily preferably administered in two or more divided doses.1 (3) For use only by or on the order of a licensed veterinarian.1
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.44 Sterile sodium acetazolamide.
