21 C.F.R. § 522.1862 Sterile pralidoxime chloride.
Title 21 - Food and Drugs
(a) Chemical name. 2-Formyl-1-methylpyridinium chloride oxime. (b) Specifications. Sterile pralidoxime chloride is packaged in vials. Each vial contains 1 gram of sterile pralidoxime chloride powder and includes directions for mixing this gram with 20 cubic centimeters of sterile water for injection prior to use. (c) Sponsor. See No. 000856 in §510.600(c) of this chapter. (d) Conditions of use. (1) It is used in horses, dogs, and cats as an antidote in the treatment of poisoning due to those pesticides and chemicals of the organophosphate class which have anticholinesterase activity in horses, dogs, and cats. (2) It is administered as soon as possible after exposure to the poison. Before administration of the sterile pralidoxime chloride, atropine is administered intravenously at a dosage rate of 0.05 milligram per pound of body weight, followed by administration of an additional 0.15 milligram of atropine per pound of body weight administered intramuscularly. Then the appropriate dosage of sterile pralidoxime chloride is administered slowly intravenously. The dosage rate for sterile pralidoxime chloride when administered to horses is 2 grams per horse. When administered to dogs and cats, it is 25 milligrams per pound of body weight. For small dogs and cats, sterile pralidoxime chloride may be administered either intraperitoneally or intramuscularly. A mild degree of atropinization should be maintained for at least 48 hours. Following severe poisoning, a second dose of sterile pralidoxime chloride may be given after 1 hour if muscle weakness has not been relieved. (3) For use only by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 49 FR 32061, Aug. 10, 1984]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1862 Sterile pralidoxime chloride.
