522.1004—Fomepizole.

(a) Specifications. Each vial contains 1.5 grams fomepizole (1.5 milliliter (mL) of 1.0 gram per mL solution).

(b) Sponsors. See Nos. 068727 and 068882 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs— (1) Amount. 20 milligrams per kilogram (mg/kg) of body weight intravenously initially, followed by 15 mg/kg at 12 and 24 hours, and 5 mg/kg at 36 hours.

(2) Indications for use. As an antidote for ethylene glycol (antifreeze) poisoning in dogs who have ingested or are suspected of having ingested ethylene glycol.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[61 FR 68147, Dec. 27, 1996, as amended at 71 FR 28266, May 16, 2006; 74 FR 26952, June 5, 2009; 74 FR 47725, Sept. 17, 2009]

CFR

522.1004—Fomepizole.

Code of Federal Regulations