21 C.F.R. § 522.1010 Furosemide.
Title 21 - Food and Drugs
(a) Specifications—(1) Each milliliter (mL) of solution contains 50 milligrams (mg) furosemide monoethanolamine. (2) Each mL of solution contains 50 mg furosemide diethanolamine. (b) Sponsors. See sponsors in §510.600(c) of this chapter for use of products described in paragraph (a) of this section for use as in paragraph (d) of this section. (1) No. 000010 as described in paragraph (a)(1) of this section for use as in paragraphs (d)(1) and (d)(2)(ii) of this section. (2) No. 061623 as described in paragraph (a)(2) of this section for use as in paragraph (d)(2)(ii) of this section. (3) No. 059130 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section. (4) No. 057926 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use—(1) Dogs and cats—(i) Amount. 1.25 to 2.5 mg per pound (/lb) body weight once or twice daily, intramuscularly or intravenously. (ii) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema. (2) Horses—(i) Amount. 250 to 500 mg per animal once or twice daily, intramuscularly or intravenously. (A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema. (B) Limitations. Do not use in horses intended for food. (ii) Amount. 0.5 mg/lb body weight once or twice daily, intramuscularly or intravenously. (A) Indications for use. For treatment of acute noninflammatory tissue edema. (B) Limitations. Do not use in horses intended for food. (3) Cattle—(i) Amount. 500 mg/animal once daily, intramuscularly or intravenously; or 250 mg/animal twice daily at 12-hour intervals, intramuscularly or intravenously. (ii) Indications for use. For the treatment of physiological parturient edema of the mammary gland and associated structures. (iii) Amount. 250 to 500 mg/animal once or twice daily, intramuscularly or intravenously. (A) Indications for use. For the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency, and acute noninflammatory tissue edema. (B) Limitations. Do not use in horses intended for human consumption. [66 FR 47961, Sept. 17, 2001, as amended at 67 FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, July 13, 2006]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1010 Furosemide.
