21 C.F.R. § 520.1196

Current through September 30, 2024
Section 520.1196 - Ivermectin and pyrantel tablets
(a)Specifications. Each chewable tablet contains either 68 micrograms ([MICRO]g) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 [MICRO]g and 114 mg, or 272 [MICRO]g and 227 mg, respectively.
(b)Sponsors. See Nos. 000010, 051311, and 053701 in § 510.600(c) of this chapter.
(c)Conditions of use -
(1)Dogs -
(i)Amount. Administer a minimum of 6 [MICRO]g of ivermectin and 5 mg of pyrantel per kilogram (2.72 [MICRO]g and 2.27 mg per pound) of body weight monthly.
(ii)Indications for use. To prevent canine heartworm disease by eliminating the tissue larval stages of Dirofilaria immitis for up to a month (30 days) after infection and treatment and control of adult roundworms Toxocara canis and Toxascaris leonina, and adult hookworms Ancylostoma caninum, A. braziliense, and Uncinaria stenocephala.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) [Reserved]

21 C.F.R. §520.1196

58 FR 8542, Feb. 16, 1993, as amended at 61 FR 15186, Apr. 5, 1996; 61 FR 59004, Nov. 20, 1996; 62 FR 63270, Nov. 28, 1997; 66 FR 35756, July 9, 2001; 67 FR 21996, May 2, 2002; 68 FR 55823, Sept. 29, 2003; 78 FR 28822, May 20, 2014; 84 FR 39183, Aug. 9, 2019; 88 FR 16547, Mar. 20, 2023; 89 FR 42357, May 15, 2024
84 FR 39183, 8/9/2019; 88 FR 16547, 3/20/2023; 89 FR 42357, 5/15/2024