§ 520.1196 - Ivermectin and pyrantel tablets.

§ 520.1196 Ivermectin and pyrantel tablets.

(a) Specifications. Each chewable tablet contains either 68 micrograms (µg) of ivermectin and 57 milligrams (mg) of pyrantel (as pamoate salt), or 136 µg and 114 mg, or 272 µg and 227 mg, respectively.

(b) Sponsors. See Nos. 000010, 051311, and 063604 053701 in § 510.600(c) of this chapter.

(c) Conditions of use —

(1) Dogs —

(i) Amount. Administer a minimum of 6 µg of ivermectin and 5 mg of pyrantel per kilogram (2.72 µg 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]

[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]