§ 520.1287. Lotilaner, moxidectin, praziquantel, and pyrantel.
322 words·~1 min read·
/us/cfr/t21/s§ 520.1287·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Specifications. Each chewable tablet contains:
(1)56.25 milligrams
(mg)lotilaner, 0.056 mg moxidectin, 14.25 mg praziquantel, and 14.25 mg pyrantel (as pamoate salt);
(2)112.5 mg lotilaner, 0.113 mg moxidectin, 28.5 mg praziquantel, and 28.5 mg pyrantel (as pamoate salt);
(3)225 mg lotilaner, 0.225 mg moxidectin, 57 mg praziquantel, and 57 mg pyrantel (as pamoate salt);
(4)450 mg lotilaner, 0.45 mg moxidectin, 114 mg praziquantel, and 114 mg pyrantel (as pamoate salt); or
(5)900 mg lotilaner, 0.9 mg moxidectin, 228 mg praziquantel, and 228 mg pyrantel (as pamoate salt).
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Amount. Administer orally once a month, at the minimum dosage of 9 mg/lb (20 mg/kg) lotilaner, 0.009 mg/lb (0.02 mg/kg) moxidectin, 2.28 mg/lb (5 mg/kg) praziquantel, and 2.28 mg/lb (5 mg/kg) pyrantel (as pamoate salt).
(2)Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (fourth stage larvae, immature adult, and adult Ancylostoma caninum and adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations (Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), Rhipicephalus sanguineus (brown dog tick), and Haemaphysalis longicornis (longhorned tick)) for one month in dogs and puppies 8 weeks of age and older, and weighing 3.3 pounds or greater. For the prevention of Borrelia burgdorferi infections as a direct result of killing Ixodes scapularis vector ticks.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [90 FR 6800, Jan. 21, 2025, as amended at 90 FR 40969, Aug. 22, 2025; 91 FR 20341, Apr. 16, 2026]