21 C.F.R. § 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet chewable tablet contains either: (1) Tablet No. 1: 22.7 milligrams praziquantel, 22.7 milligrams pyrantel base, and 113.4 milligrams febantel; or (2) Tablet No. 2: 68 milligrams praziquantel, 68 milligrams pyrantel base, and 340.2 milligrams febantel. (3) Tablet No. 3: 136 milligrams (mg) praziquantel, 136 mg pyrantel base, and 680.4 mg febantel. (b) Sponsor. See 000859 in §510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. Administer as a single dose directly by mouth or in a small amount of food as follows: (ii) Indications for use. For the removal of tapeworms (Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus); hookworms (Ancylostoma caninum, Uncinaria stenocephala); ascarids (Toxocara canis, Toxascaris leonina); and whipworms (Trichuris vulpis) and for the removal and control of tapeworm Echinococcus multilocularis in dogs. (iii) Limitations. Do not use in pregnant animals. Do not use in dogs weighing less than 0.9 kilogram (2 pounds) or puppies less than 3 weeks of age. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [59 FR 33908, July 1, 1994, as amended at 61 FR 29651, June 12, 1996; 68 FR 22293, Apr. 28, 2003; 71 FR 6677, Feb. 9, 2006]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1872 Praziquantel, pyrantel pamoate, and febantel tablets.
---------------------------------------------------------------------------------------------------------------- Weight of animal Number of tablets per dose---------------------------------------------------------------------------------------------------------------- Tablet no. Tablet no. Tablet no. Kilograms Pounds 1 2 3----------------------------------------------------------------------------------------------------------------0.9 to 1.8 2 to 4 1/22.3 to 3.2 5 to 7 13.6 to 5.4 8 to 12 1 1/25.9 to 8.2 13 to 18 28.6 to 11.4 19 to 25 2 1/211.8 to 13.6 26 to 30 ........... 114.1 to 20.0 31 to 44 ........... 1 1/220.4 to 27.2 45 to 60 ........... 2 127.7 to 40.9 61 to 90 ........... ........... 1 1/241.3 to 54.5 91 to 120 ........... ........... 2----------------------------------------------------------------------------------------------------------------
