§ 520.1871 Praziquantel and pyrantel.

Specifications.(a) (1) Each tablet contains 13.6 milligrams (mg) praziquantel and 54.3 mg pyrantel base (as pyrantel pamoate), 18.2 mg praziquantel and 72.6 mg pyrantel base (as pyrantel pamoate), or 27.2 mg praziquantel and 108.6 mg pyrantel base (as pyrantel pamoate).

(2) Each chewable tablet contains 30 mg praziquantel and 30 mg pyrantel pamoate or 114 mg praziquantel and 114 mg pyrantel pamoate.

Sponsors.(b) See sponsors in § 510.600(c) for use as in paragraph (d) of this chapter.

(1) See No. 058198 for use of tablets described in paragraph (a)(1) of this section for use as in paragraph (d)(1) of this section.

(2) See No. 051311 for use of tablets described in paragraph (a)(2) of this section for use as in paragraph (d)(2) of this section.

Special considerations.(c) See § 500.25 of this chapter.

Conditions of useCatsDosage.(d) —(1) —(i) Administer a minimum dose of 2.27 mg praziquantel and 9.2 mg pyrantel pamoate per pound of body weight according to the dosing tables on labeling. May be given directly by mouth or in a small amount of food. Do not withhold food prior to or after treatment. If reinfection occurs, treatment may be repeated.

Indications for use.Dipylidium caninumTaenia taeniaeformisAncylostoma tubaeformeToxocara cati(ii) For removal of tapeworms ( and ), hookworms (), and large roundworms () in cats and kittens.

Limitations.(iii) Not for use in kittens less than 2 months of age or weighing less than 2.0 pounds. Consult your veterinarian before giving to sick or pregnant animals.

DogsAmount.(2) —(i) Administer a minimum dose of 5 mg praziquantel and 5 mg pyrantel pamoate per kilogram body weight (2.27 mg praziquantel and 2.27 mg pyrantel pamoate per pound body weight) according to the dosing tables on labeling.

Indications for use.Toxocara canisToxascaris leoninaAncylostoma caninumAncylostoma brazilienseUncinaria stenocephalaDipylidium caninumTaenia pisiformis(ii) For the treatment and control of roundworms ( and ), hookworms (, , and ), and tapeworms ( and ) in dogs and puppies.

[58 FR 58652, Nov. 3, 1993, as amended at 72 FR 16270, Apr. 4, 2007; 75 FR 54018, Sept. 3, 2010; 86 FR 14819, Mar. 19, 2021]