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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1871]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1871 Praziquantel and pyrantel.

(a) Specifications. (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.

(b) Sponsors. 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.

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

(d) Conditions of use - (1) Cats - (i) Dosage. 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.

(ii) Indications for use. For removal of tapeworms (Dipylidium caninum and Taenia taeniaeformis ), hookworms (Ancylostoma tubaeforme ), and large roundworms (Toxocara cati ) in cats and kittens.

(iii) Limitations. 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.

(2) Dogs - (i) Amount. 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.

(ii) Indications for use. For the treatment and control of roundworms (Toxocara canis and Toxascaris leonina ), hookworms (Ancylostoma caninum , Ancylostoma braziliense , and Uncinaria stenocephala ), and tapeworms (Dipylidium caninum and Taenia pisiformis ) 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]

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