subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.1445"
section_subject: "Milbemycin oxime and praziquantel."
cfr_reference: "21 CFR 520.1445"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
11.5 mg milbemycin oxime and 114 mg praziquantel; or
(4)23 mg milbemycin oxime and 228 mg praziquantel.
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Dogs—(i) Amount. Administer orally, once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of body weight (5 mg/kg) praziquantel.
(ii)Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm (Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult tapeworm (Taenia pisiformis, Echinococcus multilocularis, E. granulosus, and Dipylidium caninum) infections in dogs and puppies 2 pounds of body weight or greater and 6 weeks of age and older.
(iii)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.