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: "520.1900"
section_subject: "Primidone."
cfr_reference: "21 CFR 520.1900"
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"
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(a)Specifications. Each tablet contains 50 or 250 milligrams of primidone.
(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(2)No. 054771 for use of 50 and 250 milligram tablets.
(c)Conditions of use in dogs—(1) Amount. Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily.
(2)Indications for use. For the control of convulsions associated with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities in dogs.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.