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: "520.2611"
section_subject: "Trimethoprim and sulfadiazine paste."
cfr_reference: "21 CFR 520.2611"
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 gram (g) of paste contains 67 milligrams (mg) trimethoprim and 333 mg sulfadiazine.
(b)Sponsors. See sponsors in § 510.600(c) of this chapter:
(1)No. 054771 for product administered as in paragraph (c)(1)(i) of this section.
(2)No. 000061 for product administered as in paragraph (c)(1)(ii) of this section.
(c)Conditions of use in horses—(1) Amount. Administer orally as a single daily dose for 5 to 7 days:
(i)5 g of paste (335 mg trimethoprim and 1,665 mg sulfadiazine) per 150 pounds (68 kilograms) of body weight per day.
3.75 g of paste (250 mg trimethoprim and 1,250 mg sulfadiazine) per 110 pounds (50 kilograms) of body weight per day.
(2)Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory infections, acute urogenital infections, and wound infections and abscesses.
(3)Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.