Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 520.370 - Cefpodoxime tablets.

(a) Specifications. (1) Each tablet contains cefpodoxime proxetil equivalent to 100 or 200 milligrams (mg) cefpodoxime.

(2) Each chewable tablet contains cefpodoxime proxetil equivalent to 100 or 200 mg cefpodoxime.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as follows:

(1) No. 017033 for use of product in paragraph (a)(1) of this section as in paragraph (c) of this section.

(2) No. 054771 for use of products in paragraph (a) of this section as in paragraph (c) of this section.

(c) Conditions of use in dogs—(1) Amount. 5 to 10 mg per kilogram (2.3 to 4.5 mg per pound) body weight daily for 5 to 7 days, or for 2 to 3 days beyond the cessation of clinical signs, up to a maximum of 28 days.

(2) Indications for use. For the treatment of skin infections (wounds and abscesses) caused by susceptible strains of Staphylococcus pseudintermedius, S. aureus, Streptococcus canis (group G, beta-hemolytic), Escherichia coli, Pasteurella multocida, and Proteus mirabilis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 52815, Aug. 30, 2004, as amended at 78 FR 5714, Jan. 28, 2013; 79 FR 28819, May 20, 2014; 80 FR 13229, Mar. 13, 2015; 82 FR 12169, Mar. 1, 2017; 88 FR 16547, Mar. 20, 2023]
authority: 21 U.S.C. 360b.
source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 520.370