Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 520.90b - Ampicillin capsules.

(a) Specifications. Each capsule contains ampicillin trihydrate equivalent to 125, 250, or 500 milligrams of ampicillin.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of body weight two or three times daily. In severe or acute conditions, 10 milligrams per pound of body weight, three times daily. Administer 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (tracheobronchitis and tonsillitis); urinary tract infections (cystitis); bacterial gastroenteritis; generalized infections (septicemia) associated with abscesses, lacerations, and wounds; and bacterial dermatitis.

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

(2) Cats—(i) Amount. 10 to 30 milligrams per pound of body weight or three times daily. Administer 1 to 2 hours prior to feeding.

(ii) Indications for use. Treatment against strains of gram-negative and gram-positive organisms sensitive to ampicillin and associated with respiratory tract infections (bacterial pneumonia); urinary tract infections (cystitis); and generalized infections (septicemia) associated with abscesses, lacerations, and wounds.

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

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 79 FR 28818, May 20, 2014. Redesignated at 85 FR 18118, Apr. 1, 2020]
authority: 21 U.S.C. 360b.
source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 520.90b