21 C.F.R. § 520.90a   Ampicillin capsules.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.90a   Ampicillin capsules.

(a) Specifications. Each capsule contains 125 milligrams or 250 milligrams of ampicillin.

(b) Sponsor. See No. 000008 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs—(i) Amount. 5 to 10 milligrams per pound of body weight, e.g., one 125 mg capsule per 14 to 25 pounds, given 2 to 4 times daily; for animals weighing 6 to 14 pounds, one capsule twice daily.

(ii) Indications for use. Treatment of urinary tract infections (cystitis) due to Proteus spp., hemolytic and nonhemolytic streptococci, beta hemolytic streptococci, and Escherichia coli. In upper respiratory tract infections tracheobronchitis (kennel cough), tonsillitis due to alpha and beta hemolytic streptococci, hemolytic positive staphylococci, E. coli, and Proteus spp. In infections associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.

(iii) Limitations. Bacteriologic studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Use of the drug is contraindicated in animals with a history of an allergic reaction to any of the penicillins. Ampicillin is contraindicated in infections caused by penicillinase-producing organisms. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats—(i) Amount. 125 milligrams twice daily; in more acute conditions three times daily.

(ii) Indications for use. Treatment of respiratory tract infections (bacterial pneumonia) due to alpha and beta hemolytic streptococci, hemolytic positive staphylococci, E. coli, and Proteus spp. In infections associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.

(iii) Limitations. Bacteriologic studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Use of the drug is contraindicated in animals with a history of an allergic reaction to any of the penicillins. Ampicillin is contraindicated in infections caused by penicillinase-producing organisms. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37321, Aug. 18, 1992]

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