[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.90a]

[Page 100]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 520_ORAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec. 520.90a  Ampicillin capsules.

    (a) Specifications. Each capsule contains 125 milligrams or 250 
milligrams of ampicillin.
    (b) Sponsor. See No. 000008 in Sec. 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]