[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.90c]

[Page 103]
 
                        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. 520.90c  Ampicillin trihydrate capsules.

    (a) Specifications. Each capsule contains ampicillin trihydrate 
equivalent to 125, 250, or 500 milligrams of ampicillin.
    (b) Sponsor. See No. 055529 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 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. The drug may be given as an emergency measure; 
however, in vitro sensitivity tests on samples collected prior to 
treatment should be made. Ampicillin is contraindicated for use in 
infections caused by penicillinase-producing organisms and for use in 
animals known to be allergic to any of the penicillins. Not for use in 
animals raised for food production. 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. The drug may be given as an emergency measure; 
however, in vitro sensitivity tests on samples collected prior to 
treatment should be made. Ampicillin is contraindicated for use in 
infections caused by penicillinase-producing organisms and for use in 
animals known to be allergic to any of the penicillins. Not for use in 
animals 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, as amended at 58 FR 61016, Nov. 19, 1993]