[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: 21CFR520.90d]

[Page 103-104]
 
                        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. 520.90d  Ampicillin trihydrate for oral suspension.

    (a) Specifications. When reconstituted as directed, each milliliter 
contains ampicillin trihydrate equivalent to 25 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 orally, 2 or 3 times daily, 1 to 2 hours prior to 
feeding. In severe or acute conditions, 10 milligrams per pound of body 
weight 3 times daily.
    (ii) Indications for use. Treatment of respiratory tract infections 
(tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas 
spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary 
tract infections (cystitis) due to E. coli, Staphylococcus spp., 
Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to 
E. coli; generalized infections (septicemia) associated with abscesses, 
lacerations, and wounds, due to Staphylococcus spp. and Streptococcus 
spp.; bacterial dermatitis due to Staphylococcus

[[Page 104]]

spp., Streptococcus spp., Proteus spp., and Pseudomonas spp.
    (iii) Limitations. Duration of treatment is usually 3 to 5 days. 
Continue treatment 48 hours after the animal's temperature has returned 
to normal and all other signs of infection have subsided. If no response 
is obtained within 3 to 5 days, reevaluate diagnosis and treatment. 
Appropriate laboratory tests should be conducted, including in vitro 
culturing and susceptibility tests on samples collected prior to 
treatment. 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 
orally, 2 or 3 times daily, 1 to 2 hours prior to feeding.
    (ii) Indications for use. Treatment of respiratory tract infections 
(bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E. 
coli, and Proteus spp.; urinary tract infections (cystitis) due to E. 
coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and 
Corynebacterium spp.; generalized infections (septicemia) associated 
with abscesses, lacerations, and wounds, due to Staphylococcus spp., 
Streptococcus spp., Bacillus spp., and Pasteurella spp.
    (iii) Limitations. Duration of treatment is usually 3 to 5 days. 
Continue treatment 48 hours after the animal's temperature has returned 
to normal and all other signs of infection have subsided. If no response 
is obtained within 3 to 5 days, reevaluate diagnosis and treatment. 
Appropriate laboratory tests should be conducted, including in vitro 
culturing and susceptibility tests on samples collected prior to 
treatment. 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]