[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR520.88g]

[Page 95-96]
 
                        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. 520.88g  Amoxicillin trihydrate and clavulanate potassium film-coated tablets.

    (a) Specifications. Each tablet contains amoxicillin trihydrate and 
clavulanate potassium, equivalent to either 50 milligrams of amoxicillin 
and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin 
and 25 milligrams clavulanic acid, or 200 milligrams amoxicillin and 50 
milligrams clavulanic acid or 300 milligrams amoxicillin and 75 
milligrams clavulanic acid.
    (b) Sponsor. See No. 000069 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 6.25 milligrams 
(equivalent to 5 milligrams amoxicillin and 1.25 milligrams clavulanic 
acid) per pound of body weight twice daily.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections such as wounds, abscesses, cellulitis, superficial/juvenile 
and deep pyoderma due to susceptible strains of beta-lactamase 
(penicillinase) Staphylococcus aureus, nonbeta-lactamase S. aureus, 
Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment 
of periodontal infections due to susceptible strains of aerobic and 
anaerobic bacteria.

[[Page 96]]

    (iii) Limitations. Wounds, abscesses, cellulitis, and superficial/
juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs 
have subsided. If no improvement is seen after 5 days of treatment, 
discontinue therapy and reevaluate diagnosis. Deep pyoderma may require 
treatment for 21 days; do not treat for more than 30 days. Not for use 
in dogs maintained for breeding. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.
    (2) Cats--(i) Amount. 62.5 milligrams (1 milliliter) (50 milligrams 
amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
    (ii) Indications for use. Treatment of skin and soft tissue 
infections, such as wounds, abscesses and cellulitis/dermatitis due to 
susceptible strains of beta-lactamase (penicillinase) producing S. 
aureus, nonbeta-lactamase producing S. aureus, Staphylococcus spp., 
Streptococcus spp., E. coli, and Pasteurella spp. Also, treatment of 
urinary tract infections (cystitis) due to susceptible strains of E. 
coli.
    (iii) Limitations. Skin and soft tissue infections: abscesses, 
cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours 
after all signs have subsided. If no response is seen after 3 days of 
treatment, therapy should be discontinued and diagnosis reevaluated. 
Urinary tract infections may require treatment for 10 to 14 days or 
longer. The maximum duration of treatment should not exceed 30 days. 
Safety of use in pregnant or breeding animals has not been established. 
Federal law restricts this drug to use by or on the order of a licensed 
veterinarian.

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 
FR 13121, Mar. 18, 1998]