[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: 21CFR520.88h]

[Page 99]
 
                        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. 520.88h  Amoxicillin trihydrate and clavulanate potassium for oral suspension.

    (a) Specifications. When reconstituted, each milliliter contains 
amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin with 
clavulanate potassium equivalent to 12.5 milligrams of 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) producing Staphylococcus aureus, nonbeta-lactamase 
Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and 
Escherichia coli. Treatment of periodontal infections due to susceptible 
strains of aerobic and anaerobic bacteria.
    (iii) Limitations. Administer for 5 to 7 days or 48 hours after all 
symptoms subsided. Deep pyoderma may require 21 days, not to exceed 30 
days. If no improvement is seen in 5 days, discontinue therapy and 
reevaluate the case. 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 
of amoxicillin and 12.5 milligrams clavulanic acid) twice daily.
    (ii) Indications for use. Treatment of feline 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 S. aureus, Staphylococcus spp., Streptococcus 
spp., E. coli, Pasteurella multocida, and Pasteurella spp.
    (iii) Limitations. Administer 48 hours after all symptoms have 
subsided. If no improvement is seen after 3 days of treatment, 
discontinue therapy and reevaluate diagnosis. Maximum duration of 
treatment should not exceed 30 days. Not for use in cats maintained for 
breeding. 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]

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