[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: 21CFR520.314]

[Page 111-112]
 
                        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. 520.314  Cefadroxil tablets.

    (a) Specifications. 50-, 100-, and 200-milligram tablets for dogs 
and cats; 1 gram tablet for dogs.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) For use in dogs as follows:
    (i) Indications for use. For the treatment of skin and soft tissue 
infections including cellulitis, pyoderma, dermatitis, wound infections, 
and abscesses due to susceptible strains of Staphylococcus aureus. For 
the treatment of

[[Page 112]]

genitourinary tract infections (cystitis) due to susceptible strains of 
Escherichia coli, Proteus mirabilis, and Staphylococcus aureus.
    (ii) Amount. Ten milligrams per pound of body weight twice daily.
    (iii) Limitations. The drug is administered orally. For skin and 
soft tissue infections, treatment should be continued for a minimum of 3 
days. For genitourinary tract infections, treatment should be continued 
for a minimum of 7 days. Continue treatment at least 48 hours after the 
dog has become afebrile or asymptomatic. If no response is seen after 3 
days of treatment, therapy should be discontinued and the case 
reevaluated. Do not treat for more than 30 days. Safety for use in 
pregnant bitches and stud dogs has not been determined. Federal law 
restricts this drug to use by or on the order of a licensed 
veterinarian.
    (2) For use in cats as follows:
    (i) Indications for use. For the treatment of skin and soft tissue 
infections including abscesses, wound infections, cellulitis, and 
dermatitis caused by susceptible strains of Pasteurella multocida, 
Staphylococcus aureus, Staphylococcus epidermidis, and Streptococcus 
spp.
    (ii) Amount. Ten milligrams per pound of body weight once daily.
    (iii) Limitations. The drug is administered orally. Continue 
treatment at least 48 hours after the cat has become afebrile or 
asymptomatic. If no response is seen after 3 days of treatment, therapy 
should be discontinued and the case reevaluated. Do not treat for more 
than 21 days. Safety for use in pregnant cats and breeding male cats has 
not been determined. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[47 FR 41105, Sept. 17, 1982, as amended at 49 FR 43052, Oct. 26, 1984; 
51 FR 4165, Feb. 3, 1986; 52 FR 11989, Apr. 14, 1987; 53 FR 27851, July 
25, 1988]