21 C.F.R. § 520.314 Cefadroxil tablets.
Title 21 - Food and Drugs
(a) Specifications. 50-, 100-, and 200-milligram tablets for dogs and cats; 1 gram tablet for dogs. (b) Sponsor. See No. 000856 in §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 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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.314 Cefadroxil tablets.
