§ 520.88g Amoxicillin trihydrate and clavulanate potassium tablets.  


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  • (a) Specifications. Each tablet or chewable tablet contains amoxicillin trihydrate and clavulanate potassium equivalent to 50 milligrams (mg) of amoxicillin and 12.5 mg clavulanic acid, 100 mg of amoxicillin and 25 mg clavulanic acid, 200 mg amoxicillin and 50 mg clavulanic acid, or 300 mg amoxicillin and 75 mg clavulanic acid.

    (b) Sponsors. See sponsors in §510.600(c) of this chapter:

    (1) No. 054771 for use of tablets and chewable tablets as in paragraph (c) of this section.

    (2) No. 026637 for use of tablets as in paragraph (c) of this section.

    (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 for 5 to 7 days or for 48 hours after all signs have subsided. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days.

    (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, non-beta-lactamase S. aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of aerobic and anaerobic bacteria.

    (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    (2) Cats—(i) Amount. 62.5 milligrams (50 milligrams amoxicillin and 12.5 milligrams clavulanic acid) twice daily for 5 to 7 days or for 48 hours after all signs have subsided. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days.

    (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, non-beta-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. 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; 79 FR 28817, May 20, 2014; 80 FR 34278, June 16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR 43484, Sept. 18, 2017; 82 FR 58556, Dec. 13, 2017]

[57 FR 37320, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995; 63 FR 13121, Mar. 18, 1998; 79 FR 28817, May 20, 2014; 80 FR 34278, June 16, 2015; 82 FR 11508, Feb. 24, 2017; 82 FR 43484, Sept. 18, 2017; 82 FR 58556, Dec. 13, 2017