§ 520.88h - Amoxicillin trihydrate and clavulanate potassium for oral suspension.

§ 520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspension.

(a) Specifications. When constituted, each milliliter (mL) of suspension contains amoxicillin trihydrate equivalent to 50 milligrams (mg) amoxicillin and clavulanate potassium equivalent to 12.5 mg clavulanic acid.

(b) Sponsors. See Nos. 017033, 054771, and 069043 in § 510.600(c) of this chapter.

(c) Conditions of use -

(1) Dogs -

(i) Amount. 6.25 mg/lb (1 mL/10 lb of body weight) twice a day. Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; 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, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: betaBeta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., and Escherichia coli. Treatment of periodontal infections due to susceptible strains of both 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 mg (1 mL) twice daily. Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5 to 7 days or 48 hours after all symptoms have subsided, not to exceed 30 days. If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated. 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 the following organisms: betaBeta-lactamase-producing Staphylococcus aureus, non-beta-lactamase-producing Staphylococcus aureus, Staphylococcus spp., Streptococcus spp., Escherichia coli, Pasteurella multocida, and Pasteurella spp. 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.

[87 FR 1096817944, FebMar. 2829, 2022]