Title 21
SECTION 520.88h
520.88h Amoxicillin trihydrate and clavulanate potassium for oral suspension.
§ 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. 054771 in § 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 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) 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. 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 amoxicillin and 12.5 milligrams clavulanic acid) twice daily. Administer 48 hours after all signs have subsided. Maximum duration of treatment should not exceed 30 days.
(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. 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]