21 C.F.R. § 520.88g Amoxicillin trihydrate and clavulanate potassium film-coated tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains amoxicillin trihydrate and clavulanate potassium, equivalent to either 50 milligrams of amoxicillin and 12.5 milligrams clavulanic acid, or 100 milligrams of amoxicillin and 25 milligrams clavulanic acid, or 200 milligrams amoxicillin and 50 milligrams clavulanic acid or 300 milligrams amoxicillin and 75 milligrams clavulanic acid. (b) Sponsor. See No. 000069 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. (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, nonbeta-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. Wounds, abscesses, cellulitis, and superficial/juvenile pyoderma: Treat for 5 to 7 days or for 48 hours after all signs have subsided. If no improvement is seen after 5 days of treatment, discontinue therapy and reevaluate diagnosis. Deep pyoderma may require treatment for 21 days; do not treat for more than 30 days. Not for use in dogs maintained for breeding. 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. (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, nonbeta-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. Skin and soft tissue infections: abscesses, cellulitis/dermatitis should be treated for 5 to 7 days or for 48 hours after all signs have subsided. If no response is seen after 3 days of treatment, therapy should be discontinued and diagnosis reevaluated. Urinary tract infections may require treatment for 10 to 14 days or longer. The maximum duration of treatment should not exceed 30 days. Safety of use in pregnant or breeding animals has not been established. 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]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.88g Amoxicillin trihydrate and clavulanate potassium film-coated tablets.
