21 C.F.R. § 520.88a Amoxicillin trihydrate film-coated tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains amoxicillin trihydrate equivalent to 50, 100, 150, 200, or 400 milligrams of amoxicillin. (b) Sponsor. See No. 000069 in §510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 5 milligrams per pound of body weight, twice a day. (ii) Indications for use. Treatment of infections of the respiratory tract (tonsillitis, tracheobronchitis), genitourinary tract (cystitis), gastrointestinal tract (bacterial gastroenteritis), and soft tissues (abscesses, lacerations, wounds), caused by susceptible strains of Staphylococcus aureus, Streptococcus spp., Escherichia coli, Proteus mirabilis, and bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis. (iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. 50 milligrams (5 to 10 milligrams per pound of body weight) once a day. (ii) Indications for use. Treatment of infections caused by susceptible organisms as follows: upper respiratory tract due to S. aureus, Streptococcus spp., and E. coli; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract due to E. coli; and skin and soft tissue (abscesses, lacerations, and wounds) due to S. aureus, Streptococcus spp., E. coli, and Pasteurella multocida. (iii) Limitations. Administer for 5 to 7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37319, Aug. 18, 1992, as amended at 60 FR 55658, Nov. 2, 1995]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.88a Amoxicillin trihydrate film-coated tablets.
