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21 C.F.R. § 520.88b   Amoxicillin trihydrate for oral suspension.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.88b   Amoxicillin trihydrate for oral suspension.

(a) Specifications. When reconstituted, each milliliter contains amoxicillin trihydrate equivalent to 50 milligrams of amoxicillin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(1) Conditions of use—(i) Dogs—(A) Amount. 5 milligrams per pound of body weight twice daily.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: respiratory tract (tonsillitis, tracheobronchitis) caused by Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary tract (cystitis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal tract (bacterial gastroenteritis) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis caused by S. aureus, Streptococcus spp., and P. mirabilis; and soft tissues (abscesses, lacerations, and wounds) caused by S. aureus, Streptococcus spp., E. coli, and P. mirabilis.

(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(ii) Cats—(A) Amount. 50 milligrams (5 to 10 milligrams per pound) once daily.

(B) Indications for use. Treatment of infections caused by susceptible strains of organisms as follows: upper respiratory tract due to Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary tract (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal tract due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.

(C) Limitations. Use for 5 to 7 days or 48 hours after all symptoms have subsided. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

(c) Sponsors. See Nos. 000856 and 051311 in §510.600(c) of this chapter.

(1) Conditions of use. Dogs—(i) Amount. 5 milligrams per pound of body weight twice daily.

(ii) Indications for use. Treatment of bacterial dermatitis due to S. aureus, Streptococcus spp., Staphylococcus spp., and E. coli, and soft tissue infections (abscesses, wounds, lacerations) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis and Staphylococcus spp.

(iii) Limitations. Use for 5 to 7 days. Continue for 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) [Reserved]

[57 FR 37319, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 60 FR 55658, Nov. 2, 1995; 62 FR 13302, Mar. 20, 1997; 67 FR 67521, Nov. 6, 2002; 68 FR 54658, Sept. 18, 2003; 68 FR 55824, Sept. 29, 2003]

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