§ 522.88 Amoxicillin.

Specifications.(a) (1) Each vial contains 3 grams (g) of amoxicillin trihydrate. Each milliliter of constituted suspension contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in paragraph (d)(1) of this section.

(2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section.

Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter.

Related tolerance.(c) See § 556.38 of this chapter.

Conditions of useDogs and catsAmount.(d) —(1) —(i) Administer 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.

Indications for useDogs.Staphylococcus aureus, StreptococcusEscherichia coli,Proteus mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis;S. aureus, StreptococcusP. mirabilis;S. aureus, StreptococcusE. coli,P. mirabilis.(ii) —(A) For treatment of infections caused by susceptible strains of organisms as follows: Respiratory infections (tonsillitis, tracheobronchitis) due to spp., and genitourinary infections (cystitis) due to spp., and gastrointestinal infections (bacterial gastroenteritis) due to spp., and bacterial dermatitis due to spp., and soft tissue infections (abscesses, lacerations, and wounds), due to spp., and

Cats.S. aureus, StaphylococcusStreptococcusHaemophilusE. coli, PasteurellaP. mirabilis;S. aureus, StreptococcusE. coli, P. mirabilis,CorynebacteriumE. coli, ProteusStaphylococcusStreptococcusS. aureus, StaphylococcusStreptococcusE. coli,Pasteurella multocida.(B) For treatment of infections caused by susceptible strains of organisms as follows: Upper respiratory infections due to spp., spp., spp., spp., and genitourinary infections (cystitis) due to spp., and spp.; gastrointestinal infections due to spp., spp., and spp.; skin and soft tissue infections (abscesses, lacerations, and wounds) due to spp., spp., and

Limitations.(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

CattleAmount.(2) —(i) Administer 3 to 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.

Indications for use.P. multocida,P. hemolytica, HaemophilusStaphylococcusStreptococcusFusobacterium necrophorum.(ii) For treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to spp., spp., and spp. and acute necrotic pododermatitis (foot rot) due to

Limitations.(iii) Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16183, Mar. 25, 2014]