Find Laws Find Lawyers Free Legal Forms USA State Laws
CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.90d—Ampicillin trihydrate for oral suspension.

CFR

520.90d—Ampicillin trihydrate for oral suspension.

(a) Specifications. When reconstituted as directed, each milliliter contains ampicillin trihydrate equivalent to 25 milligrams of ampicillin.
(b) Sponsor. See No. 055529 in § 510.600(c) of this chapter.
(c) Conditions of use— (1) Dogs— 5 to 10 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding. In severe or acute conditions, 10 milligrams per pound of body weight 3 times daily.
(ii) Indications for use. Treatment of respiratory tract infections (tracheobronchitis and tonsillitis) due to Escherichia coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and Streptococcus spp., urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., Streptococcus spp., and Proteus spp.; bacterial gastroenteritis due to E. coli; generalized infections (septicemia) associated with abscesses, lacerations, and wounds, due to Staphylococcus spp. and Streptococcus spp.; bacterial dermatitis due to Staphylococcus spp., Streptococcus spp., Proteus spp., and Pseudomonas spp.
(iii) Limitations. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal's temperature has returned to normal and all other signs of infection have subsided. If no response is obtained within 3 to 5 days, reevaluate diagnosis and treatment. Appropriate laboratory tests should be conducted, including in vitro culturing and susceptibility tests on samples collected prior to treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cats— (i) Amount. 10 to 30 milligrams per pound of body weight orally, 2 or 3 times daily, 1 to 2 hours prior to feeding.
(ii) Indications for use. Treatment of respiratory tract infections (bacterial pneumonia) due to Staphylococcus spp., Streptococcus spp., E. coli, and Proteus spp.; urinary tract infections (cystitis) due to E. coli, Staphylococcus spp., Streptococcus spp., Proteus spp., and Corynebacterium spp.; generalized infections (septicemia) associated with abscesses, lacerations, and wounds, due to Staphylococcus spp., Streptococcus spp., Bacillus spp., and Pasteurella spp.
(iii) Limitations. Duration of treatment is usually 3 to 5 days. Continue treatment 48 hours after the animal's temperature has returned to normal and all other signs of infection have subsided. If no response is obtained within 3 to 5 days, reevaluate diagnosis and treatment. Appropriate laboratory tests should be conducted, including in vitro culturing and susceptibility tests on samples collected prior to treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[57 FR 37321, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993]
Tips