21 C.F.R. § 520.90b Ampicillin trihydrate tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains ampicillin trihydrate equivalent to 50 or 100 milligrams of ampicillin. (b) Sponsor. See No. 000069 in §510.600(c) of this chapter. (c) Conditions of use. Dogs—(1) Amount. 5 milligrams per pound of body weight, at 8-hour intervals, 1 to 2 hours prior to feeding, to be continued 36 to 48 hours after all symptoms have subsided. If no improvement is seen within 5 days, stop treatment, reevaluate diagnosis, and change therapy. (2) Indications for use. Oral treatment of infections caused by susceptible organisms as follows: Upper respiratory infections, tonsillitis, and bronchitis due to Streptococcus spp., Staphylococcus spp., Escherichia coli, Proteus mirabilis, and Pasteurella spp., urinary tract infections (cystitis) due to Streptococcus spp., Staphylococcus spp., E., coli, P. mirabilis, and Enterococcus spp.; gastrointestinal infections due to Staphylococcus spp., Streptococcus spp., Enterococcus spp., and E. coli. ; infections associated with abscesses, lacerations, and wounds caused by Staphylococcus spp., and Streptococcus spp. (3) Limitations. Not for use in animals which have shown hypersensitivity to penicillin or for infections caused by penicillinase-producing organisms. Not for use in animals which are raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37321, Aug. 18, 1992, as amended at 60 FR 55659, Nov. 2, 1995]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.90b Ampicillin trihydrate tablets.
