21 C.F.R. § 522.90b Ampicillin trihydrate for sterile suspension.
Title 21 - Food and Drugs
(a) Specifications. When reconstituted, each milliliter contains ampicillin trihydrate equivalent to 50, 100, or 250 milligrams of ampicillin. (b) Sponsor. (1) See 000856 in §510.600(c) of this chapter for use of 50, 100, and 250 milligrams per milliliter ampicillin suspension. (2) See 010515 in §510.600(c) of this chapter for use of 100 and 250 milligrams per milliliter ampicillin suspension. (c) Related tolerances. See §556.40 of this chapter. (d) Conditions of use—(1) Dogs—(i) Amount. 3 milligrams per pound of body weight twice daily. (ii) Indications for use. Treatment against strains of organisms susceptible to ampicillin and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections. (iii) Limitations. Administer by subcutaneous or intramuscular injection. Treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats—(i) Amount. 3 milligrams per pound of body weight twice daily. (ii) Indications for use. Treatment against strains of organisms susceptible to ampicillin and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections. (iii) Limitations. Administer by subcutaneous or intramuscular injection. Treatment should be continued for 48 to 72 hours after the animal has become afebrile or asymptomatic. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Cattle—(i) Amount. 2 to 5 milligrams per pound of body weight once daily by intramuscular injection. (ii) Indications for use. Treatment of respiratory tract infections caused by organisms susceptible to ampicillin, bacterial pneumonia (shipping fever, calf pneumonia, and bovine pneumonia) caused by Aerobacter spp., Klebsiella spp., Staphylococcus spp., Streptococcus spp., Pasteurella multocida, and Escherichia coli. (iii) Limitations. Do not treat cattle for more than 7 days. Milk from treated cows must not be used for food during treatment and for 48 hours (4 milkings) after the last treatment. Cattle must not be slaughtered for food during treatment and for 144 hours (6 days) after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, Aug. 4, 1998]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.90b Ampicillin trihydrate for sterile suspension.
