21 C.F.R. § 520.1130c Hetacillin potassium tablets.
Title 21 - Food and Drugs
(a) Specifications. Each tablet contains hetacillin potassium equivalent to 50, 100, or 200 milligrams of ampicillin. (b) Sponsor. See No. 000856 in §510.600(c) of this chapter. (c) Conditions of use—(1) Dogs—(i) Amount. 5 milligrams per pound of body weight twice daily. In severe infections, up to three times daily, or up to 10 milligrams per pound of body weight twice daily. For stubborn urinary tract infections, up to 20 milligrams per pound of body weight twice daily. (ii) Indications for use. Oral treatment against strains of organisms sensitive to hetacillin potassium and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections. (iii) Limitations. For use in dogs and cats only. Continue treatment for 48 to 72 hours after the animal has become afebrile or asymptomatic. Administer 1 to 2 hours prior to feeding to ensure maximum absorption. In stubborn infections, therapy may be required for several weeks. 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. (2) Cats—(i) Amount. 50 milligrams twice daily. (ii) Indications for use. Treatment against strains of organisms sensitive to hetacillin potassium and associated with respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections. (iii) Limitations. For use in dogs and cats only. Continue treatment for 48 to 72 hours after the animal has become afebrile or asymptomatic. Administer 1 to 2 hours prior to feeding to ensure maximum absorption. In stubborn infections, therapy may be required for several weeks. 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 37326, Aug. 18, 1992]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1130c Hetacillin potassium tablets.
