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

PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS

520.2345f - Tetracycline phosphate complex and sodium novobiocin capsules.

  (a) Specifications. Each capsule contains the equivalent of 60 milligrams of tetracycline hydrochloride and 60 milligrams of novobiocin.

  (b) Sponsor. No. 000009 in 510.600(c) of this chapter.

  (c) Conditions of use. Dogs(1) Amount. 10 milligrams of each antibiotic per pound of body weight (1 capsule for each 6 pounds) every 12 hours.

  (2) Indications for use. Treatment of acute or chronic canine respiratory infections such as tonsillitis, bronchitis, and tracheobronchitis when caused by pathogens susceptible to tetracycline and/or novobiocin, such as Staphylococcus spp. and Escherichia coli.

  (3) Limitations. Continue treatment for at least 48 hours after the temperature has returned to normal and all evidence of infection has disappeared. As with all antibiotics, appropriate in vitro culturing and susceptibility tests of samples taken before treatment should be conducted. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37329, Aug. 18, 1992]