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 522 - IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

522.820 - Erythromycin injection.

  (a) Sponsor. See 061623 in 510.600(c) of this chapter.

  (b) NAS/NRC status. The conditions of use have been reviewed by NAS/NRC and found effective.

  (c) Dogs and cats(1) Specifications. Each milliliter of polyethylene glycol vehicle contains 100 milligrams of erythromycin base with 2 percent butyl aminobenzoate.

  (2) Conditions of use(i) Amount. 3 to 5 milligrams per pound of body weight, intramuscularly, two to three times daily, for up to 5 days.

  (ii) Indications for use(A) Dogs. For the treatment of bacterial pneumonia, upper respiratory infections (tonsillitis, bronchitis, tracheitis, pharyngitis, pleurisy), endometritis and metritis, and bacterial wound infections caused by Staphylococcus spp., Streptococcus spp., and Corynebacterium spp., sensitive to erythromycin.

  (B) Cats. For the treatment of bacterial pneumonia, upper respiratory infections (rhinitis, bronchitis), secondary infections associated with panleukopenia, and bacterial wound infections caused by Staphylococcus spp. and Streptococcus spp., susceptible to erythromycin.

  (iii) Limitations. Administer by deep intramuscular injection into the heavy muscles of the neck and limbs. Do not administer intravenously or intraperitoneally. Avoid subscutaneous use. Do not administer from moist or wet syringe. As with all antibiotics, appropriate in vitro culturing and susceptibility testing of samples taken before treatment should be conducted. Do not administer in conjunction with penicillin. As with all antibiotics, excessive continuous use may result in an overgrowth of nonsusceptible organisms. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  (d) Cattle(1) Specifications. Each milliliter of nonaqueous, buffered, alcohol base sterile solution contains 200 milligrams of erythromycin base.

  (2) Related tolerances. See 556.230 of this chapter.

  (3) Conditions of use(i) Amount. 4 milligrams of erythromycin base per pound of body weight once daily for up to 5 days.

  (ii) Indications for use. For the treatment of bovine respiratory disease (shipping fever complex and bacterial pneumonia) associated with Pasteurella multocida susceptible to erythromycin.

  (iii) Limitations. For intramuscular use only. Do not use in female dairy cattle over 20 months of age. Do not slaughter treated animals within 6 days of last treatment. To avoid excess trim, do not slaughter within 21 days of last injection.

[58 FR 43795, Aug. 18, 1993, as amended at 66 FR 14073, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]