[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.390d]

[Page 294-295]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  524.390d  Chloramphenicol-prednisolone ophthalmic ointment.

    (a) Specifications. Each gram contains 10 milligrams of 
chloramphenicol and 2.5 milligrams of prednisolone acetate.
    (b) Sponsor. See No. 017030 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. Dogs and cats. (1) Amount. Apply 4 to 6 times 
daily to the affected eye for the first 72 hours depending upon the 
severity of the condition. Continue treatment for 48 hours after the eye 
appears normal.
    (2) Indications for use. Treatment of bacterial conjunctivitis and 
ocular inflammation caused by organisms susceptible to chloramphenicol.
    (3) Limitations. Therapy for cats should not exceed 7 days, 
prolonged use in cats may produce blood dyscrasia. As with other 
antibiotics, prolonged

[[Page 295]]

use may result in overgrowth of nonsusceptible organisms. If 
superinfection occurs or if clinical improvement is not noted within a 
reasonable period, discontinue use and institute appropriate therapy. 
All topical ophthalmic preparations containing corticosteroids, with or 
without an antimicrobial agent, are contraindicated in the initial 
treatment of corneal ulcers. They should not be used until the infection 
is under control and corneal regeneration is well underway. 
Chloramphenicol products must not be used in meat-, egg-, or milk-
producing animals. The length of time that residues persist in milk or 
tissues has not been determined. Federal law restricts this drug to use 
by or on the order of a licensed veterinarian.

[57 FR 37334, Aug. 18, 1992]