[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.390d]

[Page 296]
 
                        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 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]