§ 524.390d - Chloramphenicol-prednisolone ophthalmic ointment.

Link to an amendment published at 77 FR 4897, Feb. 1, 2012.

(a) Specifications. Each gram contains 10 milligrams of chloramphenicol and 2.5 milligrams of prednisolone acetate.

(b) Sponsor . See No. 017030 in §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]