Active: chloramphenicol 0.5% (5 mg/mL). Preservative: chlorobutanol (chloral derivative) 0.5%. Inactives: polyethylene glycol 300; polyoxyl 40 stearate; sodium hydroxide or hydrochloric acid to adjust the pH and purified water.
Actions: CHLOROPTIC® (chloramphenicol) has a wide spectrum of antimicrobial activity and is effective against many gram-negative and gram-positive organisms such as Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus hemolyticus, and Moraxella lacunata (Morax-Axenfeld bacillus).
Indications: For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms.
Contraindications : Contraindicated in patients who are hypersensitive to chloramphenicol.
Warnings: As with other antibiotics, prolonged use may result in overgrowth of non-susceptible organisms. If superinfection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute appropriate therapy. Sensitivity reactions such as stinging, itching, angioneurotic edema, urticaria, vesicular and maculopapular dermatitis may also occur in some patients. Occasionally one sees hematopoietic toxicity with the use of systemic chloramphenicol, and rarely with topical administration. This type of blood dyscrasia is generally a dose related toxic effect on bone marrow and is usually reversible on cessation of the drug. Rare cases of aplastic anemia have been reported with prolonged (months to years) or frequent intermittent (over months and years) use of topical chloramphenicol.
Adverse Reactions: The most serious reaction reported following prolonged or frequent intermittent use of topical chloramphenicol is bone marrow aplasia.
Dosage and Administration: One or two drops 4 to 6 times a day for the first 72 hours, depending upon the severity of the condition. Intervals between applications may be increased after the first two days. Since the action of the drug is primarily bacteriostatic, therapy should be continued for 48 hours after an apparent cure has been attained.
How Supplied: CHLOROPTIC® (chloramphenicol) sterile ophthalmic solution is supplied in plastic dropper bottles in the following sizes:
2.5 mL--NDC 11980-109-03
7.5 mL--NDC 11980-109-08
*U.S. Patent 3,702,364