Product Monograph - Odan-Chloramphenicol
ADVERSE REACTIONS
Blood dyscrasias may be associated with the systemic use of chloramphenicol. One case of bone-marrow hypoplasia following the prolonged (23 month) topical use of chloramphenicol ophthalmic solution has been reported.
OVERDOSAGE
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DOSAGE AND ADMINISTRATION
Solution:
Two drops applied to the affected eye(s) every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night for the first 48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye(s) appears normal.
Ointment:
Apply a small amount (1 cm strip) to the lower conjunctiva sac(s) at bedtime as a supplement to the drops.
AVAILABILITY
Each mL of sterile ophthalmic solution contains: Chloramphenicol USP 0.5 % (5 mg/mL); and the following non-medicinal ingredients: boric acid, sodium borate, sodium chloride, sodium hydroxide (to adjust pH) and purified water. Available in 15 mL plastic dropper bottles.
Each gram of sterile ophthalmic ointment contains: Chloramphenicol USP 1% (10 mg/g); and the following non-medicinal ingredients: mineral oil, white petrolatum and polysorbate 60. Available in 3.5 grams tubes.
STORAGE CONDITIONS
Solution: Store between 2°C and 8°C until dispensed. After dispensing, keep the solution at room temperature (between 15°C and 30°C) for 21 days during treatment; after that period, discard unused portion. Protect from light.
Ointment: Store between 15°C and 30°C. Keep container tightly closed.
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PHARMACEUTICAL INFORMATION
Structural Formula:
Chemical Name: 2,2-dichloro-N-[2-hydroxy-1-(hydroxymethyl)-2-(4- nitrophenyl)ethyl]-, [R-(R*,R*)]-acetamide
Molecular Formula: C11H12Cl2N2O5
Molecular Weight: 323.13
Description: Fine, white to grayish-white or yellowish-white, needle-like crystals or elongated plates. Freely soluble in alcohol, in propylene glycol, in acetone, and in ethyl acetate; slightly soluble in water.