Aristophen Sterile Eye Drops: Each ml contains Chloramphenicol BP 5 mg.
Chloramphenicol is a low molecular weight, predominantly lipophilic antibiotic and is effective against Gram-positive and Gram-negative bacteria, and also against spirochaete, salmonella, rickettsiae and chlamydiae (trachoma). The mechanism of action has been shown to be by selective inhibition of bacterial protein synthesis. Chloramphenicol is moderately effective against Proteus, Serratia, Klebsiella, Enterobacter, E. coli, Staph. aureus, Enterococci, Streptococci, Salmonellae, Haemophilus influenzae and diplococci. Chloramphenicol is ineffective against Pseudomonas, Mycobacterium, fungi and Protozoa. Known resistance to this antibiotic has not changed significantly in recent years. Chloramphenicol penetrates the cornea thoroughly and therapeutically effective concentration are detectable in the aqueous humour only 15 to 30 minutes after local administration. The half-life is 3-5 hours. In the inflammed eye, the retention time is expected to be shorter. At present there are no data available on the extent of systemic absorption of Chloramphenicol following topical administration to the eye. Up to 50% of the sero-concentration have been detected in breast milk.
Aristophen is indicated for:
Chloramphenicol should not be administered simultaneously with bactericidal substances (penicillins, cephalosporins, gentamicin, tetracyclines, polymyxin B, since bacteriostatic antibiotics may inhibit bactericidal antibiotics. Furthermore Chloramphenicol should not be administered at the same time as systemic treatment with drugs which have an adverse effect on hematopoiesis, nor simultaneously with sulphonylureas, coumarin derivatives, hydantoins and methotrexate (precautionary measured).
Shortly after application a slight burning sensation and a bitter taste in the mouth may occur. Allergic reactions in the form of palpebral eczema have been reported in rare cases. Partially irreversible hematodyscrasia (aplastic anemia, pancytopenia, leukopenia, thrombocytopenia, agranulocytosis) has been observed in isolated cases following topical use of Chloramphenicol. However, the severity and the moment of manifestation of such partially irreversible and lethal effects did not correlate with the commonly elevated dosage used in these studies.
Neuritis nervi after topical use of Chloramphenicol has been reported in isolated cases which recovered after discontinuation of the treatment.
Animal experiments with Chloramphenicol have shown adverse effects on the foetus. However, no controlled human studies are available. Aristophen should not be given to pregnant patients or to newborn babies, nor to nursing mothers.