Icol^®

Chloramphenicol is a potent,broad spectrum antibiotic which is-effective against a wide range of gram-positive and gram-negative bacteria and also effective against Spirochaete,Salmonella,Rickettsiae and Chlamydiae (trachoma). Chloramphenicol is primarily a bacteriostatic,readily penetrates into bacterial cells and acts by inhibition on proiein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes. It has been noted that Chloramphenicol is found in measurable amounts in the aqueous humor following local application to the eye.

As a broad spectrum antibiotic ICOL^® can be used in a variety of infections caused by susceptible organisms, such as conjunctivitis, blepharitis, corneal ulcer, dacryocystitis etc. ICOL^® is active against the common bacterial eye pathogens listed below:

Staphylococcus aureus, Streptococci including Streptococcus pneumoniae, E.coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, Moraxella lacunata.

Chloramphenicol can destroy or inhibit the susceptible organisms present in the ear canal.

Directions for Use
The following steps should be considered to ensure the
right use of ICOL^®

a. Proper administration technique for applying the solution to the eye and ear.
b. Compliance with full course of therapy.
c. Missed dose: Applying as soon as possible; not applying if almost time for the next dose.
d. Close bottle immediately after use.
e. Proper storage of the medicament.
Do not use longer than one month after opening. It is advisable to destroy any remaining medicament after completing treatment.

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Eye
Two drops applied to the affected eye every three hours, or more frequently if deemed advisable by the prescribing physician. Administration should be continued day and night for the first48 hours, after which the interval between applications may be increased. Treatment should be continued for at least 48 hours after the eye appears normal.

Ear
2-3 drops into the ear canal twice or thrice daily.
Paediatric Use
No specific data are available and thus no specific dosage recommendation can be given.

Pregnancy: Animal experiments with Chloramphemicol have shown adverse effects on the foetus. ICOL^® should not be given to pregnant women or new-born.

NursingMother: Due to adverse etfect ICOL^® should not be given to nursing mother.

The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If new infections appear during medication, the drug should be discontinued and appropriate measures should be taken.

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 anaemia, pancytopenia, Leukopenia, thrombocytopenia, agranulocytosis) has been Observed in isolatsd cases following topical use of Chloramphenicol.

Hypersensitivity to the ingredients, acute intermittent porphyria, severe blood disorders and hepatic disfunctions due to the bone marrow depression, new-born, family history of bone marrow dep ession.

Systemic drug interactions have not been documented with the ophthalmic use of Chloramphenicol. But it is essential to observe for the known systemic drug interactions (tolbutamide, phenytoin,paracetamol and preservatives etc.).

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Store ICOL^® below 30 0 C in a tight container; protect from light.