Galentic Pharma


Full Prescribing Info
Each gram contains: Chloramphenicol 10mg.
Pharmacology: Pharmacodynamics: Chloramphenicol is an antibiotic which is mainly bacteriostatic in action, but exerts a bactericidal effect against some strains of gram-positive cocci and against Haemophilus influenzae and Neisseria. It has a broad spectrum of action against both gram-positive and gram-negative bacteria, rickettsiae and Chlamydia.
Pharmacokinetics: Absorption: Intraocular and some systemic absorption occur following topical application to the eye.
Distribution: Aqueous humor: Measurable concentrations following topical application to the eye.
Indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by the chloramphenicol susceptible organisms.
Chloramphenicol should be used only in serious infections for which less potent drugs are ineffective or contraindicated.
Dosage/Direction for Use
Usual adult and pediatric dose: To the conjunctiva, a thin strip (approximately 1cm) of ointment every three hours or more frequently.
Mode of Administration: Ophthalmic.
Symptoms and Treatments of Overdose: In the event of over dosage, no specific antidote is available; treatment is supportive and symptomatic.
If irritation develops, use of ointment should be discontinued and appropriate therapy instituted.
Special Precautions
For ophthalmic use only. Use only as directed. Keep away from children. If irritation develops, or if redness is present, discontinue the use and consult a physician immediately. Do not swallow. If swallowed induce vomiting, call a physician. Prolonged or frequent intermittent use of Chloramphenicol topically should be avoided because of the possibility of hypersensitivity reactions, including bone-marrow hypoplasia.
The content should be discarded 4 weeks after opening.
Use In Pregnancy & Lactation
Pregnancy / Reproduction: Problems in humans have not been documented.
Breast Feeding: Problems in humans have not been documented.
Side Effects
Hypersensitivity reactions, irritation.
Drug Interactions
By inhibiting microsomal enzymes, Chloramphenicol may interfere with the metabolism or dicumarol, phenytoin, tolbutamide and chlorpropamide.
Phenytoin and acetaminophen (paracetamol) may interfere with the metabolism of Chloramphenicol, causing toxic serum concentration. However, in a recent study, no interaction was noted with acetaminophen.
Phenobarbital and rifampin are known microsomal liver enzyme inducers, causing subtherapeutic concentrations of Chloramphenicol and, therefore, requiring dosage adjustments.
In vivo and in vitro studies of chloramphenicol used in conjunction with other antimicrobials reveal the possibility of antagonism: for example with β- lactams against Klebsiella pneumoniae, aminoglycosides against Escherichia coli, ampicillin against certain strains of Salmonella, penicillin against pneumococcus. This antagonism may be associated with the treatment failures and relapses.
Diuretics, such as mannitol, ethacrynic acid, and hydrochlorothiazide, increase the renal excretion of Chloramphenicol and its metabolites. These changes are clinically insignificant.
Store below 30°C in a dry place. Keep the tube tightly closed.
Shelf-Life: 36 months from the date of manufacture.
4 weeks from the date of opening the tube.
MIMS Class
Eye Anti-Infectives & Antiseptics
ATC Classification
S01AA01 - chloramphenicol ; Belongs to the class of antibiotics. Used in the treatment of eye infections.
Eye oint 1% w/w (white smooth, free from foreign particles) x 5 g.
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