CHLOROMYCETIN Eye drops, solution Ref.[50418] Active ingredients: Chloramphenicol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2022  Publisher: Amdipharm Limited, Temple Chambers, 3 Burlington Road, Dublin 4, Ireland

4.1. Therapeutic indications

Chloramphenicol is a broad spectrum antibiotic for the treatment of bacterial conjunctivitis caused by chloramphenicol susceptible organisms including: Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus haemolyticus, Morax-axenfeld, Klebsiella/Enterobacter species and others.

Chloramphenicol is indicated in both adults and children.

4.2. Posology and method of administration

Posology

Adults and children

The recommended dosage for adults and children is two drops to be applied to the affected eye every 3 hours during waking hours or more frequently if required. Treatment should be continued for at least 48 hours after the eye appears normal.

Elderly (over 65 years)

As for adults. Chloramphenicol has been used successfully at normal dosages in elderly patients. The pattern and incidence of adverse effects does not appear to differ from younger adults.

Method of administration

Topical administration to the eye only.

Consideration should be given to national or local guidance on the appropriate use of antibacterial agents.

4.9. Overdose

Accidental ingestion of Chloromycetin Redidrops is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product. If irritation, pain, swelling, lacrimation or photophobia occurs after undesired eye contact, the exposed eye(s) should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be considered.

6.3. Shelf life

2 years.

Discard remaining contents 28 days after opening.

6.4. Special precautions for storage

Store in a refrigerator between 2°C and 8°C. Keep the bottle in the outer carton in order to protect from light.

6.5. Nature and contents of container

A flexible polyethylene bottle incorporating a polyethylene plug and cap assembly containing 10 ml of solution.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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