Chloromytol 0.5% w / v Eye Drops

1. Name Of The Medicinal Product

Chloromytol 0.5% w/v Eye Drops

2. Qualitative And Quantitative Composition

Each 1ml of the drops contains 5mg of chloramphenicol

3. Pharmaceutical Form

Eye Drops

4. Clinical Particulars

4.1 Therapeutic Indications

Chloramphenicol is a broad spectrum antibiotic for the treatment of bacterial conjunctivitis caused by chloramphenicol susceptible organisms.

4.2 Posology And Method Of Administration

Topical administration to the eye only.

Adults, children and infants:

The recommended dosage for adults, children and infants of all age groups is two drops to be applied to the affected eye every 3 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.

4.3 Contraindications

Chloramphenicol eye drops should not be administered to:

• Patients hypersensitive to chloramphenicol or to any other component of the drops.

• Patients who have experienced myelosuppression during previous exposure to chloramphenicol.

• Patients with a known personal or family history of blood dyscrasias including aplastic anaemia.

4.4 Special Warnings And Precautions For Use

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure (see section 4.8).

In severe infection and where it is not confined to the conjunctivae, the patient should be referred to the doctor in case the topical use of chloramphenicol should be supplemented by appropriate systemic treatment. The prolonged use of antibiotics may occasionally result in overgrowth of non-susceptible organisms, including fungi. If any new infection appears during treatment or symptoms worsen, the patient should consult a doctor immediately.

This product must not be used for more than 5 days. It should be discarded thereafter or returned to the Pharmacy for safe disposal.

Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any time.

Chloromytol 0.5% w/v Eye Drops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia marcescens.

The packaging will convey the following information:

• If symptoms do not improve within 48 hours talk to your doctor

• Seek further immediate medical advice at any time if symptoms worsen

• Do not use if you are allergic to chloramphenicol or any of the ingredients

• Discard any remaining eye drops after the five day course of treatment

Patients should be referred to their doctor if any of the following apply:

• Disturbed vision

• Severe pain within the eye

• Photophobia

• Eye inflammation associated with a rash on the scalp or face

• The eye looks cloudy

• The pupil looks unusual

• Suspected foreign body in the eye

Patients should also be referred to their doctor if any of the following in his/her medical history apply:

• Previous conjunctivitis in the recent past

• Glaucoma

• Dry eye syndrome

• Eye surgery or laser treatment in the last 6 months

• Eye injury

• Current use of other eye drops or eye ointment

• Contact lens use

Contact lens wearers should only use Chloromytol 0.5% w/v eye drops on the advice of a doctor or contact lens practitioner. Contact lenses should not be worn during treatment. Soft contact lenses should not be worn until 24 hours after the course of treatment has finished.

This medicine contains phenylmercuric nitrate which is irritating to the skin.

Topical application to eyes has been associated with mercurialentis and atypical band keratopathy.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be avoided.

4.6 Pregnancy And Lactation

The safety of topical chloramphenicol during pregnancy and lactation has not been established.

Chloramphenicol may be absorbed systemically following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not recommended for use during pregnancy and lactation.

4.7 Effects On Ability To Drive And Use Machines

Blurring of vision can occur with the drops and patients should be warned not to drive or operate machinery unless the vision is clear.

4.8 Undesirable Effects

Transient burning or stinging sensations may occur with the use of Chloromytol 0.5% w/v/ Eye Drops. More serious side-effects include bone marrow depression and rarely aplastic anaemia, angioneurotic oedema, anaphylaxis, urticaria, fever, vesicular and maculopapular dermatitis have been reported and are causes for discontinuation.

4.9 Overdose

Accidental ingestion of Chloromytol 0.5% w/v Eye Drops is unlikely to cause systemic toxicity due to the low content of the antibiotic in the product. If irritation, pain, swelling, lacrimation or photophobia occur 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.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of Gram-negative and Gram-positive organisms, including Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus viridans, Moraxella species and Enterobacteriaceae, the main pathogens responsible for acute bacterial conjunctivitis. Chloramphenicol exerts its antibacterial effect by reversibly binding to bacterial ribosomes thereby inhibiting bacterial protein synthesis.

5.2 Pharmacokinetic Properties

Chloramphenicol is a well established antibiotic and the successful use of the eye drops is well documented. Chloramphenicol is found in measurable amounts in the aqueous humour following local application to the eye.

5.3 Preclinical Safety Data

Pre-clinical safety data does not add anything of further significance to the prescriber.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Borax

Boric acid

Phenylmercuric nitrated and

Water for Injection

6.2 Incompatibilities

None known.

6.3 Shelf Life

Twenty four months

6.4 Special Precautions For Storage

Store between 2 and 8°C.

Keep container in the outer carton.

Discard remaining contents 28 days after opening.

6.5 Nature And Contents Of Container

Flexible polypropylene bottles incorporating a polyethylene plug and cap assembly.

6.6 Special Precautions For Disposal And Other Handling

None

Administrative Data

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Ltd

NLA Tower

Croydon CR0 0XT

United Kingdom

8. Marketing Authorisation Number(S)

PL 12762/0037

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 13 February 2001

Date of last renewal: 1 April 2009

10. Date Of Revision Of The Text

03/11/2010