Brochlor eye ointment

1. Name Of The Medicinal Product

Brochlor 1.0% w/w Eye Ointment

2. Qualitative And Quantitative Composition

Chloramphenicol 1.0% w/w

For excipients see 6.1

3. Pharmaceutical Form

Eye ointment, that is smooth and translucent

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of acute bacterial conjunctivitis.

4.2 Posology And Method Of Administration

For ocular use.

The recommended dosage for adults, including the elderly and children aged 2 years and over is a small amount of ointment to be applied to the affected eye, either at night if eye drops are used during the day, or 3-4 times daily if the eye ointment is used alone.

Treatment should continue for 5 days, even if symptoms improve.

4.3 Contraindications

Chloramphenicol eye ointment should not be administered to patients hypersensitive to chloramphenicol or any other ingredients in the formulation, or given to those with a known personal or family history of blood dyscrasias including aplastic anaemia.

4.4 Special Warnings And Precautions For Use

Prolonged use of chloramphenicol eye ointment should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms.

Do not use for more than 5 days without consulting a doctor.

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

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

If you wear contact lenses, seek advice either from your contact lens practitioner (optician, optometrist) or doctor before you use this product. You should not wear your contact lenses during the course of treatment. If you wear soft contact lenses do not start wearing them for at least 24 hours after you have finished using the eye ointment.

The labels will state:

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

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

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

• (carton) Do not use if you are allergic to chloramphenicol or any of the ingredients.

• (carton) You should not use this ointment if you are allergic to chloramphenicol or any of the other ingredients.

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 Chloramphenicol Eye Ointment during pregnancy and lactation has not been established.

Chloramphenicol may be absorbed systemically following the use of eye ointment 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

Chloramphenicol Eye Ointment may cause transient blurring of vision. Patients should be warned not to drive or operate hazardous machinery unless vision is clear.

4.8 Undesirable Effects

Ointment may cause irritation when applied, such as burning stinging, itching, irritation and inflammation of the skin.

Bone marrow depression, including, irreversible and fatal aplastic anaemia has been reported following topical use of chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected from the use of this compound.

4.9 Overdose

Not applicable.

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

When chloramphenicol ointment is applied to the eye the drug is detectable in tears and aqueous humour. In one study, 1% w/w ointment gave chloramphenicol levels in tears and aqueous humour which exceeded the minimum bacteriostatic concentration (approximately 1 microgram/ml) for up to 2-4 hours.

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid paraffin,

Plastibase 50W.

6.2 Incompatibilities

Not known.

6.3 Shelf Life

48 months.

Although the shelf life once opened is 28 days, patients should be advised to discard the contents 5 days after opening.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Brochlor 1% w/w Eye Ointment is available in a 4g laminated tube.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

8. Marketing Authorisation Number(S)

PL 04425/0367

9. Date Of First Authorisation/Renewal Of The Authorisation

July 2004

10. Date Of Revision Of The Text

30 October 2009

LEGAL CLASSIFICATION

P