Chloramphenicol Eye Ointment 4g 1%

Martindale Pharma (an Ethypharm Group Company)

Pharmaceutical Product

Ophthalmic antibiotic eye ointment

UK MHRA Licensed medicinal product.
Marketing Authorisation number: PL 00156/0363 (Chloramphenicol 1.0% w/w Antibiotic Eye Ointment).
Legal classification in the UK: Pharmacy medicine (P).
ATC code: S01AA01 (Ophthalmological antiinfectives – antibiotics).

UK MHRA Licensed medicinal product.
Marketing Authorisation number: PL 00156/0363 (Chloramphenicol 1.0% w/w Antibiotic Eye Ointment).
Legal classification in the UK: Pharmacy medicine (P).
ATC code: S01AA01 (Ophthalmological antiinfectives – antibiotics).

Ophthalmic antibiotic eye ointment

Description

Chloramphenicol Eye Ointment 4g 1% is a pharmacy-only (P) ophthalmic antibiotic ointment containing 1% w/w chloramphenicol in a 4 g aluminium tube. It is licensed in the UK for the topical treatment of simple acute bacterial conjunctivitis (\red eye\) in adults, the elderly, and children aged 2 years and over.

Bnefits

Broad-spectrum topical antibiotic active against many Gram-positive and Gram-negative bacteria causing bacterial conjunctivitis.
Indicated for simple acute bacterial conjunctivitis in adults and children aged 2 years and over.
Ointment formulation provides prolonged ocular contact time, useful for night-time dosing and sustained effect.
Short, defined 5-day treatment course.
Available as a pharmacy medicine (P) for convenient access under pharmacist supervision.

Indications

Treatment of simple acute bacterial conjunctivitis in adults, the elderly, and children aged 2 years and over.
Typical features include red or pink eye, red or swollen eyelids, sticky discharge causing the eyelids to stick together (especially on waking), and a gritty or irritated sensation in the eye.
Not indicated for serious eye infections involving deeper ocular structures or for non-bacterial causes (e.g. viral, fungal, allergic conjunctivitis).

Composition

Active ingredient: Chloramphenicol 1.0% w/w (10 mg chloramphenicol per gram of ointment).
Excipients: Liquid paraffin, White soft paraffin.

Formulation

Yellowish-white ophthalmic antibiotic eye ointment.
Strength: 1.0% w/w chloramphenicol.
Pack size: 4 g tube.

Packaging

4 g aluminium tube with epoxy-phenolic-ureic resin internal coating.
Polyethylene screw cap and nozzle.
Sterile until opened.
Supplied as a single 4 g tube per pack.

Usage

For topical ocular use only.
Adults (including the elderly) and children aged 2 years and over: if using only the eye ointment, apply about a 1 cm ribbon of ointment to the affected eye(s) 3 to 4 times daily (approximately every 4–6 hours).
If using chloramphenicol eye drops during the day and the ointment at night, apply the ointment at night before going to bed.
How to apply: wash hands thoroughly; tilt the head back; gently pull down the lower eyelid to form a pocket; squeeze about 1 cm of ointment into the space between the lower eyelid and the eye; release the eyelid and blink a few times to spread the ointment.
Avoid touching the eye, eyelids, lashes, or any surface with the tip of the tube.
Remove and do not wear contact lenses during the course of treatment; soft contact lenses should not be worn until at least 24 hours after completing treatment.
Complete the full 5-day course even if symptoms improve earlier, unless advised otherwise by a healthcare professional.
Seek medical advice if symptoms worsen at any time or if there is no improvement within 48 hours.
Do not share the tube with other people.
Discard any remaining ointment after finishing the 5-day course, even though the in-use shelf life is longer.

Contraindications

Hypersensitivity to chloramphenicol or to any of the excipients (liquid paraffin, white soft paraffin).
History of myelosuppression during previous exposure to chloramphenicol.
Known personal or family history of blood dyscrasias, including aplastic anaemia or other significant bone marrow disorders.
Children under 2 years of age.
Use in pregnancy and breastfeeding is generally not recommended unless considered essential by a physician due to potential systemic absorption and transfer across the placenta and into breast milk.

Adverse Effects

Common local effects: transient burning, stinging, irritation, redness, or discomfort in the eye following application.
Temporary blurred vision immediately after application due to the ointment base.
Local hypersensitivity reactions, including eyelid or periocular swelling, itching, or rash.
Rare but serious systemic effects related to bone marrow depression, including blood dyscrasias such as aplastic anaemia, which may be fatal.
Allergic reactions including urticaria, fever, angioedema, anaphylaxis, and vesicular or maculopapular dermatitis.
Potential overgrowth of non-susceptible organisms (including fungi) with prolonged or repeated use.

Storage Conditions

Store below 25°C.
Protect from light.
Keep the tube tightly closed when not in use.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the pack.
Once opened, the in-use shelf life is up to 28 days, but patients should be advised to discard the tube after completing the 5-day treatment course.

Duration

Standard recommended course is 5 days of treatment.

Onset

Symptomatic improvement is usually seen within 24\u201348 hours; medical advice should be sought if there is no improvement after 2 days of treatment.