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Chloramphenicol Eye Ointment 4g 1%

Chloramphenicol Eye Ointment 4g 1%

Martindale Pharma (an Ethypharm Group Company)

Pharmaceutical Product
  • 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.

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