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Lumigan (Bimatoprost) 0.01% Eye Drops (3ml)

Lumigan (Bimatoprost) 0.01% Eye Drops (3ml)

Lumigan

Prescription medicine
  • Authorised as a prescription Only medicine in the UK with a valid marketing authorisation (PL/PLGB) and approved Summary of Product Characteristics and Patient Information Leaflet.
  • Regulated by national authorities (e.g. MHRA in the UK, EMA in the EU, FDA in the US) with ongoing pharmacovigilance and safety monitoring.
  • Manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products.
  • Product quality, safety and efficacy supported by clinical trial data and long Term post Marketing experience in glaucoma and ocular hypertension.
Antiglaucoma prostaglandin analogue ophthalmic solution

Description

Lumigan (Bimatoprost) 0.01% Eye Drops is a prescription-only antiglaucoma medicine containing the prostaglandin analogue bimatoprost at a concentration of 0.01% (0.1 mg/ml). It is formulated as a sterile ophthalmic solution for topical use in the eye to reduce elevated intraocular pressure (IOP) in adults with open-angle glaucoma or ocular hypertension. Bimatoprost acts mainly by increasing the outflow of aqueous humour through the trabecular meshwork and uveoscleral pathways, thereby lowering IOP and helping to prevent optic nerve damage and vision loss. The product is supplied in a 3 ml multidose bottle and is intended for once-daily dosing, usually in the evening.

Bnefits

  • Clinically proven reduction of elevated intraocular pressure in open-angle glaucoma and ocular hypertension.
  • Helps prevent or slow optic nerve damage and associated visual field loss due to high eye pressure.
  • Once-daily dosing regimen (typically one drop in the affected eye(s) in the evening) supports adherence.
  • Acts by increasing aqueous humour outflow through multiple pathways, providing effective pressure control.
  • 0.01% formulation designed to provide efficacy with an optimised safety and tolerability profile compared with higher-strength formulations.
  • Can be used as monotherapy or in combination with other IOP-lowering agents (e.g. beta-blocker eye drops) when additional pressure reduction is needed.
  • Marketed by AbbVie/Allergan, with extensive post-marketing experience and regulatory oversight worldwide.

Indications

  • Reduction of elevated intraocular pressure in adults with open-angle glaucoma.
  • Reduction of elevated intraocular pressure in adults with ocular hypertension (raised IOP without established glaucomatous damage).
  • Use as monotherapy in patients who are unsuitable for or inadequately controlled on other antiglaucoma medications.
  • Use as adjunctive therapy to other topical IOP-lowering agents when combination treatment is clinically indicated.

Composition

  • Active ingredient: Bimatoprost 0.1 mg/ml (0.01% w/v).
  • Preservative: Benzalkonium chloride (concentration as stated on the official pack leaflet).
  • Other excipients (as per SmPC/leaflet): sodium chloride, sodium phosphate dibasic heptahydrate, citric acid monohydrate, purified water.
  • Small amounts of hydrochloric acid or sodium hydroxide may be added to adjust pH.

Formulation

  • Sterile, clear ophthalmic solution for topical ocular use.
  • Concentration: 0.01% (0.1 mg/ml) bimatoprost.
  • Supplied as a preserved multidose formulation containing benzalkonium chloride.
  • Buffered and isotonic solution with pH and osmolality adjusted for ocular tolerance.

Packaging

  • Each retail pack contains 1 x 3 ml multidose plastic dropper bottle of Lumigan 0.01% eye drops.
  • Bottle fitted with a tamper-evident cap and dropper tip designed for controlled instillation of single drops.
  • Outer carton includes product name, strength, batch number, expiry date and storage instructions.
  • Pack includes a patient information leaflet with full directions for use, safety information and dosing instructions.

Usage

  • For ocular use only; do not swallow or inject.
  • Usual adult dose: instil 1 drop into the affected eye(s) once daily, typically in the evening, or as directed by the prescribing clinician.
  • Do not use more than once daily, as more frequent administration may reduce the IOP-lowering effect.
  • Wash hands before use. Avoid touching the dropper tip to any surface, including the eye or eyelids, to prevent contamination.
  • If the patient wears contact lenses, they should remove them before instillation; lenses can usually be reinserted after at least 15 minutes, in line with leaflet guidance.
  • Gently pull down the lower eyelid to create a small pocket, instil one drop into the conjunctival sac, then close the eye gently.
  • To reduce systemic absorption, patients may be advised to gently press the inner corner of the eye (nasolacrimal occlusion) for about 1 minute after instillation.
  • If more than one topical ophthalmic medicine is used, allow at least 5 minutes between instillation of different products; apply ointments last.
  • Use continuously as prescribed even if symptoms are not noticeable, as glaucoma/ocular hypertension may be asymptomatic.
  • If a dose is missed, apply the next dose at the usual time; do not double the dose to make up for a missed one.
  • Follow the prescribing doctor’s instructions and the patient information leaflet carefully; attend regular eye pressure and optic nerve examinations as scheduled.

Contraindications

  • Known hypersensitivity to bimatoprost or to any excipient in the formulation (including benzalkonium chloride).
  • Use in patients who have previously experienced serious hypersensitivity reactions to Lumigan or other bimatoprost-containing products.
  • Caution (typically not absolute contraindication but often listed under warnings) in patients with active or suspected ocular infection, uveitis, macular oedema, aphakia or pseudophakia with torn posterior lens capsule, or in those with risk factors for macular oedema; specialist assessment is required.
  • Use during pregnancy is generally avoided unless the potential benefit justifies the potential risk; breastfeeding use requires medical advice based on official prescribing information.
  • As with all prescription medicines, any additional contraindications specified in the current Summary of Product Characteristics (SmPC) or local regulatory guidance must be observed.

Adverse Effects

  • Very common and common ocular side effects: conjunctival hyperaemia (red eyes), eye irritation or discomfort, itching, foreign body sensation, burning or stinging, and mild ocular dryness or tearing.
  • Changes in eyelashes, including increased length, thickness, number and/or pigmentation over time.
  • Increased iris pigmentation (darkening of the coloured part of the eye), which may be permanent; eyelid skin pigmentation and darkening of the eyelid and lashes, which may be reversible after discontinuation.
  • Blurred vision immediately after instillation, usually transient; patients should avoid driving or operating machinery until vision is clear.
  • Less common side effects include eye pain, eyelid erythema, eyelid pruritus, photophobia, periocular skin reactions, and allergic conjunctivitis.
  • Rare events reported with bimatoprost-containing products include macular oedema (especially in predisposed individuals), uveitis, and exacerbation of pre-existing ocular conditions.
  • Systemic adverse events are uncommon but may include headache, dizziness, or mild respiratory or skin reactions; any suspected systemic reaction should be evaluated by a clinician.
  • Patients should be counselled on these potential effects and instructed to seek medical advice if they experience severe eye pain, marked visual changes, persistent redness or irritation, signs of infection, or any unexpected systemic symptoms.

Storage Conditions

  • Store below 25–30°C (as per local product labelling) in a cool, dry place away from direct heat and light.
  • Do not freeze.
  • Keep the bottle tightly closed when not in use and store in the original carton to protect from light.
  • Keep out of the sight and reach of children.
  • Discard the bottle in accordance with the expiry date on the pack and any in-use shelf-life specified in the leaflet (for example, a number of weeks after opening, depending on local packaging); do not use if the solution becomes discoloured, cloudy or shows particles.
  • Do not use if the tamper-evident seal is broken or the bottle appears damaged.

Duration

Lumigan 0.01% is used as a long-term maintenance therapy for chronic conditions such as open-angle glaucoma and ocular hypertension. Duration of treatment is typically indefinite or as long as intraocular pressure control is required and the medicine is tolerated, with periodic review by an eye specialist to assess efficacy and safety.

Onset

Intraocular pressure reduction generally begins within several hours of the first dose, with maximum IOP-lowering effect typically reached within approximately 8\u201312 hours and maintained with once-daily dosing; full clinical benefit is assessed over days to weeks of regular use.

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