Lumigan 0.3mg/ml Unit Dose Eye Drops 0.4ml x 30
Lumigan
Prescription medicineAntiglaucoma prostamide ophthalmic solution, single-dose preservative-free
Certifications
- Authorised in the UK as a prescription Only medicine (POM) with an approved Summary of Product Characteristics and Patient Information Leaflet for bimatoprost 0.3mg/ml single Dose eye drops.
- Subject to Medicines and Healthcare products Regulatory Agency (MHRA) oversight and the Yellow Card adverse event reporting scheme.
- Manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products and subject to batch release controls.
- EU/EEA and other market approvals supported by an EMA European Public Assessment Report (EPAR) for Lumigan, with established efficacy and safety data in glaucoma and ocular hypertension.
- Authorised in the UK as a prescription Only medicine (POM) with an approved Summary of Product Characteristics and Patient Information Leaflet for bimatoprost 0.3mg/ml single Dose eye drops.
- Subject to Medicines and Healthcare products Regulatory Agency (MHRA) oversight and the Yellow Card adverse event reporting scheme.
- Manufactured in accordance with Good Manufacturing Practice (GMP) for medicinal products and subject to batch release controls.
- EU/EEA and other market approvals supported by an EMA European Public Assessment Report (EPAR) for Lumigan, with established efficacy and safety data in glaucoma and ocular hypertension.
Antiglaucoma prostamide ophthalmic solution, single-dose preservative-free
Description
Lumigan 0.3mg/ml Unit Dose Eye Drops (0.4ml x 30 single-dose containers) is a prescription-only ophthalmic medicine containing bimatoprost, a prostamide/prostaglandin analogue used to reduce elevated intraocular pressure (IOP). Each single-dose container holds a sterile, preservative-free solution with bimatoprost 0.3mg/ml (0.03%) for topical use in the eye. The product is indicated for adults with chronic open-angle glaucoma or ocular hypertension, used either as monotherapy or in combination with beta-blocker eye drops. Bimatoprost lowers IOP by increasing aqueous humour outflow via trabecular and uveoscleral pathways, helping to protect the optic nerve and preserve vision. The unit-dose, preservative-free presentation is particularly useful for patients who are sensitive to benzalkonium chloride or require preservative-free therapy, and is normally dosed once daily in the evening.
Bnefits
- Clinically proven to reduce elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension.
- Once-daily dosing (typically one drop in the evening) simplifies treatment and supports adherence.
- Unit-dose, preservative-free formulation reduces exposure to benzalkonium chloride, beneficial for patients with preservative sensitivity or ocular surface disease.
- Bimatoprost acts through increased aqueous humour outflow via multiple pathways, providing effective IOP control.
- Helps protect the optic nerve and reduce the risk of glaucomatous visual field loss when used regularly as prescribed.
- Can be used as monotherapy or as adjunctive therapy to beta-blocker eye drops when additional pressure lowering is required.
- Convenient 30 x 0.4ml single-dose containers, each sufficient for treatment of both eyes for one administration.
Indications
- Reduction of elevated intraocular pressure in adults with chronic open-angle glaucoma.
- Reduction of elevated intraocular pressure in adults with ocular hypertension.
- May be used as monotherapy or as adjunctive therapy to topical beta-blockers when further IOP reduction is needed, in line with the SmPC and prescriber judgement.
- Often chosen for patients with sensitivity or intolerance to benzalkonium chloride-containing eye drops because of its preservative-free single-dose presentation.
Composition
- Active ingredient: Bimatoprost 0.3mg/ml (0.03% w/v).
- Each 0.4ml single-dose container contains 0.12mg bimatoprost.
- Excipients: Sodium phosphate dibasic heptahydrate, citric acid monohydrate, sodium chloride, hydrochloric acid or sodium hydroxide (to adjust pH), purified water.
- Preservative-free formulation (no benzalkonium chloride) in single-dose containers.
Formulation
- Sterile, clear eye drops solution in single-dose low-density polyethylene (LDPE) containers.
- Concentration: 0.3mg/ml bimatoprost (0.03%).
- Preservative-free formulation intended for single use only; one container is sufficient to treat both eyes for one dosing occasion.
- Ophthalmic solution buffered and adjusted for ocular compatibility (pH and osmolality suitable for topical eye use).
Packaging
- Outer carton containing 30 x 0.4ml single-dose LDPE containers (unit doses).
- Each single-dose container is marked and designed for one-time use; any remaining solution must be discarded immediately after administration.
- Carton and containers are labelled with product name, strength, active substance, batch number, expiry date, storage instructions and route of administration.
- Supplied with a patient information leaflet providing detailed instructions for use, safety information and advice about side effects.
Usage
- For ocular use only; do not swallow or inject.
- Usual dose for adults: one drop in the affected eye(s) once daily, administered in the evening, or as directed by the prescribing ophthalmologist or doctor.
- The dose should not exceed one application per day, as more frequent use may reduce the IOP-lowering effect.
- Before use, wash hands thoroughly. Detach a single-dose container from the strip, twist off the tab, and hold it without touching the tip.
- Tilt the head back, gently pull down the lower eyelid to form a pocket, and instil one drop into the conjunctival sac of the affected eye(s).
- After instillation, patients may gently close their eyes and apply light pressure to the inner corner of the eye (nasolacrimal occlusion) for about one minute to reduce systemic absorption.
- Each single-dose container contains enough solution for both eyes; any unused solution must be discarded immediately after use and must not be stored for later.
- If more than one topical ophthalmic medicine is being used, allow at least 5 minutes between instillations; eye ointments should be applied last.
- Contact lenses (if permitted for the patient) should generally be removed before instillation and reinserted after at least 15 minutes, according to official guidance and prescriber instructions.
- Use regularly as directed and attend scheduled follow-up appointments for IOP monitoring and ocular examination.
- If a dose is missed, apply the next dose at the usual time; do not instil extra drops to make up for a missed dose.
Contraindications
- Hypersensitivity to bimatoprost or to any of the excipients listed in the product information.
- Known hypersensitivity to prostaglandin analogues/prostamides where cross-reactivity is a concern (at the prescriber’s discretion).
- Caution is required (often listed under warnings/precautions rather than absolute contraindications) in patients with active or suspected ocular inflammation (uveitis/iritis), macular oedema, aphakia or pseudophakia with torn posterior lens capsule, or in those with risk factors for macular oedema; specialist assessment is necessary.
- Use in pregnancy should generally be avoided unless clearly needed; breastfeeding use should follow medical advice and the official prescribing information.
- Any additional contraindications or patient groups specified in the current Summary of Product Characteristics or national prescribing guidelines must be observed by prescribers.
Adverse Effects
- Very common and common ocular reactions: conjunctival hyperaemia (eye redness), mild eye irritation or discomfort, itching, burning or stinging, foreign body sensation, and transient blurred vision immediately after instillation.
- Gradual increase in eyelash growth (length, thickness, number) and darkening of lashes over time; this may be reversible upon discontinuation.
- Increased iris pigmentation (darkening of the coloured part of the eye), which may be permanent; eyelid skin darkening and periocular pigmentation that may be reversible after stopping treatment.
- Other ocular reactions reported include dry eye, excessive tearing, eye pain, eyelid erythema, eyelid pruritus, photophobia, and allergic conjunctivitis.
- Less common but clinically important events include macular oedema, uveitis, and exacerbation of pre-existing ocular inflammatory conditions, particularly in susceptible patients.
- Systemic adverse reactions are uncommon but may include headache, dizziness and rarely respiratory or skin reactions; any suspected systemic effects should be evaluated clinically.
- Patients should be informed of potential side effects, particularly changes in eye colour and eyelashes, and instructed to seek medical advice promptly if they experience severe eye pain, marked visual changes, signs of infection, persistent redness or swelling, or other unexpected symptoms.
Storage Conditions
- Store in the original outer carton in order to protect from light.
- Store below 25°C (or according to the temperature range printed on the pack for the specific market); do not freeze.
- Keep single-dose containers in the unopened tray/foil until required for use.
- For packs of 30 x 0.4ml, once the tray is opened, the unit-dose containers should be used within the time period specified in the patient leaflet (for example, within 30 days in some jurisdictions).
- Keep out of the sight and reach of children.
- Do not use after the expiry date stated on the carton and single-dose containers; discard any containers that appear damaged or if the solution looks discoloured or contains particles.
Duration
Lumigan 0.3mg/ml Unit Dose Eye Drops is intended for long-term, often indefinite use in chronic open-angle glaucoma and ocular hypertension, as long as intraocular pressure reduction is required and the medicine is tolerated. Treatment duration is determined by the prescribing specialist based on ongoing assessment of IOP, optic nerve status and overall benefit\u2013risk balance.
Onset
Measurable intraocular pressure reduction typically begins within hours of instillation, with maximal IOP-lowering effect generally achieved within approximately 8 to 12 hours after dosing. Sustained efficacy is seen with once-daily evening administration, and full clinical benefit is usually assessed over several days to weeks of regular use.
