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Lumigan is a brand name for Bimatoprost. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily, as more frequent administration may lessen the intraocular pressure lowering effect. Paediatric population The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established.
Renal and hepatic impairment LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. 3 mg/ml eye drops, solution had no adverse effect on liver function over 24 months.
Method of administration If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
1 mg/ml eye drops, solution experienced adverse reactions. The most frequently reported adverse reaction was conjunctival hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 29 % of patients. Approximately 4 % of patients discontinued due to any adverse event in the 12-month study.
1 mg/ml eye drops, solution or in the post-marketing period.
Most were ocular, mild and none was serious:
Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000); not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in Table 1.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Table 1. List of adverse reactions System Organ class Frequency Adverse reaction Nervous system disorders Uncommon Headache Not known Dizziness Eye disorders Very common Conjunctival hyperaemia, prostaglandin analogue periorbitopathy Common Punctate keratitis, eye irritation, eye pruritus, growth of eyelashes,eye pain, erythema of eyelid, eyelid pruritus Uncommon Asthenopia, blurred vision, conjunctival disorder, conjunctival oedema, iris hyperpigmentation, madarosis, eyelid oedema Not known Blepharal pigmentation, macular oedema, dry eye, eye discharge, eye oedema, foreign body sensation in eyes, lacrimation increased, ocular discomfort, photophobia Respiratory, thoracic and mediastinal disorders Not known Asthma, asthma exacerbation, COPD exacerbation and dyspnoea Gastrointestinal disorders Uncommon Nausea Skin and subcutaneous tissue disorders Common Skin hyperpigmentation, hypertrichosis Uncommon Dry skin, eyelid margin crusting, pruritus Not known Skin discoloration (periocular) General disorders and administration site conditions Common Instillation site irritation 6 Immune system disorders Not known Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis Vascular disorders Not known Hypertension Description of selected adverse reactions Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues including LUMIGAN can induce periorbital lipodystrophic changes which can lead to deepening of the eyelid sulcus, ptosis, enophthalmos, eyelid retraction, involution of dermatochalasis and inferior scleral show.
Ocular Before treatment is initiated, patients should be informed of the possibility of prostaglandin analogue periorbitopathy (PAP) and increased iris pigmentation, since these have been observed during treatment with LUMIGAN. 8). 3 mg/ml eye drops, solution.
g. aphakic patients, pseudophakic patients with a torn posterior lens capsule). 3 mg/ml eye drops, solution. g. herpes simplex) or uveitis/iritis. LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.
Skin There is a potential for hair growth to occur in areas where LUMIGAN solution comes repeatedly in contact with the skin surface. Thus, it is important to apply LUMIGAN as instructed and avoid it running onto the cheek or other skin areas.
Respiratory LUMIGAN has not been studied in patients with compromised respiratory function. While there is limited information available on patients with a history of asthma or COPD, there have been reports of exacerbation of asthma, dyspnoea and COPD, as well as reports of asthma, in post-marketing experience.
The frequency of these symptoms is not known. Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution. Cardiovascular LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.
3 mg/ml eye drops, solution. LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood pressure. 5). Patients using LUMIGAN with other prostaglandin analogues should be monitored for changes to their intraocular pressure.
1 mg/ml contains the preservative benzalkonium chloride (200 ppm), which may be absorbed by soft contact lenses. Eye irritation and discolouration of the soft contact lenses may also 4 occur because of the presence of benzalkonium chloride.
1. 1 mg/ml is contraindicated in patients who have had a suspected previous adverse reaction to benzalkonium chloride that has led to discontinuation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bimatoprost in European Union.
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Changes are typically mild, can occur as early as one month after initiation of treatment with LUMIGAN, and may cause impaired field of vision even in the absence of patient recognition. PAP is also associated with periocular skin hyperpigmentation or discoloration and hypertrichosis.
All changes have been noted to be partially or fully reversible upon discontinuation or switch to alternative treatments. Iris hyperpigmentation Increased iris pigmentation is likely to be permanent. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
The long term effects of increased iris pigmentation are not known. Iris colour changes seen with ophthalmic administration of bimatoprost may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts become more brownish.
Neither naevi nor freckles of the iris appear to be affected by the treatment. 5%. 8 Table 2) and did not increase following 3 years treatment. 3 mg/ml. 3 mg/ml usage, the most frequently reported adverse reactions were: • growth of eyelashes in up to 45 % in the first year with the incidence of new reports decreasing to 7 % at 2 years and 2 % at 3 years • conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44 % in the first year with the incidence of new reports decreasing to 13 % at 2 years and 12 % at 3 years • ocular pruritus in up to 14 % of patients in the first year with the incidence of new reports decreasing to 3 % at 2 years and 0 % at 3 years.
Less than 9 % of patients discontinued due to any adverse event in the first year with the incidence of additional patient discontinuations being 3 % at both 2 and 3 years. 3 mg/ml are presented in Table 2. The table also includes those adverse reactions which occurred with both formulations but at a different frequency.
Most were ocular, mild to moderate, and none was serious:
With each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 Table 2. List of additional adverse reactions System Organ class Frequency Adverse reaction Nervous system disorders Common Headache Uncommon Dizziness Eye disorders Very common Ocular pruritus, growth of eyelashes Common Corneal erosion, ocular burning, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival oedema, foreign body sensation, ocular dryness, eye pain, photophobia, tearing, eye discharge, visual disturbance/blurred vision, increased iris pigmentation, eyelash darkening Uncommon Retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema Vascular disorders Common Hypertension Skin and subcutaneous tissue disorders Uncommon Hirsutism General disorders and administration site conditions Uncommon Asthenia […]
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration. Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
3 mg/ml eye drops), it should be used with caution in dry eye patients, in patients where the cornea may be compromised and in patients taking multiple BAK-containing eye drops. In addition, monitoring is required with prolonged use in such patients.
There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent ocular disease.
Patients with a disruption of the ocular epithelial surface are at greater risk of developing bacterial keratitis. Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution.