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BIMATOPROST 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 MHRA 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 Bimatoprost in children aged 0 to 18 years has not yet been established.
Use in hepatic and renal impairment Bimatoprost 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 For ocular use. After the bottle cap is removed, if the tamper evident ring is loose, remove before using the product. If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.
3mg/ml eye drops, solution. 3mg/ml eye drops, solution usage, the most frequently reported treatment-related adverse events 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 and 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 eye drops, solution.
Most were ocular, mild to moderate, 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 <1/1000), or very rare (<1/10,000) and not known (cannot be estimated from available data) undesirable effects are presented according to System Organ Class in Table 1.
Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness. System Organ Class Frequency Undesirable effect Immune system disorders not known hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis common headacheNervous system disorders uncommon dizziness very common conjunctival hyperaemia, ocular pruritus, growth of eyelashes, prostaglandin analogue periorbitopathy common superficial punctate keratitis, corneal erosion, ocular burning, ocular irritation, 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, eyelid erythema, eyelid pruritus uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction, periorbital erythema, eyelid oedema Eye disorders not known ocular discomfort Vascular disorders common hypertension Respiratory, thoracic and mediastinal disorders not known asthma, asthma exacerbation, COPD exacerbation and dyspnoea Gastrointestinal disorders uncommon nausea common pigmentation of periocular skin uncommon hirsutism Skin and subcutaneous tissue disorders not known skin discoloration (periocular) General disorders and administrative site conditions uncommon asthenia Investigations common liver function test abnormal Description of selected adverse reactions Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues including Bimatoprost 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 Bimatoprost. 8).
3 mg/ml eye drops. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule). 3 mg/ml eye drops, solution. g. herpes simplex) or uveitis/iritis. Bimatoprost 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 bimatoprost solution comes repeatedly in contact with the skin surface. Thus, it is important to apply Bimatoprost as instructed and avoid it running onto the cheek or other skin areas.
Respiratory Bimatoprost 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 Bimatoprost 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. Bimatoprost should be used with caution in patients predisposed to low heart rate or low blood pressure. 5). Patients using Bimatoprost with other prostanglandim analogues should be monitored for changes to their intraocular pressure.
3 mg/ml eye drops, solution contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses and may change the colour of the contact lenses. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
3 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.
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Changes are typically mild, can occur as early as one month after initiation of treatment with Bimatoprost, 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.
Adverse reactions reported in phosphate containing eye drops:
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use. Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy.
Since Bimatoprost contains benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised. 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 bottle to contact the eye, surrounding structures, fingers or any other surface in order to avoid eye injury and contamination of the solution.