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BIMATOPROST SANDOZ is a brand name for Bimatoprost. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Bimatoprost is indicated in 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.
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. In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, Bimatoprost 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.
In clinical studies, over 1800 patients have been treated with Bimatoprost. On combining the data from phase III monotherapy and adjunctive Bimatoprost 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 noninflammatory 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. The following adverse reactions were reported during clinical trials with Bimatoprost or in the post-marketing period.
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 <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data) adverse reactions are presented according to System Organ Class in the table below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. System Organ class Frequency Adverse reaction Immune system disorders not known hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis Nervous system disorders common headache uncommon dizziness Eye disorders 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 edema 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 Skin and subcutaneous tissue disorders common pigmentation of periocular skin uncommon hirsutism General disorders and administration 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).
Cystoid macular oedema has been uncommonly reported (≥1/1000 to <1/100) following treatment with Bimatoprost. g. aphakic patients, pseudophakic patients with a torn posterior lens capsule). There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with Bimatoprost.
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 and should therefore be used with caution in such patients.
In clinical studies, in those patients with a history of a compromised respiratory function, no significant untoward respiratory effects have been seen. Cardiovascular Bimatoprost has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure.
There have been a limited number of spontaneous reports of bradycardia or hypotension with Bimatoprost. 5). Patients using bimatoprost with other prostaglandin analogues should be monitored for changes to their intraocular pressure. Bimatoprost contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.
Eye irritation and discolouration of the soft contact lenses may also occur because of the presence of benzalkonium chloride. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.
1. Bimatoprost 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).
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. The tip of the bottle should not be allowed to contact the eye, surrounding structures, fingers or any other surface in order to avoid contamination of the solution.