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BIMI 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. Bimi is a sterile solution that does not contain any preservatives.
Paediatric population The safety and efficacy of bimatoprost in children aged 0 to 18 years has not yet been established. Patients with 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 (preservative-containing formulation), solution had no adverse effect on liver function over 24 months. Method of administration For ocular use only. Bimatoprost has not been studied in patients wearing contact lenses.
Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration. Do not use more than once a day as the effectiveness of treatment may be reduced. Do not allow the tip of the multidose container to touch the eye or areas around the eye.
It could cause injury to your eye. The eye drops solution may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the multidose container, keep the tip of the dropper away from contact with any surface.
Instructions for use:
Bimi Before instillation of the eye drops: - Wash your hands before opening the bottle - Do not use if you notice that the tamper-proof seal on the bottle neck is broken before first use - When using for the first time, before delivering a drop to the eye, you should firstly practise using the dropper bottle by squeezing it slowly to deliver one drop into the air to get used to the pressure and time required to deliver one drop.
In case of difficulties of delivering one drop at a time, this step may be repeated. - When you are confident that you can deliver one drop at a time, you should choose the position that you find most comfortable for the instillation of the drops (you can sit down, lie on your back, or stand in front of a mirror).
Instillation: 1. Hold the bottle directly below the cap and turn the cap to open the bottle (see picture 1). Do not touch anything with the tip of the bottle to avoid contamination of the solution. 2. Tilt your head back and gently pull down your lower eyelid to form a pouch between your eye and eyelid (see picture 2).
3 mg/ml single-dose (preservative-free formulation) experienced adverse reactions. The most frequently reported adverse reactions were conjunctival hyperaemia (mostly trace to mild and of a non-inflammatory nature) occurring in 24% of patients, and eye pruritis occurring in 4% of patients.
3 mg/ml single-dose (preservative-free formulation) group discontinued due to any adverse event in the 3 month study. 3 mg/ml single-dose (preservative-free formulation) 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) and 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 System Organ class Frequency Adverse reaction Immune system disorders not known hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis uncommon headacheNervous system disorders not known dizziness very common conjunctival hyperaemia, prostaglandin analogue periorbitopathy Eye disorders common punctate keratitis, eye irritation, foreign body sensation, dry eye, eye pain, eye pruritus, growth of eyelashes, eyelid erythema uncommon asthenopia, conjunctival oedema, photophobia, lacrimation increased, iris hyperpigmentation, blurred vision, eyelid pruritus, eyelid oedema not known eye discharge, ocular discomfort Vascular disorders not known hypertension Respiratory, thoracic and mediastinal disorders not known asthma, asthma exacerbation, COPD exacerbation and dyspnoea common skin hyperpigmentation (periocular) uncommon hair growth abnormal Skin and subcutaneous tissue disorders not known skin discoloration (periocular) Description of selected adverse reactions Prostaglandin analogue periorbitopathy (PAP) Prostaglandin analogues including Bimi 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 (preservative-containing formulation). g. aphakic patients, pseudophakic patients with a torn posterior lens capsule). 3 mg/ml eye drops, solution (preservative-containing formulation). 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 (preservative-containing formulation). Bimatoprost should be used with caution in patients predisposed to low heart rate or low blood pressure. 3 mg/ml in patients with glaucoma or ocular hypertension, it has been shown that the more frequent exposure of the eye to more than one dose of bimatoprost daily may decrease the IOP-lowering effect.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Avoid contact between the tip of the bottle and your eye, eyelids or fingers. 3. Instil one drop into the pouch by pressing slowly on the bottle (see picture 3). Squeeze the bottle gently in the middle and let a drop fall into your eye.
There might be a few seconds delay between squeezing and the drop coming out. Do not squeeze too hard. If you are not sure how to administer your medicine, ask your doctor, pharmacist or nurse. 4. Compress the tear duct for about 2 minutes (by pressing a finger against the corner of the eye by the nose) and close your eye(s) and keep it/them closed during this time.
This ensures that the drop is absorbed by the eye and that the amount of medicine draining through the tear duct to the nose will probably be reduced. 5. Repeat steps 2, 3 and 4 in your other eye if your doctor has told you to do this.
6. If a drop misses your eye, try again. 7. ). This is necessary in order to ensure delivery of subsequent drops. Then screw the cap on the bottle (see picture 5). 8. After you have used all doses there will be some Bimi left in the bottle.
You should not be concerned since an extra amount of formulation has been added and you will get the full amount that your doctor prescribed. Do not attempt to use the excess medicine remaining in the bottle after you have completed the course of treatment.
Picture 1. Picture 2. Picture 3. Picture 4. Picture 5. Do not use the eye drops for longer than 90 days after first opening the bottle. When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced.
This may result in a decrease in systemic side effects and an increase in local activity. If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart. Eye ointments and eye gels should be administered last.
Changes are typically mild, can occur as early as one month after initiation of treatment with Bimi, 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 (preservative -containing formulation). 3 mg/ml (preservative-containing formulation) 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 (single-dose (preservative-free formulation)). Most were ocular, mild to moderate, and none were serious.
3 mg/ml (preservative-containing formulation). Most were ocular, mild to moderate, and none were serious. Table 3 System Organ class Frequency Adverse Reaction Nervous system disorders uncommon dizziness common corneal erosion, ocular burning, allergic conjunctivitis, blepharitis, worsening of visual acuity, eye discharge, visual disturbance, eyelash darkening Eye disorders uncommon retinal haemorrhage, uveitis, cystoid macular oedema, iritis, […]
Patients using bimatoprost with other prostanglandin analogues should be monitored for changes to their intraocular pressure. Bimatoprost has not been studied in patients wearing contact lenses. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.