Reduction of elevated intraocular pressure in chronic open-angle glaucoma and intraocular hypertension in adults (as monotherapy or in adjunctive therapy with beta-blockers).
Composition:
1 ml of solution contains 0.3 mg bimatoprost. The preparation contains benzalkonium chloride.
Action:
Synthetic prostamide, similar to prostaglandin F2a. Bimatoprost lowers intraocular pressure by increasing the outflow of aqueous humor through the mesh of collagen fibers at the angle of the eye and the severity of the outflow through the choroidal scleral route. Lowering the intraocular pressure begins about 4 hours after the first administration of the drug, and the maximum effect is achieved within 8-12 hours. The effect persists for at least 24 hours. Bimatoprost penetrates wellin vitro to the cornea and sclera of the human eye. When administered to the eye, systemic exposure to bimatoprost is very low without accumulation over time.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Precautions:
The drug should be used with caution in patients with known risk factors for macular edema (eg, patients with aphakicity, patients with pseudoprogular myopia with a tear of the posterior capsule of the lens). Regeneration of previous corneal infiltrates or eye infections has been reported with treatment with the preparation - care should be taken in patients who have had serious viral infections of the eyes (eg herpes) or uveitis / iritis. The drug has not been studied in patients with inflammatory ocular diseases, neovascular, inflammatory or with angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma. There is a possibility of hair growth in places where the medicine comes into contact repeatedly with the skin surface - it is important to use the drug in accordance with the instructions and avoiding it flowing to the cheek or other areas of the skin. The drug has not been studied in patients with respiratory deprivation, therefore it should be used with caution in this group of patients. The drug has not been studied in patients with a heavier heart block than Ist. or uncontrolled congestive heart failure. There are few spontaneous reports of bradycardia or hypotension. The drug should be used with caution in patients predisposed to slow heart rate or low blood pressure. The use of bimatoprost in the eye more than once a day may reduce the effect of lowering the intraocular pressure. Patients using the other analogues of prostaglandins should be monitored for changes in intraocular pressure. The preparation contains benzalkonium chloride, which can be absorbed by soft contact lenses and cause eye irritation and discoloration of soft contact lenses. Contact lenses should be removed prior to instillation of the drug and can be reinserted 15 min after administration. Benzalkonium chloride may cause punctate keratopathy and / or toxic ulcerative keratopathy - with frequent or prolonged use of the preparation, it is necessary to monitor patients with dry eye or corneal injury. The safety and efficacy of the preparation in children from 0 to 18 years have not yet been established.
Pregnancy and lactation:
There are no adequate data on the use of bimatoprost in pregnant women. The medicine should not be used during pregnancy unless clearly necessary. It is not known whether bimatoprost is excreted in human milk. Animal studies have shown excretion of bimatoprost with milk. A decision should be made whether to stop breastfeeding or discontinue the medicine, taking into account the benefits of breastfeeding for a child and the benefits of treatment for a woman.
Side effects:
Very common: conjunctival hyperemia, pruritus, eyelash growth.Common: headache, pressure, punctate superficial keratitis, corneal erosion, eye burning, eye irritation, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival edema, feeling of a foreign body, dry eye, eye pain, photophobia, tears, eye discharge, blurred vision / blurred vision, increased iris pigmentation, dark eyelashes, erythema of the eyelid, eyelid pruritus, pigmentation of the skin around the eyes, abnormal values of liver function indicators. Uncommon: dizziness, retinal hemorrhage, uveitis, cystoid macular edema, iritis, eyelid contraction, eyelid pull, erythema of the eye socket, nausea, eyelid edema, hirsutism, asthenia. Frequency unknown: collapse of the eyeball.
Dosage:
Adults: the recommended dose is 1 drop into the affected eye (eyes) once a day, in the evening. Do not give the dose more than once a day, because more frequent administration may reduce the effect of lowering the intraocular pressure. The drug has not been studied in patients with renal impairment or moderate or severe hepatic impairment, therefore it should be used with caution in this group of patients. In patients with mild liver disease or baseline abnormal ALT, AST and / or bilirubin, the drug has not adversely affected liver function for more than 24 months. If more than one ophthalmic medicinal product is used, each should be given at least 5 minutes
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