Reduction of elevated intraocular pressure in chronic open angle glaucoma and intraocular hypertension in adults (as monotherapy or as adjunctive therapy during the use of β-blockers).
Composition:
1 ml of 0.3 mg bimatoprost solution. The product contains benzalkonium chloride (0.05 mg / ml).
Action:
Synthetic prostamide, similar to prostaglandin F2α. 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:
Cystoid macular edema has been reported rarely during the use of the product - caution should be exercised in patients with known risk factors for macular edema (eg, aphakic patients, patients with pseudoprogeum with a tear in the back of the lens capsule). Cases of recurrent infiltration of the cornea or eye infection have been reported after treatment with the drug - care should be taken in patients who have had significant viral infections of the eye (eg herpetic infection), uveitis or iritis. The preparation has not been studied in patients with inflammatory ocular conditions, with neovascular glaucoma, congenital glaucoma or narrow-angle glaucoma. There is a risk of hair growth in places where the product comes into contact with the skin frequently - care should be taken that the solution does not leak out of the eye on the cheek or other area of the skin. No studies in patients with impaired respiratory function - caution should be exercised. There are no studies in patients with a heavier heart block than Ist. or decompensated congestive heart failure. There are a limited number of spontaneous reports of bradycardia or hypotension. Exercise caution in patients with a tendency to slow heart rate or low blood pressure. More frequent eye exposure to more than one dose of bimatoprost per day may reduce the effect of reducing intraocular pressure. Patients using the product together with other prostaglandin analogues should be monitored for changes in intraocular pressure. The benzalkonium chloride contained in the preparation may be absorbed by soft contact lenses. Irritation of the eye and change in the color of the soft contact lenses may also occur. The lenses should be removed before instillation and inserted 15 min after instillation. Benzalkonium chloride may cause keratopathy of punctate and / or toxic ulcerative keratopathy - the condition of patients with dry eye or damaged cornea should be monitored during frequent or long-term use of the preparation. Patients with corneal epithelial surface damage are more at risk of developing bacterial keratitis. Use with caution in patients with impaired renal function or moderate to severe hepatic impairment - no study. The efficacy and safety of the preparation in children and adolescents up to 18 years have not been established.
Pregnancy and lactation:
There are no adequate data on the use of the preparation during pregnancy. It should not be used during pregnancy unless clearly necessary. It is not known whether bimatoprost passes into the milk of nursing mothers. In animal studies, bimatoprost has been shown to be excreted in milk. Before deciding to stop breastfeeding or to discontinue use, the balance of benefits of breastfeeding for a child and continuing treatment for the mother should be taken into account.
Side effects:
Very common: conjunctival hyperemia, eye pruritus, excessive eyelash growth. Common: headache, superficial punctate keratitis, corneal erosion, burning sensation in the eye, eye irritation, allergic conjunctivitis, eyelid inflammation, worsening of visual acuity, asthenopia, conjunctival edema, feeling of a foreign body in the eye, dry eye, eye pain , photophobia, tearing, discharge from the eye, blurred vision, increased iris pigmentation, darkening eyelashes, eyelid thickening, eyelid pruritus, pigmentation of the skin around the eyes, hypertension, abnormal values of liver function indicators. Uncommon: dizziness, retinal hemorrhage, uveitis, cystoid macular edema, iritis, eyelid spasm, periorbital erythema, nausea, eyelid edema, hirsutism, weakness. Frequency unknown: collapse of the eyeballs.
Dosage:
Adults: the recommended dose is 1 drop for the affected eye (s) once a day, in the evening. Do not administer more often than once a day, because more frequent administration may reduce the effect of lowering the intraocular pressure. If the patient uses more than one eye medicine, each of these preparations should be administered with at least a 5-minute break. In patients with moderate to severe renal or hepatic impairment, the preparation should be used with caution. In patients with a history of mild liver disease or initially abnormal ALT, AST and / or bilirubin values, no adverse drug effects were found during 24 months.
(C)
