Expiration date: 01/2023
1 ml of the drug contains: Active substance: Bimatoprost 0.3 mg, excipients (benzalkonium chloride, sodium chloride, citric acid monohydrate, sodium hydrophosphate heptahydrate, sodium hydroxide, hydrochloric acid, water for injection)
anti-glaucoma agent-prostaglandin F2-alpha synthetic analog. Pharmacodynamics Bimatoprost reduces intraocular pressure in humans by increasing the outflow of watery moisture through the trabecular network and increasing the uveoscleral outflow. The decrease in intraocular pressure begins about 4 hours after the first injection and the maximum effect is achieved after about 8-12 hours. The effect lasts for at least 24 hours. Bimatoprost is a powerful ophthalmic hypotensive agent. Is it a synthetic prostamide structurally related to prostaglandin F2? (PGF2?), which does not act through known prostaglandin receptors. Bimatoprost selectively simulates the effects of recently discovered biosynthesized substances, prostamides. However, the structure of prostamide receptors has not yet been identified. Limited information is available on the effectiveness of the drug in the treatment of pseudoexfoliative and pigmented glaucoma, as well as on the experience of using bimatoprost in the treatment of angle-closure glaucoma in patients who have previously had an iridotomy. According to clinical studies, there was no significant effect of the drug on heart rate and blood pressure.
Reduction of increased intraocular pressure in open-angle glaucoma and ophthalmic hypertension in adults (as monotherapy or in combination with beta-blockers).
Method of application and dosage:
1 drop in the affected eye (eyes) 1 time a day in the evening. Do not exceed the recommended dose, since more frequent instillations can reduce the antihypertensive effect of the drug. The efficacy and safety of the use of bimatoprost in patients aged 0 to 18 years has not been established in the pediatric population. Use in patients with renal and hepatic insufficiency, the use of Bimatan® in patients with moderate and severe hepatic insufficiency has not been studied, which requires caution when using the drug in patients of these groups. In patients with anamnestic information about mild liver dysfunction or an increase in the level of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin, there is no pathological effect of bimatoprost on the functional state of the liver during 24 months of use. When using bimatoprost as part of complex therapy, it is necessary to observe at least a 5-minute interval between instillations of bimatoprost and concomitant therapy preparations. If you miss taking the drug, you should take the medicine as soon as possible in the dosage prescribed by the instructions.
The following adverse events were observed during clinical trials and in the post-registration period. The frequency of occurrence was carried out in accordance with the following classification: very often (>,1/10), often (>,1/100 to <,1/10), infrequently (>,1/1,000 to <,1/100), rarely (>,1/10,000 to <,1/1,000), very rarely (<,1/10,000) and with an unknown frequency (cannot be estimated based on available data). In each group, the undesirable effects are presented in descending order of severity. Disorders of the nervous system: Often: headache, Infrequently: dizziness. Visual disorders: Very often: conjunctival injection, itching in the eyes, eyelash growth, Often: superficial spot keratitis, corneal erosion, burning in the eyes, eye irritation, allergic conjunctivitis, blepharitis, decreased visual acuity, asthenopia, conjunctival edema, foreign body sensation in the eye, dry eye, eye pain, photophobia, lacrimation, eye discharge, visual impairment, increased iris pigmentation, darkening of eyelashes, Infrequently: hemorrhagic disorders of the retina, uveitis, cystic macular edema, iritis, blepharospasm, eyelid retraction, periorbital erythema, With unknown frequency: enophthalmos. Vascular disorders: Often: hypertension. Disorders of the skin and subcutaneous tissues: Infrequently: hirsutism. General disorders and disorders at the injection site: Infrequently: asthenia. Data from laboratory and instrumental studies: Often: deviation from the norm of biochemical parameters of liver function. In very rare cases, calcification of the cornea was observed when using phosphate-containing eye drops in patients with concomitant significant damage to the cornea.
Hypersensitivity to bimatoprost or other components of this drug, age up to 18 years. Use during pregnancy and during breastfeeding Pregnancy There are no data from clinical studies of the use of bimatoprost in pregnant women. According to animal studies, reproductive toxicity has been demonstrated when used in high, toxic doses for the mother's body. It is not recommended to use bimatoprost during pregnancy in the absence of strict indications. It is not known whether bimatoprost is excreted into human breast milk. Animal studies have shown that bimatoprost is excreted in breast milk. If it is necessary to use bimatoprost during breastfeeding, it is necessary to make a decision to stop breastfeeding or discontinue bimatoprost therapy, taking into account the benefits of breastfeeding for the child and the need for therapy with the drug for the mother. There is no information about the effect of bimatoprost on human fertility. Caution should be exercised when using the drug in the treatment of patients with known risk factors for macular edema (for example, in patients with aphakia, in patients with artifakia and rupture of the posterior lens capsule). It should be used with caution in patients with a history of severe eye infections (for example, caused by the herpes simplex virus) or iritis/uveitis. There is no experience of using bimatoprost in patients with concomitant respiratory disorders, which requires caution in such patients. When conducting clinical studies in patients with impaired respiratory function, no significant adverse effects on the respiratory system were observed. The effect of bimatoprost on patients with severe first-degree heart block or on patients with uncontrolled congestive heart failure has not been studied. There were a limited number of cases of bradycardia or hypotension when using bimatoprost. Bimatoprost should be used with caution in the treatment of patients predisposed to low heart rate or low blood pressure. The effect of bimatoprost on patients with inflammatory diseases of the visual organ, neovascular, inflammatory, closed-angle glaucoma, congenital glaucoma or narrow-angle glaucoma has not been studied.
There were no cases of overdose with topical application. In case of overdose, treatment should be symptomatic and supportive.
Before starting treatment, patients should be informed about the possibility of eyelash growth, darkening of the eyelid skin and increased pigmentation of the iris. Some of these changes may be permanent and may lead to differences in appearance between the eyes when only one eye is treated. The change in the pigmentation of the iris occurs slowly and can be imperceptible for several months or years. Most often, the change in the color of the iris is permanent. The change in the color of the iris is more associated with an increase in the content of melanin in melanocytes than with an increase in the number of melanocytes. The long-term effects of increased iris pigmentation are unknown. In typical cases, the brown pigment spreads from the area around the pupil to the root of the iris, as a result, the entire iris or parts of it become more brown. The use of bimatoprost does not affect the nevi and lentigo of the iris. The pigmentation of the periorbital tissue is reversible in some patients. There are reports of the possibility of developing cystic macular edema during bimatoprost therapy, the frequency of occurrence of this undesirable phenomenon is infrequent ((>, 1/1, 000 to <, 1/100), which requires caution when using the drug in the treatment of patients with risk factors for macular edema (patients with aphakia, pseudoaphakia and rupture of the posterior lens capsule). Bimatan® contains the preservative benzalkonium chloride, which can be absorbed by soft contact lenses. Eye irritation and discoloration of soft contact lenses may also occur due to the presence of benzalkonium chloride. It is necessary to remove contact lenses before installation and put them back on 15 minutes after instillation. Benzalkonium chloride, used in eye drops as a preservative, can cause the development of spot keratopathy and / or toxic ulcerative keratopathy. Caution should be exercised when using the drug in patients with " dry " eye syndrome, with corneal damage and in the case of simultaneous use of several types of eye drops containing benzalkonium chloride. It is necessary to monitor the condition of the cornea with prolonged use of the drug in this category of patients. There are reports of the possibility of developing bacterial keratitis associated with the use of vials for reusable eye drops. IV bottles were unintentionally contaminated by patients with concomitant diseases of the visual organ. The risk of developing bacterial keratitis was higher in patients with impaired corneal epithelial integrity. It is necessary to warn patients about the need to avoid contact of the tip of the dropper bottle with the surface of the eye and other surfaces in order to avoid damage to the visual organ and bacterial contamination of the drug. Influence on the ability to drive vehicles and work with mechanisms Bimatan® has a minor effect on the ability to drive vehicles and work with mechanisms. As with the use of other eye drops, if there is a temporary blurring of vision after instillation, it is necessary to wait for the restoration of visual perception clarity before driving a car or operating mechanisms.
3 years. Use the drops within 30 days after opening the bottle.