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Bimatoprost reduces intraocular pressure in humans by increasing the outflow of aqueous humor through the trabecular meshwork and increasing uveoscleral outflow. The reduction in intraocular pressure begins about 4 hours after the first injection and the maximum effect is achieved in about 8-12 hours. The effect lasts for at least 24 hours. Bimatoprost is a powerful ophthalmic hypotensive agent. It is a synthetic prostamide structurally related to prostaglandin F2a (PGF2a), which does not act through the known prostaglandin receptors. Bimatoprost selectively mimics the effects of newly discovered biosynthesized substances, prostamides. However, the structure of the prostamide receptor has not yet been identified. According to clinical studies, no significant effect of the drug on the heart rate and blood pressure was noted. Pediatric population There are no data on the efficacy and safety of using bimatoprost in patients under 18 years of age. Pharmacokinetics Absorption: Bimatoprost penetrates well into the human cornea and sclera in vitro. After instillation by adults, systemic exposure to bimatoprost is very small, and no accumulation of the drug is noted. After the introduction of one drop of BIMOPTIC ROMPHARM in both eyes once a day for two weeks, the concentration in the blood reached a maximum 10 minutes after the dose, and within 1.5 hours the figure was below the level of determination (0.025 ng / ml). The mean C max and AUC values of 0-24 hours were about the same on day 7 and 14 — about 0.08 ng / ml and 0.09 ng * h / ml, respectively, which indicates that the concentration of bimatoprost is stable was achieved during the first week of instillation. Distribution: Bimatoprost is moderately distributed in body tissues, and the systemic equilibrium volume is 0.67 l / kg. In human blood, bimatoprost is mainly in the plasma. The binding of bimatoprost to plasma proteins is about 88%. Metabolism: Bimatoprost reaches the systemic blood flow, mostly unchanged. Then oxidation, N-deethylation and glucuronidation take place with the formation of a number of metabolites. Withdrawal: Bimatoprost is excreted mainly through the kidneys. Up to 67% of the intravenous dose in healthy adult volunteers were excreted in the urine, 25% of the dose was excreted in the feces. The half-life after intravenous administration was approximately 45 minutes, the total clearance of blood was 1.5 L / h / kg.
Reducing elevated intraocular pressure in open-angle glaucoma and ophthalmic hypertension in adults (as monotherapy or in combination with beta-blockers).
1 ml of the drug: active substance: bimatoprost - 0.30 mg; excipients: citric acid monohydrate - 0.14 mg, sodium phosphate disubstituted heptahydrate - 2.68 mg, sodium chloride - 8.30 mg, benzalkonium chloride - 0.05 mg, 1 M sodium hydroxide solution or 1 M hydrochloric acid solution - to pH 7.3 + 0.1, purified water - up to 1.0 ml.
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Dosage and Administration
The recommended dose is one drop in the affected eye (s) once a day in the evening. You can not instil the drug more than once a day, as more frequent use can reduce the effect of reducing intraocular pressure. When using more than one ophthalmic preparation for topical administration, it is necessary to observe an interval of 5 minutes between the administration of each of them. The use in the pediatric population BIMOPTIK ROMPHARM is not recommended for use in children under the age of 18 years due to the lack of data on the safety and efficacy of the drug. BIMOPTIC ROMPHARM has not been studied in patients with moderate to severe renal or hepatic insufficiency, and therefore it should be used with caution in these patients. In patients with a history of mild hepatic impairment or elevated levels of alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and / or bilirubin in history, BIMOPTIC ROMPHARM, eye drops, 0.3 mg / ml did not adversely affect the functional state liver for 24 months.
The following adverse events were observed during clinical trials and in the post-registration period. The frequency of occurrence is in accordance with the following classification: very often (> 1/10); often (> 1/100 to <1/10); infrequently (> 1/1000 to <1/100); rarely (> 1/10000 to <1/1000); very rarely (<1/10000) and with unknown frequency (cannot be estimated on the basis of available data). In each group, unwanted effects are presented in order of decreasing severity. Nervous system disorders: Often: headache; Infrequently: dizziness; Disturbances from the organs of vision: Very often: conjunctival injection, itchy eyes, eyelash growth; Often: superficial point keratitis, corneal erosion, burning in the eyes, eye irritation, allergic conjunctivitis, blepharitis, reduced visual acuity, asthenopia, conjunctival edema, foreign body sensation in the eye, dry eye, eye pain, photophobia, tearing, discharge from the eye , blurred vision, increased pigmentation of the iris, darkening of the eyelashes; Infrequently: hemorrhagic disorders of the retina, uveitis, cystoid macular edema, iritis, blepharospasm, eyelid retraction, periorbital erythema; With unknown frequency: enophthalmos. Vascular disorders: Often: hypertension. Disturbances of the skin and subcutaneous tissues: Infrequently: hirsutism. Common disorders and disorders at the injection site: Infrequently: asthenia. Data from laboratory and instrumental studies Often: abnormal biochemical parameters of liver function. In very rare cases, corneal calcification was observed when phosphate-containing eye drops were used by patients with significant corneal damage.
Hypersensitivity to the active substance or to any of the excipients, age up to 18 years. Caution Be careful when using BIMOPTIC ROMPHARM for the treatment of patients with known risk factors for macular edema (for example, in patients with aphakia, in patients with artifacia and rupture of the posterior lens capsule). BIMOPTIC ROMPHARM should be used with caution in patients with a history of severe eye infections (such as those caused by the herpes simplex virus) or iritis / uveitis. There is no experience of using bimatoprost in patients with concomitant violations of respiratory function, which requires caution in such patients. When conducting clinical studies in patients with impaired respiratory function, there was no significant adverse effect on the respiratory system.The effects of bimatoprost on patients with heart block heavier than first degree or on patients with uncontrolled congestive heart failure have not been studied.
Special studies regarding the interaction of BIMOPTIC ROMPHARM with other drugs have not been conducted. There are no expected interactions in the human body, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng / ml) after instillation of the preparation BIMOPTIC ROMPHARM, eye drops, 0.3 mg / ml. In clinical studies, bimatoprost was used simultaneously with several different ophthalmologic beta-blockers, but no interactions were observed. Simultaneous use of bimatoprost and other antiglaucoma drugs, except for ophthalmologic beta-blockers, was not studied in the course of research on the efficacy and safety of combination therapy. A decrease in the hypotensive effect of bimatoprost was observed when it was used together with other prostaglandin analogues in the treatment of ophthalmopertension and glaucoma.
Pregnancy and Lactation
Fertility There is no information about the effect of bimatoprost on fertility. Pregnancy There are no data from clinical studies on the use of bimtoprost in pregnant women. According to animal studies, reproductive toxicity has been demonstrated when used in high, toxic for the mother's body doses. The use of bimatoprost during pregnancy in the absence of strict indications is not recommended. Breastfeeding period It is not known whether bimatoprost is excreted into human breast milk. Animal studies have shown that bimatoprost is excreted in breast milk. The decision to continue / stop breastfeeding or continue / stop treatment for BIMOPTIC ROMPHARM should be made taking into account the benefits of breastfeeding for the baby and the benefits of BIMOPTIC ROMPHARM for the mother.
Before starting treatment, patients should be informed about the possibility of growth of eyelashes, darkening of the skin of the eyelids and increasing the pigmentation of the iris. Some of these changes can be permanent and can lead to differences in appearance between the eyes when only one eye is treated. Changes in the pigmentation of the iris occurs slowly and may be imperceptible for several months or years. Most often, the color change of the iris is permanent. The change in the color of the iris is more associated with an increase in the melanin content in melanocytes than with an increase in the number of melanocytes. The long-term effects of increased iris pigmentation are unknown. In typical cases, brown pigment spreads from the area around the pupil to the root of the iris, as a result of which the entire iris or its parts become more brown. The use of bimatoprost does not affect nevi and lentigo of the iris. Periorbital tissue pigmentation is reversible in some patients. There are reports of the possibility of developing cystic macular edema during the period of treatment with bimatoprost, the frequency of occurrence of this undesirable phenomenon is infrequent ( aphakia, pseudo-ophakia and rupture of the posterior lens capsule). BIMOPTIC ROMPHARM, eye drops, 0.3 mg / ml contains a preservative benzalkonium chloride, which can be absorbed by soft contact lenses. Irritation may also occur. eye and change in the color of soft contact lenses due to the presence of benzalkonium chloride. It is necessary to remove contact lenses before instillation and put them on again 15 minutes after instillation.Benzalkoniya chloride, used in eye drops as a preservative, can cause the development of punctate keratopathy and / or toxic ulcerative keratopathy. Care should be taken when using the drug in patients with the syndrome of "dry" eye, with damage to the cornea and in the case of the simultaneous use of several types of eye drops containing benzalkonium chloride. It is necessary to control the state of the cornea with long-term use of the drug in this category of patients. There are reports of the possibility of the development of bacterial keratitis associated with the use of vials for multiple use of eye drops. Dropper vials were inadvertently contaminated by patients with concomitant diseases of the organ of vision. The risk of developing bacterial keratitis was higher in patients with impaired corneal epithelium 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 organ of vision and bacterial contamination of the drug. Influence on the ability to drive motor vehicles and control mechanisms BIMOPTIC ROMPHARM has little impact on the ability to drive a vehicle and work with mechanisms. As with the use of other eye drops, if after instillation a temporary blurring of vision occurs, it is necessary to wait for the patient to clear up the visual perception before driving a car or driving machinery.
There were no cases of overdose when applied topically. In case of overdose, treatment should be symptomatic and supportive.
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