Bimoptik Rompharm eye drops 0.3mg/ml vials, 3ml

Composition

1 ml of the drug: Active ingredient: bimatoprost-0.30 mg; excipients: citric acid monohydrate-0.14 mg, sodium phosphate di-substituted 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-up to pH 7.3+ 0.1, purified water – up to 1.0 ml

Pharmacological action

Bimatoprost reduces intraocular pressure in humans by increasing the outflow of aqueous humor through the trabecular meshwork and increasing uveoscleral outflow. Reduction of intraocular pressure begins approximately 4 hours after the first injection and the maximum effect is achieved after approximately 8-12 hours. The effect lasts for at least 24 hours. Bimatoprost is a powerful ophthalmic antihypertensive agent. It is a synthetic prostamide structurally related to prostaglandin F2a (PGF2a), which does not act through known prostaglandin receptors. Bimatoprost selectively mimics the effects of recently discovered biosynthesized substances, prostamides. However, the structure of prostamide receptors has not yet been identified. According to clinical studies, there was no significant effect of the drug on heart rate and blood pressure. Paediatric population There are no data on the efficacy and safety of bimatoprost in patients under 18 years of age. Pharmacokineticsabsorption: Bimatoprost penetrates well into the human cornea and sclera in vitro. After instillation to adults, the systemic exposure of bimatoprost is very low, and no accumulation of the drug is noted. After use of one drop of the drug BIMOPTIC ROMPHARM in both eyes once a day for two weeks, the concentration in the blood reached a maximum 10 minutes after the dose was administered, and within 1.5 hours this indicator was below the level of determination (0.025 ng / ml). Mean Cmax and AUC values of 0-24 hours were approximately the same on days 7 and 14 – approximately 0.08 ng / ml and 0.09 ng * h / ml, respectively, indicating that a stable concentration of bimatoprost 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 found in plasma. The binding of bimatoprost to plasma proteins is about 88%. Metabolism: Bimatoprost reaches the systemic circulation, mostly unchanged. This is followed by oxidation, N-deethylation, and glucuronidation to form a number of metabolites. Deduction: Bimatoprost is mainly excreted through the kidneys. Up to 67% of the intravenous dose in healthy adult volunteers was excreted in the urine, and 25% of the dose was excreted in the faeces. The half-life after intravenous use was approximately 45 minutes, and the total blood clearance was 1.5 l / h / kg.

Indications

Reduction of elevated intraocular pressure in open-angle glaucoma and ophthalmic hypertension in adults (as monotherapy or in combination with beta-blockers).

Use during pregnancy and lactation

fertility There is no information about the effect of bimatoprost on fertility. Pregnancythere are no data from clinical studies of the use of bimtoprost in pregnant women. According to animal studies, reproductive toxicity has been demonstrated when used in high doses that are toxic to the mother’s body. It is not recommended to use bimatoprost during pregnancy in the absence of strict indications. Breast-feeding period It is not known whether bimatoprost is excreted in human breast milk. Animal studies have shown that bimatoprost is excreted in breast milk The decision to continue / stop breastfeeding or continue / stop treatment with BIMOPTIC ROMPHARM should be made taking into account the benefits of breastfeeding for the child and the benefits of BIMOPTIC ROMPHARM therapy for the mother.

Recommendations for use

The recommended dose is one drop in the affected eye (s) once a day in the evening. Do not instill the drug more than once a day, as more frequent use may reduce the effect of reducing intraocular pressure. When using more than one topical ophthalmic drug, it is necessary to observe an interval of 5 minutes between the use of each of them. Use in the pediatric population, BIMOPTIC ROMPHARM is not recommended for use in children under 18 years of age due to the lack of data on the safety and efficacy of the drug. Use in hepatic and renal insufficiency BIMOPTIC ROMPHARM has not been studied in patients with moderate to severe renal or hepatic insufficiency, so it should be used with caution in such patients. In patients with a history of mild hepatic impairment or elevated levels of alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and / or bilirubin, the drug BIMOPTIC ROMPHARM, eye drops,0.3 mg / ml did not adversely affect the functional state of the liver for 24 months.

Contraindications

Hypersensitivity to the Active ingredient or to any of the excipients, under 18 years of age. Caution Should be exercised when using BIMOPTIC ROMPHARM in the treatment of patients with known risk factors for macular edema (for example, in patients with aphakia, in patients with artiphakia and rupture of the posterior lens capsule). BIMOPTIC ROMPHARM 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. No significant adverse effects on the respiratory system were observed in clinical studies in patients with impaired respiratory function. The effects of bimatoprost on patients with severe first-degree heart block or on patients with uncontrolled congestive heart failure have not been studied.

Side effects

The following adverse events were reported in clinical trials and in the post-marketing period. The frequency of occurrence is given according to the following classification: very common (>1/10); common (>>1/100 to >><1/10); uncommon (>1/1000 to <1/10); uncommon (><1/100); rare (>1/10000 to <1/100); rare (><1/1000); very rare ( In each group, undesirable effects are presented in descending order of severity. Nervous system disorders: Common: Headache; Uncommon: dizziness;Visual disorders: Very common: conjunctival injection, itchy eyes, eyelash growth; Common: superficial pinpoint keratitis, corneal erosion, burning 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 the eyelashes; Infrequently: retinal hemorrhagic disorders, uveitis, cystic macular edema, iritis, blepharospasm, eyelid retraction, periorbital erythema; With unknown frequency: enophthalmos. Vascular disorders: Common: hypertension. Skin and subcutaneous tissue disorders: 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, corneal calcification has been observed with the use of phosphate-containing eye drops in patients with concomitant significant corneal damage.

Interaction

Special studies regarding the interaction of BIMOPTIC ROMPHARM with other drugs have not been conducted. No interactions are expected in humans, as systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ml) after instillation of the drug BIMOPTIC ROMPHARM, eye drops,0.3 mg / ml. In clinical studies, bimatoprost was used simultaneously with several different ophthalmic beta-blockers, but no interactions were observed. The concomitant use of bimatoprost and other anti-glaucoma drugs, other than ophthalmic beta-blockers, has not been studied in studies of the efficacy and safety of combination therapy. There was a decrease in the hypotensive effect of bimatoprost when it was used together with other prostaglandin analogues in the treatment of ophthalmohypertension and glaucoma.

Overdose

There were no cases of overdose when applied topically. In case of overdose, treatment should be symptomatic and supportive.

Special instructions

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. Changes in the pigmentation of the iris occur slowly and may not be noticeable 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, rather 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, resulting in the entire iris or parts of it becoming more brown. The use of bimatoprost does not affect the nevi and lentigo of the iris. 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 adverse event is infrequent ((>1/1000 to > BIMOPTIC ROMPHARM, eye drops,0.3 mg / ml contains the preservative benzalkonium chloride, which can be absorbed by soft contact lenses. There may also be eye irritation and discoloration of soft contact lenses due to the presence of benzalkonium chloride. Remove contact lenses before instillation and put them back on 15 minutes after instillation. Benzalkonium chloride, used in eye drops as a preservative, can cause 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 bacterial keratitis associated with the use of refillable eye drop bottles. 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 motor vehicles and manage Mechanicsmimoptic ROMPHARM has a slight effect on the ability to drive a vehicle and work with mechanisms. As with other eye drops, if temporary blurring of vision occurs after instillation, it is necessary to wait for the patient to restore clarity of visual perception before driving a car or operating mechanisms.

Form of production

Transparent from colorless to light yellow solution.

Storage conditions

Store at a temperature not exceeding 25 °C, in the original packaging. Keep out of reach of children! 

Shelf

life is 3 years. After opening the bottle, the drops should be used for 4 weeks. Do not use after the expiration date!

Active ingredient

Bimatoprost

Conditions of release from pharmacies

By prescription

Dosage form

eye drops