Bimatan eye drops 0.03%, 2.5ml

The recommended dose is one drop of bimatoprost in the affected eye (s) 1 time / day in the evening. Do not exceed the recommended dose.

When using more than one ophthalmic drug for topical use, it is necessary to observe an interval of 5 minutes between the introduction of each of them.

Eye drops in the form of a clear, colorless solution.

1 ml

bimatoprost 0.3 mg

Excipients: benzalkonium chloride - 0.05 mg, sodium chloride - 8.3 mg, citric acid monohydrate - 0.14 mg, sodium hydrogen phosphate heptahydrate - 2.68 mg, sodium hydroxide - up to pH 7.3, hydrochloric acid - up to pH 7.3, water d / i - up to 1 ml.

• Hypersensitivity to bimatoprost;

• age up to 18 years.

pharmachologic effect

Antiglaucoma remedy. Bimatoprost is a synthetic prostamide that is structurally related to prostaglandin F2, which does not act through known prostaglandin receptors. Bimatoprost selectively mimics the effects of recently discovered biosynthesized substances, prostamides. However, the structure of the prostamide receptors has not yet been identified. Reduces intraocular pressure by increasing the outflow of aqueous humor through the trabecular network and increasing uveoscleral outflow. A decrease in intraocular pressure begins approximately 4 hours after the first administration, the maximum effect is achieved approximately after 8-12 hours. The effect lasts for at least 24 hours. According to clinical studies, there was no significant effect of bimatoprost on heart rate and blood pressure.

Pharmacokinetics

Bimatoprost penetrates well into the human cornea and sclera in vitro. After instillation in adults, the systemic exposure of bimatoprost is very small, no accumulation of the active substance was noted. After the introduction of one drop of the drug into both eyes 1 time / day for 2 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 detection level (0.025 ng / ml). The average values ??of Cmax and AUC0-24 h were approximately the same on days 7 and 14 - approximately 0.08 ng / ml and 0.09 ng h / ml, respectively, this indicates that the Css of bimatoprost was achieved within 1 week of instillation. Bimatoprost is moderately distributed in body tissues, and Vd in an equilibrium state is 0.67 l / kg. In human blood, bimatoprost is found mainly in plasma. Plasma protein binding of bimatoprost is about 88%.Bimatoprost reaches the systemic circulation, mainly unchanged. Then oxidation, N-deethylation and glucuronization occurs with the formation of a number of metabolites. Bimatoprost is excreted mainly by the kidneys. Up to 67% of the dose administered intravenously to healthy adult volunteers was excreted in the urine, 25% - in the feces. T1 / 2 after intravenous administration was approximately 45 minutes, the total clearance from the blood was 1.5 l / h / kg.

Side effect

From the nervous system: often - headache; infrequently - dizziness. From the side of the organ of vision: very often - conjunctival injection, itching in the eyes, growth of eyelashes; often - superficial punctate keratitis, corneal erosion, burning eyes, eye irritation, allergic conjunctivitis, blepharitis, decreased visual acuity, asthenopia, conjunctival edema, foreign body sensation in the eye, dry eyes, eye pain, photophobia, lacrimation, discharge from the eyes , blurred vision, increased pigmentation of the iris, darkening of the eyelashes; infrequently - retinal hemorrhagic disorders, uveitis, cystic macular edema, iritis, blepharospasm, eyelid retraction, periorbital erythema; frequency unknown - enophthalmos.In very rare cases, corneal calcification has been observed with the use of phosphate-containing eye drops in patients with concomitant significant damage to the cornea. From the side of the cardiovascular system: often - arterial hypertension. From the hepatobiliary system: often - a deviation from the norm of the biochemical parameters of the liver function. On the part of the skin and subcutaneous tissues: infrequently - hirsutism. General reactions: infrequently - asthenia.

Application during pregnancy and lactation

There are no data from clinical studies of the use of bimatoprost during pregnancy. The use of bimatoprost during pregnancy is not recommended, unless there are strict indications. According to preclinical studies in animals, reproductive toxicity has been shown when using bimaptoprost in high doses that are toxic to the mother's body. It is not known whether bimatoprost is excreted in human breast milk. In animal studies, it has been shown that bimatoprost is excreted in breast milk. The decision to continue / discontinue breastfeeding or continue / discontinue treatment with bimatoprost should be made taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the mother.

Application in children

The drug is contraindicated for use in children and adolescents under the age of 18 years.

Use in elderly patients

The drug is approved for use in elderly patients

special instructions

Caution is needed when using bimatoprost preparations for the treatment of patients with known risk factors for macular edema (for example, in patients with aphakia, in patients with pseudophakia and rupture of the posterior lens capsule); in patients with a history of severe eye infections (eg, caused by herpes simplex virus) or iritis / uveitis. There is no experience with the use of bimatoprost in patients with concomitant impaired respiratory function, 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 noted. The effect of bimatoprost on patients with AV block II and III degrees and on patients with uncontrolled congestive heart failure has not been studied.Before starting treatment, patients should be informed about the possibility of eyelash growth, darkening of the eyelid skin and an increase in iris pigmentation. Some of these changes can be permanent and can lead to differences in appearance between the eyes when only one eye is treated. Pigmentation changes in the iris are slow and may not be noticeable for months or years. Most often, the color change in 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. Typically, brown pigment spreads from the area around the pupil to the root of the iris,as a result, all or parts of the iris become more brownish. The use of bimatoprost does not affect the nevi and lentigo of the iris. Pigmentation of periorbital tissue is reversible in some patients. Use with caution in patients with risk factors for macular edema (patients with aphakia, pseudophakia and rupture of the posterior lens capsule).

Drug interactions

There was a decrease in the hypotensive effect of bimatoprost when it was used together with other analogs of prostaglandins in the treatment of ophthalmic hypertension or glaucoma.