Bimatan drops 0.03% 2.5ml

Eye drops Bimatan instruction

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Composition

1 ml of the preparation contains:
Active substance: Bimatoprost 0.3 mg.
Excipients: benzalkonium chloride 0.05 mg, sodium chloride 8.30 mg, citric acid monohydrate 0.14 mg, sodium hydrogen phosphate heptahydrate 2,68 mg, sodium hydroxide to pH 7.3, hydrochloric acid to pH 7.3, water for injections up to 1 ml.
Description: Clear, colorless solution.
Pharmacotherapeutic group: anti-glaucoma prostaglandin F2-alpha analogue synthetic.
ATX code: S01EE03

Pharmacological properties

Pharmacodynamics of Bimatan

Bimatoprost reduces intraocular pressure in humans by increasing the outflow of aqueous humor through the trabecular network and increasing the outgrowth of the outflow. Decrease in intraocular pressure begins approximately 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 ophthalmologic antihypertensive agent. This is a synthetic prostamide structurally associated with prostaglandin F2a (PGF2a), which does not act through known prostaglandin receptors. Bimatoprost selectively simulates the effects of newly discovered biosynthesized substances, proteas. However, the structure of the protease receptors has not yet been identified.
Limited information is available on the effectiveness of the drug in the treatment of pseudoexfoliation and pigment glaucoma, as well as on the experience of using bimatoprost in the treatment of closed-angle glaucoma in patients who had previously undergone iridotomy.
According to clinical studies, there was no significant effect of the drug on heart rate and blood pressure.
Pediatric population
There are no data on the efficacy and safety of bimatoprost in patients under 18 years of age.

Pharmacokinetics

Suction
Bimatoprost penetrates well into the cornea and the human sclera in vitro. After instillation to adults, the system exposure of bimatoprost is very small, there is no accumulation of the drug. After the administration of one drop of the drug 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, this value was below the detection level (0.025 ng / ml). The mean values ​​of Cmax and AUC of 0-24 hours were approximately the same at days 7 and 14, approximately 0.08 ng / ml and 0.09 ng * h / ml, respectively, indicating that the stable concentration of bimatoprost was achieved during the first week of instillations.
Distribution
Bimatoprost is moderately distributed in the tissues of the body, and the systemic equilibrium volume is 0.67 l / kg. In human blood, the bimatoprost is mainly in the plasma. The binding of bimatoprost with plasma proteins is about 88%.
Metabolism
Bimatoprost reaches the systemic blood flow, mostly unchanged. Then there is oxidation, N-deethylation and glucuronidation with the formation of a number of metabolites.
Excretion
Bimatoprost is excreted mainly through the kidneys. Up to 67% of the intravenously administered dose in healthy adult volunteers was excreted from the body with urine, 25% of the dose was excreted with feces. The half-life after intravenous administration was approximately 45 minutes, the total clearance from the blood was 1.5 l / h / kg.

Indications for use

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

Contraindications for Bimatan

Hypersensitivity to bimatoprost or other components of this drug, age to 18 years.
Application in pregnancy and during breastfeeding

Pregnancy

There are no clinical studies data on the use of bimatoprost in pregnant women. According to animal studies, reproductive toxicity has been demonstrated when used in high doses, toxic to the body.
It is not recommended to use bimatoprost during pregnancy in the absence of strict indications.

Breastfeeding period

It is not known whether bimatoprost is excreted into human breast milk. In animal studies, it has been shown that bimatoprost is excreted in breast milk. If it is necessary to use bimatoprost during breastfeeding, it is necessary to decide whether to stop breastfeeding or stop bimatoprost treatment, taking into account the benefits of breastfeeding for the baby and the need for therapy with the drug for the mother.

Fertility

There is no information on the effect of bimatoprost on human fertility.

Dosing and Administration

1 drop to the affected eye (eyes) 1 time a day in the evening. Do not exceed the recommended dose, as more frequent instillations can reduce the hypotensive effect of the drug.

Use in the pediatric population

The efficacy and safety of the use of bimatoprost in patients aged 0 to 18 years is not established.

Use in patients with renal and hepatic impairment

The use of Bimatan in patients with hepatic insufficiency of moderate to severe severity has not been studied, which requires caution when using the drug in patients of these groups. Patients with anamnestic information on mild liver function disorder or elevated levels of alanine aminotransferase (ALT), aspartate aminotransferase (ACT) and / or bilirubin have no pathological effect of bimatoprost on the functional state of the liver for 24 months of use.
When using Bimatan in complex therapy, it is necessary to observe no less than 5-minute interval between instillations of bimatoprost and preparations of concomitant therapy.
If you miss a drug, you should take the medicine as soon as possible in the dosage prescribed by the instructions.

Side effect of Bimatan

The following undesirable phenomena were noted during clinical trials and post-marketing period.
Frequency of occurrence was carried out according to 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 (can not be estimated from the available data).
In each group, undesirable effects are presented in descending order of severity.
Impaired nervous system:
Often: headache;
Infrequently: dizziness.
Disorders from the organs of vision:
Very often: conjunctival injection, itchy eyes, eyelash growth;
Often: superficial pinpoint 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 eyes, eye pain, photophobia, lacrimation, discharge from the eyes , impaired vision, increased pigmentation of the iris, darkening of the eyelashes;
Infrequent: hemorrhagic disorders from the retina, uveitis, cystoid macular edema, iritis, blepharospasm, retraction of the eyelid, periorbital erythema;
With unknown frequency: enophthalmos.
Vascular disorders:
Often: hypertension.
Disturbances from the skin and subcutaneous tissues:
Infrequently: hirsutism.
General disorders and disorders at the site of administration:
Infrequently: asthenia.
Laboratory and instrumental research data:
Often: deviation from the norm of biochemical indicators of liver function.
In very rare cases, calcification of the cornea was observed with the use of phosphate-containing eye drops in patients with concomitant significant damage to the cornea.

Carefully

Caution should be exercised when using the drug in the therapy of patients with known risk factors for macular edema (eg, in patients with aphakia, in patients with artifacty and rupture of the posterior capsule of the lens).
Use with caution in patients with severe eye infections and anamnesis (eg, caused by the herpes simplex virus) or irit / uveitis.
There is no experience of using bimatoprost in patients with concomitant disturbances of the function of external respiration, which requires caution in such patients. When conducting clinical trials in patients with impaired respiratory function, no significant adverse effects on the respiratory system were noted.
The impact of bimatoprost has not been studied on patients with cardiac blockade that is heavier than the first degree or on patients with uncontrolled congestive heart failure. There was a limited number of cases of bradycardia or hypotension with bimatoprost. Bimatoprost should be used with caution in the treatment of patients prone to low heart rate or low blood pressure.
The effects of bimatoprost have not been studied in patients with inflammatory diseases of the organ of vision, neovascular, inflammatory, occlusive glaucoma, congenital glaucoma, or narrow-angle glaucoma.

Overdose

There were no cases of overdose with topical application. In case of an overdose, treatment should be symptomatic and supportive.
Interaction Bimatan with other drugs
Special studies of interaction with other drugs have not been conducted. No interactions are expected in the human body, since the systemic concentrations of bimatoprost are extremely low (less than 0.2 ng / ml) after topical application of the drug in ophthalmology.
In clinical trials, bimatoprost was used in conjunction with several different beta-blockers for topical application in ophthalmology, but no interactions were observed.
Simultaneous use of bimatoprost and other antiglaucoma 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 in its joint use with other analogues of prostaglandins in the therapy of ophthalmic hypertension or glaucoma.

special instructions for Bimatan

Before starting treatment, patients should be informed about the possibility of eyelash growth, darkening of the skin of the eyelids and increased 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. The change in the pigmentation of the iris occurs slowly and may be unnoticeable for several months or years. Most often the change in iris color is permanent. The change in the color of the iris is more associated with an increase in melanin content in melanocytes than with an increase in the number of melanocytes. 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, the entire iris or part of it becomes more brown. The use of bimatoprost does not affect the nevi and lentigo iris. Pigmentation of periorbital tissue is reversible in some patients.
There are reports of the possibility of developing cystoid macular edema during bimatoprost treatment, 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, pseudo-aphakia and rupture of the posterior capsule of the lens).
Bimatan contains a preservative of benzalkonium chloride, which can be absorbed by soft contact lenses. Eye irritation and discoloration of soft contact lenses due to benzalkonium chloride may also occur. It is necessary to remove contact lenses before installation and again to put them on in 15 minutes after instillation.
Benzalkonium chloride, used in eye drops as a preservative, can cause the development of point keratopathy and / or toxic ulcer keratopathy. Care should be taken 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 required 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 the multiple use of eye drops. The droppers were unintentionally contaminated with patients with concomitant diseases of the organ of vision. The risk of developing bacterial keratitis was higher in patients with a violation of the integrity of the corneal epithelium. It is necessary to warn patients about the need to avoid contact of the tip of the vial-dropper with the surface of the eye and other surfaces in order to avoid damage to the eye and bacterial contamination of the drug.
Influence on ability to drive vehicles and work with mechanisms
Bimatan has little effect on the ability to drive vehicles and work with machinery. As with the application of other eye drops, if a temporary blurring of vision occurs after instillation, it is necessary to wait for the restoration of the clearness of the visual perception before driving the machine or controlling the mechanisms.

Form of issue

Eye drops 0.03%.
For 2.5 ml of the preparation in a polyethylene bottle with a stopper-dropper and a screw cap of turquoise color with the control of the first autopsy. One bottle with instructions for use in a cardboard pack.
Shelf life - 3 years.
Drops should be used within 30 days after opening the vial.
Do not use after the expiry date printed on the package.

Storage conditions

Store at a temperature of 2 to 25 ° C.
Keep out of the reach of children.

Conditions of leave from pharmacies

To buy Bimatan the prescription is not required.