Eye drops – 1 ml:
- Active ingredient: 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.
Bottle with dropper plug, 2.5 ml.
Antiglaucoma remedy. Bimatoprost is a synthetic prostamide structurally linked to prostaglandin F2α, which does not act through known prostaglandin receptors. Bimatoprost selectively imitates the effects of recently discovered biosynthesized substances, prostamides. However, the structure of prostamide receptors has not yet been identified.
Bimatoprost 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 after approximately 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.
Open-angle glaucoma and ophthalmic hypertension in adults (as monotherapy or in combination with beta-blockers).
Mode of administration and dosage
1 drop of bimatoprost into the affected eye (s) 1 time / day in the evening. Do not exceed the recommended dose.
Application during pregnancy and lactation
Contraindicated in children and adolescents under 18 years of age.
There are no data from clinical studies of the bimatoprost use during pregnancy. The use of bimatoprost during pregnancy is not recommended, except in cases of strict indications.
According to preclinical studies in animals, reproductive toxicity was shown when using bimaptoprost in high doses that are toxic to the mother’s body.
It is unknown 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.
Hypersensitivity to bimatoprost; age up to 18 years. 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.
- The nervous system: often – headache; infrequently – dizziness.
- 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 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, blurred vision, increased pigmentation of the iris, darkening of 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 corneal damage.
- The cardiovascular system: often – arterial hypertension.
- The hepatobiliary system: often – a deviation from the norm of the biochemical parameters of the liver function.
- The skin and subcutaneous tissues: infrequently – hirsutism.
- General reactions: infrequently – asthenia.
There were no cases of overdose with topical application. In case of overdose, treatment should be symptomatic and supportive.
A decrease in the hypotensive effect of bimatoprost was noted when it was used together with other prostaglandin analogs in the treatment of ophthalmic hypertension or glaucoma.
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 degree 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 are slow and may not be noticeable over several months or years. Most often, the color change in the iris is permanent. Changes in the color of the iris are more associated with an increase in 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, resulting in the entire iris or parts of it becoming brownish. The use of bimatoprost has no effect on nevi and iris lentigo. Pigmentation of periorbital tissue is reversible in some patients.