Glauprost eye drops f drops0.005% 2.5 ml N3
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Active ingredients
Latanoprost
Release form
Drops
Composition
1 ml contains latanoprost 50 mcg. Excipients: disodium hydrogenphosphate dodecahydrate - 17 mg, sodium dihydrogen phosphate dihydrate - 7 mg, sodium chloride - 3 mg, benzalkonium chloride - 0.2 mg, purified water - up to 1 ml.
Pharmacological effect
Eye drops Glauprost, an antiglaucoma drug, is a complete analogue of prostaglandin F2α and a selective agonist of FP receptors. The drug is able to reduce intraocular pressure by activating the outflow of aqueous humor, via the uveoscleral route or through the trabecular network. No significant effect on the production of aqueous humor, does not affect the hematophthalmic barrier. The decrease in pressure begins 3-4 hours after the administration of the agent and reaches its maximum effect after 8 or 12 hours. The duration of the drug - at least one day
Pharmacokinetics
It penetrates the cornea well, while hydrolysis occurs to a biologically active form. The time to reach the maximum concentration (TS max) in aqueous humor is 2 h after topical application. In the tissues of the eye, latanoprost acid is practically not metabolized; metabolism occurs mainly in the liver. The half-life (T 1/2) - 17 min. The major metabolites, 1,2-dinor and 1,2,3,4-tetranormetabodites, do not have or have a weak biological activity. Excreted by the kidneys
Indications
Glaucoma of various types
Contraindications
Hypersensitivity to the drug components patients with inflammatory, neovascular or congenital glaucoma (due to the lack of sufficient experience with the drug).
Precautionary measures
Do not use latanoprost more than 1 time per day, as more frequent administration reduces the therapeutic effect. The patient should be warned about the need for urgent appeal for help in the development of any unwanted eye reactions. Before instillation of Glaupros, contact lenses should be removed due to their adsorption of benzalkonium chloride contained in the preparation. Lenses can be put on 15 minutes after instillation.
Use during pregnancy and lactation
Contraindicated
Dosage and administration
Adults (incl.elderly patients) 1 drop to the affected eye (a) 1 time / day. The optimal effect is achieved with the use of the drug in the evening. It is not necessary to instil the drug more often than 1 time per day, since it has been shown that more frequent administration reduces the hypotensive effect. in order to reduce the possible systemic effect of the drug, immediately after instillation of each drop, it is recommended to press on the lower lacrimal point located at the inner corner of the eye on the lower eyelid for 1 min. This procedure must be performed immediately after instillation. Before instillation, you need to remove contact lenses and install them no earlier than 15 minutes after the injection. same dose as adults. Data on the use of the drug in preterm (gestational age <36 weeks) are not available. Data in children under the age of 1 year is very limited.
Side effects
Most adverse reactions were noted by the organ of vision. In an open 5-year safety study, 33% of patients developed iris pigmentation. Other undesirable reactions from the organ of vision, as a rule, are transient and are observed immediately after instillation. The gradation of undesirable reactions in terms of frequency of occurrence was carried out as follows: very often (> 1/10); often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10 000, <1/1000) and very rarely (<1/10 000). Frequency is not known (it is impossible to estimate the frequency based on available data). Infections and invasions: frequency is unknown - herpetic keratitis. sand in the eyes, itching, tingling and foreign body sensation), change in the eyelashes (increase in length, thickness, quantity and pigmentation); often - transient point erosion of the epithelium (mostly asymptomatic), blepharitis, pain in the eyes; infrequently - eyelid edema, dryness of the mucous membrane of the eye, keratitis, blurring of vision,conjunctivitis; rarely - iritis / uveitis (mainly in predisposed patients), macula edema, eyelid edema, corneal edema, corneal erosion, periorbital edema, darkening of the eyelid skin, eyelid skin reaction, changing the direction of eyelash growth, thickening, darkening and lengthening of eyelashes, distyhiaz photophobia; very rarely, changes in the periorbital region and in the region of the eyelashes, leading to a deepening of the furrow of the upper eyelid; frequency unknown - iris cyst. From the nervous system: frequency unknown - dizziness, headache. From the cardiovascular system: very rarely - aggravation of angina in patients with concomitant angina; frequency is unknown - feeling of heartbeat. On the part of the respiratory system: rarely - bronchospasm (including exacerbation of the disease in patients with a history of bronchial asthma), shortness of breath. On the side of the skin and subcutaneous tissues: rarely - rash; rarely - darkening of the eyelid skin and local skin reactions on the eyelids. From the musculoskeletal system: frequency unknown - myalgia, arthralgia. Others: very rarely - chest pain. Children According to the results of two short-term (<12 weeks) clinical studies in 93 children The safety of latanoprost in children did not differ from the safety profile in adults. The safety profile between different age groups in children is comparable. Compared with the adult population, nasopharyngitis and fever were most common in children.
Overdose
Symptoms: in addition to irritation of the mucous membrane of the eyes and hyperemia, other undesirable reactions from the organ of vision are not described in case of overdose of latanoprost. When accidentally taking latanoprost orally, the following information should be taken into account: one bottle of 2.5 ml of solution contains 125 μg of latanoprost. More than 90% of latanoprost is metabolized during the first passage through the liver. In / in the infusion at a dose of 3 mcg / kg in healthy volunteers did not cause any symptoms, however, with a dose of 5.5-10 mcg / kg nausea, abdominal pain, dizziness, fatigue, hot flashes and sweating. In / in the introduction of latanoprost monkeys at a dose of 500 mg / kg did not cause significant effects on the part of the cardiovascular system. In / in the introduction of latanoprost monkeys caused transient bronchospasm.In patients with moderate bronchial asthma, instillation of latanoprost in the eye at a dose 7 times higher than therapeutic did not cause bronchospasm. Treatment: symptomatic therapy.
Interaction with other drugs
Unambiguous data on the drug interaction of latanoprost are not available. With simultaneous instillation of two prostaglandin analogues, a paradoxical increase in IOP is described, therefore the simultaneous use of two or more prostaglandins, their analogs or derivatives, is not recommended. In vitro studies have shown that when mixing eye drops containing thiomersal, eye drops containing latanoprost, precipitate is formed. If necessary, the simultaneous use of these drugs should be observed 5-minute interval between their instillation.
special instructions
The use of latanoprost can gradually change the eye color by increasing the content of brown pigment in the iris. Before treatment, patients should be informed of the possible irreversible change in eye color. Heterochromia may develop in patients using only one eye drop. This effect is detected mainly in patients with a mixed color of the iris, for example, blue-brown, gray-brown, green-brown or yellow-brown. In studies of latanoprost, darkening usually began during the first 8 months of treatment, rarely during the second or third year and was not observed after 4 years of treatment. The progression of iris pigmentation decreased with time and stabilized after 5 years. Data on the enhancement of pigmentation over 5 years are not available. In an open 5-year study of the safety of latanoprost, 33% of patients developed iris pigmentation. In most cases, the change in the color of the iris was insignificant and, often, was not clinically detected. The frequency of occurrence ranges from 7% to 85% in patients with mixed iris coloration, prevailing in patients with yellow-brown iris. Changes in patients with a uniformly colored blue iris were not observed, in rare cases changes were observed with evenly colored iris gray, green and brown. The change in eye color is due to an increase in melanin content in the stromal melanocytes of the iris, rather than an increase in the number of melanocytes themselves. In typical cases, brown pigmentation appears around the pupil and concentrically spreads to the periphery of the iris.In this case, the entire iris or its parts become brown. After discontinuation of therapy, further pigmentation was not observed. According to the available clinical data, the color change was not associated with any symptoms or pathological disorders. The drug has no effect on nevi and irti lentigo. According to the results of 5-year clinical studies, pigment accumulation in the sclero-corneal trabecular network or other parts of the anterior chamber eyes not marked. It has been shown that darkening of the iris does not lead to undesirable clinical consequences; therefore, the use of latanoprost can occur if such a darkening occurs. However, such patients should be monitored regularly and, depending on the clinical situation, treatment can be discontinued. The experience of using latanoprost in the treatment of angle-closure and congenital glaucoma, pigmentary glaucoma, open-angle glaucoma in patients with pseudo-ophakia is limited. There is no information on the use of latanoprost in the treatment of secondary glaucoma due to inflammatory diseases of the eye and neovascular glaucoma. Latanoprost does not affect the size of the pupil. Due to the lack of experience of using latanoprost in the treatment of acute attack of angle-closure glaucoma, the drug should be used with caution in such patients. Due to the fact that there is limited information on the use of latanoprost in the postoperative period of cataract extraction, use of the drug in this category of patients . Care should be taken when applying latanoprost in patients with a history of herpetic keratitis. In case of acute herpetic keratitis, as well as in case of availability of anamnestic information about chronic recurrent herpetic keratitis, it is necessary to avoid prescribing latanoprost. Macular edema, incl. cystic, was noted during the period of treatment with latanoprost mainly in patients with aphakia, pseudo-ophakia, rupture of the posterior lens capsule or in patients with risk factors for cystic macular edema (in particular, in diabetic retinopathy and retinal vein occlusion). Care should be taken when using latanoprost in patients with aphakiapseudo-ophakia with posterior capsule rupture or anterior chamber intraocular lenses, as well as in patients with known risk factors for cystic edema of the macula. Care should be taken when using latanoprost in patients with risk factors for developing iritis / uveitis. In some cases, in the post-registration period, asthma exacerbation and / or dyspnea were observed. Caution should be exercised when using latanoprost in this category of patients. There have been cases of darkening of the skin of the periorbital region, which in some patients were reversible with continued therapy with latanoprostom. thicknesses and changing the direction of growth of eyelashes. Changes to the eyelashes were reversible and passed after cessation of therapy. Glauprost contains benzalkonium chloride, often used as a preservative in ophthalmic medications. Benzalkoniya chloride can cause eye irritation, pinpoint keratopathy and / or toxic ulcerative keratopathy, as well as be absorbed by soft contact lenses and discolor them. Careful monitoring of the condition of patients with dry eye syndrome or other corneal diseases with long-term use of latanoprost is required. Before using the drug, it is necessary to remove contact lenses and reinstall them no earlier than 15 minutes after instillation. Use in pediatrics Information about the efficacy and safety of using latanoprost in children under 1 year of age is limited. There is no experience with the drug in premature babies (gestational age less than 36 weeks). There is no information about the safety of long-term use of latanoprost in children. In primary congenital glaucoma in children aged 0 to 3 years, surgical intervention remains the standard method of treatment (goniotomy / trabeculotomy). Effect on the ability to drive motor vehicles and control mechanisms As with other ophthalmologic drugs, temporary visual impairment is possible; it is not recommended to drive vehicles or work with mechanisms until it is restored