Xalatan eye drops 2.5 ml 3 bottles
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Active ingredients
Latanoprost
Release form
Drops
Composition
Active ingredient: latanoprost (LATANOPROSTUM) Concentration of active ingredient (mg): latanoprost 50 mcg
Pharmacological effect
An antiglaucoma drug, an analogue of prostaglandin F2α, is a selective FP receptor agonist (prostaglandin F) and reduces intraocular pressure (IOP) by increasing the outflow of aqueous humor, mainly through the uveoscleral pathway, as well as through the trabecular network. It is established that latanoprost does not have a significant effect on the production of aqueous humor and on the hematophthalmic barrier. When used in therapeutic doses, latanoprost does not have a significant pharmacological effect on the cardiovascular and respiratory sistemy.Snizhenie IOP starts approximately 3-4 hours after drug administration, the maximum effect is observed after 8-12 hours, the effect persists for at least 24 hours.
Pharmacokinetics
Absorption Latanoprost is a prodrug, absorbed through the cornea, where it hydrolyzes (under the action of esterases) to form a biologically active acid. Cmax of latanoprost in aqueous humor is reached approximately 2 hours after topical administration of the drug. The distribution of Vd is 0.16 ± 0.02 l / kg. Acid latanoprost is determined in aqueous humor during the first 4 hours, and in plasma only during the first hour after topical administration. Metabolism Latanoprost acid entering the systemic circulation is metabolized mainly in the liver by beta-oxidation of fatty acids with the formation of 1,2- dinor- and 1,2,3,4-tetranor-metabolites. Injection The acid latanoprost is rapidly removed from the plasma: T1 / 2 is 17 minutes. Systemic clearance is approximately 7 ml / min / kg. After beta-oxidation in the liver, metabolites are excreted mainly by the kidneys: after topical administration, approximately 88% of the dose is excreted in the urine. Pharmacokinetics in special clinical situations The exposure of latanoprost is approximately 2 times higher in children aged 3 to 12 years compared with adult patients and 6 times higher in children under 3 years old. However, the safety profile of the drug does not differ in children and adults. The time to reach Cmax of latanoprost acid in plasma is 5 minutes for all age groups.T1 / 2 acid latanoprost in children is the same as in adults. At equilibrium concentration, the accumulation of latanoprost acid in the blood plasma does not occur.
Indications
Used in the treatment of patients with elevated intraocular pressure at: increased intraocular pressure; glaucoma (open-angle form).
Contraindications
Topical use of Xalatan is contraindicated in allergic reactions to the components of the drug.
Precautionary measures
Do not exceed the recommended dose. The drug should be used with caution in patients with aphakia, pseudo-aphakia with a rupture of the posterior lens capsule, in patients with risk factors for macular edema (cases of macular edema, including cystoid, are described in the treatment with latanoprost); in patients with inflammatory, neovascular glaucoma (due to the lack of sufficient experience with the drug); in case of bronchial asthma, herpetic keratitis in history. It is necessary to avoid using Xalatan in patients with active herpetic keratitis and recurrent herpetic keratitis, especially associated with taking prostaglandin F2α analogues. limited data on the use of the drug Xalatan in patients who are planning surgery for cataracts. In this regard, in this group of patients Xalatan must be used with caution.
Use during pregnancy and lactation
Adequate controlled studies in pregnant women have not been conducted. The drug should be prescribed during pregnancy only in cases where the expected benefit to the mother outweighs the possible risk to the fetus. Latanoprost and its metabolites may be excreted in breast milk, therefore during the period of breastfeeding the drug should be used with caution.
Dosage and administration
Prescribed to adults (including elderly patients), 1 drop 1 time per day in the eye with increased intraocular pressure. It is recommended to instil the drug in the evening hours. Research has shown that with a decrease in the time interval between instillations, the effectiveness of lowering intraocular pressure deteriorates significantly, therefore it is recommended not to exceed the indicated dosage.If the instillation of Xalatan is missed, the next instillation is carried out, as usual - only 1 drop.
Side effects
Against the background of local use of the drug for a long time, about 10% of patients develop conjunctival hyperemia (slight), and only 1% of patients have hyperemia of moderate severity. Allergic reactions in the form of skin rashes are possible. In some patients, point erosion of the epithelium was noted, which proceeded mostly without any symptoms. It is also possible to increase the pigmentation of the iris. In isolated cases, macula edema was observed, mainly in patients with pseudo or aphakia.
Overdose
Symptoms: in addition to irritation of the mucous membrane of the eyes, conjunctival hyperemia or episclera, there were no other undesirable changes on the part of the organ of vision in the case of overdose of latanoprost. More than 90% of the drug is metabolized during the first passage through the liver. In a / infusion 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, flushes and sweating were observed. In patients with bronchial asthma of moderate severity, administration of latanoprost into the eye at a dose 7 times higher than therapeutic did not cause bronchospasm. Treatment: symptomatic therapy.
Interaction with other drugs
When two prostaglandin analogs are instilled into the eyes at the same time, a paradoxical increase in IOP is described; therefore, the simultaneous use of two or more prostaglandins, their analogs or derivatives is not recommended.
special instructions
Xalatan should be prescribed no more than 1 time / day, because more frequent use of latanoprost leads to a weakening of the IOP-lowering effect. When skipping a single dose, the next dose should be administered at the usual time. Latanoprost can be used simultaneously with other classes of ophthalmic topical preparations to reduce IOP.If the patient simultaneously uses other eye drops, they should be used at intervals of at least 5 minutes. Benzalkonium chloride is included in Xalatan, which can be absorbed by contact lenses. Before dropping drops, contact lenses must be removed and re-installed after 15 minutes. Latanoprost may cause a gradual increase in the content of brown pigment in the iris. The change in eye color is due to an increase in the melanin content in the stromal melanocytes of the iris, and not 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. In most cases, the color change is minor and may not be established clinically. Increased pigmentation of the iris of one or both eyes is observed mainly in patients with mixed color of the iris, which is mainly based on brown color. The drug has no effect on nevi and lentigo iris; accumulation of pigment in the trabecular network or in the anterior chamber of the eye was not observed. When determining the degree of pigmentation of the iris for more than 5 years, no undesirable effects of increased pigmentation were detected, even with continued treatment of latanoprost. In patients, the degree of IOP reduction was the same regardless of the presence or absence of increased iris pigmentation. Consequently, the treatment of latanoprost can be continued in cases of increased iris pigmentation. Such patients should be monitored regularly and, depending on the clinical situation, treatment can be discontinued. Increased iris pigmentation is usually observed during the first year after the start of treatment, rarely during the second or third year. After the fourth year of treatment, this effect is not observed. The rate of progression of pigmentation decreases with time and stabilizes after 5 years. In more distant terms, the effects of increased pigmentation of the iris have not been studied. After cessation of treatment, the enhancement of the brown pigmentation of the iris was not observed, however, the change in eye color may be irreversible. In connection with the use of latanoprost, cases of darkening of the eyelid skin that may be reversible are described. increased pigmentation, increase in thickness and change the direction of growth of eyelashes.Changes to the eyelashes are reversible and disappear after stopping treatment. Patients using only one eye drops may develop heterochromia. Effects on the ability to drive vehicles and control mechanisms. The use of eye drops can cause transient blurred vision. It is necessary to drive a car or use a complicated technique while using the drug.