Xalatan eye drops 0.005% 2.5ml
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Active ingredients
Latanoprost
Release form
Solution
Composition
Eye drops, composition (1 ml): latanoprost - 50 μg adjuvants: sodium chloride; sodium dihydrophosphate (monohydrate); sodium hydrogen phosphate (anhydrous); benzalkonium chloride; water for injections
Pharmacological effect
antiglaucoma
Pharmacokinetics
Suction. Latanoprost, being a prodrug form, is absorbed through the cornea, where it hydrolyses to a biologically active acid. Concentration in aqueous humor reaches a maximum in about 2 hours after topical administration. Distribution. Vd is (0.16 ± 0.02) l / kg. Acid latanoprost is determined in watery moisture during the first 4 hours, and in plasma - only during the first hour after topical administration. Metabolism. Latanoprost, being a prodrug form, undergoes hydrolysis in the cornea under the action of esterases to form a biologically active acid. Acid latanoprost, 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. Excretion. Acid latanoprost is rapidly removed from the plasma (T1 / 2 = 17 min). 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 administered dose is excreted in the urine).
Indications
Reduced IOP in patients with open-angle glaucoma or increased intraocular pressure.
Contraindications
hypersensitivity to latanoprost or other components of the drug; age up to 18 years. With caution: aphakia, pseudo-ophakia with a rupture of the posterior lens capsule, patients with known risk factors for macular edema (cases of macular edema, including cystoid, are described in the treatment with latanoprost) ; inflammatory, neovascular or congenital glaucoma (due to the lack of sufficient experience with the drug).
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 potential benefit to the mother outweighs the possible risk to the fetus. Latanoprost and its metabolites can be excreted into breast milk, therefore during the period of breastfeeding the drug should be used with caution.
Dosage and administration
Adults (including the elderly) - 1 drop to the affected eye (a) 1 time per day.The optimal effect is achieved with the use of the drug in the evening.
Side effects
The following adverse reactions related to the use of the drug were recorded: On the part of the organ of vision: eye irritation (burning sensation, feeling of sand in the eyes, itching, tingling and foreign body sensation); blepharitis; conjunctival hyperemia; Pain in the eyes; increased pigmentation of the iris; transient point erosion of the epithelium, swelling of the eyelids, edema and erosion of the cornea; conjunctivitis; lengthening, thickening, increasing the number and strengthening of the pigmentation of eyelashes and vellus hair; changing the direction of eyelash growth, sometimes irritating to the eyes; iritis / uveitis; keratitis; macular edema, incl. cystoid; blurred vision. From the skin and subcutaneous tissues: rash, darkening of the eyelid skin and local skin reactions on the eyelids. From the nervous system: dizziness, headache. From the respiratory organs: asthma (including acute attacks or exacerbation of the disease in patients with a history of bronchial asthma), dyspnea. On the part of the musculoskeletal system and connective tissue: pain in the muscles / joints. Non-specific reactions: nonspecific chest pain.
Overdose
Symptoms: in addition to irritation of the mucous membrane of the eyes, conjunctival hyperemia or episclera, other undesirable changes on the part of the organ of vision in the case of overdose of latanoprost are not known. More than 90% of the drug is metabolized during the first passage through the liver. In a / infusion of 3 mcg / kg in healthy volunteers, no volunteers caused any symptoms, however, with a dose of 5.5–10 mcg / kg, nausea, abdominal pain, dizziness, fatigue, hot flashes and sweating were observed. In patients with moderate bronchial asthma, administration of latanoprost into the eye at a dose 7 times higher than the therapeutic one did not cause bronchospasm. Treatment: in case of overdose, symptomatic treatment is carried out.
Interaction with other drugs
When two PG 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 PG, their analogs or derivatives is not recommended. Pharmaceutically incompatible with eye drops containing thiomersal is precipitation.
special instructions
The drug Xalatan should be used no more than 1 time per day, as more frequent administration 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. purpose of reducing IOP. If the patient simultaneously uses other eye drops, they should be used at intervals of at least 5 minutes. Benzalkonium chloride is a part of Xalatan, which can be absorbed by contact lenses. Before dropping the drops, contact lenses must be removed and re-installed after 15 minutes. Latanoprost can 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 reduction in IOP was the same, regardless of the presence or absence of increased pigmentation of the iris. 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 pigmentation of the iris 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 was 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 the treatment. Patients using only one eye drops may develop heterochromia. The use of eye drops can cause transient blurred vision. Effects on the ability to drive a car and control mechanisms. Care should be taken when using the drug.