Trilactan eye drops 0.005% 2.5ml vial, 1pc

Product description

Eye drop compositioncomposition: 1 ml of the drug contains: Active ingredient: Latanoprost 0.05 mgm Auxiliary substances: Benzalkonium chloride 0.20 mg sodium chloride 4.10 mg sodium dihydrogen phosphate monohydrate 4.60 mg sodium hydrophosphate anhydrous 4.74 mg Water for injection up to 1 ml. Description: Clear, colorless liquid.

Pharmacological action

Pharmacotherapy group: Anti – glaucoma agent-Prostaglandin F2a synthetic analogath: S. 01. E. E Prostaglandin analogsas. 01. E. E. 01 Latanoprost Pharmacodynamics : Latanoprost, an analog of prostaglandin F2a, is a selective agonist of FP (prostaglandin F) receptors and reduces intraocular pressure (IOP) by increasing the outflow of aqueous humor, mainly by the uveoscleral route, as well as through the trabecular network. A decrease in IOP begins approximately 3-4 hours after use of the drug, the maximum effect is observed after 8-12 hours, and the effect persists for at least 24 hours. It was found that latanoprost does not significantly affect the production of aqueous humor and the blood-ophthalmic barrier. When used in therapeutic doses, latanoprost does not have a significant pharmacological effect on the cardiovascular and respiratory systems. Pharmacokinetics: Latanoprost (molecular weight 432.58) is a prodrug esterified with an isopropyl group, inactive; after hydrolysis to an acidic form, it becomes biologically active. Suctionthe drug is well absorbed through the cornea and is completely hydrolyzed when it gets into watery moisture. Distribution Studies in humans have shown that the maximum concentration in aqueous humor is reached 2 hours after instillation. After instillation to monkeys, latanoprost is distributed mainly in the anterior chamber of the eye, conjunctiva and eyelids. Only a small amount of latanoprost reaches the posterior chamber of the eye. Biotransformation The active form of latanoprost is practically not metabolized in the eye, but undergoes biotransformation in the liver. Elimination The plasma half-life is 17 minutes. Animal studies have shown that the main metabolites (1,2-dinor – and 1,2,3,4-tetranormetabolites) do not have (or have low) biological activity and are mainly excreted in the urine. Children’s exposure to latanoprost is approximately 2 times higher in children aged 3 to 12 years compared to adult patients and 6 times higher in children under 3 years of age. However, the safety profile of the drug does not differ in children and adults. The time to reach the maximum concentration of latanoprost acid in blood plasma is 5 minutes for all age groups. The half-life of latanoprost acid in children is the same as in adults. At equilibrium concentrations, no accumulation of latanoprost acid occurs in the blood plasma.

Indications

Reduction of elevated intraocular pressure in adults and children (over 1 year of age) with open-angle glaucoma or increased ophthalmotonus.

Contraindications

Hypersensitivity to latanoprost or other components of the drug. Age up to 1 year (efficacy and safety have not been established). With caution: Aphakia, pseudoaphakia with rupture of the posterior lens capsule; patients with risk factors for macular edema (cases of macular edema, including cystoid edema, have been described during treatment with latanoprost); inflammatory, neovascular glaucoma (due to lack of sufficient experience with the drug); bronchial asthma; a history of herpetic keratitis. The drug should be avoided in patients with active herpetic keratitis and recurrent herpetic keratitis, especially associated with the use of prostaglandin F2a analogues. The drug should be used with caution in patients with risk factors for iritis/uveitis. There are limited data on the use of the drug in patients who are planning cataract surgery. In this regard, the drug should be used with caution in this group of patients.

Side effects

Most of the adverse reactions were observed on the part of the visual organ. In an open-label 5-year safety study,33% developed iris pigmentation (see section “Special Instructions”). Other adverse reactions from the visual organ are usually transient and occur immediately after instillation. The frequency of adverse reactions was graded as follows: very common (≥1/10); common (≥1/100, <1/10); infrequent (≥1/1000, <1/100); rare (≥1/10 000, <1/1000); very rare (Infections and infestations Frequency unknown: herpetic keratitis. From the side of the visual organ very often: hyperpigmentation of the iris, conjunctival hyperemia, mild to moderate eye irritation (burning sensation, sand sensation in the eyes, itching, tingling and foreign body sensation), changes in the eyelashes (increase in length, thickness, quantity and pigmentation). Often: transient pinpoint erosion of the epithelium (mostly asymptomatic), blepharitis, eye pain. Infrequently: edema of the eyelids, dryness of the eye mucosa, keratitis, blurred vision, conjunctivitis. Rare: iritis/uveitis (mainly in predisposed patients), macular edema, eyelid edema, corneal edema, corneal erosion, periorbital edema, darkening of the skin of the eyelids, reactions from the skin of the eyelids, changing the direction of eyelash growth, thickening, darkening and lengthening of the eyelashes, distichiasis, photophobia. Very rare: changes in the periorbital area and in the area of the eyelashes, leading to a deepening of the furrow of the upper eyelid. Frequency unknown: iris cyst, conjunctival pseudopemphigoid. Nervous system disorders: Frequency unknown: dizziness, headache. From the side of the heart often: angina pectoris, palpitation. Frequency unknown: unstable angina pectoris. From the respiratory system Occasionally: bronchospasm (including exacerbation of the disease in patients with a history of bronchial asthma), shortness of breath. From the side of the skin and subcutaneous tissue often: a rash. Rare: pruritus of the skin. Very rare: darkening of the eyelid skin and local skin reactions on the eyelids. From the musculoskeletal system and connective tissue, the frequency is unknown: myalgia, arthralgia. General disorders and local reactions Very rare: chest pain.

Interaction

When two prostaglandin analogues are simultaneously instilled into the eyes, a paradoxical increase in IOP has been described, so the simultaneous use of two or more prostaglandins, their analogues or derivatives is not recommended Pharmacologically incompatible with eye drops containing thiomersal-precipitation.

How to take, course of use and dosage

Dosage regimen for adults (including the elderly)But one drop in the affected eye(s) once a day. The optimal effect is achieved when using the drug in the evening. Do not instill the drug more often than once a day, as it has been shown that more frequent use reduces the hypotensive effect. If one dose is missed, treatment is continued according to the usual scheme. As with any eye drops, in order to reduce the possible systemic effect of the drug, immediately after instillation of each drop, it is recommended to press for 1 minute on the lower lacrimal point located at the inner corner of the eye on the lower eyelid. This procedure should be performed immediately after instillation. Before instillation, remove contact lenses and install them no earlier than 15 minutes after insertion (see also the section “Special instructions”). If other eye drops need to be applied simultaneously, their use should be separated by a 5-minute interval. Dosage regimen for detey Latanoprost is used in children at the same dose as in adults. Data on the use of the drug in premature children (gestational age Data for children

Overdose

In addition to irritation of the eye mucosa, conjunctival hyperemia or episclera, other undesirable changes on the part of the visual organ with an overdose of latanoprost are not known. In case of accidental ingestion of latanoprost, the following information should be taken into account: one bottle with 2.5 ml of the solution contains 125 mcg of latanoprost. More than 90% of the drug is metabolized at the first pass through the liver. Intravenous infusion at a dose of 3 mcg / kg in healthy volunteers did not cause any symptoms, but 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, the introduction of latanoprost into the eyes at a dose 7 times higher than the therapeutic dose did not cause bronchospasm. In case of overdose, symptomatic treatment is performed.

Special instructions

Latanoprost can gradually change the color of the eyes by increasing the content of brown pigment in the iris. Before starting treatment, patients should be informed about possible irreversible changes in eye color. The use of the drug in one eye can cause irreversible heterochromia. This change in eye color was mainly observed in patients with unevenly colored irises, namely: square-blue, gray-brown, yellow-brown and green-brown. In latanoprost studies, darkening usually started during the first 8 months of treatment, rarely during the second and third years, and was not observed after four years of treatment. The progression of iris pigmentation decreased over time and stabilized after 5 years. There are no data on increased pigmentation over 5 years. In an open-label 5-year safety study of latanoprost,33% of patients developed iris pigmentation (see section “Side effects”). In most cases, the change in the color of the iris was insignificant and, often, not clinically detected.The frequency of occurrence ranged from 7 to 85% in patients with different iris colors, prevailing in patients with yellow-brown irises. No changes were observed in patients with uniformly colored irises of blue color; in rare cases, changes were noted in patients with uniformly colored irises of gray, green and brown color. The change in eye color is caused by an increase in the content of melanin in the stromal melanocytes of the iris, and not by an increase in the number of melanocytes themselves. In typical cases, brown pigmentation appears around the pupil and extends concentrically to the periphery of the iris. In this case, the entire iris or parts of it turn brown. No further pigmentation was observed after discontinuation of therapy. According to available clinical data, color change was not associated with any symptoms or pathological disorders. The drug does not affect the nevi and lentigo of the iris. According to the results of 5-year clinical studies, there was no accumulation of pigment in the sclerocorneal trabecular network or other parts of the anterior chamber of the eye. It has been shown that darkening of the iris does not lead to undesirable clinical consequences, so the use of latanoprost can be continued if such darkening occurs. However, such patients should be regularly monitored and, depending on the clinical situation, treatment may be discontinued. The experience of using latanoprost in the treatment of angle-closure and congenital glaucoma, pigmented glaucoma, and open-angle glaucoma in patients with pseudoaphakia is limited. There is no information about the use of latanoprost in the treatment of secondary glaucoma due to inflammatory eye diseases and neovascular glaucoma. Latanoprost does not affect the pupil size. Due to the fact that information on the use of latanoprost in the postoperative period of cataract extraction is limited, caution should be exercised when using the drug in this category of patients. Caution should be exercised when using latanoprost in patients with a history of herpetic keratitis. In acute herpetic keratitis, as well as in the presence of anamnestic information about chronic recurrent herpetic keratitis, it is necessary to avoid the appointment of latanoprost. Macular edema, including cystic edema, was observed during latanoprost therapy mainly in patients with aphakia, pseudoaphakia. posterior lens capsule rupture, or in patients with risk factors for developing cystic macular edema (in particular, diabetic retinopathy and retinal vein occlusion). Caution should be exercised when using latanoprost in patients with aphakia, pseudoaphakia with posterior capsule rupture or anterior chamber intraocular lenses, as well as in patients with known risk factors for cystic macular edema. Caution should be exercised when using latanoprost in patients with risk factors for iritis/uveitis. Experience with the use of latanoprost in patients with bronchial asthma is limited, but in some cases, in the post-marketing period, there was an exacerbation of the course of asthma and / or the appearance of shortness of breath. Caution should be exercised when using latanoprost in this category of patients (see also the section “Side effects”). There were cases of darkening of the skin of the periorbital area, which in a number of patients were reversible with continued therapy with latanoprost. Latanoprost can cause gradual changes in the eyelashes and downy hair, such as lengthening, thickening, increasing pigmentation, increasing density, and changing the direction of lash growth. The changes in the eyelashes were reversible and resolved after discontinuation of therapy. Trilactan® contains benzalkonium chloride, often used as a preservative in ophthalmic medicinal products. Benzalkonium chloride can cause eye irritation, pinpoint keratopathy, and / or toxic ulcerative keratopathy, as well as being absorbed by soft contact lenses and discoloring them. Careful monitoring of the condition of patients with dry eye syndrome or other corneal diseases with prolonged use of latanoprost is required. Before using the drug, remove contact lenses and re-install them no earlier than 15 minutes after instillation (see also the section “Dosage and use”). Children’s information about the efficacy and safety of latanoprost in children under one year of age is limited. There is no experience of using the drug in premature children (gestational age less than 36 weeks). There is no information on the safety of long-term use of latanoprost in children. For primary congenital glaucoma in children from 0 to 3 years of age, surgical intervention (goniotomy/trabeculotomy) remains the standard treatment method. Influence on the ability to drive vehicles and mechanisms:As with the use of other ophthalmic medications, temporary visual impairment may occur; it is not recommended to drive vehicles or work with mechanisms until it is restored.

Form of production

Eye drops 0.005%.2.5 ml each in a bottle with a low-density polyethylene dropper and a lid with control of the first opening, or in a high-pressure polyethylene dropper bottle complete with a screw-on lid and a dropper plug. 1 or 3 vials together with the instructions for use, the stop device or without it in a pack of cardboard.

Storage conditions

At a temperature of 2 to 8 °C. The opened bottle should be stored at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years. After opening the bottle – 1 month. Do not use after the expiration date!

Active ingredient

Latanoprost

Conditions of release from pharmacies

By prescription

Dosage form

eye drops