Active substanceLatanoprostLatanoprost
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  • Dosage form: & nbspeye drops
    Composition:

    1 ml of the solution contains:

    Active substance: latanoprost 50 mcg.

    Excipients: sodium chloride - 4,10 mg, benzalkonium chloride - 0.20 mg, sodium hydrophosphate - 4.74 mg, sodium dihydrogen phosphate monohydrate - 4.60 mg, water for injection - 0.9974 mg.

    Description:A clear, colorless solution.
    Pharmacotherapeutic group:Antiglaucoma means - prostaglandin F2α analogue synthetic
    ATX: & nbsp

    S.01.E.E   Prostaglandin analogues

    S.01.E.E.01   Latanoprost

    Pharmacodynamics:

    Latanoprost, an analogue of prostaglandin E2-alpha, is a selective proponoid receptor agonist FP. The drug reduces intraocular pressure (IOP) by increasing the outflow of aqueous humor, mainly by the uveoscleral route, and also through the trabecular network.Decrease in IOP begins approximately 3-4 hours after the administration of the drug, the maximum effect is observed after 8-12 hours, the effect persists for at least 24 hours. Determined that latanoprost does not have a significant effect on the production of aqueous humor and on the hemato-ophthalmic barrier. In the short-term treatment of patients with pseudo-pharmacies latanoprost does not cause penetration of fluorescein into the posterior segment of the eye. When used in therapeutic doses latanoprost has no significant pharmacological effect on the cardiovascular and respiratory systems.

    Pharmacokinetics:

    Suction

    Latanoprost, being a prodrug, is absorbed through the cornea, where its hydrolysis occurs to a biologically active acid. The maximum concentration (CmOh) in aqueous humor is achieved approximately 2 hours after topical application.

    Distribution

    Volume of distribution (Vd) is about 0.16 l / kg. Latanoprost acid is determined in aqueous humor during the first 4 hours, and in plasma only within the first hour after topical application.

    Metabolism

    Latanoprost, being a prodrug, undergoes hydrolysis in the cornea under the action of esterases to form a biologically active acid. Latanoprost acid, entering the systemic circulation, is metabolized mainly in the liver by beta-oxidation of fatty acids to form 1,2-dinor- and 1,2,3,4-tetranor metabolites.

    Excretion

    Latanoprost acid is rapidly excreted from the plasma, the elimination half-life (T1 / 2) which is about 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 application of the kidneys, approximately 88% of the dose is excreted.

    Indications:

    - Open angle glaucoma.

    - Increased intraocular pressure.

    Contraindications:

    - Hypersensitivity to latanoprost and other components of the drug.

    - Children's age (up to 18 years).

    Carefully:Afakia, pseudo-aphakia with a rupture of the posterior capsule of the lens; patients with known risk factors for macular edema (in the treatment with latanoprost, cases of development of macular edema, including cystoid edema); inflammatory, neovascular or congenital glaucoma (due to a lack of sufficient experience in the use of the drug).
    Pregnancy and lactation:

    The use of the drug Latatomol during pregnancy is possible only under the supervision of a doctor and only if the expected benefit for the mother exceeds the potential risk to the fetus.

    Latanoprost and its metabolites can be excreted in breast milk. If it is necessary to administer the drug Latatomol during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Locally, one drop in the conjunctival sac of the affected eye once a day, in the evening. To reduce the possible systemic absorption, it is recommended to press the middle of the inner corner of the eye for one minute (occlusion of lacrimal points) after instillation of each drop of the drug.

    Do not exceed the daily dose of latanoprost, since more frequent use of the drug reduces the effect of reducing intraocular pressure.

    In case of missed dose, the following use of Latatomol is carried out in the usual mode, that is, the dose is not doubled.

    Side effects:

    Depending on the frequency of occurrence, the following groups of side effects are distinguished: very often:> 1/10; often:> 1/100, <1/10; infrequently:> 1/1000, <1/100; rarely:> 1/10000, <1/1000; very rarely: <1/10000, including individual messages.

    From the side of the organ of vision: very often - increased pigmentation of the iris, irritation of the eyes (burning sensation, sensation of sand in the eyes, itching, tingling and foreign body sensation), lengthening, thickening, increased number and increased pigmentation of the eyelashes; often congestion hyperemia, transient point erosions of the epithelium (often asymptomatic), blepharitis, pain in the eyes; infrequently - the swelling of the eyelids, keratitis, blurred vision; rarely iritis / uveitis, macular edema (including cystoid edema), edema and erosion of the cornea, periorbital edema, darkening of the eyelid skin, local skin reactions from the eyelids, changes in the direction of eyelash growth (sometimes causing eye irritation), lengthening, thickening, enlargement number and intensification of pigmentation of the hair of the eyelids, distichiasis.

    From the cardiovascular system: often - palpitations; very rarely - the progression of angina pectoris.

    On the part of the respiratory and mediastinal organs: rarely - bronchial asthma (including acute attacks or exacerbation of the disease in patients with bronchial asthma in the anamnesis), dyspnea.

    From the skin: infrequently - a skin rash.

    Common violations: very rarely - nonspecific pain in the chest.

    From the nervous system: rarely - dizziness, headache.

    From the musculoskeletal system: rarely - pain in muscles, joint pain.

    Overdose:

    Symptoms: irritation of the mucous membrane of the eye, hyperemia of the conjunctiva or episcler.

    In case of an overdose of latanoprost, symptomatic treatment is recommended.
    Interaction:

    Pharmaceutically incompatible with eye drops containing thiomersal (a precipitation reaction develops).

    When prescribing a combination therapy, eye drops of various drugs should be injected with an interval of at least 5 minutes. Simultaneous instillation of two analogues of prostaglandins can cause a paradoxical increase in intraocular pressure.

    Special instructions:

    Latamonom contains benzalkonium chloride, which can be absorbed by contact lenses. Before instilling eye drops, contact lenses should be removed; You can insert the lenses only 15 minutes after instillation.

    Latanoprost is able to cause a gradual change in the color of the iris of the eyes by increasing the amount of brown pigment in the iris. This effect is revealed mainly in patients with mixed color of the iris, for example, blue-brown,gray-brown, green-brown or yellow-brown, which is explained by the increase in melanin content in the stromal melanocytes of the iris. Typically, brown pigmentation spreads concentrically around the pupil to the periphery of the iris of the eyes, while the entire iris or parts of it can acquire a more intense brown color. In the case of an intense change in eye pigmentation, therapy is discontinued.

    In patients with a uniformly colored iris of blue, gray, green or brown eyes, changes in the color of the iris after 2 years of use are rare. The developed color change can be irreversible. Before starting treatment, patients should be informed about the possibility of changing the color of the iris of the eyes.

    Latanoprost can cause gradual changes in eyelashes and fleece hair, such as lengthening, thickening, increased pigmentation, increased density and change directions of eyelash growth. The eyelash changes are reversible and pass after the cessation of treatment.

    Patients who apply drops to only one eye may develop heterochromia.

    Effect on the ability to drive transp. cf. and fur:

    With the use of the drug Latatomol, a brief blurring of vision (sensation of a "veil before the eyes") can develop, so before this effect disappears it is necessary to refrain from driving and other potentially dangerous mechanisms.

    Form release / dosage:

    Eye drops 0.005%.

    Packaging:

    For 2.5 ml of the drug in a vial-dropper with a screw cap of low-density polyethylene.

    For 1 bottle with instructions for use in a cardboard bundle.

    Storage conditions:

    In the dark place at a temperature of 2 to 8 ° C.

    The opened vial should be stored at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    The opened vial should be used within 4 weeks.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-001321
    Date of registration:02.12.2011
    The owner of the registration certificate:Pharmaceutical factory "POLFARMA" JSCPharmaceutical factory "POLFARMA" JSC Poland
    Manufacturer: & nbsp
    TAEJOON PHARM, Co., Ltd. The Republic of Korea
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp17.11.2015
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