Index of drugs

Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension. Reduction of elevated intraocular pressure in children and adolescents with elevated intraocular pressure and childhood and adolescent glaucoma.

1 ml of solution contains 50 μg latanoprost. The preparation contains banzalkonium chloride.

Prostaglandin analog F2_α, a selective prostanoid agonist of FP receptors. It reduces intraocular pressure by increasing the outflow of aqueous humor. Increases choroidal-scleral outflow and reduces the flow resistance. The drug has no significant effect on the production of aqueous humor, does not affect the blood-liquid barrier. The reduction in intraocular pressure occurs about 3-4 hours after administration of the drug, the maximum effect occurs after 8-12 h, the effect persists for at least 24 h. Latanoprost is an inactive prodrug that is well absorbed through the cornea and the entire active substance that it enters the aqueous humor when it is passed through the cornea to the biologically active latanoprost acid. The maximum concentration of the drug in aqueous humor occurs approximately 2 hours after administration. It is distributed mainly in the anterior chamber, in the conjunctiva and the eyelids, only minimal amounts reach the chamber of the posterior eye. The drug is practically not metabolized in the eye. Metabolism occurs mainly in the liver. T_0,5 drug in plasma is 17 min. Inactive metabolites are mainly excreted in the urine.

Hypersensitivity to the active substance or to any of the excipients.

During treatment, the pigmentation of the iris may change; if this symptom is present, treatment may be continued, however, patients should be tested regularly and if required by clinical status, treatment with latanoprost can be discontinued. Caution should be exercised when administering the formulation in chronic angle-closure glaucoma, open-angle glaucoma in patients with pseudophakia, pigmented glaucoma, inflammatory and neovascular glaucoma, in inflammatory conditions of the eye or congenital glaucoma - limited clinical experience. There is no experience regarding the use of the drug in acute attacks of closed-angle glaucoma - be careful. Caution should be used during the perioperative period after cataract removal (limited data). The drug should be used with caution in patients with a history of herpetic keratitis and avoid its use in the case of active herpetic keratitis and in patients with recurrent herpetic keratitis in a history that is particularly related to the use of prostaglandin analogues. Because of the risk of macular edema, the preparation should be used with caution in patients with afaquia, patients with pseudophakia and discontinuous posterior capsule or implantable intraventricular lens, and patients with documented risk factors for cystoid macular edema (eg diabetic retinopathy and venous occlusion) retina). Patients with known risk factors for iritis or uveitis can be used with caution. There is limited experience in the use of patients with bronchial asthma; in the post-marketing period, there have been reports of several cases of asthma exacerbation and / or dyspnea. Patients with bronchial asthma should be treated with caution until sufficient data is available. Changes in the color of the skin around the orbendum were observed, but in most cases this symptom was reported by patients from Japan; the change in the color of the skin in the orbital area was not permanent and in some cases resolved during continued treatment with latanoprost. The preparation contains benzalkonium chloride, which can cause punctate keratopathy and / or toxic ulcerative keratopathy, eye irritation and discoloration of soft contact lenses.Patients with dry eye syndrome or conditions in which the cornea is damaged require close monitoring in case of frequent or long-term use. The contact lenses should be removed before instillation and can be replaced after 15 minutes. Data on efficacy and safety in the under-1 age group (4 patients) are very limited. There are no data on premature babies (born before the 36th week of pregnancy). In children from 0 to 3 years of age, in whom primary congenital glaucoma develops mainly, surgical treatment is used first (eg trabeculotomy / goniotomy). Long-term safety of the preparation in children has not been established.

The preparation should not be used during pregnancy and breastfeeding.

Very common: increased iris pigmentation (mainly in patients with iris mixed color, i.e. blue-brown, gray-brown, yellow-brown and green-brown); mild or moderate conjunctival hyperemia, irritation of the eyeball (burning sensation, sand in the eye, pricking and the presence of a foreign body in the eye); changes in eyelashes and follicular hair (increased length, thickness, pigmentation and number) (the vast majority of cases affect the Japanese population). Common: transient punctate epithelial erosions, in most cases asymptomatic eyelid inflammation, eye pain. Uncommon: eyelid edema, dry eye syndrome, keratitis, blurred vision, conjunctivitis, skin rash. Rarely: iritis and / or uveitis (the majority of cases affect patients with comorbid predisposing factors), macular edema, symptomatic swelling and corneal erosions, periorbital edema, changes in the direction of eyelash growth, sometimes causing eye irritation, additional row of hairs at the mouth of the glands Meiboma (Distichiasis- eyelash function), bronchial asthma, exacerbation of bronchial asthma and shortness of breath, local eyelid skin reactions, darkening of eyelid skin. Very rare: exacerbation of angina symptoms in patients with angina pectoris, chest pain. Not known: Herpes keratitis, headache and dizziness, iris cyst, palpitations, myalgia, arthralgia. In pediatric patients, a similar safety profile was observed for the safety profile observed in adults, as well as the absence of new adverse events. Adverse events reported more frequently in children and adolescents than in adults included nasopharyngitis and fever.

Adults (including the elderly): 1 drop for eye or eyes covered by the disease once a day. The optimal effect is obtained if the preparation is administered in the evening. Do not administer more often than once a day. If you miss one dose, continue with the Next dose at the usual time. In order to limit the potential absorption of the active substance into the bloodstream, it is recommended to compress the tear sac in the medial angle of the eye for one minute (punctual closure). This should be done immediately after instilling each drop. If other topical ophthalmic medications are used, they should be administered after at least a 5-minute interval. The preparation can be used in children and adolescents according to the same dosing regimen as in adults.