Index of drugs

Reduction of elevated intraocular pressure in patients with open-angle glaucoma and intraocular hypertension. Reduction of elevated intraocular pressure in children and adolescents with increased intraocular pressure and with childhood 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, latanoprost should be discontinued. Caution should be used in patients with closed-angle, open-angle glaucoma in patients with pseudophakia, pigmented glaucoma, inflammatory glaucoma, neovascular glaucoma, in inflammatory conditions of the eye, and 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). Latanoprost should be used with caution in patients who have had a history of herpetic keratitis. Latanoprost should be avoided in patients with existing herpetic keratitis and in patients with a history of positive recurrence of herpetic inflammation associated with prostaglandin analogs. Due to the risk of macular edema, the preparation should be used with caution in patients with aphasia, patients with pseudophakia and ruptured posterior lens capsule or lenses implanted into the anterior chamber of the eye, or in patients at risk of cystic macular edema (eg patients with diabetic retinopathy or retinal vein closure). Latanoprost should be used with caution in patients with known tendencies to develop iritis / uveitis. Experience in the use of the drug in patients with asthma is limited, however, based on post-marketing experience, asthma and / or dyspnoea have been reported in some cases - caution should be exercised when treating patients with asthma until sufficient data are available. There was a change in the color of the skin around the orbendum, but in most cases this symptom was reported by patients coming from Japan (the change of skin color in the orbital area was not stable and in some cases resolved during continued treatment with latanoprost). The preparation contains benzalkonium chloride, which may cause eye irritation. Avoid contact of the preparation with soft contact lenses.Before using the product, contact lenses should be removed and the contact lenses should be left for at least 15 minutes before being replaced. Benzalkonium chloride may discolour soft contact lenses. Benzalkonium chloride causes point keratopathy and / or toxic ulcerative keratopathy and can cause eye irritation. Close monitoring of frequent or long-term use of latanoprost is recommended in patients with dry eye syndrome or corneal injury. Data on the efficacy and safety of the product in children under one year (4 patients) are very limited. There are no data on the use in premature babies (born before 36 weeks of pregnancy). In children from 0 to 3 years with primary congenital glaucoma, surgical treatment (eg trabeculotomy, goniotomy) remains the primary treatment. The safety profile of long-term use 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, eye irritation (burning, pruritus, stinging, feeling of a foreign body in the eye); changes in the appearance of eyelashes and follicle hair on the eyelid (lengthening, thickening, darkening and increasing the amount) (most cases in the Japanese population). Common: transient point epithelial defects, mostly non-symptomatic, blepharitis, eye pain. Uncommon: eyelid edema, dry eye, keratitis, blurred vision, conjunctivitis, skin rash. Rarely: iritis or uveitis (most cases in predisposed patients), macular edema, symptomatic swelling and corneal defects, periorbital edema, changes in the direction of eyelash growth, which may cause eye irritation, the appearance of a double row of eyelashes on the holes of the thyroid glands (Distichiasis), asthma, exacerbation of asthma and shortness of breath, local skin reactions on the eyelids, darkening of the eyelid skin. Very rare: intensification of angina pectoris in patients with pre-existing disease, pain in the chest. Not known: herpetic keratitis, headache and dizziness, palpitations, muscle pain, joint pain, iris cyst. In children and adolescents treated with latanoprost, the safety profile was similar to the safety profile in adult patients. No new side effects were observed. Side effects that are more common in the pediatric population compared to the adult population are 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 scheduled dose. In order to limit the potential absorption of the active substance into the bloodstream, it is recommended to compress the conjunctival sac in the medial part of the canthus (spot pressure) for one minute. The pressure should occur 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.