Index of drugs

Open angle glaucoma and intraocular hypertension. The indication for the use of the drug in children and adolescents is increased intraocular pressure and glaucoma of childhood.

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

Prostaglandin analog F_2α, 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, which after hydrolysis to latanoprostic acid obtains biological activity. The prodrug is well absorbed through the cornea and is completely hydrolyzed when penetrating through it. The maximum concentration in the aqueous humor after about 2 hours after topical 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. Latanoprostic acid 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; no negative consequences of increased pigmentation of the iris were found; if this symptom occurs, treatment can be continued. Patients should be monitored regularly and if clinically necessary, latanoprost should be discontinued. Caution should be exercised when administering the drug in chronic angle glaucoma, open angle glaucoma in patients with pseudophakia, pigmented glaucoma, and in inflammatory and neovascular glaucoma, in inflammatory conditions of the eye. Data from studies on the use of the preparation in the perioperative period after cataract removal are limited. Caution should be exercised when using these patients. Caution should be exercised when using the drug in patients with aphasia, pseudophakia with discontinued posterior capsule or lenses implanted in the anterior chamber of the eye, in patients at risk of cystic macular edema, in patients with known tendencies to develop iritis / uveitis . The preparation should be used with caution in patients who have had a history of herpetic keratitis. Avoid use in patients with existing herpetic keratitis and in patients suffering from recurrent herpetic keratitis, in particular related to the use of prostaglandin analogues. Currently, there is no experience in the use of the drug in patients with severe or unstable asthma - therefore caution should be exercised in treating these patients. There was a change in the color of the skin around the orbital region, but in most cases this symptom was reported by patients from Japan. The experimental data indicate that the change in the color of the skin in the orbital area was not stable and in some cases resolved in the course of further treatment with the preparation. Data on the efficacy and safety of latanoprost in children under one year (4 patients) are very limited. There are no data on the use of latanoprost in newborn infants (born before 36 weeks gestation). 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 contains benzalkonium chloride, which may, however, cause keratopathy, toxic ulcerative keratitis or eye irritation and change the color of contact lenses.In patients with dry eye syndrome and patients with changes in the cornea, frequent or long-term use of the preparation requires close monitoring. Due to the fact that benzalkonium chloride can be absorbed by contact lenses, they should be removed before administration; they can be applied again 15 min after the drop.

The drug should not be used during pregnancy. Latanoprost and its metabolites can penetrate into breast milk. Do not use the drug in women who are breastfeeding or should stop feeding.

Very common: increased pigmentation of the iris (most commonly in people with mixed iris color eg: blue-brown, gray-brown, yellow-brown and green-brown), congestion of small or moderate conjunctivitis, eye irritation (including feeling of body presence) in the eye), changes in eyelashes and follicular hair (lengthening, thickening, increased pigmentation and quantity) - these symptoms were observed mainly in Japanese. Common: transient punctate epithelial defects (most often without symptoms), eyelid inflammation, eye pain, photophobia. Uncommon: eyelid edema, dry eye, keratitis, blurred vision, conjunctivitis, skin rash. Rarely: iritis or uveitis (most often in patients with risk factors for these diseases), macular edema, symptomatic changes of the type of swelling or erosions of the cornea, periorbital edema, darkening of the eyelid skin, changes in the direction of eyelashes (sometimes leading to eye irritation), appearance of a double row of eyelashes on the holes of the thyroid glands, asthma, exacerbation of asthma, shortness of breath. Very rare: changes in the periorbital area and eyelid changes leading to deepening of the eyelid, unstable angina, chest pain. Not known: herpetic keratitis, headache, dizziness, iris cyst, palpitations, myalgia, arthralgia. Macular edema was observed during treatment with the product. This symptom occurred mainly in patients with aphasia, pseudophakia with interrupted posterior lens capsule or lenses implanted into the anterior chamber of the eye, as well as in patients at risk of macular edema (patients with diabetic retinopathy and retinal vascular retinal closure). A relationship between the occurrence of unexplained macular edema and the use of the preparation can not be excluded. In some patients with severely damaged corneas, very rare cases of corneal calcification associated with the use of eye drops containing phosphates have been reported. In two short clinical studies (≤12 weeks) in children and adolescents, the safety profile was similar to the safety profile in adult patients. The safety profiles of drug use for a short period in different populations of children and adolescents were similar. Side effects that are more common in the pediatric population compared to the adult population are nasopharyngitis and fever.

Adults (including elderly patients): it is recommended to administer 1 drop to the eye or both eyes covered by the disease once a day. The best action is obtained by administering the drug in the evening. Do not administer the drug more than once a day, because more frequent administration reduces the effect of lowering the intraocular pressure. If you miss one dose, continue with the Next scheduled dose. In order to limit the 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. Before administering eye drops, contact lenses should be removed. Lenses can be worn after 15 minutes. If other topical ophthalmic medications are used, they should be administered at least 5 minutes apart. Children and adolescents: the drug can be administered to children and adolescents according to the same dosing regimen as for adults. There are no data on the use of the drug in premature babies (born before the 36th week of pregnancy). Data on the use of the drug in children under one year (4 patients) are very limited.