Reduction of elevated intraocular pressure in adult patients with open angle glaucoma and intraocular hypertension. Reduction of elevated intraocular pressure in children and adolescents with elevated intraocular pressure and with childhood glaucoma.
Composition:
1 ml of solution contains 50 μg latanoprost.
Action:
Prostaglandin analog F2α, 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. T0,5 drug in plasma is 17 min. Inactive metabolites are mainly excreted in the urine.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Precautions:
During treatment, the pigmentation of the iris may change; if this symptom occurs, treatment may be continued; however, patients should be tested regularly and if required by the clinical condition, latanoprost should be discontinued. Caution is advised when latanoprost is administered in chronic angle glaucoma, in open-angle glaucoma in patients with pseudophakia, in pigmented glaucoma, in inflammatory and neovascular glaucoma, in inflammatory conditions of the eye, in the treatment of acute attacks of closed angle glaucoma. In very rare cases, some patients with severe corneal damage have appeared cloudy patches on the cornea due to Calcium deposition during treatment. Caution should be exercised when using the preparation in perioperative patients. Latanoprost should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpetic keratitis and in patients with a history of recurrent herpetic keratitis, especially if it has been associated with prostaglandin analogs. Caution should be exercised when using latanoprost in patients with aphasia, in patients with pseudophakia with an interrupted posterior lens capsule or with lenses implanted into the anterior chamber of the eye or in patients with known risk factors for cystoid macular edema (eg diabetic retinopathy, retinal vein occlusion) . The preparation can be used with caution in patients with known risk factors that predispose to iritis and / or uveitis. Due to the risk of exacerbation of the disease and / or shortness of breath, caution should be exercised in patients with asthma. Changes in the color of the skin around the orbendum were observed, 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). Data on the efficacy and safety of the drug in children under 1 year of age (4 patients) are very limited. No data are available on the use of the drug in premature babies (born before the 36th week 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.
Pregnancy and lactation:
It is not recommended during pregnancy and in women of childbearing potential who do not use contraception. Latanoprost and its metabolites can pass into breast milk to such an extent that it is possible to affect breastfed newborns / infants - do not use the drug in women during breastfeeding.
Side effects:
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), conjunctival congestion with low or moderate severity, eye irritation (burning with a feeling of sand under the eyelids, pruritus, stinging and feeling of the presence of a foreign body), changes in eyelashes and follicular hair (lengthening, thickening, increased pigmentation and number) - the majority of these symptoms were observed in Japanese. Common: transient punctate epithelial defects (mostly non-symptomatic), eyelid inflammation, eye pain. Uncommon: eyelid edema, dry eye, keratitis, blurred vision, conjunctivitis, skin rash. Rarely: iritis or uveitis (mostly in patients with comorbid conditions that predispose to this condition), macular edema, symptomatic changes of the type of swelling and erosions of the cornea, periorbital edema, changes in the direction of eyelash growth (which may cause eye irritation), appearance double row of eyelashes on the thyroid glands (Distichiasis), photophobia, asthma, exacerbation of asthma and shortness of breath, local skin reactions on the eyelids, darkening of the skin on the eyelids. Very rare: changes in the periorbital area and eyelid changes, leading to deepening of the eyelid, intensification of angina pectoris in patients with this disease, pain in the chest. Not known: herpetic keratitis, headache and dizziness, iris cyst, palpitations, myalgia, arthralgia. In children and adolescents, safety parameters were similar to those found in adults and no new adverse events were identified. Adverse events observed more often in children than in adults are: rhinitis and fever.
Dosage:
Adults: 1 drop for 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 give the medicine more than once a day because it has been found that more frequent administration reduces the effect of lowering the intraocular pressure. If you miss one dose, continue with the Next scheduled dose. For children and adolescents, use according to the same dosing regimen as for adults. 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 given at least 5 minutes apart.