Index of drugs

Decrease in intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to topically administered beta-blockers or prostaglandin analogs.

1 ml drops contain 0.05 mg latanoprost and 5 mg Timolol (as maleate); drops contain benzalkonium chloride.

The product contains two active substances that reduce intraocular pressure due to different mechanisms of action. The combined administration leads to an additional reduction in intraocular pressure, compared to administering each of these substances separately. Latanoprost is an analog of prostaglandin F_2α, a selective prostanoid FP receptor agonist. It lowers intraocular pressure by increasing the outflow of aqueous humor. After application to the conjunctival sac latanoprost is absorbed through the cornea, undergoing full hydrolysis to the biologically active latanoprost acid. The maximum concentration of latanoprostic acid in aqueous humor occurs approximately 2 hours after administration. Latanoprostic acid is practically not metabolised in the eye; metabolism occurs mainly in the liver. T_0,5 in plasma is 17 min. Inactive metabolites are mainly excreted in the urine. Timolol is a non-selective beta-blocker, lacking intrinsic sympathomimetic activity and specific membrane function. Timolol reduces intraocular pressure by reducing the production of aqueous humor in the ciliary epithelium. The maximum concentration in the aqueous humor occurs after 1 hour after local instillation. Part of the dose penetrates into the bloodstream - the maximum plasma concentration is reached after 10-20 min. Timolol is metabolised in the liver and excreted in the urine (in the form of metabolites and partly as a parent substance). T_0,5 is 6 hours.

Hypersensitivity to the components of the preparation. Diseases with airway hyperresponsiveness (including bronchial asthma, history of asthma, severe chronic obstructive pulmonary disease). Sinus bradycardia, sick sinus syndrome, sinoatrial block, atrioventricular block II or III. uncontrolled pacemaker, overt cardiac failure, cardiogenic shock.

The safety and efficacy of using a complex drug in children and adolescents has not been established. Due to the content of Timolol, patients with cardiovascular disease (eg coronary heart disease, Prinzmetal's angina, heart failure) and hypotension should be carefully evaluated and the treatment should be considered with other drugs that do not contain β-blockers. It should be observed that patients with cardiovascular disease have not exacerbated the symptoms of these diseases and side effects. Exercise caution in patients with atrioventricular block Ist; with severe peripheral circulation disorders (e.g., severe forms of Raynaud's disease or Raynaud's syndrome); with mild or moderate chronic obstructive pulmonary disease (risk of β-blocker-induced bronchoconstriction - these drugs should only be used if the potential benefit outweighs the potential risk); susceptible to the occurrence of idiopathic hypoglycaemia or with unstable diabetes, and also with hyperthyroidism (beta-blockers may mask the symptoms of these diseases); with corneal diseases (beta-blockers may cause the eyeball to dry). The anesthetist should be informed that the patient is taking timolol because of the possible blockade of systemic β-agonistic activity, e.g. adrenaline. When using β-blockers, patients with a history of atopy or history of severe anaphylactic reactions to a variety of allergens may have an increased response to re-exposure to these allergens; these patients may not respond to the doses of adrenaline usually used to treat anaphylactic reactions. After administration of drugs that inhibit the production of aqueous humor (eg timolol), choroidal dissection has been found after fistula surgery.There is no documented experience with the use of latanoprost in inflammatory glaucoma, neovascular, chronic with closed-angle or congenital angle, open-angle glaucoma in patients with pseudophakia and pigmented glaucoma, in acute attacks of closed-angle glaucoma - therefore it is recommended that in these diseases the combined preparation should be used with caution. Due to the risk of macular edema (including cystoid macular edema), the drug should be used with caution in patients with aphasia, pseudophakia with discontinued posterior capsule or patients with documented risk factors for macular edema. Due to latanoprost, use with caution in patients with a history of herpetic herpetic keratitis; avoided in the case of active herpetic keratitis and in patients with a history of recurrent herpetic keratitis, particularly associated with the use of prostaglandin analogs. During treatment with latanoprost, the pigmentation of the iris may change; treatment can be continued, however, patients should be regularly examined and if required by the clinical condition the treatment should be discontinued; the patient should be informed about the possibility of a permanent change in the color of the iris of the treated eye (treatment of one eye can lead to permanent heterochromia). The preparation contains benzalkonium chloride, which may cause eye irritation, and also cause punctate keratopathy and / or toxic ulcerative keratopathy - patients with dry eye syndrome or corneal injury disorders should be closely monitored if the drug is used frequently or for a long time. Because contact lenses can absorb benzalkonium chloride, they should be removed before instillation; they can be put on again after 15 minutes.

Do not use during pregnancy and breast-feeding.

Very common: increased iris pigmentation (most commonly in patients with mixed iris, eg blue-brown, gray-brown, yellow-brown and green-brown, in patients with blue, gray, green or brown eyes, these changes were rare; iris color change is very slow, it does not involve any side effects or pathological changes, it can be permanent). Common: eye irritation (including stinging, burning and itching), eye pain. Uncommon: headache, eye congestion, conjunctivitis, blurred vision, increased tearing, blepharitis, corneal disorders, skin rash, pruritus. Additional side effects associated with the use of individual components of the preparation (frequency unknown). Latanoprost: herpetic keratitis, dizziness, change of eyelashes and primary hair (increased length, thickness, pigmentation and quantity), point corneal epithelial erosion, periorbital edema, iritis / uveitis, macular edema (in patients with aphakia, pseudophakia and an interrupted posterior capsule or patients with a documented risk of macular edema), dry eye syndrome, keratitis, edema and corneal erosions, ingrowth of eyelashes leading in some cases to eye irritation, iris cyst, exacerbation of pre-existing angina, palpitations heart, asthma, exacerbation of asthma, shortness of breath, dark eyelid skin, joint pain, muscle pain, chest pain. Timolol: systemic allergic reactions (including angioneurotic edema, urticaria and local or generalized rash, pruritus, anaphylactic reaction), hypoglycaemia, insomnia, depression, nightmares, memory loss, syncope, cerebral circulation disorders, cerebral ischaemia, exacerbation of signs and symptoms myasthenia gravis, dizziness, paresthesia, headache, signs and symptoms of eye irritation (eg burning sensation, stinging, itching, tearing, redness), eyelid inflammation, keratitis, blurred vision, choroidal dissection after a fistula surgery, reduced corneal sensitivity , dry eye syndrome, eyelid droop, diplopia, tinnitus, bradycardia, chest pain, palpitations, edema, arrhythmia, congestive heart failure, atrioventricular block, cardiac arrest, heart failure, hypotension, Raynaud's syndrome, cold syndrome hands and feet,bronchospasm (mainly in patients with pre-existing bronchospasm), shortness of breath, cough, dysgeusia, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting, alopecia, psoriasis-like rash or exacerbation of psoriasis, skin rash, pain muscle, sexual dysfunction, decrease in libido, asthenia.

Adults (including the elderly): 1 drop to the affected eye (eyes) once a day, preferably in the evening. If you miss one dose, continue with the Next scheduled dose. Do not administer the preparation more than once a day. Immediately after instillation, it is recommended to compress the nasolabial duct or close the eyelid for 2 minutes to limit the absorption of the drug into the bloodstream. When using several topical ophthalmic medications, a gap of at least 5 minutes should be allowed between instillations of subsequent medications.