Index of drugs

Decrease in intraocular pressure in adults (also elderly) of patients with open-angle glaucoma and elevated intraocular pressure, in whom the response to topically applied beta-blockers or prostaglandin analogs is insufficient.

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 the intraocular pressure by increasing the choroidal scleral flow. 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 lowers 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 the co-administered drug in children and adolescents <18 years has not been established - the use in this group is not recommended. Due to the content of Timolol, adverse reactions occurring during the general use of β-blockers may occur during the administration of the preparation (less frequently than after the general administration). In patients with cardiovascular disease (eg ischemic heart disease, Prinzmetal's angina, heart failure) and those using β-blockers to lower blood pressure, initiation of treatment with the preparation should be critically evaluated and the use of therapy with other active substances should be considered. 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. (due to the dromotropic effect of a negative β-blocker); 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 application of drugs that inhibit the production of aqueous humor (eg timolol), choroidal dissection has been found after filtration. 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 color, for example: green-brown, yellow-brown or blue-gray-brown, in patients with blue, gray, green or brown eyes, these changes were rare; iris is very slow, it is not associated with any side effects or pathological changes, it can be persistent). Common: eye irritation (including stinging, burning and itching), eye pain. Uncommon: headache, ocular 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), punctate corneal epithelial defects, periorbital edema, iritis and uveitis, macular edema (in patients with aphasia, pseudophakia and an interrupted posterior capsule or patients with documented risk factors for macular edema), dry eye, keratitis, edema and corneal erosions, incorrectly directed eyelashes (sometimes leading to eye irritation and iris cyst formation), exacerbation of pre-existing angina, palpitations, 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, depression, memory loss, decreased libido, insomnia, nightmares, dizziness, paresthesia, cerebral ischaemia, cerebral episodes vascular diseases, worsening of signs and symptoms of myasthenia gravis, syncope, headache, signs and symptoms of eye irritation (e.g.burning, burning, itching, tearing, redness), blepharitis, keratitis, visual disturbances and choroidal detachment resulting from surgical filtration, reduction of corneal sensation, dry eye, corneal erosion, ptosis, diplopia, vision changes including refractive changes ( conditioned in some cases by discontinuation of treatment constricting the pupil), tinnitus, palpitations, edema, arrhythmia, bradycardia, chest pain, cardiac arrest, heart block, congestive heart failure, atrioventricular block, heart failure, hypotension, Raynaud's syndrome, cold hands and feet syndrome, bronchospasm (mainly in patients with pre-existing bronchospasm), dyspnoea, cough, taste disturbances, nausea, diarrhea, indigestion, dry mouth, abdominal pain, vomiting, alopecia, rash peeling cough-like or exacerbation of psoriasis, skin rash, muscle pain, sexual dysfunction, decreased libido, weakness and fatigue.

Adults (including the elderly): 1 drop to the affected eye (eyes) once a day. 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 canal or close the eyelid for 2 minutes to limit systemic absorption; this may result in reduced systemic side effects and increased local activity. When using several topical ophthalmic medications, a gap of at least 5 minutes should be allowed between instillations of subsequent medications.