Index of drugs

Treatment of increased intraocular pressure in patients with open-angle glaucoma or glaucoma in the course of exfoliative epilepsy syndrome when treatment with a topical β-adrenolytic agent is insufficient.

1 ml of solution contains 20 mg of dorzolamide (as hydrochloride) and 5 mg of Timolol (as maleate). The preparation contains benzalkonium chloride.

The preparation contains two active substances that reduce elevated intraocular pressure by reducing the secretion of aqueous humor through various mechanisms of action. The combined effect of both substances results in a greater decrease in intraocular pressure than any of them used separately. Dorzolamide hydrochloride strongly inhibits carbonic anhydrase II. Inhibition of this enzyme in the ciliary processes of the eye causes a reduction in the volume of secreted aqueous humor. This is probably due to a reduction in the rate of bicarbonate ions, followed by a reduction in sodium and liquid transport. Timolol maleate is a non-selective blocker of β-adrenergic receptors. The main action of timolol may be associated with a decrease in aqueous humor production, and a slight increase in fluid outflow was also observed. After topical application, the preparation lowers elevated intraocular pressure, regardless of whether it is associated with glaucoma or not.

Hypersensitivity to the active substances or to any of the excipients. Airway hyperreactivity, including bronchial asthma currently or in history, and severe chronic obstructive pulmonary disease. Sinus bradycardia, syndrome of a sick sinus-atrial node, atrio-ventricular block IIst. or IIIst. uncontrolled with a pacemaker, overt cardiac failure, cardiogenic shock. Severe renal impairment (creatinine clearance <30 ml / min) or hyperchloraemic acidosis.

Due to the content of β-blocker, the preparation may cause the same side effects as in the case of β-blockers administered generally (lower frequency than after the general administration). In patients with cardiovascular problems (eg ischemic heart disease, Prinzmetal's angina and heart failure) and hypotension, the potential for β-blocker therapy should be critically evaluated, and the use of active substances other than β-blocker should be considered. Patients with cardiovascular disorders should be monitored for deterioration of these disorders and for the severity of side effects. Due to the negative effect on conduction time, β-blockers should be used with caution in patients with Ist block of flats. Patients with severe peripheral circulatory disorders / diseases (eg severe Raynaud's or Raynaud's syndrome) should be treated with caution. Due to the risk of bronchospasm, the preparation should be used with caution in patients with mild to moderate chronic obstructive pulmonary disease and only if the potential benefit outweighs the potential risk. When co-administered with another systemic β-blocker, it may lead to increased intraocular pressure-lowering effects or known activities associated with systemic β-adrenergic blockade - these patients should be closely monitored for response. The use of two locally acting β-blockers is not recommended. Caution should be exercised in patients with hepatic impairment (no study). The active substance dorzolamide is sulfonamide - the same side effects that occur after the general administration of sulfonamides may occur after topical application. If severe side effects or signs of hypersensitivity are found, the preparation should be discontinued.When beta-blockers are used in patients with a history of atopy or severe anaphylactic reactions to multiple allergens, increased reactivity to repeated contact with the allergen may occur; these patients may not respond to doses of adrenaline commonly used to treat anaphylactic reactions. Co-administration of dorzolamide and oral carbonic anhydrase inhibitors is not recommended. β-blockers should be used with caution in patients at risk of spontaneous hypoglycaemia or in patients with unstable diabetes because they may mask the signs and symptoms of acute hypoglycaemia. β-blockers may also mask the symptoms of hyperthyroidism. Abrupt discontinuation of β-blockers may result in worsening of disease symptoms. Treatment with β-blockers may exacerbate the symptoms of myasthenia gravis. In patients with a history of nephrolithiasis, the risk of urolithiasis during treatment may be increased. The use of the preparation in patients with acute angle-closure glaucoma has not been studied. Β-blockers administered to the eye may inhibit the systemic effects of β-agonists, e.g. adrenaline - inform your anesthesiologist if you are using the product. Due to the risk of edema and irreversible corneal decompensation, caution should be exercised when topically applying dorzolamide in patients with existing chronic corneal injury and / or intraocular history. β-blockers applied to the eyes may cause dry eyes - they should be used with caution in patients with corneal diseases. Choroidal detachment has been reported after administration of drugs that inhibit the secretion of aqueous humor (eg Timolol, acetazolamide) after filtration. The preparation contains benzalkonium chloride, which may cause eye irritation. Benzalkonium chloride can discolour soft contact lenses. Avoid contact with soft contact lenses. Contact lenses should be removed prior to instillation and re-inserted no earlier than 15 minutes after instillation. The efficacy of use in pediatric patients has not been established.

The preparation should not be used during pregnancy and breast-feeding.

Dorzolamide with thymol. Very often: the feeling of burning and stinging in the eye, changing the taste sensation. Common: conjunctival injections, blurred vision, corneal epithelial defect, itching, tearing, sinusitis. Uncommon: kidney stones. Rare: shortness of breath, respiratory failure, rhinitis, contact dermatitis, signs or symptoms of a general allergic reaction (including angioedema, urticaria, pruritus, rash, anaphylactic reaction, rarely bronchospasm). Additional side effects observed with monotherapy for each component.timolol. Common: headache, signs and symptoms of eye irritation (eg stinging, burning, itching, tearing, redness), blepharitis, keratitis, decreased corneal sensitivity, dry eye. Uncommon: dizziness, depression, visual disturbances (including refraction disturbances, in some cases due to discontinuation of the miocular narrowing drug), slow heart rate, fainting, shortness of breath, nausea, dyspepsia, fatigue / weakness. Rarely: insomnia, nightmares, memory loss, paresthesia, worsening of signs and symptomsmyastenia gravis, decreased libido, stroke, eyelid droop, double vision, blurred vision, choroidal detachment after filtration procedures, tinnitus, hypotension, chest pain, palpitations, edema, arrhythmias, congestive heart failure, atrioventricular block, cardiac arrest, cerebral ischaemia, claudication, Raynaud's phenomenon, cold hands and feet, bronchospasm (mainly in patients with pre-existing bronchial spasticity), cough, diarrhea, dry mouth, alopecia, psoriasis-like rash or exacerbation of psoriasis, lupus erythematosus systemic, Peyronie's disease. Frequency unknown: systemic allergic reactions (including angioneurotic edema, urticaria, local and generalized rash, pruritus, anaphylactic reactions), hypoglycaemia, syncope, cerebral ischemia, corneal erosion, heart failure, abnormal taste, abdominal pain, vomiting, rash, muscle pain , sexual dysfunction, lower libido.dorzolamide. Common: headache, blepharitis, eyelid irritation, nausea, fatigue / weakness. Uncommon: inflammation of the iris and ciliary body. Rarely: dizziness, paresthesia, irritation (including redness) of the eye, eye pain, stickiness of the eyelids, transient myopia, corneal edema, reduction of eye pressure, choroidal detachment (after filtration procedures), nosebleeds, throat irritation, dry mouth rash.

1 drop into the conjunctival sac of the affected eye (eyes) 2 times a day. If topically more than one ophthalmic medicinal product is used, a gap of at least 10 minutes should be observed between these medicinal products. Compression of the naso-lacrimal canal or occlusion of the eyelid for 2 min after administration of the drug reduces systemic absorption; this may reduce systemic side effects and increase local activity.