Treatment of increased intraocular pressure in patients with open-angle glaucoma or glaucoma in the course of epidural exfoliative syndrome, when beta-adrenoceptor therapy is insufficient.
Composition:
1 ml of solution contains 20 mg of dorzolamide (as hydrochloride) and 5 mg of timolol (as maleate). The preparation contains benzalkonium chloride.
Action:
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 drugs results in a greater reduction in intraocular pressure compared to the treatment of each drug used separately. Dorzolamide hydrochloride strongly inhibits carbonic anhydrase II. Inhibiting the activity of this enzyme in the cilia reduces the secretion of aqueous humor, presumably by slowing the formation of bicarbonate ions, thereby reducing the transport of sodium and liquid. Timolol maleate is a non-selective drug blocking β-adrenergic receptors. The main action of timolol is 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.
Contraindications:
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, atrio-ventricular block IIst. or III., overt cardiac failure, cardiogenic shock. Severe renal impairment (creatinine clearance <30 ml / min) or hyperchloraemic acidosis.
Precautions:
Due to the content of β-blocker, the preparation may cause side effects, which were found in the general administration of β-blockers, eg severity of Prinzmetal angina symptoms, exacerbation of peripheral and central circulatory disorders, hypotension. Before commencing treatment with the product, the circulatory insufficiency should be properly compensated. In patients with a history of severe cardiac disease, attention should be paid to possible symptoms of circulatory failure and to check the pulse rate. After administration of timolol maleate, adverse reactions from the respiratory and cardiovascular systems have been reported, including deaths due to bronchospasm in patients with bronchial asthma and, in rare cases, deaths associated with cardiac insufficiency. Caution should be exercised when administering the drug to patients with hepatic impairment (no study). Due to the sulfonamide content, topical use of the drug may cause the same side effects as systemic administration of sulfonamides, including serious reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. If severe side effects or signs of hypersensitivity are found, the preparation should be discontinued. If local side effects occur, discontinuation of the preparation should be considered. When beta-blockers are used in patients with a history of atopy or severe anaphylactic reactions to multiple allergens, there may be increased reactivity to random, diagnostic, therapeutic or repeated contact with the allergen. These patients may not respond to doses of adrenaline commonly used to treat anaphylactic reactions. Co-administration of the following medicines is not recommended: dorzolamide and oral carbonic anhydrase inhibitors; ß-blockers used externally. In patients with diabetes mellitus or hypoglycaemia, treatment with β-adrenergic blockers may mask the symptoms of hypoglycaemia. Treatment with β-blockers may mask some of the symptoms of hyperthyroidism. Abrupt discontinuation of β-blockers may increase the symptoms of the disease. Β-blocker therapy may aggravate the symptoms of myasthenia gravis.In patients with a history of renal calculi, the risk of urolithiasis during treatment may be increased. Treatment of acute angle-closure glaucoma, in addition to the use of drugs that lower the intraocular pressure, requires additional therapeutic intervention. The use of the preparation in patients with acute angle-closure glaucoma has not been studied. In patients with existing chronic corneal injury and / or intraocular surgery, a history of edema and irreversible corneal decompensation when using dorzolamide. Caution should be exercised when topical administration of dorzolamide is given to these patients. During the use of agents that inhibit the production of aqueous humor, after the filtration surgery, the occurrence of dissection of the choroid with the simultaneous reduction of pressure in the eye has been observed. The effectiveness of the drug in children has not been determined. The preparation contains benzalkonium chloride, which may cause eye irritation. Contact lenses should be removed prior to instillation and re-inserted no earlier than 15 minutes after instillation. Benzalkonium chloride can discolour soft contact lenses.
Pregnancy and lactation:
The preparation should not be used during pregnancy. If treatment with the preparation is required, breast-feeding is not recommended.
Side effects:
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, Stevens-Johnson syndrome, toxic epidermal necrolysis, signs and symptoms of a general allergic reaction (including angioedema, urticaria, pruritus, rash, anaphylactic reaction, 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, tinnitus, chest pain, palpitations, arrhythmias, congestive heart failure, heart block, cardiac arrest, low blood pressure , edema, cerebral ischemia, 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, systemic lupus erythematosus Peyronie's disease.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.
Dosage:
Adults: 1 drop into the conjunctival sac of the affected eye (eyes) twice a day. If topically more than one ophthalmic medicinal product is used, a break should be maintained for at least 10 minutes between each administration of the Next medication.