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).
Action:
A medicament lowering the increased intraocular pressure, which is a combination of a carbonic anhydrase inhibitor with a non-selective β-adrenergic receptor blocker. The combined effect of both substances results in a greater decrease in intraocular pressure than each one given separately. Dorzolamide hydrochloride is a potent inhibitor of carbonic anhydrase II. Inhibition of carbonic anhydrase in the ciliary processes of the eye reduces the secretion of aqueous humor, presumably by slowing the formation of bicarbonate ions and, consequently, reducing the transport of sodium and liquids. Timolol 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 its outflow. After topical administration, the preparation reduces elevated intraocular pressure, regardless of whether it is associated with glaucoma or not. After administration to the conjunctival sac, dorzolamide and timolol are absorbed through the cornea and penetrate into the systemic circulation.
Contraindications:
Hypersensitivity to any of the ingredients. Airway hyperresponsiveness (including bronchial asthma) present or present in history and severe chronic obstructive pulmonary disease. Sinus bradycardia, atrio-ventricular block IIst. or III., overt cardiac failure, cardiogenic shock. Severe renal failure (creatinine clearance less than 30 ml / min), hyperchloraemic acidosis.
Precautions:
The effectiveness of the preparation in children has not been confirmed. The safety of the medicine in children <2 years has not been confirmed. Data on the use of the drug in children aged ≥2 and <6 years are limited. The use of the preparation in patients with acute angle-closure glaucoma has not been studied. The use of the preparation has not been studied in patients with hepatic insufficiency - care should be taken. Before starting treatment with Timolol, heart failure should be compensated. Patients with a history of advanced cardiac disease should be monitored for signs of cardiac insufficiency and should be monitored for heart rate. Exercise caution in patients with diabetes mellitus or hypoglycaemia and hyperthyroidism, as β-blockers may mask the symptoms of these diseases. Abrupt discontinuation of β-blockers may result in increased thyroid hyperfunction. In the use of β-blockers, patients with a history of atopy or history suggestive of severe anaphylactic reactions to a variety of allergens may show an increased response to repeated contact with these allergens, both accidentally and during diagnostic or therapeutic procedures; these patients may not respond to the doses of adrenaline usually used to treat anaphylactic reactions. Due to the risk of urolithiasis (the drug contains dorzolamide) caused by water and electrolyte disturbances, the drug should be used with caution in patients with a history of urinary calculi. Carefully use in patients with pre-existing chronic corneal defects and / or intraocular surgery (risk of corneal edema and irreversible corneal decompensation). Co-administration of oral carbonic anhydrase inhibitors and topical β-blockers is not recommended. The preparation should be discontinued if hypersensitivity reactions or serious side effects occur (side effects typical of sulphonamides generally administered).
Pregnancy and lactation:
Do not use during pregnancy and during breastfeeding.
Side effects:
Very often: burning and stinging in the eye, taste disturbances. Common: conjunctival injections, blurred vision, corneal epithelial defect, itchy eye, tearing, sinusitis.Rare: dyspnoea, respiratory failure, rhinitis, contact dermatitis, urolithiasis, signs and symptoms of general allergic reactions (including angioneurotic edema, urticaria, pruritus, rash, anaphylactic reactions, bronchospasm). Additional side effects associated with mono-therapy of each component. Dorzolamide. Common: headache, blepharitis, eyelid irritation, nausea. Uncommon: inflammation of the iris and ciliary body, fatigue, weakness. Rarely: dizziness, paresthesia, irritation (including redness, pain, stickiness of the eyelids), temporary short-sightedness (disappearing after discontinuation of therapy), corneal edema, lowering of pressure in the eye, choroidal detachment (after filtration procedures), nose bleed, throat irritation , dry mouth, rash. Tymolo. Common: headache, signs and symptoms of eye irritation (including blepharitis, keratitis, decreased corneal sensitivity and dry eye). Uncommon: dizziness, depression, visual disturbances, including refraction disorders (in some cases due to discontinuation of the miocinating drug), bradycardia, fainting, shortness of breath, nausea, indigestion, fatigue, weakness. Rare: systemic lupus erythematosus, insomnia, nightmares, memory loss, parasthesia, worsening of symptoms and symptoms of myasthenia gravis, decreased libido, stroke, ptosis, diplopia, choroidal detachment (after filtration procedures), tinnitus, hypotension , chest pain, palpitations, edema, arrhythmia, congestive heart failure, heart block, cardiac arrest, cerebral ischemia, claudication, Reynaud's sign, cold hands and feet, bronchospasm (especially in patients with pre-existing bronchial spasticity) , cough, diarrhea, dry mouth, alopecia, psoriasis-like rash or exacerbation of psoriasis, Peyronie's disease. After administration of β-blockers, serious respiratory adverse reactions (including deaths due to bronchospasm in patients with asthma) or cardiovascular system (including death due to cardiac insufficiency) may occur. During long-term use, a reduced response to timolol in the form of eye drops was observed.
Dosage:
1 drop into the conjunctival sac of the affected eye (eyes) 2 times a day. When using several topical ophthalmic medications, a minimum of 10 minutes should be allowed between the instillation of subsequent medications.