Pharmacological properties
Dorzopt Plus solution is an antiglaucoma combination drug. Each of its components reduces intraocular pressure, reducing the secretion of aqueous humor inside the eye.
Dorzolamide is a carbonic anhydrase inhibitor. Its action reduces the production of intraocular fluid and slows down the formation of bicarbonate, which subsequently weakens the transfer of sodium and water. It is not capable of causing accommodation spasm, miosis or hemeralopia.
Timolol is a non-selective β-adrenergic receptor blocker. Prevents the effect of catecholamines on β-adrenergic receptors. When applied topically as a solution of eye drops, it reduces intraocular pressure as it reduces the formation of aqueous humor and slightly increases its outflow.
Dorzolan® Extra
Like other ophthalmic drugs used topically, it can be absorbed into the systemic circulation. Since timolol, which is part of the drug, is a beta-blocker, adverse reactions that develop with the systemic use of beta-blockers may occur with topical use of the drug.
Reactions from the cardiovascular and respiratory systems
Patients with a history of cardiovascular disease, including heart failure, should be closely monitored for signs of worsening of these diseases. In such patients, it is necessary to monitor the pulse.
Patients with first degree heart block should be prescribed beta blockers with caution due to their ability to slow impulse conduction. There have been reports of cases of fatal bronchospasm in patients with bronchial asthma and cases of fatal heart failure during the use of timolol maleate eye drops.
In patients with mild to moderate chronic obstructive pulmonary disease, the drug should be prescribed with caution and only if the expected benefit of treatment outweighs the potential risk.
The drug should be administered with caution to patients with severe peripheral circulatory disorders (severe forms of Raynaud's disease or Raynaud's syndrome).
Hypoglycemia in patients with diabetes mellitus
Beta-blockers should be prescribed with caution to patients predisposed to spontaneous hypoglycemia, or to patients with diabetes mellitus (especially labile diabetes mellitus), while taking insulin or oral hypoglycemic drugs. Beta blockers may mask the signs and symptoms of acute hypoglycemia.
Thyrotoxicosis
Beta blockers may mask some clinical signs of hyperthyroidism (eg, tachycardia). If the development of thyrotoxicosis is suspected, patients should be closely monitored. Abrupt withdrawal of beta-blockers should be avoided due to the risk of developing thyrotoxic crisis.
Anesthesia in surgery
The need to discontinue beta-blockers in the event of upcoming major surgery has not been proven. If necessary during surgery, the effects of beta-blockers can be eliminated by using sufficient doses of adrenergic agonists.
Liver dysfunction
There have been no studies of the use of the drug in patients with liver failure, and therefore the drug should be used with caution in such patients.
Allergy and hypersensitivity
Like other ophthalmic drugs for topical use, Dorzolan® extra can penetrate into the systemic circulation. Dorzolamide, which is part of the drug, is a sulfanilamide. Thus, adverse reactions identified with systemic use of sulfonamides may occur with local use of the drug (Stevens-Johnson syndrome and toxic epidermal necrolysis). If signs of serious hypersensitivity reactions occur, the drug should be discontinued.
When treated with beta-blockers in patients with atopy or a history of severe anaphylactic reactions to various allergens, the response may be enhanced upon repeated exposure to these allergens. In this group of patients, taking epinephrine at the standard therapeutic dose used to relieve allergic reactions may not be effective.
Concomitant therapy
When using the drug Dorzolan® extra in patients taking systemic beta-blockers, it is necessary to take into account the possible mutual enhancement of the pharmacological action of the drugs, both in relation to the known systemic effects of beta-blockers and in relation to the reduction of intraocular pressure.
Concomitant use of the drug with other beta-blockers is not recommended.
Stopping treatment
If it is necessary to discontinue topical use of timolol, as in the case of systemic beta-blockers, discontinuation of therapy in patients with coronary heart disease should be carried out gradually.
Corneal disorders
Beta blockers used in ophthalmology can cause dry eyes. In patients with corneal disorders, the drug should be prescribed with caution.
Patients with low endothelial cell counts are at increased risk of developing corneal edema.
Urolithiasis disease
The use of carbonic anhydrase inhibitors can lead to acid-base imbalance and be accompanied by urolithiasis, especially in patients with a history of urolithiasis. No such disturbances were observed during use of the drug; reports of urolithiasis were rare. Since the drug contains a carbonic anhydrase inhibitor, which, when applied topically, can be absorbed and penetrate into the systemic circulation, the risk of developing urolithiasis in patients with a history of urolithiasis may increase when treated with Dorzolan® extra.
Miscellaneous
Patients with acute angle-closure glaucoma, in addition to the prescription of drugs that reduce intraocular pressure, require other therapeutic measures. Studies of the drug's effect in patients with acute angle-closure glaucoma have not been conducted.
Use in the elderly
49% of patients in clinical trials of the drug were aged 65 years or older, 13% of patients were aged 75 years or older. There were no differences in the effectiveness and safety of the drug in these age groups compared with younger patients. However, the possibility of higher sensitivity to the drug in some elderly patients should not be excluded.
Contraindications
- COPD and bronchial asthma (including indication in medical history);
- Sinus bradycardia;
- Severe heart failure and AV block;
- Cardiogenic shock;
- Severe degrees of renal failure;
- Corneal degeneration;
- Pregnancy;
- Lactation;
- Age up to 18 years;
- Individual hypersensitivity.
The drug should be prescribed with caution in case of liver failure, diabetes mellitus, and in old age.
Dorzolamide-timolol Solopharm eye drops 20mg/ml + 5mg/ml 5ml
Contraindications
Airway hyperresponsiveness, bronchial asthma, history of bronchial asthma, severe chronic obstructive pulmonary disease.
Sinus bradycardia, sick sinus syndrome, sinoatrial block, atrioventricular block II–III degree without a pacemaker, severe heart failure, cardiogenic shock. Severe renal failure (creatinine clearance less than 30 ml/min) or hyperchloremic acidosis. Dystrophic processes in the cornea. Pregnancy and breastfeeding period. Hypersensitivity to any component of the drug. Children under 18 years of age (due to insufficient study of effectiveness and safety). With caution: Like other ophthalmic drugs used topically, it can be absorbed into the systemic circulation. Since timolol, which is part of the drug, is a beta-blocker, adverse reactions that develop with the systemic use of beta-blockers may occur with topical use of the drug. Reactions from the cardiovascular and respiratory systems. Patients with a history of cardiovascular disease, including heart failure, should be closely monitored for signs of worsening of these diseases. In such patients, it is necessary to monitor the pulse. Patients with first degree heart block should be prescribed beta blockers with caution due to their ability to slow impulse conduction. There have been reports of cases of fatal bronchospasm in patients with bronchial asthma and cases of fatal heart failure during the use of timolol maleate eye drops. In patients with mild to moderate chronic obstructive pulmonary disease, the drug should be prescribed with caution and only if the expected benefit of treatment outweighs the potential risk. The drug should be administered with caution to patients with severe peripheral circulatory disorders (severe forms of Raynaud's disease or Raynaud's syndrome). Hypoglycemia in patients with diabetes mellitus Beta-blockers should be prescribed with caution to patients predisposed to spontaneous hypoglycemia, or to patients with diabetes mellitus (especially labile diabetes mellitus), while taking insulin or oral hypoglycemic drugs. Beta blockers may mask the signs and symptoms of acute hypoglycemia. Thyrotoxicosis Beta-blockers may mask some clinical signs of hyperthyroidism (eg, tachycardia). If the development of thyrotoxicosis is suspected, patients should be closely monitored. Abrupt withdrawal of beta-blockers should be avoided due to the risk of developing thyrotoxic crisis.
Anesthesia in surgery. The need to discontinue beta-blockers in the event of upcoming major surgery has not been proven. If necessary during surgery, the effects of 5 beta-blockers can be eliminated by using sufficient doses of adrenergic agonists. Impaired liver function There have been no studies of the use of the drug in patients with liver failure, and therefore the drug should be used with caution in such patients. Allergy and hypersensitivity Like other ophthalmic drugs for topical use, Dorzolamide + Timolol SOLOpharm can penetrate into the systemic circulation. Dorzolamide, which is part of the drug, is a sulfanilamide. Thus, adverse reactions identified with the systemic use of sulfonamides may occur with topical use of the drug (Stevens-Johnson syndrome and toxic epidermal necrolysis). If signs of serious hypersensitivity reactions occur, the drug should be discontinued. When treated with beta-blockers in patients with atopy or a history of severe anaphylactic reactions to various allergens, the response may be enhanced upon repeated exposure to these allergens. In this group of patients, taking epinephrine at the standard therapeutic dose used to relieve allergic reactions may not be effective.
Concomitant therapy. When using the drug Dorzolamide + Timolol SOLOpharm in patients taking systemic beta-blockers, it is necessary to take into account the possible mutual enhancement of the pharmacological action of the drugs, both in relation to the known systemic effects of beta-blockers and in relation to the reduction of intraocular pressure. Concomitant use of the drug with other beta-blockers is not recommended.
Stopping treatment. If it is necessary to discontinue topical use of timolol, as in the case of systemic beta-blockers, discontinuation of therapy in patients with coronary heart disease should be carried out gradually. Corneal disorders Beta-blockers used in ophthalmology can cause dry eyes. 6 In patients with corneal disorders, the drug should be prescribed with caution. Patients with low endothelial cell counts are at increased risk of developing corneal edema.
Urolithiasis disease. The use of carbonic anhydrase inhibitors can lead to disruption of the acid-base balance and be accompanied by urolithiasis, especially in patients with a history of urolithiasis. No such disturbances were observed during use of the drug; reports of urolithiasis were rare. Since the drug contains a carbonic anhydrase inhibitor, which, when applied topically, can be absorbed and penetrate into the systemic circulation, the risk of developing urolithiasis in patients with a history of urolithiasis may increase when treated with Dorzolamide + Timolol SOLOpharm. Miscellaneous Patients with acute angle-closure glaucoma, in addition to the prescription of drugs that reduce intraocular pressure, require other therapeutic measures. Studies of the drug's effect in patients with acute angle-closure glaucoma have not been conducted.
Use in elderly people. 49% of patients in clinical trials of the drug were aged 65 years or older, 13% of patients were aged 75 years or older. There were no differences in the effectiveness and safety of the drug in these age groups compared with younger patients. However, the possibility of higher sensitivity to the drug in some elderly patients should not be excluded.
Side effects
- Inflammation, irritation and peeling of the eyelids, iridocyclitis, myopia, which goes away when the drug is discontinued, punctate keratitis, conjunctivitis, keratitis, dry eye syndrome, diplopia, ptosis.
- Headache, asthenia, paresthesia, tinnitus, depression, memory loss.
- Angioedema, bronchospasm, itching, urticaria, alopecia, exacerbation of psoriasis.
- Nosebleeds, dry mouth, throat irritation, rash.
- Arrhythmia, fainting, decreased blood pressure, rhythm disturbances, decreased temperature of the extremities, edema, Raynaud's syndrome.
- Bronchospasm, cough and chest pain.
- Diarrhea, dry mouth, decreased libido, Peyronie's disease.
special instructions
The use of Dorzopt Plus solution requires adequate control of the cardiovascular system.
Dorzopt Plus contains benzalkonium chloride, a preservative that can precipitate in hydrophilic contact lenses, causing a damaging effect on the tissues of the organ of vision. Therefore, patients using soft contact lenses should remove them before applying drops, and install them back after instillation approximately 20 minutes later.
When prescribing a planned surgical operation, Dorzopt Plus solution is canceled 48 hours before general anesthesia, due to the enhanced effect of muscle relaxants, as well as general anesthesia.
During the treatment period, there is a need to refrain from driving vehicles and not engage in activities associated with dangerous mechanisms.
Store Dorzopt Plus solution at room temperature. Keep away from children.
Shelf life – 2 years. Shelf life after opening is one month.
