Instructions for use Dorzopt and Dorzopt Plus: composition and analogues


Dorzopt and Dorzopt Plus are eye drops that are used in the treatment of glaucoma. The drug belongs to carbonate hydrolysis inhibitors. The medication does not cause myopia or pupil constriction .

Many patients think about the difference between Dorzopt and Dorzopt Plus. The difference between these drugs is that the second has a more pronounced effect due to the content of two active substances - dorzolamide and timolol.

Composition and release form

The drug Dorzopt plus is available in the form of eye drops, a colorless, transparent, somewhat viscous solution. Each milliliter of medicine contains two active substances:

  • Dorzolamide (hydrochloride) 20 mg;
  • Timolol (maleate) 5 mg.

Auxiliary components include mannitol, benzalkonium chloride, hydroxyethylcellulose, purified water, acidity stabilizers.

5 ml of solution are placed in dropper bottles made of polymer material.

Reviews

Anatoly, 56 years old: “This remedy clearly reduced the pressure in my eyes, but I began to notice constant fatigue and this, I think, is a side effect.”

Irina, 48 years old: “I used Politimol for many years. At one point the doctor said there was nothing he could do to save my vision, and then another doctor prescribed me these drops and my blood pressure slowly decreased and was stable for about 5 years. I didn’t lose my sight.”

pharmachologic effect

Dorzopt plus drops are an antiglaucoma drug that helps stabilize intraocular pressure by reducing the secretion of aqueous humor.

The action is based on two mechanisms. Dorzolamide is a carbonic anhydrase inhibitor and slows down the formation of bicarbonate, water and sodium transport. Timolol is a non-selective beta blocker and prevents catecholamines from stimulating receptors. At the same time, it not only inhibits the synthesis of aqueous humor, but also somewhat facilitates its outflow.

Precautionary measures

Patients should be instructed to avoid contact of the tip of the dosing container with the eye or surrounding structures.
Read how to use inocaine eye drops here.

You should be aware that ophthalmic solutions, if not handled correctly or if the tip of the dispensing container comes into contact with the eye or surrounding structures, may become contaminated with common bacteria known to cause eye infections.

You can see analogues of hyphenation here.

Severe eye damage and subsequent loss of vision can result from the use of contaminated solutions.

You should also be advised that if they have eye surgery or develop an infection, they should immediately seek medical advice regarding continued use of the drug.

Contraindications

The use of Dorzopt plus is contraindicated for:

  • Bronchial asthma;
  • Heart rhythm disturbances (bradycardia, 2-3 degree AV block);
  • Heart failure, including cardiogenic shock;
  • Hyperchloremic acidosis;
  • Severe renal failure, accompanied by a decrease in creatinine clearance less than 30 ml/min;
  • Breastfeeding;
  • Pregnancy;
  • Hypersensitivity to the components of the drug.

Interactions

No special studies have been conducted regarding the interaction of Dorzopt plus with other medications.

Increased hypotension, bradycardia and cardiac depression are possible with simultaneous use of systemic beta-blockers, antiarrhythmics, calcium blockers, glycosides, opioid analgesics, parasympathomimetics, MAO inhibitors.

With simultaneous administration of CYP2D6 inhibitors, the systemic effects of beta blockers (depression, bradycardia, etc.) may be enhanced.

Since Dorzopt plus can penetrate into the systemic circulation in some quantities, it may increase the toxic effects of large doses of salicylates.

It is not recommended to combine Dorzopt Plus with systemic carbonic anhydrase inhibitors.

Dorzopt plus eye drops 5ml bottle

A country

Russia, Romania
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.

Active substance

Dorzolamide + Timolol

Compound

hyethylose - 1 mg, citric acid monohydrate - 4 mg, sodium hydroxide solution 1M - 0.066 ml, mannitol - 20 mg, benzalkonium chloride - 0.075 mg, sodium hydroxide solution 1M/hydrochloric acid solution 1M - to pH 5.6±0.1, purified water - up to 1 ml.

pharmachologic effect

An antiglaucoma drug that contains two active ingredients: dorzolamide and timolol, each of which reduces increased intraocular pressure by reducing the secretion of intraocular fluid. The combined effect of these substances in the combined drug Dorzopt Plus leads to a more pronounced decrease in intraocular pressure. Dorzolamide is a selective inhibitor of type II carbonic anhydrase. Inhibition of carbonic anhydrase of the ciliary body leads to a decrease in the secretion of intraocular fluid, presumably due to a decrease in the formation of bicarbonate ions, which in turn leads to a slowdown in the transport of sodium and intraocular fluid. Timolol is a non-selective beta-blocker. Although the exact mechanism of action of timolol in reducing intraocular pressure has not yet been established, a number of studies have shown a predominant decrease in the formation of intraocular fluid, as well as a slight increase in its outflow. The decrease in intraocular pressure occurs 20 minutes after instillation, reaches a maximum after 2 hours and continues for at least 24 hours

Indications for use

- increased intraocular pressure in open-angle glaucoma and pseudoexfoliative glaucoma with insufficient effectiveness of monotherapy.

Mode of application

The drug Dorzopt Plus is recommended to instill 1 drop into the conjunctival sac of the eye (or both eyes) 2 times a day. If the drug Dorzopt Plus is prescribed as a replacement for another ophthalmic drug for the treatment of glaucoma, the latter must be discontinued 1 day before the start of therapy with Dorzopt Plus. In the case of combined use with other local ophthalmic drugs, the drug Dorzopt Plus should be administered at intervals of 10 minutes. With nasolacrimal occlusion (closing of the eyelids) for 2 minutes after instillation of the drug, its systemic absorption decreases, which can lead to increased local action. The drug Dorzopt Plus is a sterile solution, so patients must be instructed how to use the bottle correctly. The duration of treatment is determined by the doctor depending on the clinical condition of the patient. Dorzopt Plus is contraindicated for use during pregnancy and lactation (breastfeeding). Dorzolamide Data on the use of dorzolamide not enough during pregnancy. Studies on rats have revealed the teratogenic effect of dorzolamide in doses toxic to pregnant females. It is not known whether dorzolamide passes into the breast milk of nursing women. A decrease in body weight gain was found in the offspring of lactating female rats treated with dorzolamide. Timolol There is insufficient data on the use of timolol during pregnancy. Epidemiological studies have not found the effect of beta-blockers when taken orally on the formation of congenital malformations, but intrauterine growth retardation has been identified. In addition, signs and symptoms of β-adrenergic receptor blockade (bradycardia, hypotension, respiratory failure, hypoglycemia) were found in newborns when beta-blockers were used before birth. Beta-blockers pass into breast milk. During the period of breastfeeding, it is necessary to discontinue use of the drug Dorzopt Plus or stop breastfeeding. Contraindicated in children and adolescents under the age of 18 years.

Interaction

There have been no studies of the interaction of the drug Dorzopt Plus with other drugs. However, there is a possibility of enhancing the hypotensive effect and/or developing severe bradycardia when timolol ophthalmic solution is used together with slow calcium channel blockers, sympatholytics, beta-blockers, antiarrhythmic drugs (including amiodarone ), cardiac glycosides, parasympathomimetics, opioid analgesics and MAO inhibitors. With the combined use of timolol and inhibitors of the CYP2D6 isoenzyme (for example, quinidine or selective serotonin reuptake inhibitors), a potentiated effect of systemic blockade of β-adrenergic receptors (for example, decreased heart rate, depression) has been reported. Despite the fact that the carbonic anhydrase inhibitor dorzolamide, which is part of Dorzopt Plus, is used topically, it can penetrate into the systemic circulation. In clinical studies of the use of dorzolamide ophthalmic solution, no acid-base balance disorders were identified. However, with systemic use of carbonic anhydrase inhibitors, these disorders are known, and in some cases they may affect interactions with other drugs (for example, enhance toxic reactions when using salicylates in high doses). Systemic beta-blockers may enhance the effect of hypoglycemic drugs. Systemic beta-blockers can increase the severity of arterial hypertension, which is the effect of clonidine withdrawal. There is isolated data on the development of mydriasis with the combined use of timolol and adrenaline. There is a possibility of enhancing the known systemic effects of carbonic anhydrase inhibition with the combined use of local and systemic carbonic anhydrase inhibitors. Because There are no data on the use of such a combination; the combined use of Dorzopt Plus and systemic carbonic anhydrase inhibitors is not recommended.

Side effect

In clinical studies, the drug was generally well tolerated. Adverse reactions were limited to known adverse reactions with dorzolamide and timolol. Systemic adverse reactions were mild and did not lead to drug discontinuation. In approximately 1.2% of patients, the drug was discontinued due to local allergic reactions. Among the most common adverse local reactions were a burning sensation or itching in the eyes, corneal erosions, injection of the vessels of the conjunctiva of the sclera, blurred vision, lacrimation, distortion of taste. In the post-registration period, when using the combination of dorzolamide + timolol, the following adverse reactions were noted: shortness of breath, respiratory failure, bradycardia , AV block, choroidal detachment, nausea, contact dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Cases of edema and irreversible destruction of the cornea have been reported in patients with chronic corneal defects and/or those who have undergone intraocular surgery. The following possible adverse reactions of the active components of the drug are known. Dorzolamide From the nervous system: headache, dizziness, asthenia/fatigue, paresthesia. From the organ of vision : inflammation of the eyelid, lacrimation, irritation and peeling of the eyelid, iridocyclitis, punctate keratitis, transient myopia (passing after discontinuation of the drug). Allergic reactions: angioedema, bronchospasm, urticaria, itching, rash. From the respiratory system: nosebleeds. Timolol (local application) Mental disorders: depression. From the immune system: anaphylaxis, angioedema, urticaria, local or generalized rash. From the nervous system: tinnitus, paresthesia, headache, asthenia, fatigue, dizziness, insomnia, nightmares, decreased memory, increasing symptoms of myasthenia gravis. From the respiratory system: bronchospasm (mainly in patients with previous broncho-obstructive pathology), cough, chest pain. From the organ of vision: conjunctivitis, blepharitis, keratitis, decreased sensitivity of the cornea, dry eye syndrome; visual disturbances, including changes in the refractive power of the eye (in some cases due to the withdrawal of miotics), diplopia, ptosis. From the cardiovascular system: arrhythmia, cardiac arrest, decreased blood pressure, fainting, Raynaud's syndrome, decreased temperature of the hands and feet. from the digestive system: diarrhea, dyspepsia, dry mouth, pharyngeal irritation, abdominal pain. From the skin and subcutaneous tissues: alopecia, psoriasis-like rash or exacerbation of psoriasis. From the musculoskeletal system and connective tissue: lameness, systemic lupus erythematosus. From the reproductive system: decreased libido, Peyronie's disease. General disorders and disorders at the injection site: edema. Timolol (systemic use) From the blood and lymphatic system: non-thrombocytopenic purpura. From the nervous system: weakness, dizziness, increased drowsiness, decreased concentration attention. From the endocrine system: hyperglycemia, hypoglycemia. From the respiratory system: pulmonary edema, wheezing. From the cardiovascular system: decreased tolerance to physical exercise, AV blockade II-III degree, sinotrial blockade, decompensation of heart failure, progression angina pectoris, vasodilation. From the digestive system: vomiting. From the skin and subcutaneous tissues: exfoliative dermatitis, skin itching, increased sweating. From the kidneys and urinary tract: urinary disorders. From the musculoskeletal system: pain in the extremities, arthralgia. From the reproductive system: impotence. Laboratory and instrumental data: rarely - a slight increase in the concentration of residual nitrogen, potassium, uric acid and triglycerides in the blood plasma; a slight decrease in the concentration of hemoglobin, hematocrit, cholesterol, HDL. These changes were not clinically manifested and did not progress.

Contraindications

- hyperreactivity of the respiratory tract; - bronchial asthma (including a history); - severe chronic obstructive pulmonary disease (COPD); - sinus bradycardia; - SSSS; - sinoatrial block; - AV block II-III degree; - severe heart failure;—cardiogenic shock;—severe renal failure (creatinine clearance less than 30 ml/min);—hyperchloremic acidosis;—dystrophic processes in the cornea;—pregnancy;—lactation (breastfeeding);—childhood and adolescence up to 18 years ( because the effectiveness and safety have not been sufficiently studied); - hypersensitivity to the components of the drug. The drug should be prescribed with caution if there is a history of cardiovascular diseases, including heart failure; AV blockade of the first degree; mild to moderate COPD; severe peripheral circulatory disorders (severe forms of Raynaud's disease or Raynaud's syndrome); liver failure; diabetes mellitus; urolithiasis (including history); hyperthyroidism; corneal disorders; elderly patients.

Overdose

There are no data on accidental or intentional overdose of the drug. Cases of unintentional overdose of timolol in the form of eye drops with the development of systemic symptoms of beta-blocker overdose with systemic use have been described: dizziness, headache, shortness of breath, bradycardia, bronchospasm, cardiac arrest. The most expected symptoms of dorzolamide overdose are electrolyte imbalance, development of acidosis, headache, asthenia/fatigue, paresthesia. Treatment: symptomatic and supportive therapy. The concentration of electrolytes (primarily potassium) and blood plasma pH should be monitored. Timolol is not excreted during dialysis.

special instructions

Dorzopt Plus, like other ophthalmic drugs for topical use, can penetrate into the systemic circulation. Since timolol, which is part of the drug, is a beta-blocker, undesirable reactions that develop with the systemic use of beta-blockers may be observed with topical use of the drug Dorzopt Plus. Reactions from the cardiovascular and respiratory systems Before starting the use of the drug Dorzopt Plus, it is necessary to ensure adequate monitoring of the condition cardiovascular system. Patients with a history of cardiovascular disease, including heart failure, should be closely monitored for signs of worsening of these diseases (monitoring heart rate and blood pressure). Cases of fatal heart failure have been reported with the use of timolol in the form of eye drops. When the first signs or symptoms of heart failure appear, the use of the drug Dorzopt Plus should be discontinued. Patients with first-degree heart block should be prescribed beta-blockers with caution due to their ability to slow impulse conduction. Cases of bronchospasm with fatal outcome in patients have been reported with bronchial asthma while using timolol in the form of eye drops. In patients with mild to moderate COPD, Dorzopt Plus should be used with caution and only if the expected benefit of treatment outweighs the potential risk. The drug should be used with caution in patients with severe peripheral circulatory disorders (severe forms of Raynaud's disease or Raynaud's syndrome). Diabetes mellitus The drug should be used with caution in patients with spontaneous hypoglycemia or in patients with diabetes mellitus (especially with a labile course) while using insulin or oral hypoglycemic drugs, since beta-blockers can mask symptoms of hypoglycemia. Hyperthyroidism Beta-blockers may mask some clinical signs of hyperthyroidism (for example, tachycardia). If hyperthyroidism is suspected, patients should be closely monitored. Abrupt withdrawal of beta-blockers should be avoided due to the risk of developing a thyrotoxic crisis. Anesthesia in surgery The need to discontinue beta-blockers in the event of an upcoming major surgical intervention has not been proven. The effects of beta-blockers during surgery, if necessary, can be eliminated by using sufficient doses of adrenergic agonists. Impaired liver function. Studies on the use of the drug Dorzopt Plus in patients with liver failure have not been conducted, so the drug should be used with caution in such patients. Allergy and hypersensitivity reactions Like others ophthalmic preparations for topical use, the drug Dorzopt Plus can penetrate into the systemic circulation. Dorzolamide, which is part of the drug, is a sulfanilamide. Adverse reactions identified with 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 appear, the drug should be discontinued. When treating patients with atopy or severe anaphylactic reactions to various allergens in history, the response may be enhanced upon repeated contact with these allergens. In this group of patients, the use of epinephrine in a standard therapeutic dose to relieve allergic reactions may be ineffective. Concomitant therapy When using the drug Dorzopt Plus in patients taking systemic beta-blockers, it is necessary to take into account the possible mutual enhancement of the pharmacological action of the drugs, as in relation to the known systemic effects of beta-blockers , and in relation to reducing intraocular pressure. The combined use of Dorzopt Plus with other beta-blockers is not recommended. Discontinuation of therapy If it is necessary to discontinue topical use of timolol, as in the case of discontinuation of systemic beta-blockers, discontinuation of therapy in patients with coronary artery disease should be carried out gradually. Corneal disorders Beta-blockers used in ophthalmology may cause dryness of the eye mucosa. In patients with corneal disorders, the drug should be used with caution. Patients with a low number of endothelial cells have an increased risk of developing corneal edema. Urolithiasis The use of systemic carbonic anhydrase inhibitors can lead to acid-base imbalance and be accompanied by urolithiasis, especially in patients with a history of urolithiasis. Dorzopt Plus contains a carbonic anhydrase inhibitor, which when applied topically, it can be absorbed and penetrate into the systemic circulation, therefore the risk of developing urolithiasis in patients with a history of urolithiasis during treatment with Dorzopt Plus may increase. Use in elderly patients In clinical studies of the difference in the effectiveness and safety of the combination of dorzolamide + timolol in patients over the age of 65 years of age compared with younger patients was not identified. However, the possibility of higher sensitivity to the drug in some elderly patients should not be excluded. Use of contact lenses Dorzopt Plus contains the preservative benzalkonium chloride, which may cause eye irritation. Therefore, before using the drug, patients should remove soft contact lenses and put them back no earlier than 15 minutes after instillation of the drug. Benzalkonium chloride can discolor soft contact lenses. Effect on the ability to drive vehicles and machinery During the period of use of the drug Dorzopt Plus, it is necessary to refrain from driving vehicles and machinery and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Dispensing conditions in pharmacies

On prescription

special instructions

Prescribing Dorzopt plus to patients with liver dysfunction and diabetes mellitus requires caution.

When instilling other medications together, a 15-minute break must be observed. During treatment, monitoring of the electrolyte composition and acidity of blood plasma is required.

The drops contain benzalkonium chloride. This preservative can be deposited on the surface of contact lenses and cause irritation and toxic damage to the eyes. In this regard, the lenses must be removed.

During treatment with Dorzopt Plus, care must be taken when driving and operating dangerous machinery.

How are medications similar?

There are the following similarities between the drugs Dorzopt and Dorzopt Plus:

  • Both medications are available in eye drops.
  • Both drugs are used for open-angle and pseudoexfoliative glaucoma.
  • Eye drops are contraindicated if you are allergic to their composition, children under 18 years of age, pregnant women and those supporting breastfeeding, patients with chronic renal failure when the glomerular filtration rate is less than 30 ml per minute. They should be used with caution in diabetes mellitus and liver failure.
  • Both medications can cause pinpoint keratitis, lacrimation, irritation and inflammation of the eyelid, iridocyclitis, headache, nausea, impotence, paresthesia, conjunctivitis.
  • Dorzopt and Dorzopt plus can be purchased at the pharmacy upon presentation of a prescription.
  • To ensure that medications do not lose their therapeutic effect, they must be stored at temperatures up to 25 degrees, in a dry place, protected from light, for 2 years from the date of issue. After opening the bottle, eye drops can be used for a month.

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