Tapticom drops 0.0015 + 0.5%, 0.3ml No. 30
Expiration Date: 05/2027
Russian Pharmacy name:
Таптиком капли 0,0015+0,5%, 0,3мл №30
The drug is intended for ophthalmic use only.
The recommended dose is 1 drop of TapticomЃ in the conjunctival sac of the affected eye (s) 1 time / day.
The dose should not exceed 1 drop in the affected eye (s) / day, since more frequent use of the drug can reduce the expected effect of lowering IOP. If one dose is missed, treatment is continued with the next scheduled dose.
TapticomЃ is a sterile, preservative-free solution packaged in disposable dropper tubes. The solution in one dropper tube is for single use only and is sufficient for use in both eyes. The use of TapticomЃ in children and adolescents under the age of 18 is not recommended. Elderly patients do not require dose adjustment of the drug.
The use of the drug TapticomЃ has not been studied in patients with renal and hepatic insufficiency, therefore, the drug should be used with caution in such patients. Method of application To reduce the risk of darkening of the eyelid skin, patients should remove excess solution from the skin. As with the use of other eye drops, with short-term finger pressure of the nasolacrimal canals or closing the eyelids for 2 minutes after application, there is a decrease in systemic absorption of the drug. This measure reduces the risk of systemic side effects and enhances the local effect of the drug. When using several ophthalmic preparations of local action, the intervals between their use should be at least 5 minutes. Before using the drug, contact lenses must be removed and reinstalled after 15 minutes.Patients should be warned not to touch the eye and surrounding tissues with the tip of the dropper tube, as this may damage them.
tafluprost, timolol
syndrome of increased airway reactivity, including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease;
sinus bradycardia;
SSSU;
sinoatrial blockade;
AV block II and III degree without a pacemaker;
decompensated heart failure;
cardiogenic shock;
age up to 18 years (no data on clinical use);
pregnancy;
breast-feeding;
hypersensitivity to tafluprost, timolol or any of the components of the drug.
The drug should be used with caution (due to limited experience of use) in patients with hepatic and renal insufficiency, with aphakia, pseudophakia with rupture of the posterior lens capsule or implantation of the lens into the anterior chamber of the eye, pseudoexfoliative or pigmentary glaucoma, as well as in patients with established factors risk of developing cystic macular edema or iritis / uveitis; with neovascular, closed-angle, narrow-angle and congenital glaucoma (there is no experience with tafluprost); in patients with corneal diseases (can cause dry eye syndrome), cardiovascular diseases (coronary artery disease, Prinzmetal angina pectoris, heart failure, 1st degree AV block), with peripheral circulation disorders (with severe forms of Raynaud's disease or Raynaud's syndrome),COPD of mild to moderate severity (the use of the drug is possible only if the expected benefit outweighs the potential risk), in patients with a labile course of diabetes mellitus or spontaneous hypoglycemia (since beta-blockers can mask the clinical signs and symptoms of acute hypoglycemia), concomitant treatment with beta-blockers (with ingestion and in the form of ophthalmic agents).
pharmachologic effect
A drug containing a fixed combination of two active ingredients - tafluprost and timolol. Both active substances reduce intraocular pressure (IOP), mutually reinforcing each other's action, as a result of which the effect of reducing IOP when using the combined preparation is more pronounced than the effect of each of the active substances separately. Tafluprost is a fluorinated analogue of prostaglandin F2 ?. Tafluprost acid, being a biologically active metabolite of tafluprost, has high activity and selectivity against human FP receptors (prostaglandin F2 receptors?). Data from pharmacodynamic studies (preclinical studies) indicate that tafluprost reduces IOP, increasing the uveoscleral outflow of aqueous humor. Timolol maleate is a non-selective beta-blocker.The exact mechanism of lowering IOP with the use of timolol maleate is currently not fully established, however, the methods of fluorescence and tonography indicate that the main effect may be due to a decrease in the formation of intraocular fluid. At the same time, some studies have noted a slight increase in its outflow. It was shown that in patients with open-angle glaucoma or ocular hypertension and an average IOP before treatment of 24-26 mm Hg. the effect of lowering IOP against the background of the use of TapticomЃ was not lower than the effect observed with the combined use of tafluprost 0.0015% and timolol 0.5%, and the decrease in the average daily IOP after 6 months was 8 mm Hg. from the original values. Besides,the activity of TapticomЃ and the corresponding monotherapy drugs was compared in patients with open-angle glaucoma or ophthalmic hypertension and the mean IOP before treatment, which was 26-27 mm Hg. The decrease in the average daily IOP with the use of TapticomЃ was statistically more significant than that with the monotherapy with tafluprost, administered 1 time / day in the morning, or timolol, administered 2 times / day. After 3 months of treatment, the decrease in the average daily IOP compared to its baseline level in the TapticomЃ group was 9 mm Hg. compared with 7 mm Hg observed in both monotherapy groups. The decrease in IOP in those who used TapticomЃ during the day ranged between 7 and 9 mm Hg. Pooled data from these two clinical studies in patients (n = 168) with an initial high IOP of 26 mm Hg.or higher showed that in those who received TapticomЃ after 3 or 6 months, the average daily decrease in IOP was 10 mm Hg, with a range of 9 to 12 mm Hg. during the day.
Side effect
In clinical trials, more than 484 patients received treatment with TapticomЃ. The most commonly reported treatment-related side effect, which occurred in approximately 7% of patients, was conjunctival / ocular hyperemia, in most cases mild. Adverse reactions observed in clinical trials of the drug TapticomЃ were limited to the same reactions that were previously observed with the separate use of tafluprost and timolol. No new adverse reactions characteristic only of TapticomЃ have been identified in clinical trials. Most of the adverse reactions were observed on the part of the organ of vision, were mild or moderate, serious reactions were not noted. To assess the frequency of adverse reactions, according to MedDRA terminology,the following classification was used: very often (? 1/10 cases); often (? 1/100, <1/10); infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000); very rare (<1/10 000) and unknown (frequency cannot be determined from available data). TapticomЃ (combination of tafluprost and timolol) From the nervous system: infrequently - headache. From the side of the organ of vision: often - hyperemia of the conjunctiva / eyes, itching in the eyes, pain in the eyes, changes in eyelashes (increase in length, thickness and number of eyelashes), discoloration of eyelashes, eye irritation, sensation of a foreign body in the eyes, blurred vision, photophobia; infrequently - discomfort in the eye area, dryness of the mucous membrane of the eyes, a feeling of discomfort in the eyes, conjunctivitis, erythema of the eyelids, symptoms of allergic eye damage, eyelid edema, superficial punctate keratitis, lacrimation,inflammatory reaction in the moisture of the anterior chamber, asthenopia, blepharitis. Adverse reactions that were observed during treatment with tafluprost or timolol, and which can potentially develop with the use of TipticomЃ, are presented below. Tafluprost From the side of the organ of vision: decreased visual acuity, increased pigmentation of the iris, pigmentation of the eyelids, edema of the conjunctiva, the appearance of discharge from the eyes, cellular opalescence in the anterior chamber of the eye, allergic conjunctivitis, pigmentation of the conjunctiva, conjunctival follicles, deepening / crease of the eyelid, and. On the part of the skin and subcutaneous tissues: hypertrichosis of the eyelids. Respiratory system: unknown - exacerbation of asthma, shortness of breath. Timolol from the immune system: allergic reactions, including angioedema, urticaria, local or generalized skin rash,anaphylaxis, pruritus. From the side of metabolism: hypoglycemia. Mental disorders: depression, insomnia, nightmares, memory loss, nervousness. From the nervous system: dizziness, fainting, paresthesia, increased symptoms of myasthenia gravis, acute cerebrovascular accident, cerebral ischemia. From the side of the organ of vision: keratitis, decreased sensitivity of the cornea, impaired visual acuity, including refractive changes (in some cases as a result of the cancellation of miotic therapy), ptosis, diplopia, detachment of the choroid after fistulizing surgery, lacrimation, corneal erosion. On the part of the organ of hearing and balance: ringing in the ears. From the cardiovascular system: bradycardia, chest pain, palpitations, edema, arrhythmia, congestive heart failure, cardiac arrest, heart block, AV block,heart failure, decreased blood pressure, intermittent claudication, Raynaud's phenomenon, cold hands and feet. From the respiratory system: shortness of breath, bronchospasm (mainly in patients with a history of bronchospastic disease), respiratory failure, cough. From the digestive system: nausea, dyspepsia, diarrhea, dryness of the oral mucosa, dysgeusia, abdominal pain, vomiting. On the part of the skin and subcutaneous tissues: alopecia, psoriasis-like rash or exacerbation of the course of psoriasis, skin rash. From the musculoskeletal system: systemic lupus erythematosus, myalgia, arthropathy. Reproductive system and breast disorders: Peyronie's disease, decreased libido, sexual dysfunction. General disorders: asthenia / fatigue, thirst. Very rarely when using eye drops containing phosphates,Cases of corneal calcification have been reported in some patients with severe corneal injury.
Application during pregnancy and lactation
Pregnancy
There are no adequate data on the use of TapticomЃ in pregnant women. Women of childbearing age need to use effective methods of contraception during treatment with TapticomЃ. You should not use TapticomЃ during pregnancy, except in special cases (if there are no other methods of treatment).
Tafluprost
There are no adequate data on the use of tafluprost in pregnant women. Tafluprost may have adverse pharmacological effects on pregnancy and / or on the development of the fetus or newborn baby. In animal studies, there is evidence of reproductive toxicity of tafluprost, at the same time, the potential risk of its use in humans is unknown.
Timolol
јдекватные данные о применении тимолола у беременных женщин отсутствуют. “аптикомЃ не следует примен¤ть у беременных женщин, кроме случаев, когда ожидаема¤ польза дл¤ матери превышает потенциальный риск дл¤ плода. »нформаци¤ о мерах по уменьшению системной абсорбции представлена в разделе '–ежим дозировани¤'. ¬ эпидемиологических исследовани¤х не было вы¤влено системных нарушений развити¤ плода, но отмечен риск замедлени¤ внутриутробного развити¤ в случае приема бета-адреноблокаторов внутрь. роме того, клинические про¤влени¤ и симптомы блокады ?-адренорецепторов (например, брадикарди¤, гипотензи¤, нарушени¤ дыхани¤ и гипогликеми¤) наблюдались у новорожденных, если бета-адреноблокаторы использовались до родов. ¬ случае применени¤ препарата “аптикомЃ до родоразрешени¤, следует тщательно наблюдать за состо¤нием новорожденного в течение первых дней жизни.
Breast-feeding
Beta-blockers are known to pass into breast milk. However, it is unlikely that when timolol is used in eye drops at the recommended therapeutic doses, sufficient amounts of the substance can pass into breast milk to cause symptoms of ?-adrenergic receptor blockade in an infant. Information on measures to reduce systemic absorption is presented in the section 'Dosing regimen'. There are no data on the excretion of tafluprost or its metabolites into human breast milk. The available toxicological data in animals indicate the possible excretion of tafluprost and its metabolites into breast milk. However, it is unlikely that when using tafluprost in eye drops at recommended therapeutic doses, sufficient amounts of the substance will penetrate into breast milk,to induce clinical symptoms in an infant. As a precaution, breastfeeding of children is not recommended if the mother requires therapy with TapticomЃ.
Fertility
There is no data on the effect of TapticomЃ on fertility (fertility) in humans.
Application for violations of liver function
The use of the drug TapticomЃ has not been studied in patients with hepatic insufficiency, therefore, the drug should be used with caution in such patients.
Application for impaired renal function
The use of the drug TapticomЃ has not been studied in patients with renal insufficiency, therefore, the drug should be used with caution in such patients.
Application in children
The use of the drug under the age of 18 is contraindicated (no data on clinical use). Use in elderly patients
Elderly patients do not require dose adjustment of the drug.
special instructions
Systemic Effects
Like other ophthalmic drugs, tafluprost and timolol are absorbed systemically. Due to the presence of the beta-adrenergic component of timolol in the composition of the drug, the same adverse reactions from the cardiovascular system and respiratory system may develop, as with the use of systemic beta-blockers. The incidence of systemic adverse reactions after topical application of eye drops is lower than after systemic administration. Information on measures to reduce systemic absorption is presented in the section 'Dosing regimen'.
Heart disorders
In patients with cardiovascular diseases (for example, ischemic heart disease, Prinzmetal angina pectoris, heart failure) and arterial hypotension, it is necessary to carefully assess the need for therapy with beta-blockers and consider the use of drugs of other groups. It is necessary to monitor the condition of patients with cardiovascular diseases in order to timely detect symptoms of worsening diseases and adverse reactions. Due to their negative effect on the rate of conduction of the pulse, beta-blockers should be used with caution in patients with AV block of I degree.
Vascular disorders
It is necessary to use the drug with caution in patients with severe impairment of peripheral circulation (for example, severe forms of Raynaud's disease or Raynaud's syndrome).
Respiratory disorders
After the use of some ophthalmic beta-blockers, the risk of adverse reactions from the respiratory system may increase, including deaths due to bronchospasm in patients with bronchial asthma. In patients with mild / moderate COPD, TapticomЃ should be used with caution, and only if the expected benefits of its use outweigh the possible risks. Hypoglycemia / Diabetes Mellitus Beta-blockers should be used with caution in patients prone to spontaneous hypoglycemia, or in patients with labile diabetes mellitus. beta-blockers can mask the signs and symptoms of acute hypoglycemia. Hyperthyroidism
Beta-blockers can also mask signs of hyperthyroidism. Abrupt withdrawal of beta-blocker therapy may worsen the symptoms of the disease. Corneal diseases Ophthalmic beta-blockers can contribute to the development of dry eye syndrome. Caution should be exercised when using the drug in patients with corneal diseases. Other beta-blockers
The effect on intraocular pressure or the known effects of systemic blockade of ?-adrenergic receptors can be enhanced with the use of timolol (one of the active ingredients of TapticomЃ) in patients already receiving a systemic beta-blocker. The condition of such patients should be carefully monitored. It is not recommended to use two local beta-blockers at the same time. Angle-closure glaucoma In patients with angle-closure glaucoma, the primary goal of therapy is to open the angle of the anterior chamber of the eye. This requires constriction of the pupil with a miotic drug. Timolol has minimal or no effect on the pupil. When timolol is used to reduce increased intraocular pressure in angle-closure glaucoma, it should be used in combination with a miotic rather than monotherapy.
Anaphylactic reactions
With the use of beta-blockers, patients with a history of atopy or a severe anaphylactic reaction to a number of allergens in history may react more strongly to repeated administration of such allergens and not respond to the usual doses of epinephrine used to treat anaphylactic reactions. Detachment of the choroid Cases of detachment of the choroid have been reported with the use of drugs that suppress the production of aqueous humor (eg, timolol, acetazolamide) after fistulizing operations. General anesthesia Ophthalmic beta-blockers can block the effects of systemic ?-adrenergic receptor agonists, such as epinephrine. The anesthesiologist should be informed about the use of timolol by the patient. Before starting therapy, patients should be informed about the possible excessive growth of eyelashes,darkening of the eyelid skin and increased pigmentation of the iris of the eye, which are associated with tafluprost therapy. Some of these changes can be permanent and can lead to differences in the appearance of the eyes if only one eye has been treated. The change in the pigmentation of the iris is slow and may not be noticeable for several months. Eye discoloration occurs predominantly in patients with mixed-colored irises, for example, if the eyes are blue-brown, gray-brown, tan, or green-brown. Treatment of only one eye can lead to persistent heterochromia. If the rules for storing eye preparations are not followed, their bacterial contamination is possible, which can lead to the development of bacterial infections of the organ of vision,potentially leading to significant visual impairment or loss.
Influence on the ability to drive vehicles and use mechanisms
The effect of TapticomЃ on the ability to drive and operate machinery has not been studied. As with the use of any other ophthalmic agents, short-term blurred vision may occur after using the drug, therefore it is necessary to refrain from driving vehicles and performing activities that require increased concentration of attention and speed of psychomotor reactions until vision is restored.
Overdose
No cases of overdose of TapticomЃ have been reported. When instilling the drug into the eye, overdose symptoms are unlikely to occur. Symptoms: There were reports of unintentional overdose of timolol, which led to the development of systemic effects similar to those with systemic use of beta-blockers, namely, dizziness, headache, shortness of breath, bradycardia, bronchospasm and cardiac arrest. Treatment: if symptoms of an overdose occur when using TapticomЃ, symptomatic and supportive therapy is necessary. Excretion of timolol during hemodialysis is slowed down.
Drug interactions
Clinical studies to study the interaction of the drug have not been conducted. A decrease in blood pressure and / or the appearance of clinically pronounced bradycardia is possible in the case of the simultaneous use of ophthalmic drugs containing beta-blockers, and systemic use of slow calcium channel blockers, other beta-blockers, antiarrhythmic drugs (including amiodarone), cardiac glycosides, parasympathomimetics, guanethidine. Taking beta-blockers inside can lead to an increase in rebound arterial hypertension, which is observed when clonidine is withdrawn. With the simultaneous use of inhibitors of the isoenzyme CYP2D6 (for example, quinidine, fluoxetine, paroxetine) and timolol, an increase in the systemic action of a beta-blocker (decreased heart rate, depression) was reported. With the simultaneous use of ophthalmic drugs,containing a beta-blocker and adrenaline (epinephrine), in some cases, pupil dilation was noted.
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