Active substanceTimololTimolol
Similar drugsTo uncover
  • Arutimol
    drops d / eye 
    VALEANT, LLC     Russia
  • Glaoutam
    drops d / eye 
  • Okumed®
    drops d / eye 
  • Okumol
    drops d / eye 
  • Okupres-E®
    drops d / eye 
  • Oftan® Timogel
    gel d / eye 
    Santen, AO     Finland
  • Ofthan® Timolol
    drops d / eye 
    Santen, AO     Finland
  • Timolol
    drops d / eye 
  • Timolol
    drops d / eye 
    UPDATE OF PFC, CJSC     Russia
  • Timolol
    drops d / eye 
  • Timolol
    drops d / eye 
    BELMEDPREPARATY, RUP     Republic of Belarus
  • Timolol
    drops d / eye 
  • Timolol Solofarma
    drops d / eye 
    GROTEKS, LLC     Russia
  • Timolol-Akos
    drops d / eye 
    SYNTHESIS, OJSC     Russia
  • Timolol-Betalek
    drops d / eye 
    BETA-LEK, LLC     Russia
  • Timolol-DIA
    drops d / eye 
  • Timolol-Lens®
    drops d / eye 
    LENS-PHARM, LLC     Russia
  • Timolol-MEZ
    drops d / eye 
  • Timolol-POS®
    drops d / eye 
  • Timolol-Teva
    drops d / eye 
  • Timololong®
    drops d / eye 
    FIRN M, ZAO     Russia
  • Dosage form: & nbspeye drops
    Composition:
    1 ml solution (0.25% / 0.5%) contains: active ingredient timolol maleate (in terms of timolol) 3.42 (2.5) mg / 6.834 (5.0) mg; auxiliary substances: sodium hydrophosphate 6.71 mg / 8.676 mg; sodium dihydrogen phosphate dihydrate 2.6 mg / 2.47 mg; disodium edetate 0.557 mg / 1.0 mg; benzalkonium chloride 0.11 mg / 0.11 mg; water for injection up to 1 ml / up to 1 ml

    Description:a clear, colorless or almost colorless solution.
    Pharmacotherapeutic group:Antiglaucoma means β-blocker.
    ATX: & nbsp

    S.01.E.D.   Beta-blockers

    S.01.E.D.01   Timolol

    Pharmacodynamics:
    Timolol is a non-selective betar and betag-adrenoblocker. Has no significant internal sympathomimetic, directly oppressing myocardium and local anesthetic (membrane-stabilizing) activity.
    Blockade of beta-adrenoreceptors reduces cardiac output in healthy subjects and patients with heart disease. In patients with severe myocardial dysfunction, beta-adrenergic blockade can weaken the stimulatory effect of the sympathetic nervous system necessary to maintain adequate cardiac function.
    Blockade of beta-adrenergic receptors in the bronchi and bronchioles increases the resistance of the respiratory tract, due to the absence of antagonism to parasympathomimetic activity. This effect in patients with bronchial asthma or other bronchospastic states may pose a potential hazard.
    When applied topically, the dosage of timolol in the form of "eye drops" decreases as high, and the normal inner pressure irrespective of glaucoma. Increased intraocular pressure is the main risk factor in the pathogenesis of the narrowing of the visual field boundaries caused by glaucoma. The higher the intraocular pressure, the greater the likelihood of narrowing the visual field boundaries and optic nerve damage resulting from glaucoma.
    The onset of decrease in intraocular pressure, as a rule, is noted in half an hour after a single instillation of timolol. The maximum effect after a single administration, usually observed after 1-2 hours after administration, and significant reduction in intraocular pressure is maintained for 24 h. Regular observations throughout the year showed good ability of timolol in the dosage form of "eye drops" to maintain reduced intraocular pressure.
    The exact mechanism for reducing intraocular pressure due to timolol is not known. According to the data of tonography and fluorophotometry in humans, the action of timolol is mainly based on the decrease in the formation of intraocular fluid. However, some studies have also shown a slight increase in the outflow of intraocular fluid.

    Pharmacokinetics:
    To study the systemic effect of timolol in 6 people, the concentration of timolol in the blood plasma was determined after a two-fold instillation of a 0.5% solution of timolol. The maximum concentration in blood plasma after morning administration was 0.46 ng / ml, after daytime - 0.35 ng / ml.

    Indications:
    Decreased elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

    Contraindications:
    Hypersensitivity to timolol or other components of the drug; bronchial asthma (including anamnesis); severe chronic obstructive pulmonary disease; sinus bradycardia; atrioventricular blockade (AV blockade) of II or III degree; cardiogenic shock; decompensated chronic heart failure; childhood.

    Carefully:
    Heart failure in the stage of compensation, light and moderate severity of chronic obstructive pulmonary disease (COPD), extensive surgical interventions, diabetes, thyrotoxicosis.

    Pregnancy and lactation:
    Appropriate and well-controlled studies of the use of timolol in pregnant women have not been conducted. The drug Timolol-Teva should be used during pregnancy only if the expected benefit for the mother exceeds the possible risk to the fetus.
    It is known that beta-adrenoblokatory at ingestion can affect the fetal development of the fetus. In addition, neonates may have bradycardia, hypotension, respiratory failure and hypoglycemia with beta-blockers prior to delivery. Therefore, when using Timolol-Teva during pregnancy, it is necessary to monitor the state of newborns during the first days after birth.
    Timolol excreted in breast milk after ingestion. However, when applying a therapeutic dose in the form of eye drops of Timolol-Teva, it is unlikely that there will be enough timolol in breast milk to have clinically significant effects.Due to the possibility of developing serious adverse reactions in the child, it is necessary either to interrupt breastfeeding or to refuse the use of the drug (taking into account its importance for the mother).

    Dosing and Administration:
    Treatment, as a rule, begins with the application of 0.25% solution of the drug Timolol-Teva. 1 drop is applied twice a day to the affected eye.
    If the required clinical effect is not achieved, apply a 0.5% solution of the drug Timolol-Teva. 1 drop is applied twice a day to the affected eye. Decrease in intraocular pressure on a background of application of a preparation Timolol-Teva occurs within several weeks. Measurement of intraocular pressure is carried out 4 weeks after the start of the drug.
    If a satisfactory level of intraocular pressure is achieved, the dosage regimen can be changed to 1 drop 1 time per day in the affected eye. Due to daily fluctuations in intraocular pressure, the best way to identify a satisfactory level for a single application of Timolol-Teva is to measure intraocular pressure at various times throughout the day.
    Doses exceeding 1 drop of a 0.5% solution of Timolol-Teva 2 times a day, as a rule, do not lead to an additional decrease in intraocular pressure. If Timolol-Teva does not manage to achieve the required level of intraocular pressure, it is necessary to consider the use of additional medications that reduce intraocular pressure. Simultaneous use of two beta-blockers for topical application is not recommended (see the section "Interaction with other drugs").
    As with the application of other eye drops, nasolacrimal occlusion is recommended - soft eyelid closure after instillation of the drug (within 3-5 min). This can reduce the systemic absorption of the Timolol-Teva drug administered through the eyes.

    Side effects:
    Undesirable reactions that occur after ingestion of timolol and other beta-blockers can be regarded as potential adverse reactions and for eye-level drugs timolol in the form of a drug.
    The most common adverse reactions are burning and tingling after instillation (approximately in 1/8 of patients).
    Described below are undesirable reactions that occurred with a lower frequency in patients using timolol eye forms.
    General reactions and reactions at the site of administration: headache, asthenia / fatigue, chest pain.
    Cardiovascular system: bradycardia, arrhythmia, decreased or increased blood pressure, fainting, heart block, cerebral circulation, cerebral ischemia, heart failure, exacerbation of angina pectoris tension, palpitations, cardiac arrest, pulmonary edema, edema, intermittent claudication, Raynaud's phenomenon, coldness of the hands and feet.
    On the part of the digestive system: nausea, diarrhea, dyspepsia, anorexia, dryness of the oral mucosa.
    On the part of the immune system: systemic lupus erythematosus.
    From the nervous system / mental disorders: dizziness, exacerbation of myasthenia gravis flow, paresthesia, drowsiness, insomnia, nightmares, behavioral changes and mental disorders, including depression, confusion, hallucinations, anxiety, disorientation, nervousness and memory loss.
    From the skin and subcutaneous tissues: alopecia, psoriasiforme rash, aggravation of the course of psoriasis.
    Allergic reactions: systemic allergic reactions, including anaphylaxis, angioedema, hives, local or generalized rash.
    On the part of the respiratory system: bronchospasm (mainly in patients with concomitant bronchospastic conditions), respiratory failure, shortness of breath, nasal congestion, cough, upper respiratory tract infections.
    On the part of the endocrine system: the subclinical course of hypoglycemia in patients with diabetes mellitus (see section "Special instructions").
    From the senses: eye irritation, including conjunctivitis, blepharitis, keratitis, pain in the eye, discharge from the eyes (eg, peel), sensation of foreign body in the eye, itching and lacrimation, dry eyes; ptosis; decreased sensitivity of the cornea; cystic macular edema; visual impairment, including refraction and diplopia; pseudopemphigoid; detachment of the choroid after filtration surgery (see section "Special instructions"); noise in ears.
    From the genitourinary system: retroperitoneal fibrosis, decreased libido, impotence, Peyronie's disease.
    Undesirable drug reactions that occurred after taking tgsholol or other beta-adrenoblockers orally
    Allergic reactions: erythematous rash, fever, accompanied by pain in the throat, laryngospasm, accompanied by a distress syndrome.
    General reactions and reactions at the injection site: pain in the limbs, reduced exercise tolerance, weight loss.
    From the cardiovascular system: aggravation of arterial insufficiency, vasodilation.
    On the part of the digestive system: gastrointestinal pain, hepatomegaly, vomiting, thrombosis of the mesenteric arteries, ischemic colitis.
    From the side of blood and lymphatic system: non-morbocytopenic purpura, thrombocytopenic purpura.
    On the part of the endocrine system: hyperglycemia, hypoglycemia.
    From the skin and subcutaneous tissues: itching, skin irritation, increased pigmentation, sweating.
    From the musculoskeletal system: arthralgia.
    From the nervous system / mental disorders: vertigo, local weakness, decreased concentration of attention, reversible suppression of mental functions, progressing to catatonia, acute reversible syndrome,characterized by a violation of orientation in time and space, emotional lability, some difficulty in perception and a reduced ability to perform neuropsychiatric tests.
    From the respiratory system, wheezing, bronchial obstruction.
    From the genitourinary system, difficulty urinating.

    Overdose:
    Cases of unintentional thymolol overdose in the form of drug "eye drops", manifested by systemic effects similar to the systemic effect of beta-blockers are described: dizziness, headache, shortness of breath,
    bradycardia, bronchospasm, generalized convulsions, loss of consciousness, cardiogenic shock and cardiac arrest.
    An overdose was observed in a 30-year-old woman who took 650 mg timolol inwards (the maximum recommended dose was 60 mg), AV blockade of MI degree occurred. Treatment was not required, but after about 2 months she developed an arrhythmia, arterial hypertension, dizziness, tinnitus, pallor, tachycardia and borderline AB blockade of the 1st degree.
    Although timolol well undergoes hemodialysis in vitro,in patients with renal insufficiency, significant removal of timolol in hemodialysis is not observed.
    In case of symptoms develop symptomatic therapy. To eliminate severe bradycardia or bronchospasm, intravenous isoprenaline can be administered, to treat arterial hypotension - dobutamine.

    Interaction:
    Despite the fact that the use of timolol does not affect the size of the pupil, its simultaneous use with epinephrine can cause mydriasis. Beta-blockers
    Patients taking beta-blockers inward and timolol in the dosage form, "eye drops", should be observed for systemic and local reactions due to beta-adrenergic blockade. Simultaneous use of two beta-blockers for topical application is not recommended.
    Blocks of "slow" calcium channels
    In view of potential violations of atrioventricular conduction, left ventricular failure and reduction of blood pressure, simultaneous use of beta-blockers, including timolol, and blockers of "slow" calcium channels (for oral or intravenous administration) should be done with caution.In patients with impaired cardiac function, simultaneous use of these groups of drugs is not recommended.
    Sympatholytics
    With the simultaneous use of beta-blockers and sympatholytics, for example, reserpine, patients should be closely monitored, due to the mutual enhancement of their effects, lowering blood pressure and / or severe bradycardia, which can lead to vertigo, fainting and postural hypotension.
    Cardiac glycosides
    The simultaneous use of beta-blockers and cardiac glycosides can lead to disruption of atrioventricular conduction.
    Inhibitors of the isoenzyme CYP2D6
    Simultaneous use of timolol with inhibitors of the isoenzyme CYP2D6 (for example, quinidine, selective serotonin reuptake inhibitors) can lead to an increase in the blockade of beta-adrenoreceptors (including a decrease in heart rate, depression).
    Clonidine
    Beta-adrenoblockers for oral administration may aggravate the "ricochet" hypertension that may occur after the withdrawal of clonidine. Information on the aggravation of "ricochet" hypertension against the background of the use of timolol in the dosage form "eye drops" is absent.

    Special instructions:
    Like other ophthalmic drugs, timolol is subjected to systemic absorption.
    With topical application of beta-blockers, the same unwanted reactions can occur as with systemic application. For example, both in systemic and local administration of timolol, severe respiratory and cardiac events, including fatal outcome due to bronchospasm in patients with bronchial asthma and, more rarely, death due to heart failure (see "Contraindications") were noted. ,
    Heart failure
    To maintain circulation in people with impaired contractility of the myocardium requires sympathetic stimulation. The use of beta-blockers can aggravate the course of heart failure.
    In patients without heart failure in history, prolonged myocardial depression by beta-adrenoblockers may in some cases lead to the development of heart failure. When the first signs of heart failure occur timolol necessary cancel.
    Chronic obstructive pulmonary disease
    Patients with COPD (for example, chronic bronchitis, emphysema) of mild and moderate severity, bronchospastic diseases, including anamnesis (not a bronchial asthma (including anamnesis), in which the use of timolol is contraindicated), the use of beta-blockers in including timolol, in general, is not recommended.
    Extensive surgery
    The necessity and desirability of abolishing beta-blockers before carrying out extensive surgical interventions has not been fully established. The blockade of beta-adrenergic receptors disrupts the ability of the heart to respond to β-adrenergic receptor-mediated reflex stimuli, which may increase the risk of complications of general anesthesia. In some patients who continued to use beta-blockers during general anesthesia, there was a prolonged severe drop in blood pressure. The difficulty of renewal and maintenance of cardiac contractions was also noted. In this regard, patients sent to planned operations, it is recommended to gradually abolish the use of beta-blockers. In about the time of surgery, if necessary, the effects of beta-adrenoblockers are stopped by high doses of adrenomimetics.
    Diabetes
    Patients with spontaneous hypoglycemia or diabetes mellitus (especially with unstable flow) using insulin or oral hypoglycemic agents, use beta-blockers should be used with caution. Beta-adrenoblockers can mask the signs and symptoms of acute hypoglycemia.
    Thyrotoxicosis
    Beta-adrenoblockers are able to mask certain clinical symptoms of hyperthyroidism (for example, tachycardia). The use of beta-adrenoblockers in patients who can develop thyrotoxicosis should be done with caution, avoiding a sharp abortion to prevent the development of thyrotoxic crisis.
    General recommendations
    In view of the potential effect on BP and the number of cardiac contractions, beta-blockers should be used with caution in patients with cerebrovascular insufficiency. If, after the initiation of thymolol therapy, the symptoms of cerebral circulatory disorders develop, alternative therapies should be considered.
    Cases of bacterial keratitis caused by the use of containers for multiple dosing of ophthalmic drugs are described.These containers were unintentionally contaminated by patients who, in most cases, had concomitant diseases of the cornea or a breach of the integrity of the epithelium of the surface of the eyeball.
    In patients who used drugs that reduce the formation of intraocular fluid (for example, timolol), there were cases of detachment of the choroid after filtration surgery.
    Closed-angle glaucoma
    The main goal of treating patients with closed-angle glaucoma is opening the angle of the eye, which requires a pupil contraction. Timolol does not affect the pupil, so the use of timolol in monotherapy for the treatment of closed-angle glaucoma is not allowed. Anaphylaxis
    The use of beta-blockers in patients with atopy or severe anaphylactic reactions to various allergens in a history can provoke more severe reactions in response to the accidental, diagnostic or therapeutic administration of allergens. Such patients may respond poorly to the administration of conventional doses of epinephrine to relieve anaphylactic reactions. Muscle weakness
    The use of beta-blockers increases muscle weakness in myasthenia (for example, increased diplopia, ptosis and general weakness). In some patients with myasthenia gravis and other myasthenic diseases, there was an increase in muscle weakness with timolol.
    Excipients
    Timolol-Teva contains benzalkonium chloride, which can cause eye irritation, absorbed by soft contact lenses, causing a change in their color, and have an adverse effect on eye tissue. Before using the drug, remove contact lenses and re-install them, if necessary, no earlier than 15 minutes after instillation.

    Effect on the ability to drive transp. cf. and fur:
    During the period of treatment, care must be taken when driving vehicles and working with mechanisms that require high concentration of attention, speed of psychomotor reactions and good vision (within 30 minutes after instillation into the eye), as vision may be impaired, dizziness and fatigue develop .

    Form release / dosage:
    To 5 ml of solution in a bottle of dark glass with a cork of rubber brombutilovoy, aluminum cap. 1 bottle is enclosed in a cardboard bundle complete with a sterile dropper and instructions for use.

    Packaging:
    To 5 ml of solution in a bottle of dark glass with a cork of rubber brombutilovoy, aluminum cap. 1 bottle is enclosed in a cardboard bundle complete with a sterile dropper and instructions for use.

    Storage conditions:
    Store at a temperature not exceeding 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    3 years.
    Shelf life after bottle opening 4 weeks.
    Do not use after the expiration date
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002509
    Date of registration:23/06/2014
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Information update date: & nbsp31.08.2015
    Illustrated instructions
      Instructions
      Up