Active substanceTimololTimolol
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  • Dosage form: & nbspeye gel
    Composition:
    1 g of the preparation contains:
    Active substances:
    Timolol 1.00 mg
    (in the form of timolol maleate) 1.37 mg)
    Excipients:
    Benzalkonium chloride 0.05 mg
    Carbomer 3.00 mg
    Lysine monohydrate 5.90 mg
    Polyvinyl alcohol 10.00 mg
    Sodium acetate trihydrate 0.20 mg
    Sorbitol 45.00 mg
    Water for injections up to 1 g.
    Description:
    Colorless, opalescent gel odorless.
    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 beta-adrenoblocker, which reduces the increased intraocular pressure due to a decrease in the production of aqueous humor. Like other beta-blockers, Timolol has a negligible effect on the system of outflow of intraocular fluid. Has a weak anesthetic effect and does not affect pupil size and accommodation. The effect of reducing intraocular pressure is achieved under the condition of instillation of 1 drop of Ophthalmic Timogel per day.
    Pharmacokinetics:
    The maximum decrease in intraocular pressure occurs a few hours after instillation and persists for 24 hours. Timolol can be systemically absorbed through the vessels of the conjunctiva, the nasal mucosa and the lacrimal tract and, thus, reach the systemic blood flow. Very rarely, the serum level is determined within 90 minutes after instillation. Nevertheless, the minimum concentration of timolol is present in the urine for a longer time. Penetrates into breast milk.
    Indications:
    Increased intraocular pressure (ophthalmic hypertension), open-angle glaucoma, secondary glaucoma (uveal, aphakic post-traumatic).
    Contraindications:
    Dystrophic diseases of the cornea, acute and chronic heart failure, cardiac arrhythmia, in particular, atrioventricular blockade of II and III degree, bradycardia, cardiogenic shock, bronchial asthma, chronic obstructive bronchitis with bronchospasm phenomena.
    Increased individual sensitivity to timolol maleate or one of the components of the drug.
    Because of the experience of using Eye Drops of Offan® Timogel in children under the age of 12 years, the drug is not recommended for use in this category of patients.
    Carefully:
    Pulmonary insufficiency, severe cerebrovascular insufficiency,chronic heart failure, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, simultaneous administration of other beta-blockers. With special care, appoint newborns and premature babies.
    Pregnancy and lactation:
    Currently, there are no data on the clinical trials conducted in pregnant women. During pregnancy, Oftan Timogel should be used only if the expected therapeutic effect exceeds the risk of possible side effects. Timolol penetrates into breast milk. Because the Timolol can cause serious side effects in infants, it is necessary to decide whether to stop breastfeeding or to cancel the drug.
    Dosing and Administration:Adults and children over 12 years: 1 drop per day in the affected eye.
    Side effects:
    When applying ophthalmic gel Oftan Timogel (as well as other local ophthalmic agents), it is possible that the drug will enter the systemic bloodstream. When entering timolol into the systemic blood stream, the same undesirable phenomena can be observed, as in systemic application.
    From the side of the organ of vision (local reactions): mild hyperemia
    conjunctiva, sensation of foreign body in the eye, burning or pain immediately after instillation, 1-3 % transient vision loss lasting more than 3 minutes, lacrimation, photophobia, corneal epithelial edema, eyelid hyperemia, blepharitis, conjunctivitis, keratitis, ptosis, decreased corneal sensitivity, visual impairment including refractive changes (caused in some cases due to cancellation of miotics) , diplomacy; with prolonged use, it is possible to develop a surface point keratopathy. When using beta-blockers, there were cases of the development of the "dry eye" syndrome.
    From the side of the cardiovascular system: bradycardia, violation of atrioventricular conduction (development of atrioventricular blockade for the first time or progression of an existing atrioventricular blockade), arterial hypotension, heart failure, arrhythmias, syncope (syncope), cerebrovascular accident, palpitation, Raynaud's syndrome, coldness of hands and feet, transient lameness , sudden cardiac arrest.
    From the respiratory system: bronchospasm (in most cases in patients with obstructive bronchopulmonary diseases), respiratory failure, dyspnea and cough.
    From the body as a whole: increased fatigue, asthenia, pain in the chest.
    Dermatological reactions: hypersensitivity reactions, local or generalized erythema, urticaria, hair loss, psoriatic lesions of the skin or progression of psoriasis.
    The incidence of these adverse events was low. In most cases, dermatological reactions disappeared after discontinuation of therapy with the drug.
    From the central and peripheral nervous system: dizziness, worsening of myasthenia, paresthesia, headache, asthenia, general weakness.
    Mental disorders: depression, insomnia, night fear (nightmarish dreams), memory loss.
    From the digestive system: nausea, diarrhea, dyspepsia, dry mouth.
    Immunologic disorders: systemic lupus erythematosus.
    From the side of the urinary system: decreased libido, erectile dysfunction, Peyronie's disease.
    With the systemic appointment of timolol, the following undesirablephenomena (regardless of the presence of a causal relationship with the use of the drug): aphakic cystic macular edema, dry mouth, nasal congestion, anorexia, confusion, hallucinations, increased excitability, anxiety, disorientation, drowsiness and other mental disorders, hypertension and retroperitoneal fibrosis.
    Overdose:
    When topical application in the recommended dose, an overdose is unlikely. Possible symptoms in case of accidental overdose: symptomatic bradycardia, arterial hypotension, bronchospasm, acute heart failure, atrioventricular blockade of the heart of II and III degrees.
    In case of an overdose, treatment is symptomatic. Treatment of overdose may include, but is not limited to:
    Gastric lavage (if the drug was ingested). Removing timolol from the body with hemodialysis is ineffective.
    With symptomatic bradycardia: to obtain vagal blockade intravenously injected atropine sulfate in a dose of 0.25-2.0 mg (0.25-1 ml of 0.1% solution). If the bradycardia persists, intravenously slowly inject isoprenaline.In the case of refractoriness, it may be necessary to install an artificial pacemaker.
    With arterial hypotension: treated with sympathomimetic drugs that increase blood pressure, such as dopamine, dobutamine, or norepinephrine. In case of inefficiency, glucagon.
    When bronhospazme: conduct treatment with isoprenaline, possibly in combination with aminophylline.
    Acute heart failure: it is necessary to immediately begin therapy with the use of digitalis preparations, diuretic and oxygen. In case of ineffectiveness, it is recommended to use intravenously aminophylline, if necessary, the subsequent use of glucagon.
    Atrioventricular heart block (II and III degree): use isoprenaline or artificial pacemakers.
    Interaction:
    Although Oftan®Timogel had little effect on the size of the pupils, when the drug was used together with sympathomimetics (such as epinephrine) there was a dilated pupil (mydriasis).
    With the use of Oftan® Timogel together with systemic beta-blockers, a more pronounced decrease in intraocular pressure is possible, as well as an increase in the systemic effect of beta-blockers.Patients receiving Offan® Timogel along with systemic beta-blockers should be under strict medical supervision.
    Patients receiving sympatolytic (for example, reserpine) together with beta-blockers should be under strict medical supervision. In the application of Oftan® Timogel together with preparations releasing catecholamines, it is possible to develop such undesirable phenomena: arterial hypotension, pronounced bradycardia,
    dizziness, syncope and orthostatic hypotension.
    When beta-blockers are used simultaneously with calcium channel blockers, it is possible to develop arterial hypotension, atrioventricular conduction disorders, or left ventricular failure.
    It should be used with caution beta-blockers simultaneously with calcium channel blockers, administered intravenously.
    Derivatives of dihydropyridine, such as nifedipine, can cause arterial hypotension, whereas verapamil and diltiazem have a tendency to cause violations of atrioventricular conduction or left ventricular failure, if they are combined with beta-blockers.
    Simultaneous use of beta-adrenoblockers and digitalis preparations can lead to an increased disruption of atrioventricular conduction.
    When beta-blockers are used together with clonidine (an antihypertensive drug of central action), a significant increase in blood pressure (BP) after abrupt withdrawal of clonidine therapy is possible.
    The appointment of beta-blockers in combination with antiarrhythmic drugs of Class I (quinidine, disopyramide) and class III (amiodarone) can lead to a pronounced inhibition of conduction in the atria and an increase in the negative inotropic effect.
    When combined with insulin and oral
    hypoglycemic agents should be taken into account that beta-blockers can mask symptoms of hypoglycemia (palpitations and tachycardia).
    Not should take beta-blockers at the same time with
    antipsychotic (neuroleptics) and anxiolytic (tranquilizers) drugs. Since the intake of ethanol during therapy with beta-blockers can lead to a sharp decrease in blood pressure, during the treatment with the drug it is recommended to refrain from taking ethanol.
    In the case of surgical procedures using general anesthesia, the drug should be gradually withdrawn and an anesthesiologist warned about the previous therapy of Ophthaltin® Timogel. Simultaneous application of Ophthalmol® Timogel together with general anesthetics can lead to the development of compensatory tachycardia and severe arterial hypotension.
    With the simultaneous use of cimetidine and timolol, an increase in the concentration of the latter in the blood plasma is possible.
    Caution should be exercised when prescribing Offan® Timogel together with lidocaine (intravenous administration) and iodine-containing radiopaque preparations.
    Special instructions:
    With the development of dermatological reactions, possibly associated with the use of the drug, Oftan Timogel's treatment should be stopped immediately. Benzalkonium chloride, which is part of Eye Gel Oftan Timogel, can also cause allergic reactions in sensitive patients.
    Patients suffering from heart failure need to undergo an examination before starting treatment with Oftan Timogel. Patients with other severe heart conditions should be examined for possible symptoms of latent cardiacinsufficiency and regular monitoring of heart rate and blood pressure.
    If Ophthalmos® Timogel is used to reduce increased intraocular pressure in closed-angle glaucoma, the drug should be administered in combination with miotics. As in the case of other antiglaucomatous drugs, after long-term treatment, cases of lack of response to timolol maleate.
    When applying Oftan® Timogel, it is necessary to monitor the function of teardropping, the condition of the cornea and to evaluate the magnitude of the visual fields at least once every 6 months.
    When using other eye drops, the interval should be at least 5 minutes in order to maintain the activity of Ophthaltin® Timogel. Any eye drops should be used prior to instillation of Ophthaltin® Timogel. Regular monitoring of intraocular pressure every 3-4 weeks is necessary.
    Before using the eye gel, it is necessary to remove contact lenses and do not use them for 15 minutes after instillation of the drug.
    Effect on the ability to drive transp. cf. and fur:
    The influence of Oftan® Timogel on the ability to drive vehicles and / or work with mechanisms has not been studied.Such side effects of Oftan® Timogel as a short-term decrease in visual acuity, ptosis, visual impairment, including changes in refraction and diplopia, dizziness and fatigue, can adversely affect the ability to drive vehicles and carry out potentially dangerous activities requiring increased concentration and speed of psychomotor reactions.
    Form release / dosage:
    Eye gel 0.1% 5 g.
    Packaging:
    For 5 grams in a polyethylene bottle with a dropper with a screw cap made of low density polyethylene.
    The bottle is provided with an additional polyethylene lid on top of the screw cap to ensure the stability of the bottle when stored upside down after opening. 1 bottle is placed in a cardboard box together with instructions for use.
    Storage conditions:
    Store at a temperature not exceeding 25 ° C. Do not freeze.
    The drug should be stored out of the reach of children.
    After the first opening, store the vial by turning it upside down in a cardboard box.
    Shelf life:

    2 years. Shelf life after autopsy vial for 4 weeks.

    The drug should not be used after the expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006665/08
    Date of registration:15.08.2008 / 17.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate: Santen, AO Santen, AO Finland
    Manufacturer: & nbsp
    EXCELVISION, AG Switzerland
    Representation: & nbspSANTEN AS SANTEN AS Finland
    Information update date: & nbsp20.06.2017
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