Active substanceBetaxololBetaxolol
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  • Dosage form: & nbspeye drops
    Composition:

    1 ml of the preparation contains:

    active substance: betaxolol hydrochloride is equivalent to betaxolol 5 mg;

    Excipients: Benzalkonium chloride 0.1 mg, hypromellose 2.0 mg, sodium chloride 8.0 mg, sodium hydroxide q.s., disodium edetate 1.0 mg, water for injection up to 1.0 ml.

    Description:Transparent solution from colorless to light yellow color.
    Pharmacotherapeutic group:Anti-glaucoma - beta-blocker
    ATX: & nbsp

    S.01.E.D.02   Betaxolol

    Pharmacodynamics:

    Antiglaucoma preparation.Selective beta1-adrenoceptor without internal sympathomimetic activity. Does not have a membrane-stabilizing (local anesthetic) action.

    With topical application betaxolol reduces intraocular pressure due to decreased production of intraocular fluid.

    The onset of hypotensive action is observed 30 minutes after instillation, the maximum effect develops after 2 hours. After a single instillation, the effect on the ophthalmotonus persists for 12 hours.

    Betaxolol (in comparison with other beta-adrenoblockers) does not cause a decrease in blood flow in the optic nerve.

    The use of Xonef® eye drops does not lead to the formation of miosis, spasm of accommodation, hemeralopia (in contrast to myotics).

    Pharmacokinetics:Betaxolol is highly lipophilic, as a result of which it penetrates well through the cornea into the anterior chamber of the eye, CmOh (1.17 mg / ml) in the anterior chamber is determined 20 minutes after instillation. Penetrates into the systemic circulation. T1/2 from intraocular fluid about 1 hour. T1/2 from the blood plasma 16-22 hours. Excretion mainly through the kidneys.
    Indications:

    The drug is used to reduce intraocular pressure as a monotherapy or in combination with other drugs with:

    - open-angle glaucoma;

    - ocular hypertension.

    Contraindications:

    Hypersensitivity to the components of the drug, sinus bradycardia, AV-blockade II and III degree, severe heart failure, cardiogenic shock, hypotension, children under 18 years of age.

    Carefully:

    Thyrotoxicosis, myasthenia gravis, diabetes mellitus, Raynaud's syndrome, pheochromocytoma, bronchial asthma, chronic obstructive bronchitis.

    Pregnancy and lactation:

    Sufficient experience in the use of Xonef® during pregnancy and lactation is not available. The use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother exceeds the potential risk to the fetus or child.

    Dosing and Administration:

    The drug is instilled in the conjunctival sac 1-2 drops twice a day.

    In some patients, intraocular pressure stabilization occurs within a few weeks, therefore it is recommended to monitor intraocular pressure during the first month of treatment.

    With insufficient clinical efficacy of monotherapy, additional therapy is prescribed.

    Side effects:

    From the side of the organ of vision: often - short-term discomfort in the eyes after instillation, lacrimation; in some cases - a decrease in the sensitivity of the cornea, redness of the eyes, punctate keratitis, photophobia, anisocoria, photophobia, itching, a feeling of "dryness" of the eyes, allergic reactions.

    System side effects are rare:

    From the side of the central nervous system: dizziness, nausea, drowsiness, insomnia, headache, depression, increased symptoms of myasthenia gravis.

    From the cardiovascular system: bradycardia, impaired cardiac conduction and heart failure.

    From the respiratory system: dyspnea, bronchospasm, bronchial asthma, respiratory failure.

    Overdose:

    If eye contact occurs in excess of the drug, wash your eyes with warm water.

    With an overdose of beta1-adreno-blockers may be observed reduction in blood pressure, bradycardia, acute heart failure.

    Treatment symptomatic.

    Interaction:

    With the simultaneous use of Xonef® and beta-adrenoblockers for oral administration, the risk of side effects (both local,and systemic) due to the additive effect (therefore patients receiving this combination of drugs should be under medical supervision).

    When using the Xonef® preparation in combination with preparations depleting catecholamine stocks (such as reserpine), there may be a decrease in blood pressure and bradycardia.

    With the simultaneous appointment of muscle relaxants and hypoglycemic agents, there may be an increase in their effect.

    When combined with sympathomimetics, they intensify their vasoconstrictive effect.

    Caution should be exercised in the joint use of Xonef® and psychotropic drugs, as a result of the possible increase in their effect.

    Special instructions:

    Diabetes. Caution is prescribed to patients with diabetes mellitus, since beta-blockers may mask the symptoms of acute hypoglycemia.

    Thyrotoxicosis. With caution appoint the drug to patients with thyrotoxicosis, tk. beta-blockers may mask the symptoms of thyrotoxicosis (eg, tachycardia). Patients with suspected thyrotoxicosis should not abstain from beta-blockers, this can cause an increase in symptoms.

    Myasthenia gravis. It should be borne in mind that beta-blockers can cause symptoms similar to those in myasthenia gravis (diplopia, ptosis, general weakness).

    Pulmonology. Caution should be given to beta-blockers in patients with severe impairment of the function of the respiratory system. Despite the fact that in clinical studies the absence of betaxolol in the ophthalmic dosage form on the function of external respiration has been shown, it is impossible to exclude the possibility of hypersensitivity to the drug.

    Surgery. Before the planned surgery, you should gradually cancel the beta-blockers 48 hours before the general anesthesia, tk. during general anesthesia, they can reduce the sensitivity of the myocardium to sympathetic stimulation.

    The risk of developing an anaphylactic reaction. Patients who use beta-blockers may have a history of atopy or anaphylactic reactions. In the case of the development of repeated reactions of hypersensitivity, such patients may not be sensitive to the usual doses of epinephrine (adrenaline) necessary for arresting anaphylaxis.

    The drug should be administered with caution to patients with Reynaud's syndrome or pheochromocytoma.

    When instilled in the eye, beta-blockers can be absorbed into the systemic circulation. In this case, the same side effects can be noted, as in systemic application. Cases of severe respiratory and cardiovascular disorders, including bronchospasm with fatal outcome in patients with bronchial asthma and death from heart failure are described.

    Xonef® has minimal impact on blood pressure and heart rate. However, care should be taken when prescribing the drug to patients with AV-blockade of the I degree and mild and moderate heart failure. Treatment with Xonef® should be stopped immediately if the first symptoms of cardiovascular decompensation appear.

    Xonef® contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the eye tissue. Therefore, patients wearing contact lenses should be removed before using drops and installed back no earlier than 20 minutes after instillation.

    Effect on the ability to drive transp. cf. and fur:

    If, after the application of droplets, patients temporarily lose visual clarity, it is not recommended to drive vehicles and engage in activities requiring increased attention and reaction before recovery.

    Form release / dosage:Eye drops, 0,5%.
    Packaging:

    5 ml in a plastic bottle-dropper with a screw cap.

    Each vial-dropper along with the instruction for use is placed in a cardboard box.

    Storage conditions:

    Store at a temperature of no higher than 25 ° C in a dark place. Do not freeze. After instillation it is necessary to close the bottle tightly. Keep out of the reach of children.

    Shelf life:

    3 years.

    Drops should be used within 45 days after opening the vial.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009608/09
    Date of registration:30.11.2009 / 05.12.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia
    Information update date: & nbsp06.02.2018
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