Xonef eye drops 0.5%, 5 ml

As monotherapy:

• to reduce intraocular pressure.

In combination with other drugs for:

• open-angle glaucoma; ocular hypertension.

The drug is instilled into the conjunctival sac, 1-2 drops 2 times / day.

In some patients, intraocular pressure stabilization occurs within several weeks, therefore it is recommended to control intraocular pressure during the first month of treatment. In case of insufficient clinical efficacy of monotherapy, additional therapy is prescribed.

Eye drops 0.5% in the form of a clear solution from colorless to light yellow.

1 ml

betaxolol (in the form of hydrochloride) 5 mg

Excipients: benzalkonium chloride - 0.1 mg, hypromellose - 2 mg, sodium chloride - 8 mg, sodium hydroxide - qs, disodium edetate - 1 mg, water d / i - up to 1 ml.

• Sinus bradycardia;

• AV block II and III degree;

• severe heart failure;

• cardiogenic shock; arterial hypotension;

• children under 18 years of age;

• hypersensitivity to the components of the drug.

  The drug should be used with caution in thyrotoxicosis, myasthenia gravis, diabetes mellitus, Raynaud's syndrome, pheochromocytoma, bronchial asthma, chronic obstructive bronchitis.

pharmachologic effect

Antiglaucoma drug. Selective beta1-blocker without intrinsic sympathomimetic activity. Does not have a membrane stabilizing (local anesthetic) effect. When applied topically, betaxolol reduces intraocular pressure by reducing the 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 ophthalmotonus persists for 12 hours. Betaxolol (compared to other beta-blockers) does not cause a decrease in blood flow in the optic nerve. The use of XonefЃ eye drops does not lead to miosis, accommodation spasm, hemeralopia (unlike miotics).

Pharmacokinetics

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

Side effect

From the side of the organ of vision: often - short-term discomfort in the eyes after instillation, lacrimation; in some cases - decreased sensitivity of the cornea, redness of the eyes, punctate keratitis, photophobia, anisocoria, photophobia, itching, sensation of 'dryness' of the eyes, allergic reactions. Systemic 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 side of the cardiovascular system: bradycardia, impaired cardiac conduction and heart failure. From the respiratory system: dyspnea, bronchospasm, bronchial asthma, respiratory failure.

Application during pregnancy and lactation

There is no sufficient experience of using XonefЃ during pregnancy and lactation. The use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

special instructions

The drug is prescribed with caution to patients with diabetes mellitus, since beta-blockers can mask the symptoms of acute hypoglycemia. The drug is prescribed with caution to patients with thyrotoxicosis, because beta-blockers can mask the symptoms of thyrotoxicosis (eg, tachycardia). In patients with suspected thyrotoxicosis, beta-blockers should not be abruptly canceled, because this can lead to increased symptoms. It should be borne in mind that beta-blockers can cause symptoms similar to those in myasthenia gravis (diplopia, ptosis, general weakness). Precautions should be taken in prescribing beta-blockers to patients with severe impairment of the respiratory system. Despite the fact that clinical studies have shown the absence of the effect of betaxolol in an ophthalmic dosage form on the function of external respiration,the possibility of hypersensitivity to the drug cannot be ruled out. Before the planned surgery, beta-blockers should be gradually withdrawn 48 hours before general anesthesia. during general anesthesia, they can reduce the sensitivity of the myocardium to sympathetic stimulation. Patients using beta-blockers may have a history of atopy or anaphylactic reactions. If repeated hypersensitivity reactions develop, such patients may not be sensitive to the usual doses of epinephrine (adrenaline) required to stop anaphylaxis. The drug should be used with caution in patients with Raynaud's syndrome or pheochromocytoma. When instilled into the eyes, beta-blockers can be absorbed into the systemic circulation. In this case, the same side effects may be noted,as with systemic use. Cases of severe respiratory and cardiovascular disorders have been described, including fatal bronchospasm in patients with bronchial asthma and death from heart failure. XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.Cases of severe respiratory and cardiovascular disorders have been described, including fatal bronchospasm in patients with bronchial asthma and death from heart failure. XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.Cases of severe respiratory and cardiovascular disorders have been described, including fatal bronchospasm in patients with bronchial asthma and death from heart failure. XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.including fatal bronchospasm in patients with bronchial asthma and death from heart failure. XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.including fatal bronchospasm in patients with bronchial asthma and death from heart failure. XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.XonefЃ has a minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing the drug to patients with grade I AV block and mild to moderate heart failure. Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.Treatment with XonefЃ should be stopped immediately when the first symptoms of decompensation from the cardiovascular system appear. XonefЃ contains a preservative benzalkonium chloride, which can be deposited on soft contact lenses and have a toxic effect on the tissues of the eye. Therefore, patients wearing contact lenses should remove them before applying drops and reinstall them no earlier than 20 minutes after instillation.

Influence on the ability to drive vehicles and use mechanisms

If, after using the drops, the clarity of vision temporarily decreases in patients, it is not recommended to drive vehicles and engage in activities that require increased attention and reaction until it is restored.

Overdose

In case of contact with the eyes of an excessive amount of the drug, rinse the eyes with warm water. Symptoms: with an overdose of beta1-blockers, a decrease in blood pressure, bradycardia, and acute heart failure may occur. Treatment: symptomatic therapy is performed.

Drug interactions

With the simultaneous use of the drug Xonef and beta-blockers for oral administration, the risk of side effects (both local and systemic) increases due to the additive effect (therefore, patients receiving this combination of drugs should be under medical supervision). When using XonefЃ in combination with drugs that deplete catecholamines (such as reserpine), a decrease in blood pressure and bradycardia may occur. With the simultaneous appointment of muscle relaxants and hypoglycemic agents, an increase in their action may be observed. When used together with sympathomimetics, it enhances their vasoconstrictor effect. Caution should be exercised when using XonefЃ and psychotropic drugs together due to the possible enhancement of their action.