Xonef BK - instructions for use, dose, side effects, contraindications

Excipients: disodium edetate 1.0 mg, sodium chloride 8.0 mg, hypromellose 2.0 mg, sodium hydroxide up to pH 7.3, hydrochloric acid up to pH 7.3, water for injection up to 1 ml.

Description:Transparent solution, from colorless to light yellow color.

Pharmacotherapeutic group:antiglaucoma agent - beta-blocker

ATX: & nbsp

S.01.E.D.02 Betaxolol

Pharmacodynamics:

Antiglaucoma preparation. Selective β₁-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 improves microcirculation of the retina. The use of eye drops Xonef® BC 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, the average maximum concentration in plasma C_m_Oh-1,17 mg / ml in the anterior chamber is determined 20 minutes after instillation. Penetrates into the systemic circulation. Half-life T_1/2from intraocular fluid about 1 hour. T_1/2from 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;

- atrioventricular blockade of II and III degree;

- severe chronic heart failure;

- cardiogenic shock;

- arterial hypotension;

- Children under 18 years.

Carefully:

Thyrotoxicosis, myasthenia gravis, diabetes mellitus, Reynaud's syndrome, pheochromocytoma, bronchial asthma, chronic obstructive pulmonary disease.

Pregnancy and lactation:

Sufficient experience in the use of the Xonef® BC preparation 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.

The duration of the drug is determined by the attending physician depending on the effectiveness of the therapy.

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

Side effects:

In general, the drug is characterized by good tolerability. In rare cases, side effects led to the abolition of therapy. Serious adverse reactions are rare.

Local reactions: often (≥1 / 100, <1/10) - short-term discomfort in the eyes after instillation and lacrimation.

In some cases, blurred vision, pinpoint keratitis, decreased corneal sensitivity, photophobia, lacrimation, itching, dry eyes, red eyes, anisocoria and photophobia, allergic reactions.

Systemic side effects are rare (≥1 / 10000, <1/1000):

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: shortness of breath, bronchospasm, respiratory failure.

Overdose:

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

When an overdose of β₁-adreno-blockers may be observed reduction in blood pressure, bradycardia, acute heart failure.

Treatment: symptomatic.

Interaction:

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

When using the drug Xonef® BC in combination with drugs 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® BC 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 hypersensitivity reactions, such patients may be insensitive 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.

Treatment with Xonef® BK should be stopped immediately if the first symptoms of decompensation from the cardiovascular system appear.

Xoneus® BC does not contain a preservative and can therefore be used in patients using contact lenses.

To reduce the sensation of dry eye as an auxiliary substance in the formulation of the keratoprotector - hypromellose, which has a lubricating and softening effect, increases the duration of contact of the solution with the cornea.

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 [no preservative], 0.5%.

Packaging:

To 0.4 ml in disposable tubes-droppers.

On 5 tubes-droppers in a package from the laminated foil.

6 packages of laminated foil in a pack of cardboard along with instructions for use.

Storage conditions:

The drug should be stored at a temperature of no higher than 30 ° C, in a place protected from light. Do not freeze.

Keep out of the reach of children.

Shelf life:

18 months.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001178

Date of registration:11.11.2011

Date of cancellation:2016-11-11

The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India

Manufacturer: & nbsp

SENTISS PHARMA Pvt. Ltd India

Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia

Information update date: & nbsp14.11.2015

Illustrated instructions

Instructions

Xonef® BK (Xonef® BK)