Betofan - instructions for use, dose, side effects, contraindications

Excipients: sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate dihydrate, benzalkonium chloride, purified water.

Description:

Transparent, colorless or light yellow with a brown tint solution.

Pharmacotherapeutic group:Anti-glaucoma - beta-blocker

ATX: & nbsp

S.01.E.D.02 Betaxolol

Pharmacodynamics:

Betaxolol - selective beta₁-adrenoceptor without internal sympathomimetic activity. Does not have a membrane-stabilizing (local anesthetic) action.

With topical application betaxolol reduces both increased and normal intraocular pressure, due to decreased production of intraocular fluid. The onset of an antihypertensive effect is usually observed 30 minutes after the drug is used, and the maximum decrease in the ophthalmotonus occurs approximately in 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 reduction in blood flow in the optic nerve.

Betaxolol does not cause 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 maximum concentration (C_max) in the anterior chamber is determined 20 minutes after the installation.In local applications, systemic absorption is low, the concentration in the plasma is below the threshold (2 ng / ml) of detection.

Connection with plasma proteins - 50%. The half-life (T_1/2) - 14-22 h. It is excreted by the kidneys (15% unchanged). Permeability through the blood-brain barrier (BBB) and the placental barrier is low, secretion with breast milk is insignificant.

Indications:

- Ocular hypertension;

- Chronic open-angle form of glaucoma;

- Closed-angle glaucoma (in combination with miotics).

Contraindications:

- Hypersensitivity to the components of the drug;

- sinus bradycardia;

- atrioventricular blockade of II and III degree;

- syndrome of weakness of the sinus node;

- children under 18 years of age (due to lack of data on effectiveness and safety).

Carefully:

Diabetes mellitus, thyrotoxicosis, simultaneous administration of oral beta-blockers, Reynaud's syndrome, pheochromocytoma, bronchial asthma, chronic obstructive bronchitis, atrioventricular blockade of the I degree, heart failure.

Pregnancy and lactation:

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:

Locally.1-2 drops in the conjunctival sac of the eye 2 times 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.

If the required level of intraocular pressure is not achieved with monotherapy with Betofan, additional therapy should be prescribed.

Side effects:

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

System side effects are rare.

From the central nervous system (CNS): 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:

At present, cases of overdose of Betofan were not reported.

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

With an overdose of beta₁- adrenoblockers can be observed: hypotension, bradycardia, acute heart failure.

Treatment symptomatic.

Interaction:

With the simultaneous use of the preparation Betofan and adrenaline solution for ophthalmic use in some cases, the development of mydriasis is possible.

When using the preparation Betofan in combination with drugs that deplete the stores of catecholamines (such as reserpine), there may be an increase in such effects as lowering blood pressure (BP) and bradycardia.

With the simultaneous use of the preparation Betofan and beta-adrenoblockers for oral administration, the risk of side effects (both local and systemic) is increased due to the additive effect.

Caution should be exercised in the joint use of the preparation Betoftan and adrenergic psychotropic agents due to the possible strengthening of their action.

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

When combined with sympathomimetics, they intensify their vasoconstrictive effect.

If necessary, it can be used in combination with other local ophthalmic preparations. In this case, the interval between their use should be at least 10 minutes.

Special instructions:

Betofatan contains a preservative benzalkonium chloride, which can be adsorbed by soft contact lenses and have a damaging effect on the eye tissue. Therefore, patients wearing soft contact lenses should take them off before applying drops and install, back no earlier than 20 minutes after instillation.

To prevent contamination of the pipette, do not touch the eye when instilled.

Diabetes: beta-blockers should be administered with caution to patients with a tendency to hypoglycemia, because these drugs can mask the symptoms of acute hypoglycemia.

Thyrotoxicosis: beta-blockers may mask some symptoms of hyperthyroidism (eg, tachycardia). In patients with suspected thyrotoxicosis, beta-blockers should not be abruptly abolished, as this may cause an increase in symptoms.

Myasthenia gravis: beta-blockers can cause symptoms similar to those of myasthenia gravis (for example: diplopia, ptosis, general weakness).

Surgery: before the planned operation, beta-blockers should be gradually (not instantaneously!) canceled 48 hours before general anesthesia, because during general anesthesia they can reduce the sensitivity of the myocardium to sympathetic stimulation necessary for the work of the heart.

Pulmonology: caution should be exercised in prescribing beta-blockers to patients with a greatly reduced function of the respiratory system. Despite the fact that clinical studies have shown no effect of betaxolol on the function of external respiration, one should not exclude the possibility of hypersensitivity to the drug.

Risk of anaphylactic reaction: patients taking beta-blockers may have a history of atopy or anaphylactic reactions. In the case of repeated reactions, such patients may not be sensitive to the usual doses of epinephrine needed to stop anaphylaxis.

When instillation, the drug can enter the systemic circulation. Thus, the same side effects can be observed,as with intravenous and parenteral administration of beta-blockers.

Betofanum has a minimal effect on blood pressure and heart rate. However, care should be taken when prescribing it to patients with atrioventricular blockade of degree I or heart failure. Treatment should be discontinued at the appearance of the first signs of decompensation of the cardiovascular system.

Effect on the ability to drive transp. cf. and fur:Patients who, after instillation of the drug, temporarily lose their clearness of vision, not It is recommended that you engage in activities that require increased attention and response before recovery.

Form release / dosage:

Eye drops, 0,5%.

Packaging:

To 5 ml of solution in a white polymer bottle-dropper closed with a polymer lid with a safety ring.

One bottle-dropper along with instructions for use in a cardboard pack.

Storage conditions:

AT dry, protected from light, at a temperature not higher than 25 ° C.

In a place inaccessible to children.

Shelf life:

3 years.

After opening the bottle, the drops should be used within 4 weeks.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-008604/09

Date of registration:28.10.2009

Expiration Date:Unlimited

The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania

Manufacturer: & nbsp

S.C. ROMPHARM Company, S.R.L. Romania

Representation: & nbspРомфарма ОООРомфарма ООО

Information update date: & nbsp25.01.2017

Illustrated instructions

Instructions

Betofan (Betoftan)