Betoptik S cap. eye. 0.25% fl. 5 ml

Pharmacological properties

Betaksolol (1-{ 4-[2 (tsiklopropilmetoks) ethyl] fenoks }-3-izopropilaminopropan-2-ol a hydrochloride) — a cardioselective blocker β1-адренорецепторов, without vs and significant membrane stabilizing action. at introduction to an eye, suspension betoptik s reduces the increased intraocular pressure which is followed by glaucoma or without it. betaksolol in the form of eye drops minimum influences respiratory and cardiovascular systems.

Increased intraocular pressure — a major factor of risk of developing glaukomatozny scotoma. The intraocular pressure is higher, the probability of damage of an optic nerve and visual field constriction is higher. Betaksolol can reduce as raised, and normal intraocular pressure. The mechanism of its hypotensive action is connected with decrease in products of intraocular liquid.

In controlled double blind researches degree and duration of hypotensive ophthalmologic effect of Betoptik suspension S and 0.5% of Betoptik solution were clinically equivalent, however Betoptik suspension was transferred by S much better, than Betoptik solution.

In controlled clinical trials on patients with a chronic open angle glaucoma and intraocular hypertensia it is shown that treatment betaksololy provides more long positive influence in the field of sight, than that with use of Timololum or a non-selective blocker of a β-adrenoceptor. Moreover, it was noted that betaksolol not only did not worsen blood supply of an optic nerve, and and improved eye blood circulation.

Betaksolol has high lipophilicity thanks to what high concentrations of medicine in eye tissues are created. Begins to work in 30 min., and the maximum effect, as a rule, is reached in 2 h after topical administration. The single dose provides decrease in intraocular pressure during 12 h

Polar nature of a betaksolol can cause discomfort at instillation in an eye. In the medicament Betoptik S molecules of a betaksolol are connected by an ionic bond with amberlitovy pitch. After instillation of a molecule of a betaksolol are transferred by ions to a plaintive film. Process of movement takes place within several minutes, reducing discomfort at use of medicine.

Indication

Open angle glaucoma, increase in intraocular pressure.

Use

Adult (including to patients of advanced age) the recommended dose makes 1–2 drops in the affected eye(s) 2 times a day. at some patients for stabilization of hypotensive action several weeks can be required. careful observation of patients with glaucoma is necessary. if when assigning of the recommended doses the adequate decrease in intraocular pressure is not reached, it is possible to perform combination therapy with pilocarpine or other miotika and/or epinephrine (adrenaline), and/or karboangidraza inhibitors.

24 mkl.

Before application a bottle with medicine needs to be stirred up well.

Contraindication

Hypersensitivity to medicine components. betoptik s is contraindicated to patients with sinus bradycardia, av-heart block of ii or iii of degree, cardiogenic shock and the patient with the expressed heart failure in the anamnesis.

Side effects

Local: right after burying the short-term discomfort in eyes is possible. sometimes — a dot keratitis of a cornea, a photophobia, dacryagogue, an itch, xerophthalmus, eye pain, decrease in visual acuity, formation of crusts on edges of the lids. besides, at use of other medicines of a betaksolol the side effects included allergic reactions, decrease in sensitivity of a cornea, pointed coloring of a cornea, hypostasis and an anisocoria.

System — it is rare, but can develop also at topical administration of blockers in ₁ - adrenoceptors:

— from a cardiovascular system: bradycardia, AV blockade, strengthening of expressiveness of symptoms of heart failure;

— from a respiratory system: dispnoe with a bronchospasm, the increased bronchial secretion and respiratory insufficiency;

— from central nervous system: insomnia, dizziness, headache, depression, slackness, strengthening of expressiveness of symptoms and signs of a myasthenia;

— others: rash, toxic epidermal necrolysis, hair loss, glossitis. There were messages about change of flavoring feelings and smells.

Special instructions

With care appoint betoptik s the patient with heart failure or av-heart block in the anamnesis. use of medicine should be stopped immediately at the first symptoms of heart failure.

Blockers of β-adrenoceptors with care appoint

patient with a spontaneous hypoglycemia and to patients who take insulin or the oral hypoglycemic drugs. Blockers of β-adrenoceptors can mask signs and symptoms of a sharp hypoglycemia.

Thyrotoxicosis

Blockers of β-adrenoceptors can mask some clinical signs of a hyperthyroidism (for example tachycardia). Patients with suspicion of a thyrotoxicosis have to be under constant medical observation not to allow the sudden termination of reception of a blocker of a β-adrenoceptor capable sharply to worsen a condition of the patient.

Myasthenia

Blockers of β-adrenoceptors can strengthen muscle weakness and some symptoms of a myasthenia (for example a diplopia, a ptosis and the general weakness).

Surgical intervention

Before the general anesthesia use of medicine needs to be stopped gradually, reducing thereby sensitivity of heart to β - adrenergic stimulation.

Though results of tests did not show to

an adverse effect on function of lungs at the patients accepting betaksolol in the form of eye drops it is not necessary to neglect the probability of emergence of side reactions from a respiratory system at the patients sensitive to blockers of β-adrenoceptors.

Patients having in the anamnesis an atopy or acute anaphylactic reaction on various allergens during reception of blockers of β-adrenoceptors can be more sensitive

to repeated, accidental, diagnostic or medical administration of the corresponding allergens and not react to the usual doses of epinephrine applied to elimination of anaphylactic reaction.

Organ of sight

At patients with closed-angle glaucoma with the purpose of treatment is disclosure of a corner by narrowing of a pupil by means of miotik. Betaksolol is not enough or does not influence a pupil at all. If Betoptik is used by S for decrease in intraocular pressure at closed-angle glaucoma, it needs to be applied only in a combination with miotocs.

. With care appoint blockers of β-adrenoceptors sick with Shegren's syndrome or violations of formation of a plaintive film of other genesis. Patients who carry contact lenses have to remove them before use of the medicine Betoptik S and wait 15 min. after burying eyes before again putting on contact lenses.

Is forbidden to touch with a bottle dropper tip any surfaces as it can lead to pollution of contents of a bottle.

Period of pregnancy and feeding by a breast

Adequate, well controlled researches on pregnant women was not spent. Betoptik S should appoint during pregnancy only when the potential advantage of use of medicine justifies possible risk for a fruit.

whether the betaksolola a hydrochloride gets into breast milk therefore with care appoint Betoptik of S during feeding by a breast.

Clinical trials of efficiency and safety of medicine at children were not carried out by

.

Influence on ability to operate motor transportation or other potentially dangerous mechanisms is limited to illegibility of sight which arises directly after use of the medicine Betoptik S, but quickly takes place.

Interaction

needs careful observation of the patients who are at the same time accepting sympatholytics (such as reserpine) as synergy effects with development of the expressed hypotension and/or bradycardia are possible.

With care is appointed Betoptik to S patients who in parallel take adrenergic psychotropic drugs.

Overdose

At topical administration of medicine. in case of local overdose betoptik s it is necessary to wash with suspension quickly an eye by means of the cotton plug moistened with warm water.

Storage conditions

At a temperature of 8-30 °C. to hold a bottle densely closed. not to use more than 28 days after opening of a bottle.