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

Excipients: disodium edetate dihydrate 0.5 mg, sodium chloride 8.0 mg, benzalkonium chloride solution 50% 0.2 mg, sodium hydroxide solution 10% (to pH 4.0-8.0), water purified to 1 ml.

Description:

Transparent, colorless or light yellow liquid.

Pharmacotherapeutic group:beta-blocker

ATX: & nbsp

S.01.E.D.02 Betaxolol

Pharmacodynamics:

Betaxolol is a selective β₁-adrenoceptor without its own sympathomimetic activity. Application in the form of eye drops is accompanied by a decrease in intraocular pressure due to a decrease in the production of intraocular fluid. Resorptive effect is expressed minimally. Besides, betaxolol improves ocular circulation (perfusion). Does not cause miosis, spasm of accommodation due to lowering the production of watery moisture, hemeralopia.

Pharmacokinetics:

Betaxolol is characterized by a high degree of lipophilicity, as a result of which it is rapidly absorbed by the corneal epithelium, and high concentration is created in the intraocular fluid.

The time of onset (decrease in intraocular pressure) is 30 minutes, the maximum effect is after 2 hours, the duration of action is 24 hours.

The half-life (T_1/2) is 12-16 hours, the connection with plasma proteins is 50%. It is mainly excreted by the kidneys, to a small extent with feces, in the form of two carboxylic acids and unchanged (about 16% of the applied dose).

Permeability through the blood-brain barrier (BBB) and the placental barrier is low, secretion with breast milk is insignificant.

Indications:

- Dlaznaya hypertension;

- open angle glaucoma.

Contraindications:

- Hypersensitivity to betaxolol and other components of the drug;

- bradycardia;

- Atrial-ventricular conduction block II or III degree (AV-blockade);

- cardiogenic shock;

- decompensated chronic heart failure;

- age to 18 years.

Carefully:

Treatment of patients using β-blocker action and betaxolol (eye drops) should be performed under regular medical supervision in connection with the risk of a total potential effect on intraocular pressure and the appearance of undesirable systemic effects.

Despite the weakly expressed general effect of betaxolol (in the form of drops of the eye) on the body, caution should be exercised when it is administered to patients with thyrotoxicosis and diabetes mellitus (especially unstable), since the drug may mask hypoglycemia.

Before surgery with the use of general anesthesia should gradually stop using the drug, as the drug can change the patient's reaction to the use of general anesthetics.

Betaxolol is a cardioselective drug that blocks β₁-adrarenergic receptors, which minimally affects the tone of the bronchi, but caution should be exercised when prescribing the drug to people with obstructive diseases of the upper respiratory tract.

Dosing and Administration:

Adults (including elderly patients) in the conjunctival sac 1 drop 2 times a day.

Method of administration

The drug is intended for topical use only - in the conjunctival sac.

When using the drug, avoid touching the tip of the drip feeder with any surface to avoid microbial contamination.

Before instillation of the drug should be thoroughly washed hands. Remove the lid and drip the medication into the conjunctival sac. If the drop does not hit the conjunctival sac, the next drop should be dripped. Carefully close eyelids without blinking or opening your eyes for about 2 minutes to allow the drug to absorb. Then wash your hands to remove the remnants of the drug and close the bottle.

Side effects:

Usually the drug is well tolerated by patients.

Local Reactions

Disturbances on the part of the organ of sight

Short-term discomfort in the eyes, transient tearing, reduced sensitivity of the cornea, erythema, conjunctival itching, spotted corneal stain, keratitis, anisocoria (different pupil diameter), photophobia.

Systemic reactions

Disturbances from the nervous system

Insomnia, depression, headache, nightmares, memory loss.

Impaired heart function

Bradycardia (decrease in heart rate).

Disturbances from the respiratory system, chest and mediastinal organs

Shortness of breath, bronchospasm, cough.

Disturbances from the skin

Hair loss, psoriatic rash or exacerbation of psoriasis, skin rash.

Immune system disorders

Systemic allergic reactions, including angioedema, hives, local and generalized rash, itching, anaphylactic reaction.

Metabolic disorders

Decreased glucose concentration.

Disorders from the gastrointestinal tract

Dyspepsia, nausea, vomiting, diarrhea, stomach pain.

Vascular disorders

Arterial hypotension, Raynaud's disease, cold hands and feet.

Disorders from the skeletal muscles and connective tissue

Muscle Pain.

Overdose:

If the excess amount of the drug is ingested, rinse the eyes with warm water.

Interaction:Separately applied betaxolol does not affect, or affects to a small extent the pupil; when used simultaneously with epinephrine may cause a dilated pupil.

Treatment of patients who simultaneously use betaxolol and agents that lower the concentration of catecholamines (for example, reserpine), as well as psychotropic drugs that affect adrenergic transmission (for example, some antidepressants) should be performed under regular medical supervision, since it is possible to lower blood pressure and / or bradycardia.

Special instructions:

If you missed the time of taking the drug Optibetol®, you should take it as soon as possible. Do not take the missed dose at the onset of the next appointment. The next dose should be taken at the appropriate time in accordance with the treatment regimen. Do not double the dose.

Betaxolol does not affect the size of the pupil, so with closed angle glaucoma, the drug should be used only in combination with miotics as an intraocular pressure lowering agent.

Since the preparation contains benzalkonium chloride, during the period of using the drug, patients are not recommended to use soft (hydrophilic) contact lenses. Contact lenses should be removed before instilling the drug and reapply not earlier than 15 minutes. Benzalkonium chloride can cause eye irritation and change the color of contact lenses.

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

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Eye drops, 0,5%.

Packaging:

5 ml are packed in a polyethylene bottle with a dropper, closed with a lid with the control of the first opening.

One bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Shelf life after autopsy - 4 weeks.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001572

Date of registration:06.03.2012

Date of cancellation:2017-03-06

The owner of the registration certificate:Warsaw Pharmaceutical Plant Polfa, JSCWarsaw Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

Pharmaceutical Works POLPHARMA, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp14.11.2015

Illustrated instructions

Instructions

Optibetol® (Optibetol®)