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

Active substance:
Betaxolol hydrochloride	5.6 mg
in terms of betaxolol base	5.0 mg
Excipients:
sodium chloride	8.0 mg
disodium edetate dihydrate (disodium salt	0.1 mg
ethylenediaminetetraacetic acid dihydrate)
benzethonium chloride	0.1 mg
Hydrochloric acid 1 M or sodium hydroxide 1 M	to pH 6.0-7.7
purified water	up to 1 ml

Description:Transparent, colorless or slightly yellowish liquid.

Pharmacotherapeutic group:Anti-glaucoma - beta-blocker

ATX: & nbsp

S.01.E.D.02 Betaxolol

Pharmacodynamics:

Antiglaucoma preparation. Selective beta₁-adrenoceptor without internal sympathomimetic activity. Does not have a membrane-stabilizing (local anesthetic) action.

With topical application betaxolol reduces intraocular pressure due to decrease in production intraocular fluid. Betaxolol (in comparison with other beta-adrenoblockers) does not cause a reduction in blood flow in the optic nerve. Does not cause a contraction of the circular muscle (miosis) and ciliary muscle (spasm of accommodation), hemeralopia, the effect of "swaddling" before the eyes.

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.

Pharmacokinetics:With topical application of the drug, systemic absorption of betaxolol hydrochloride is possible. Resorptive effect is not significant. Connection with plasma proteins - 50%. Half-life (T_1/2) - 14-22 hours. It is excreted by the kidneys (15% at unchanged form). Permeability through the blood-brain barrier - low; secretion with breast milk - insignificant.

Indications:

The drug is used to reduce intraocular pressure as a monotherapy or in combination with other drugs with open-angle glaucoma and ocular hypertension.

Contraindications:

Hypersensitivity to the components of the drug, sinus bradycardia (less than 45-50 beats per minute), sinus node weakness syndrome, atrioventricular blockade of grade II and III, severe chronic heart failure, cardiogenic shock, myasthenia gravis, severe obstructive respiratory failure, arterial hypotension, bronchial asthma, age to 18 years.

Carefully:Chronic obstructive pulmonary disease, unstable angina, propensity to bradycardia, atrioventricular blockade of the 1st degree, peripheral circulation disturbance, diabetes mellitus in the stage of decompensation, hypoglycemia, Raynaud's syndrome, pheochromocytoma, liver function abnormalities and kidney, thyrotoxicosis, myasthenia gravis, elderly age.

Pregnancy and lactation:

Sufficient experience in the use of the drug Betaxolol during pregnancy and lactation there. 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.

Bury in the conjunctival sac 1 drop 2 times a day; During the first month, treatment is carried out under the control of intraocular pressure.

Side effects:

From the sense organs: often - short-term discomfort in the eyes after instillation, lacrimation. In rare cases - a decrease in the sensitivity of the cornea, redness, eyes, acne keratitis, photophobia, anisocoria, photophobia, itching, a feeling of "dryness" of the eyes, allergic reactions.

Systemic side effects are rare:

From the central nervous system: dizziness, nausea, drowsiness, insomnia, headache, depression, increased symptoms of myasthenia gravis.

From the respiratory system: shortness of breath, bronchospasm, respiratory failure.

From the side of the cardiovascular system: bradycardia, impaired cardiac conduction, heart failure.

If the side effects indicated in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

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

Interaction:

With the simultaneous use of Betaxolol with beta-adrenoblockers for oral administration, the risk of an additive effect increases (manifestation of local and systemic side effects). Patients receiving this combination of drugs should be under medical supervision.

When using Betaxolol in combination with drugs that inhibit the deposition of catecholamines (reserpine), hypotension and bradycardia can be observed.

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 when Betaxolol is used together with adrenergic psychotropic agents due to the possible increase in their effect.

Special instructions:

Does not affect the size of the pupil; Apply closed-angle glaucoma only in combination with miotics.

When transferring the patient to Betaxolol after treatment with several antiglaucoma drugs, the latter are canceled gradually.

With caution appoint the drug to patients with diabetes, due to the fact that beta-adrenoblockers can mask the symptoms of acute hypoglycemia.

With caution appoint the drug to patients with thyrotoxicosis due to the fact that beta-adrenoblockers can mask the symptoms of thyrotoxicosis (for example, tachycardia). Patients with suspected thyrotoxicosis should not abruptly abolish beta-blockers, this can cause increased symptoms.

It should be borne in mind that beta-adrenoblockers can cause symptoms similar to those in myasthenia gravis (diplopia, ptosis, general weakness).

Betaxolol has minimal effect on blood pressure and heart rate. However, care should be taken when prescribing the drug to patients with atrioventricular blockage or heart failure.Treatment with Betaxolol should be stopped immediately if the first symptoms of cardiovascular decompensation appear.

Before the planned surgery, beta-blockers should be gradually abolished 48 hours before the general anesthesia, because during general anesthesia they can reduce the sensitivity of the myocardium to sympathetic stimulation.

Care should be taken when using Betaxolol together with adrenergic psychotropic drugs.

Eye drops Betaxolol contain preservatives that can precipitate in soft contact lenses and have a damaging effect on the eye tissue. Therefore, patients wearing contact lenses should be removed before using drops and installed back no earlier than 20 minutes after instillation.

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

If, after the application of Betaxolol, patients temporarily lose their visual clarity, it is not recommended to drive the car and engage in activities requiring increased attention and reaction before recovery.

Form release / dosage:

Eye drops, 0,5%.

Packaging:

1.5 ml, 2 ml or 5 ml in a tube-dropper polymer.

1, 2, 4, 5 or 10 tubes with the instruction for the use of the drug and instructions for the use of a tube-dropper are placed in a pack of cardboard with partitions or without partitions.

5 ml or 10 ml into the bottle-dropper polymer.

1 or 2 bottles of dropper with instructionson the use of the drug and the instruction for the use of a vial-dropper are placed in a pack of cardboard.

5 ml into glass bottles. 1 bottle complete with a sterile cap-dropper and instruction on the use of the drug is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 15 ° C (for the drug in a tube-droppers, a bottle of droppers);

in the dark place at a temperature of no higher than 25 ° C (for the drug in vials).

Protect from freezing.

Keep out of the reach of children.

Shelf life:

2 year in a tube-droppers, a bottle-droppers.

3 year in vials.

Shelf life after the opening - 1 month.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001193

Date of registration:11.11.2011

Date of cancellation:2016-11-11

The owner of the registration certificate:MOSCOW ENDOCRINE FACTORY, FSUE MOSCOW ENDOCRINE FACTORY, FSUE Russia

Manufacturer: & nbsp

MOSCOW ENDOCRINE FACTORY, FSUE Russia

Representation: & nbspMOSCOW ENDOCRINE FACTORY FGUP MOSCOW ENDOCRINE FACTORY FGUP Russia

Information update date: & nbsp14.11.2015

Illustrated instructions

Instructions

Betaxolol (Betaxolol)