Betoptik, eye drops 0.5% 5 ml

Betaxolol is a selective beta 1 -adrenoblocker without intrinsic sympathomimetic activity. It has no membrane stabilizing (local anesthetic) effect.

Betaxololol reduces intraocular pressure by reducing intraocular fluid production when used topically.

The onset of hypotensive effect is observed 30 min after injection, the maximum effect occurs after 2 h. After single instillation the effect on ophthalmotonus lasts for 12 hours.

Betaxolol (in comparison with other beta-adrenoblockers) does not cause reduction of blood flow in the optic nerve.

Betaxolol does not cause myosis, accommodation spasm, hemeralopia, the effect of “shrouds” in front of the eyes (unlike myotics).

Pharmacokinetics

Betaxololol is highly lipophilic, resulting in good penetration through the cornea into the anterior chamber, C max in the anterior chamber is determined 20 minutes after instillation. When applied topically, systemic absorption is low, with plasma concentrations below the threshold (2 ng/ml) of detection.

The excretion is mainly through the kidneys.

Indications

The drug is used to reduce intraocular pressure as monotherapy or in combination with other drugs for:

Betoptic may be used to treat open-angle glaucoma or eye hypertension in patients with respiratory conditions.

Active ingredient

Composition

Ocular drops 0.5% as a clear colorless or slightly yellowish solution.

1 ml of betaxolol hydrochloride5.6 mg, which corresponds to the content of betaxolol5 mg

Associates:

benzalkonium chloride,

hydrochloric acid and/or sodium hydroxide solution (to maintain pH),

purified water.

How to take, the dosage

The drug is injected into the conjunctival sac in 1-2 drops 2 times a day.

In some patients it takes several weeks for intraocular pressure to stabilize, so it is recommended that intraocular pressure be monitored during the first month of treatment.

If monotherapy is not clinically effective, additional therapy is indicated.

Interaction

Patients receiving Betoptik C eye drops while taking other oral beta-adrenoblockers may have a higher risk of adverse effects (both systemic and local) due to possible additive effects. Such patients should be under close medical supervision.

In combination with catecholamine depleting drugs, increased effects such as decreased blood pressure and bradycardia may be observed.

The concomitant administration of muscle relaxants and hypoglycemic agents may increase their effects.

In co-administration with sympathomimetics, an increase in their vasoconstrictor effect.

Precautions should be taken when co-administering betaxololol and adrenergic psychotropic drugs due to possible potentiation of their effects.

Contrast use of betaxololol with agents affecting atrioventricular conduction (such as quinidine-type antiarrhythmics, amiodarone, cardiac glycosides, calcium channel blockers, parasympathomimetics) may produce additive effects – bradycardia, atrioventricular blockade, and hypotension.

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

Special Instructions

Diabetes mellitus

Beta-adrenoblockers should be used with caution in patients who are prone to hypoglycemia, because these drugs may mask symptoms of acute hypoglycemia.

The thyrotoxicosis

Beta-adrenoblockers may mask some symptoms of hyperthyroidism (e.g., tachycardia). In patients with suspected thyrotoxicosis, beta-adrenoblockers should not be abruptly withdrawn, as this may cause worsening of symptoms.

Muscular weakness

Beta-adrenoblockers may cause symptoms similar to those of Myasthenia gravis (e.g., diplopia, ptosis, general weakness).

Surgery

Beta-adrenoblockers should be gradually (not overnight!) withdrawn 48 hours before general anesthesia before elective surgery because they can decrease myocardial sensitivity to sympathetic stimulation necessary for heart function during anesthesia.

Pulmonology

Perhaps caution should be exercised when prescribing beta-adrenoblockers in patients with severe respiratory insufficiency. Although clinical studies have shown no effect of betaxolol on respiratory function, hypersensitivity should not be excluded.

The risk of anaphylactic reaction

Patients taking beta-adrenoblockers may have a history of atopy or anaphylactic reactions. In case of repeated reactions, these patients may not be sensitive to the usual doses of adrenaline (epinephrine ) needed to stop anaphylaxis.

The drug should be used with caution in patients with Raynaud’s syndrome and pheochromocytoma. When administered topically, beta-adrenoblockers may enter the systemic bloodstream and have the same side effects as when administered systemically. Serious respiratory and cardiovascular disorders have been described, including death from bronchospasm in patients with bronchial asthma and death from heart failure.

Betoptic C has minimal effect on blood pressure and heart rate. However, caution should be exercised when prescribing it to patients with atrioventricular block or heart failure. Treatment should be discontinued when the first signs of decompensation of the cardiovascular system appear.

The drug contains the preservative benzalkonium chloride, which may be absorbed by contact lenses (soft lenses). Lenses should be removed and put back on no earlier than 20 minutes after application of the product.

Do not touch any surface with the tip of the dropper bottle to avoid contaminating the dropper bottle and its contents. The bottle should be closed after each use.

Impact on driving and operating machinery

Patients whose vision is temporarily reduced after instillation of the drug are not recommended to engage in activities requiring increased attention and reaction until it is restored.

Contraindications

Side effects

Topical

Transient eye discomfort, blurred vision, pitting keratitis, decreased corneal sensitivity, sensation of a foreign body in the eye, photophobia, lacrimation, itching, burning, dry eyes, red eyes, anisocoria, pain in the eye, decreased visual acuity, allergic reactions.

CNS disorders

Dizziness , nausea , drowsiness , insomnia , headache , depression , increased symptoms of Myasthenia gravis .

Cardiovascular system disorders

Bradycardia , impaired cardiac conduction and heart failure.

Respiratory system disorders

Dyspnea, bronchospasm, bronchial asthma, respiratory failure.

Systemic side effects are rare.

Overdose

In case of contact with the eyes with an excessive amount of the drug, rinse the eyes with warm water.

Pregnancy use

There is no sufficient experience on the use of Betoptik during pregnancy, breastfeeding.

Betoptic may be used to treat pregnant and lactating women by prescription of the attending physician if the expected therapeutic effect exceeds the risk of possible side effects.

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