Betoptic^® (Drops) Instructions for Use

ATC Code

S01ED02 (Betaxolol)

Active Substance

Betaxolol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Antiglaucoma agent – beta-adrenergic blocking agent

Pharmacological Action

Antiglaucoma drug. A selective beta₁-adrenergic blocker without intrinsic sympathomimetic activity. It does not possess membrane-stabilizing (local anesthetic) action.

When applied topically, Betaxolol reduces intraocular pressure by decreasing the production of intraocular fluid.

The onset of the hypotensive effect is observed 30 minutes after instillation, with the maximum effect developing after 2 hours. After a single instillation, the effect on ophthalmotonus persists for 12 hours.

Betaxolol (compared to other beta-blockers) does not cause a reduction in blood flow in the optic nerve.

The use of the drug Betoptic^® does not lead to miosis, accommodation spasm, hemeralopia, or a “veil” effect before the eyes (unlike miotics).

Pharmacokinetics

Systemic absorption of betaxolol hydrochloride is possible with topical application of the drug.

Indications

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

• open-angle glaucoma;
• ocular hypertension.

Betoptic^® can be used to treat open-angle glaucoma or ocular hypertension in patients with respiratory diseases.

ICD codes

Dosage Regimen

Drops

The drug is instilled into the conjunctival sac, 1-2 drops 2 times/day.

In some patients, stabilization of intraocular pressure occurs over several weeks, so it is recommended to monitor intraocular pressure during the first month of treatment.

If monotherapy is insufficiently clinically effective, combination therapy should be prescribed.

The bottle should be shaken before use.

Adverse Reactions

From the organ of vision: frequent – short-term eye discomfort after instillation, lacrimation; in some cases – decreased corneal sensitivity, eye redness, punctate keratitis, photophobia, anisocoria, photophobia, itching, dry eyes.

From the CNS: rare – insomnia, depressive neuroses.

Contraindications

• hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for sinus bradycardia, AV block of II and III degree, severe heart failure, cardiogenic shock, myasthenia, diabetes mellitus.

Use in Pregnancy and Lactation

There is insufficient experience with the use of the drug Betoptic^® during pregnancy and lactation. The use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Pediatric Use

There is insufficient experience with the use of the drug Betoptic^® in children.

Special Precautions

The drug should be prescribed with caution to patients with diabetes mellitus, since beta-blockers can mask the symptoms of acute hypoglycemia.

The drug should be prescribed with caution to patients with thyrotoxicosis, because beta-blockers can mask the symptoms of thyrotoxicosis (e.g., tachycardia). In patients with suspected thyrotoxicosis, beta-blockers should not be abruptly discontinued, as this may exacerbate the symptoms.

It should be considered that beta-blockers can cause symptoms similar to those of myasthenia (diplopia, ptosis, general weakness).

Beta-blockers should be prescribed with caution to patients with severe respiratory disorders. Although clinical studies have shown no effect of betaxolol on external respiratory function, the possibility of increased sensitivity to the drug cannot be excluded.

Before planned surgical intervention, beta-blockers should be gradually discontinued 48 hours before general anesthesia, because during general anesthesia they can reduce myocardial sensitivity to sympathetic stimulation.

Patients using beta-blockers may have a history of atopy or anaphylactic reactions. In case of recurrent hypersensitivity reactions, such patients may not respond to the usual doses of epinephrine (adrenaline) necessary to stop anaphylaxis.

The drug should be prescribed with caution to patients with Raynaud’s syndrome or pheochromocytoma.

When instilled into the eyes, beta-blockers can be absorbed into the systemic circulation. In this case, the same side effects as with systemic use may be observed. Cases of severe respiratory and cardiovascular disorders, including bronchospasm with fatal outcome in patients with bronchial asthma and death from heart failure have been described.

Betoptic^® has a minimal effect on BP and HR. However, caution should be exercised when prescribing the drug to patients with AV block or heart failure. Treatment with Betoptic^® should be immediately discontinued at the first symptoms of decompensation from the cardiovascular system.

Caution should be exercised when using the drug Betoptic^® concomitantly with adrenergic psychotropic agents.

Betoptic^® eye drops contain preservatives that can deposit in soft contact lenses and have a damaging effect on eye tissues. Therefore, patients wearing contact lenses should remove them before using the drops and reinsert them no earlier than 20 minutes after instillation.

Use in pediatrics

There is insufficient experience with the use of the drug Betoptic^® in children.

Effect on ability to drive vehicles and operate machinery

If after application of the drops patients experience temporary blurred vision, it is not recommended to drive a car or engage in activities requiring increased attention and reaction until vision is restored.

Overdose

If an excessive amount of the drug gets into the eyes, the eyes should be rinsed with warm water.

Drug Interactions

With the simultaneous use of the drug Betoptic^® and oral beta-blockers, the risk of side effects (both local and systemic) increases due to an additive effect (therefore, patients receiving this combination of drugs should be under medical supervision).

When using the drug Betoptic^® in combination with drugs that deplete catecholamine reserves (such as reserpine), a decrease in BP and bradycardia may be observed.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 30°C (86°F).

Shelf Life

Shelf life – 3 years.

After opening the bottle, the drug should be used within 28 days.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.