Betoptic, eye drops 0.5%, 5ml

Composition

Eye drops 0.5% in the form of a clear colorless or slightly yellowish solution.

1 ml of betaxolol hydrochloride 5.6 mg, which corresponds to the content of betaxolol 5 mg

Auxiliary substances:

benzalkonium chloride,

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

purified water.

Pharmacological action

Betaxolol is a selective beta-1-adrenoblocker with no intrinsic sympathomimetic activity. It does not have a membrane-stabilizing (local anesthetic) effect.

When applied topically, betaxolol reduces intraocular pressure due to reduced production of intraocular fluid.

The onset of antihypertensive action is observed 30 minutes after instillation, the maximum effect develops in 2 hours. After a single instillation, the effect on ophthalmotonus persists for 12 hours.

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

Betoptic does not cause miosis, spasm of accommodation, hemeralopia, the “veil” effect in front of the eyes (unlike myotics).

Pharmacokinetics

Betaxolol is highly lipophilic, as a result of which it penetrates well through the cornea into the anterior chamber, with max in the anterior chamber determined 20 minutes after instillation. When applied topically, systemic absorption is low and the plasma concentration is below the threshold (2 ng/ml) of detection.

Excretion mainly through the kidneys.

Indications

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

• Open-angle glaucoma.
• Ocular hypertension.

Betoptic can be used to treat open-angle glaucoma or ocular hypertension in patients with diseases of the respiratory system.

Use during pregnancy and lactation

There is no sufficient experience with the use of Betoptic during pregnancy and lactation.

It is possible to use Betoptic for the treatment of pregnant and lactating mothers as prescribed by the attending physician, if the expected therapeutic effect exceeds the risk of possible side effects.

Contraindications

• Individual hypersensitivity to the components of the drug.
• Sinus bradycardia.
• AV blockage of II and III degrees.
• Cardiogenic shock.
• Severe heart failure.
• Children under 18 years of age.

Side effects

Local users

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

From the central nervous system

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

From the cardiovascular system

Bradycardia, cardiac conduction disorders, and heart failure.

From the respiratory system

Dyspnoea, bronchospasm, bronchial asthma, respiratory failure.

Systemic side effects are rare.

Interaction

In patients receiving Betoptic C eye drops and simultaneously taking other beta-blockers orally, the risk of side effects (both systemic and local) may be higher due to the possible additive effect. Such patients should be under close medical supervision.

In combination with drugs that deplete catecholamine stores, there may be increased effects such as lowering blood pressure and bradycardia.

With simultaneous use of muscle relaxants and hypoglycemic agents, their effect may increase.

When combined with sympathomimetics, their vasoconstrictor effect is enhanced.

Caution should be exercised when concomitantly using betaxolol and adrenergic psychotropic drugs due to the possible increase in their effect.

With the simultaneous use of betaxolol and drugs that affect atrioventricular conduction (such as quinidine – type antiarrhythmics, amiodarone, cardiac glycosides, calcium channel blockers, parasympathomimetics), an additive effect may develop-bradycardia, atrioventricular block, arterial hypotension.

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

How to take, course of use and dosage

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

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

If the clinical effectiveness of monotherapy is insufficient, additional therapy is prescribed.

Overdose

If an excessive amount of the drug gets into the eyes, rinse your eyes with warm water.

Special instructions

Diabetes Mellitus

Beta-blockers should be used with caution in patients with a tendency to hypoglycemia, as these drugs can mask the symptoms of acute hypoglycemia.

Thyrotoxicosis

Beta-blockers can mask some of the symptoms of hyperthyroidism (for example, tachycardia). In patients with suspected thyrotoxicosis, beta-blockers should not be abruptly discontinued, as this may cause increased symptoms.

Muscle weakness

Beta-blockers can cause symptoms similar to those of Myasthenia gravis (for example: diplopia, ptosis, general weakness).

Surgery

Before elective surgery, beta-blockers should be taken gradually (not simultaneously!) they are canceled 48 hours before general anesthesia, because during anesthesia they can reduce the sensitivity of the myocardium to sympathetic stimulation necessary for heart function.

Pulmonology

Caution should be exercised when prescribing beta-blockers to patients with severe respiratory failure. Despite the fact that clinical studies have shown no effect of betaxolol on the function of external respiration, the possibility of hypersensitivity to the drug should not be excluded.

Risk of anaphylactic reaction

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

The drug should be used with caution in patients with Raynaud’s syndrome and pheochromocytoma. When administered topically, beta-blockers can enter the systemic circulation and have the same side effects as when administered systemically. Cases of severe respiratory and cardiovascular disorders, including death from bronchospasm in patients with bronchial asthma and death from heart failure, are described.

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

The preparation contains the preservative benzalkonium chloride, which can be absorbed by contact lenses (soft). Before using the drug, the lenses should be removed and replaced no earlier than 20 minutes after using the drug.

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

Influence on the ability to drive motor vehicles and manage mechanisms

Patients who have temporarily reduced visual clarity after instillation of the drug are not recommended to engage in activities that require increased attention and reaction before it is restored.

Form of production

Eye drops 0.5%.

Storage conditions

Store at a temperature of 8° to 30°C out of the reach of children. After opening the bottle, the drug should be used for 1 month.

Shelf

life is 3 years.

Active ingredient

Betaxolol

Conditions of release from pharmacies

By prescription

Dosage form

eye drops

Purpose

Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Glaucoma