Betoftan eye drops 0. 5% 5 ml (Betaxolol)

Latin name

Betoftan

Release form

Betoftan. Eye drops.

Packaging

5 ml - polymer dropper bottle (1) - packs of cardboard.

Pharmacological action of

Anti-glaucoma drug. Betaxolol is a selective beta1-blocker without internal sympathomimetic activity. It does not have a membrane stabilizing (local anesthetic) effect.

Topical application of betaxolol reduces both elevated and normal intraocular pressure, due to a decrease in the production of intraocular fluid. The onset of the hypotensive effect is usually observed 30 minutes after using the drug, and the maximum decrease in ophthalmotonus occurs in about 2 hours. After a single instillation, the effect on the ophthalmotonus persists for 12 hours.

Betaxolol, in comparison with other beta-blockers, does not cause a decrease in blood flow in optic nerve, miosis, accommodation spasm, hemeralopia (unlike myotics).

Pharmacokinetics

Absorption

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

Distribution and excretion of

Plasma Protein Binding - 50%. T1 / 2 - 14-22 hours. It is excreted by the kidneys (15% unchanged). Permeability through the BBB and the placental barrier is low, secretion with breast milk is negligible.

Indications

ocular hypertension

chronic open-angle glaucoma

angle-closure glaucoma (in combination with myotics).

Contraindications

sinus bradycardia

AV block II and III degree

SSSU

children and adolescents under 18 years of age (due to lack of data on efficacy and safety)

hypersensitivity to the drug.

s ostrovThe drug is prescribed for diabetes mellitus, thyrotoxicosis, concomitant use of oral beta-blockers, Raynaud's syndrome, pheochromocytoma, bronchial asthma, chronic obstructive bronchitis, degree I AV block, heart failure.

Use in childhood

Contraindicated in children and adolescents under 18 years of age.

Use during pregnancy and lactation

Use of the drug during pregnancy and lactation (breastfeeding) is possible only if the intended benefits to the mother outweigh the potential risk to the fetus or baby.

Composition

Eye drops 0.5% in the form of a clear solution, colorless or light yellow in color with a brown tint.

1 ml

betaxolol (in the form of hydrochloride) 5 mg

Excipients: sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate dihydrate, benzalkonium chloride, purified water.

Dosage and administration

Instill 1-2 drops in the conjunctival sac 2 times / day. In some patients, stabilization of intraocular pressure occurs within a few weeks, so it is recommended to control intraocular pressure during the first month of treatment.

If the required level of intraocular pressure is not achieved with Betoftan monotherapy, additional therapy should be prescribed.

Side effects

Local reactions: short-term discomfort in the eyes after instillation, lacrimation in some cases - decreased sensitivity of the cornea, redness of the eye, keratitis, photophobia, anisocoria, blurred vision, itching, dry eyes, allergic reactions.

Systemic side effects are rare.

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

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

From the respiratory system: dyspnea, bronchospasm, bronchial asthma, respiratory failure.

Drug Interaction

Concurrent use of Betoftan and adrenaline for ophthalmic use may result in the development of mydriasis in some cases.

When using the drug Betoftan in combination with drugs that deplete catecholamines (such as reserpine), an increase in effects such as BP and bradycardia may be observed.

The concurrent use of Betoftan and beta-blockers for oral administration increases the risk of side effects (both local and systemic) due to the additive effect.

Caution should be exercised when co-administering Betoftan and adrenergic psychotropic agents due to possible enhancement of their action.

When both muscle relaxants and hypoglycemic agents are given, their effects may increase.

When combined with sympathomimetics, an increase in their vasoconstrictor effect is noted.

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

Overdose

There have been no reports of overdosage with Betofan.

In case of contact with eyes, excess water should be washed with warm water.

Symptoms of an overdose of beta1-blockers: arterial hypotension, bradycardia, acute heart failure are possible.

Treatment: symptomatic.

Storage conditions

The drug should be stored in a dry, dark place, inaccessible to children at a temperature not exceeding 25 ° C.

The Expiration of

is 3 years.

After opening the vial, the drops should be used for 4 weeks.

Deystvuyuschee substances

Betaxolol



pharmacy terms for prescription

dosage form

dosage form

eye drops

K.O.Rompharm Company S.R.L., Romania



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