Timohexal (Drops) Instructions for Use

ATC Code

S01ED01 (Timolol)

Active Substance

Timolol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Antiglaucoma agent – beta-adrenergic blocking agent

Pharmacological Action

A non-selective beta-adrenergic blocking agent. When applied topically in ophthalmology, it reduces both normal and elevated intraocular pressure by decreasing the production of aqueous humor and improving its outflow; it does not affect accommodation or pupil size.

It possesses antianginal, hypotensive, and antiarrhythmic effects, which manifest with systemic use. It reduces sinus node automaticity, decreases heart rate, slows AV conduction, and reduces myocardial contractility and oxygen demand.

Pharmacokinetics

When applied topically, it rapidly penetrates the cornea and enters the systemic circulation in small amounts due to absorption through the conjunctival vessels, nasal mucosa, and lacrimal tract.

Indications

For use in ophthalmology: elevated intraocular pressure, chronic open-angle glaucoma, angle-closure glaucoma (as an adjunctive agent in combination with miotics), secondary glaucoma (including aphakic), congenital glaucoma (when other therapeutic measures are ineffective).

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye(s) twice daily.

Administer the drops at approximately 12-hour intervals for consistent intraocular pressure control.

Do not exceed the prescribed once-daily or twice-daily dosing frequency.

If using other topical ophthalmic medications, administer them at least 10 minutes apart.

For chronic open-angle glaucoma, the initial dose is one drop of a 0.25% solution twice daily.

If the therapeutic response is insufficient, increase to one drop of a 0.5% solution twice daily.

For angle-closure glaucoma, use as an adjunct to miotics; follow the same twice-daily instillation schedule.

In cases of elevated intraocular pressure or secondary glaucoma, initiate therapy with the 0.25% solution unless otherwise directed.

For congenital glaucoma where other agents fail, use the lowest effective concentration under strict medical supervision.

To minimize systemic absorption, apply gentle pressure to the lacrimal sac (nasolacrimal occlusion) for 1-2 minutes after instillation.

Close eyes gently after application; avoid blinking excessively.

Do not touch the dropper tip to any surface to prevent contamination of the solution.

If a dose is missed, administer it as soon as possible; however, if it is nearly time for the next dose, skip the missed dose and continue with the regular schedule.

Adverse Reactions

From the organ of vision: with local application, irritation and hyperemia of the conjunctiva, eyelid skin, burning and itching in the eyes, lacrimation, photophobia, corneal epithelial edema, punctate superficial keratopathy, corneal hypesthesia, diplopia, ptosis, dry eyes may occur. When performing fistulizing antiglaucoma surgeries, retinal detachment may develop in the postoperative period.

With systemic use: heart failure, bradycardia, AV block, arterial hypotension; headache, sleep disorders, nightmares, asthenia, agitation, depression, paresthesia and cold extremities; nausea, vomiting, diarrhea; dyspnea, bronchospasm; muscle weakness; skin allergic reactions, exacerbation of psoriasis, dry conjunctiva may occur.

Contraindications

AV block of second and third degree, sinoatrial block, bradycardia, sick sinus syndrome, arterial hypotension, chronic heart failure stage IIB-III, acute heart failure, vasomotor rhinitis, Raynaud’s disease and other obliterative vascular diseases, metabolic acidosis, lactation.

Use in Pregnancy and Lactation

The safety and efficacy of use during pregnancy have not been studied.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

The safety and efficacy of use in children have not been studied.

Special Precautions

Use with caution in patients with impaired liver function, renal function, and diabetes mellitus (especially of the labile type). With long-term use, it increases the level of triglycerides in blood plasma.

The safety and efficacy of use in children have not been studied.

In ophthalmology, it is used for a long time, therefore, during treatment, the cornea should be examined, tear production function should be monitored, and visual fields should be checked at least once every 6 months.

Effect on ability to drive vehicles and operate machinery

During treatment, one should refrain from engaging in potentially hazardous activities that require increased attention and rapid psychomotor reactions.

When used in ophthalmology, immediately after instillation, a decrease in visual acuity and slowing of psychomotor reactions are possible, therefore, for 30 minutes, one should refrain from engaging in potentially hazardous activities that require increased attention.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.