Timolollong^® (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 are manifested 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. The recommended dosage for chronic open-angle glaucoma is one drop of a 0.25% solution twice daily. If the clinical response is inadequate, increase to one drop of a 0.5% solution twice daily.

For angle-closure glaucoma, use as an adjunctive therapy with miotics. The dosage for secondary and congenital glaucoma is also one drop of the 0.25% solution twice daily, titrating upward to the 0.5% solution if necessary. Do not exceed one drop of the 0.5% solution twice daily.

Administer the drops at approximately 12-hour intervals. If you are using other topical ophthalmic medications, instill them at least 10 minutes apart. To minimize systemic absorption, apply gentle pressure to the lacrimal sac at the inner corner of the eye for one to two minutes immediately after instillation.

Close the eye gently after application. Do not blink excessively. Avoid allowing the dropper tip to contact any surface, including the eye, to prevent contamination of the solution. Replace the cap securely after each use.

Adhere strictly to the prescribed dosing schedule. Do not discontinue therapy without consulting your physician, as this may lead to a loss of intraocular pressure control. The therapeutic effect on intraocular pressure usually occurs within 30 minutes, with maximum effect observed after 1 to 2 hours.

Adverse Reactions

From the organ of vision: with topical application, irritation and hyperemia of the conjunctiva, eyelid skin, burning and itching in the eyes, lacrimation, photophobia, corneal epithelial edema, punctate superficial keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes may occur. When performing fistulizing antiglaucoma surgery, 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 II and III degree, sinoatrial block, bradycardia, sick sinus syndrome, arterial hypotension, chronic heart failure of 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 or kidney function, 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 and visual fields should be monitored at least once every 6 months.

Effect on the ability to drive vehicles and 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.