Arutimol (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 used 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 the automaticity of the sinus node, 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 to maintain consistent therapeutic effect.

Do not exceed the recommended dosage of one drop per eye, twice daily.

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

For patients with adequately controlled intraocular pressure, a reduction to once-daily administration may be sufficient.

Monitor intraocular pressure 4 weeks after initiating therapy to assess the response.

In cases of elevated intraocular pressure not sufficiently controlled with this regimen, consider concomitant therapy with other antiglaucoma agents.

Apply gentle pressure to the lacrimal sac for 1-2 minutes after instillation to minimize systemic absorption.

This reduces the risk of systemic adverse effects such as bradycardia or bronchospasm.

Avoid allowing the dropper tip to contact the eye, eyelids, or any other surface to prevent contamination of the solution.

Immediately after instillation, a temporary blurring of vision or stinging may occur; exercise caution if driving or operating machinery.

Use the medication continuously as prescribed; do not discontinue therapy without consulting a physician.

Abrupt cessation in patients with glaucoma may lead to a rapid return of elevated intraocular pressure.

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 are possible.

When performing fistulizing antiglaucoma surgery, the development of retinal detachment in the postoperative period is possible.

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 are possible.

Contraindications

AV block of the 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, impaired renal function, and diabetes mellitus (especially of the labile type).

With prolonged use, it increases the level of triglycerides in the 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 at least once every 6 months, and tear production function and visual fields should be monitored.

Influence on the ability to drive vehicles and mechanisms

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, so 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.