Timolet OD^® (Drops) Instructions for Use

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Manufactured By

Sun Pharmaceutical Medicare Ltd. (India)

ATC Code

S01ED01 (Timolol)

Active Substance

Timolol (Rec.INN registered by WHO)

Dosage Form

Timolet OD®

Ophthalmic drops 0.5%: dropper bottle 5 ml 1 pc.

Dosage Form, Packaging, and Composition

Ophthalmic drops from colorless to light yellow, transparent, viscous.

Excipients: hypromellose – 5 mg, povidone K90 – 20 mg, zinc chloride – 0.025 mg, macrogol 400 – 30 mg, boric acid – 10 mg, trometamol – 3.67 mg, water for injections – up to 1 ml.

5 ml – dropper bottle (1) – cardboard package.

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Antiglaucoma agent – beta-adrenergic blocking agent

Pharmacological Action

Non-selective beta-adrenergic blocker. When applied topically in ophthalmology, it reduces both normal and elevated intraocular pressure by decreasing the production of intraocular fluid and improving its outflow, does not affect accommodation and pupil size.

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

Pharmacokinetics

When applied topically, it rapidly penetrates the cornea, and a small amount enters the systemic circulation 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 additional 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) once daily.

Administer the preparation in the morning. Do not exceed the recommended once-daily dosage.

Ensure proper hand hygiene before use. Avoid contact between the dropper tip and any surface to prevent contamination.

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

For patients with adequately controlled intraocular pressure transitioning from timolol solution, initiate this regimen at the next scheduled dose.

Close the bottle tightly immediately after use.

Monitor intraocular pressure response periodically. The therapeutic effect is typically maintained for 24 hours.

Discard the bottle 4 weeks after first opening. Do not use the solution if it changes color or becomes cloudy.

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 epithelium edema, punctate superficial keratopathy, corneal hypoesthesia, diplopia, ptosis, dry eyes are possible. When performing fistulizing antiglaucoma surgeries, the development of retinal detachment in the postoperative period is possible.

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

Contraindications

AV block II and III 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 obliterating 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, kidney function, diabetes mellitus (especially of labile course). 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 at least once every 6 months, and lacrimal function and visual field status should be monitored.

Effect 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.