Timadren^® (Drops) Instructions for Use

Marketing Authorization Holder

Hemofarm, A.D. (Serbia)

ATC Code

S01ED01 (Timolol)

Active Substance

Timolol (Rec.INN registered by WHO)

Dosage Forms

	Timadren®	Eye drops 0.5%: 5 ml bottle
		Eye drops 0.25%: 5 ml bottle

Dosage Form, Packaging, and Composition

Eye drops 0.25% as a transparent, colorless solution.

Excipients: benzalkonium chloride (preservative), sodium phosphate monobasic anhydrous, sodium phosphate dibasic anhydrous, sodium chloride, water for injections.

5 ml – dark glass bottles (1) with a dosing nozzle – cardboard packs.

Eye drops 0.5% as a transparent, colorless solution.

Excipients: benzalkonium chloride (preservative), sodium phosphate monobasic anhydrous, sodium phosphate dibasic anhydrous, sodium chloride, water for injections.

5 ml – dark glass bottles (1) with a dosing nozzle – cardboard packs.

Clinical-Pharmacological Group

Antiglaucoma drug – beta-adrenoblocker

Pharmacotherapeutic Group

Antiglaucoma agent – beta-adrenergic blocking agent

Pharmacological Action

Non-selective beta-adrenoblocker without sympathomimetic activity.

When applied topically, it reduces intraocular pressure by decreasing the production of aqueous humor and slightly increasing its outflow.

The effect appears 20 minutes after instillation, the maximum effect is after 1-2 hours, the duration of action is 24 hours.

Pharmacokinetics

Absorption

Timolol maleate rapidly penetrates the cornea into the eye tissues.

Distribution

It enters the systemic circulation in small amounts through absorption via the conjunctiva, nasal mucosa, and lacrimal tract.

Elimination

Metabolites are excreted by the kidneys.

Pharmacokinetics in special clinical cases

In newborns and young children, the concentration of the active substance significantly exceeds its C_max in the plasma of adults.

Indications

• Open-angle glaucoma;
• Angle-closure glaucoma (in combination with miotics);
• Secondary glaucoma (uveal, aphakic, post-traumatic);
• Acute increase in ophthalmotonus.

ICD codes

Dosage Regimen

Instill one drop of the 0.25% solution into the conjunctival sac of the affected eye(s) twice daily.

If the therapeutic response is insufficient, transition to the 0.5% solution. Instill one drop twice daily.

For maintenance therapy, after intraocular pressure is controlled, reduce the dosage to one drop of the 0.25% solution once daily.

This regimen applies to adults and children over one year of age.

Do not allow the dropper tip to contact the eye or any other surface to avoid contamination.

Wait at least five minutes before instilling any other topical ophthalmic medication.

Remove contact lenses prior to application and reinsert them no sooner than 15 minutes post-instillation.

Monitor intraocular pressure approximately three to four weeks after initiating therapy to assess efficacy.

Adverse Reactions

From the respiratory system dyspnea, bronchospasm, pulmonary insufficiency.

From the digestive system nausea, vomiting, diarrhea.

From the CNS and peripheral nervous system dizziness, headache, drowsiness, hallucinations, depression, paresthesia, muscle weakness, sexual dysfunction, decreased potency, transient cerebrovascular accident, collapse, rhinitis, nasal congestion, nosebleed.

From the cardiovascular system decreased BP, bradycardia, bradyarrhythmia, AV block, heart failure, cardiac arrest.

From the organ of vision eyelid skin hyperemia, burning and itching in the eyes, conjunctival hyperemia, lacrimation or decreased tear production, photophobia, corneal epithelial edema, transient visual acuity impairment; blepharitis, conjunctivitis, with prolonged use, the development of superficial punctate keratopathy (decreased corneal transparency) and decreased corneal sensitivity is possible, ptosis may occur; rarely – diplopia.

Allergic reactions including urticaria.

Contraindications

• Bronchial asthma;
• Sinus bradycardia;
• AV block II and III degree;
• Acute and chronic heart failure;
• Cardiogenic shock;
• Dystrophic diseases of the cornea;
• Rhinitis;
• Hypersensitivity to the components of the drug.

Use with caution in newborns and premature infants; with pulmonary emphysema, pulmonary insufficiency, cerebrovascular insufficiency, chronic heart failure, diabetes mellitus, hypoglycemia, thyrotoxicosis, myasthenia gravis, simultaneous use of other beta-adrenergic blockers.

Use in Pregnancy and Lactation

The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided.

Special Precautions

Efficacy control should be performed approximately 3-4 weeks after the start of therapy.

During treatment, tear production function, corneal integrity, and visual fields should be monitored at least once every 6 months.

With prolonged use of timolol, a weakening of the effect is possible.

Two beta-blockers should not be instilled into the eyes simultaneously.

When transferring patients to treatment with timolol, refraction correction may be required.

Contact lenses should be removed before instillation and put on no earlier than 15 minutes after it.

Timadren^® should be discontinued 48 hours before the upcoming surgery using general anesthesia.

Effect on the ability to drive vehicles and mechanisms

It is recommended to exercise caution when driving a car at night.

Overdose

When used topically at the recommended dose, symptoms of overdose were not noted.

Symptoms in case of accidental ingestion nausea, vomiting, dizziness, headache, decreased BP, bronchospasm, bradycardia.

Treatment symptomatic.

To eliminate severe bradycardia or bronchospasm, isoprenaline is used IV, to treat arterial hypotension – dobutamine.

Drug Interactions

Epinephrine, pilocarpine, systemic beta-blockers enhance the effect of Timadren^®.

When using Timadren^® with reserpine, the development of severe bradycardia or arterial hypotension is possible (careful medical supervision is necessary).

When using Timadren^® with calcium channel blockers, cardiac glycosides – possible impairment of AV conduction, acute left ventricular failure or arterial hypotension.

Timolol enhances the effect of muscle relaxants (Timadren^® should be discontinued 48 hours before the intended general anesthesia using peripheral muscle relaxants).

Storage Conditions

List B. The drug should be stored out of the reach of children, protected from light, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 2 years. The drug should be used within 30 days after opening the bottle.

Dispensing Status

The drug is dispensed by prescription.

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.