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Glautam (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

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; it does not affect accommodation and pupil size.

It possesses antianginal, hypotensive, and antiarrhythmic effects, which are manifested during 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 additional agent in combination with miotics), secondary glaucoma (including aphakic), congenital glaucoma (when other therapeutic measures are ineffective).

ICD codes

ICD-10 code Indication
H40.0 Glaucoma suspect (ocular hypertension)
H40.1 Primary open-angle glaucoma
H40.2 Primary angle-closure glaucoma
H40.3 Secondary post-traumatic glaucoma
H40.4 Glaucoma secondary to inflammatory eye disease
H40.5 Glaucoma secondary to other eye disorders
Q15.0 Congenital glaucoma
ICD-11 code Indication
9C60 Glaucoma suspect
9C61.0Z Primary open-angle glaucoma, unspecified
9C61.1Z Primary angle-closure glaucoma, unspecified
9C61.24 Glaucoma due to ocular inflammation
9C61.29 Traumatic glaucoma
9C61.2Z Secondary open-angle glaucoma, unspecified
9C61.4Z Congenital glaucoma, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Instill one drop into the conjunctival sac of the affected eye(s) twice daily. The recommended dosage frequency is every 12 hours.

Administer the drops at approximately the same times each day to maintain consistent therapeutic effect. If another topical ophthalmic agent is prescribed, administer the medications at least five minutes apart.

For patients with adequately controlled intraocular pressure, a reduction to one drop once daily may be sufficient. Titrate the dosage based on individual patient response as determined by tonometric measurements.

Do not exceed the prescribed dosage. If therapy is to be discontinued, do not stop abruptly; gradually reduce the frequency of application over one to two weeks under medical supervision.

Prior to administration, remove contact lenses. You may reinsert lenses 15 minutes after instillation. 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 bottle tightly immediately after use. Do not touch the dropper tip to any surface to avoid contamination.

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 operations, 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, dry 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, renal 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 tear secretion 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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Dosage Form

Bottle Rx Icon Glautam Eye drops 0.25%: 5 ml bottle.

Dosage Form, Packaging, and Composition

Eye drops 0.25% 1 ml
Timolol maleate 3.42 mg,
   Including Timolol 2.5 mg

5 ml – polyethylene dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Jadran-Galenski Laboratorij, D.D. (Croatia)

Dosage Form

Bottle Rx Icon Glautam Eye drops 0.5%: 5 ml bottle.

Dosage Form, Packaging, and Composition

Eye drops 0.5% 1 ml
Timolol maleate 6.84 mg,
   Including Timolol 5 mg

5 ml – polyethylene dropper bottles (1) – cardboard packs.

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