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Glymol (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-adrenoblocker. 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 the automaticity of the sinus node, decreases heart rate, slows AV conduction, and reduces myocardial contractility and oxygen demand.

Pharmacokinetics

When applied topically, it quickly 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, approximately every 12 hours.

For chronic open-angle glaucoma, the initial dose is one drop of a 0.25% solution twice daily. If the therapeutic response is inadequate, increase to one drop of a 0.5% solution twice daily.

For angle-closure glaucoma, use as an adjunct to miotics. Administer one drop of a 0.25% solution twice daily.

If intraocular pressure is not sufficiently controlled, transition to the 0.5% solution at the same frequency.

Do not exceed one drop of the 0.5% solution in each affected eye twice daily.

Wait at least 10 minutes between instillations if using other topical ophthalmic medications.

To minimize systemic absorption, apply gentle pressure to the lacrimal sac at the inner corner of the eye for 1-2 minutes immediately after instillation.

If switching from another antiglaucoma agent, continue the previous medication and add timolol. On the following day, discontinue the previous therapy.

Regularly monitor intraocular pressure to assess the therapeutic response and adjust the regimen accordingly.

Adverse Reactions

From the organ of vision, local application may cause 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. When performing fistulizing antiglaucoma operations, the development of retinal detachment in the postoperative period is possible.

With systemic use, the following are possible: 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, dryness of the conjunctiva.

Contraindications

AV block of 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 a 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

M.J. Biopharm Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Glymol Eye drops solution 0.25%: 5 ml bottle

Dosage Form, Packaging, and Composition

Eye drops solution 0.25% 1 ml
Timolol maleate 3.42 mg,
   Incl. Timolol 2.5 mg

5 ml – bottles (1) complete with a dropper – carton packs.

Marketing Authorization Holder

M.J. Biopharm Pvt. Ltd. (India)

Dosage Form

Bottle Rx Icon Glymol Eye drops solution 0.5%: 5 ml bottle

Dosage Form, Packaging, and Composition

Eye drops solution 0.5% 1 ml
Timolol maleate 6.83 mg,
   Incl. Timolol 5 mg

5 ml – bottles (1) complete with a dropper – carton packs.

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