XOLAMOL EYE DROPS 5ML

Indications

Approved Uses

Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers alone

Dosage & Administration

Dosing by Condition

Open-angle glaucoma / Ocular hypertension: One drop in the affected eye(s) twice daily (morning and evening)

Initial Dose

One drop in the affected eye(s) two times daily.

Maintenance Dose

One drop in the affected eye(s) two times daily.

Maximum Dose

Maximum recommended: 1 drop in the affected eye(s) twice daily.

Children's Dosage

Safety and efficacy have not been established in children younger than 2 years of age. For children 2 years and older, the dose is determined by the doctor.

How to Take

Wash hands. Tilt head back, pull down lower eyelid, instill 1 drop into the conjunctival sac of the affected eye(s). Close eye gently and perform nasolacrimal occlusion (press inner canthus) for 1-2 minutes to reduce systemic absorption. Do not touch dropper tip. If using other ophthalmic products, separate by at least 5-10 minutes (apply drops before ointments).

Side Effects

Common Side Effects

Common: ocular burning/stinging, bitter/metallic taste (dysgeusia), blurred vision, conjunctival hyperemia (redness), ocular itching/irritation, tearing; may also cause dry eye/foreign-body sensation.

Side Effect Frequency

Very common (>10%): ocular burning/stinging; dysgeusia (bitter/altered taste). Common (1-10%): blurred vision, conjunctival hyperemia/redness, ocular irritation/itching, tearing, superficial punctate keratitis; headache. Less common/rare: systemic beta-blocker effects (e.g., bradycardia, hypotension, bronchospasm) and hypersensitivity reactions.

Safety & Warnings

Contraindications

Bronchial asthma, history of bronchial asthma, severe chronic obstructive pulmonary disease (COPD), sinus bradycardia, second or third-degree atrioventricular block, overt cardiac failure, cardiogenic shock, hypersensitivity to dorzolamide, timolol, or sulfonamides.

Warnings & Precautions

Avoid in bronchial asthma/history of asthma and severe COPD; contraindicated/avoid in significant bradycardia, 2nd/3rd‑degree AV block, overt cardiac failure/cardiogenic shock; caution in milder COPD, diabetes (masks hypoglycemia), thyrotoxicosis (masks symptoms), myasthenia gravis, corneal disease, and sulfonamide allergy; use nasolacrimal occlusion/eyelid closure ~2 minutes to reduce systemic absorption; avoid in severe renal impairment (CrCl <30 mL/min).

Age Restriction

Not recommended in children <2 years; safety/efficacy not established (use only if specialist judges benefit > risk).

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: systemic beta‑blockers; calcium channel blockers (verapamil/diltiazem); digoxin; antiarrhythmics (e.g., amiodarone); catecholamine‑depleting drugs (e.g., reserpine); CYP2D6 inhibitors (e.g., quinidine/fluoxetine/paroxetine); oral carbonic anhydrase inhibitors (e.g., acetazolamide); clonidine (rebound risk if withdrawn). High‑dose salicylates: theoretical/rare-use caution.

Interaction Severity

MAJOR/Clinically significant: systemic beta-blockers (additive bradycardia/hypotension/AV block/bronchospasm), calcium channel blockers (especially verapamil/diltiazem) and other AV-node-depressing antiarrhythmics (additive conduction depression), digoxin (bradycardia/AV block), clonidine (rebound hypertension risk if clonidine withdrawn while on beta-blocker), oral carbonic anhydrase inhibitors (additive CAI adverse effects). Other notable: CYP2D6 inhibitors (e.g., quinidine, paroxetine/fluoxetine) may increase timolol systemic effects.

Special Populations

Pregnancy

C

Breastfeeding

Use with caution

Children

Safety and efficacy have not been established in children younger than 2 years of age. For children 2 years and older, the dose is determined by the doctor.

Storage & Patient Advice

Missed Dose

Instill the missed dose as soon as remembered. If it is almost time for the next dose, skip the missed dose and continue the regular schedule. Do not double the dose.

Patient Counseling

Use as prescribed (commonly 1 drop in affected eye(s) twice daily). Perform nasolacrimal occlusion for 1-2 minutes. Do not touch the dropper tip. If using other eye meds, separate by 5-10 minutes. Remove contact lenses before use and reinsert after ~15 minutes if applicable. Temporary blurred vision may occur-use caution with driving. Seek care for wheeze/shortness of breath, fainting/bradycardia, or severe eye irritation/allergy. Store below 30°C.

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual field as clinically indicated; in at-risk patients monitor pulse/heart rate and blood pressure and assess for bronchospasm/respiratory symptoms.

Pharmacology

Mechanism of Action

Dorzolamide inhibits carbonic anhydrase II in the ciliary processes, decreasing bicarbonate formation and aqueous humor secretion; timolol is a non-selective beta-blocker that reduces aqueous humor production; together they provide additive IOP lowering.

Bioavailability

Systemic absorption occurs via the nasolacrimal duct; ophthalmic timolol can achieve substantial systemic exposure (often cited up to ~80% systemic bioavailability compared with oral due to avoidance of first-pass), and dorzolamide is also systemically absorbed and concentrates in red blood cells.

Product Information

Available Dosage Forms

Eye drops, solution (ophthalmic solution).

Composition per Dose

Each 1 mL of solution: Dorzolamide 20 mg (as dorzolamide hydrochloride) + Timolol 5 mg (as timolol maleate)

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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