XOLA EYE DROPS 5ML

Indications

Approved Uses

Reduction of elevated intraocular pressure 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 or ocular hypertension: Instill 1 drop in the affected eye(s) twice daily (approximately 12 hours apart).

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

1 drop in the affected eye(s) twice daily (BID); more frequent dosing is not standard for the fixed combination.

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 corner) 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. Remove contact lenses before use and wait at least 15 minutes before reinserting.

Side Effects

Common Side Effects

Common: ocular burning/stinging or discomfort on instillation, blurred vision, conjunctival hyperemia (redness), ocular itching/irritation, tearing, dry eye/foreign-body sensation, and dysgeusia (bitter/abnormal taste).

Side Effect Frequency

Very common/common: ocular burning/stinging on instillation and dysgeusia (taste perversion); Common: blurred vision, conjunctival hyperemia/redness, ocular irritation/itching, tearing; Systemic beta-blocker effects (e.g., bradycardia, hypotension, bronchospasm) are uncommon/rare but clinically important.

Safety & Warnings

Contraindications

Bronchial asthma/history of asthma or severe COPD; sinus bradycardia; 2nd/3rd-degree AV block; overt cardiac failure; cardiogenic shock; severe renal impairment (CrCl <30 mL/min) and hyperchloremic acidosis; hypersensitivity to dorzolamide, timolol, sulfonamides, or any component.

Warnings & Precautions

Systemic absorption can cause beta-blocker cardiopulmonary effects-avoid in asthma/severe COPD and use caution in cardiac disease; dorzolamide is a sulfonamide-stop if hypersensitivity/SJS/TEN signs occur; caution in diabetes (masks hypoglycemia) and hyperthyroidism (masks symptoms); contact lens caution if benzalkonium chloride present-remove lenses and reinsert after ~15 minutes; separate different eye drops by ≥5-10 minutes; avoid abrupt withdrawal in CAD.

Driving Warning

Safe

Drug Interactions

Food Interaction

No restriction

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Storage & Patient Advice

Missed Dose

Instill the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Overdose

Ocular overdose: rinse/flush with water or saline; systemic overdose/ingestion: may cause beta-blocker toxicity (bradycardia, hypotension, AV block, bronchospasm) and carbonic anhydrase inhibitor effects (electrolyte disturbances, metabolic acidosis)-seek urgent medical care; treat supportively (e.g., atropine for bradycardia, bronchodilators, IV fluids).

Patient Counseling

Use exactly as prescribed (typically 1 drop in affected eye(s) twice daily). Use proper drop technique and avoid contaminating the tip; perform nasolacrimal occlusion for 1-2 minutes to reduce systemic absorption. Remove contact lenses and wait 15 minutes before reinsertion. Separate from other eye drops by at least 5-10 minutes. Seek medical advice if wheezing/shortness of breath, faintness, slow heartbeat, or severe eye irritation occurs. Store below 30°C. Follow local/label instructions for in-use discard period (commonly 4 weeks after opening if specified by the manufacturer).

Monitoring Requirements

Monitor intraocular pressure regularly and assess optic nerve/visual fields periodically; monitor for systemic beta-blocker effects (heart rate, blood pressure, bronchospasm/respiratory symptoms) especially in at-risk patients.

Pharmacology

Mechanism of Action

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

Bioavailability

Both components can be systemically absorbed after ophthalmic use via the nasolacrimal duct; timolol may achieve substantial systemic exposure (bypassing first-pass metabolism), and dorzolamide is absorbed and accumulates in erythrocytes with renal elimination-nasolacrimal occlusion reduces systemic absorption.

Metabolism

Dorzolamide: metabolized to an active N-desethyl metabolite; Timolol: hepatic metabolism primarily via CYP2D6.

Product Information

Available Dosage Forms

Eye drops, solution (ophthalmic solution).

Composition per Dose

Each mL: Dorzolamide 20 mg (as dorzolamide hydrochloride) + Timolol 5 mg (as timolol maleate); Each 5 mL bottle: Dorzolamide 100 mg + Timolol 25 mg

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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