COMBIGAN EYE DROPS 5ML

Indications

Approved Uses

Reduction of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

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) twice daily.

Maintenance Dose

One drop in the affected eye(s) twice daily (approximately every 12 hours)

Maximum Dose

1 drop in the affected eye(s) twice daily (about 12 hours apart); do not exceed BID dosing.

Children's Dosage

Not approved for children under 2 years; contraindicated in neonates and infants due to risk of apnea and CNS depression from brimonidine. Use in children aged 2-17 years is not recommended due to insufficient safety and efficacy data

How to Take

Wash hands; remove contact lenses (especially soft) before use; instill 1 drop into the affected eye(s) twice daily about 12 hours apart; avoid touching the dropper tip; close the eye and perform nasolacrimal occlusion (press at the inner corner/medial canthus) for 1-2 minutes to reduce systemic absorption; if using other ophthalmic products, separate by at least 5 minutes; wait at least 15 minutes before reinserting contact lenses.

Side Effects

Common Side Effects

Common: ocular burning/stinging, conjunctival hyperemia/redness, blurred vision, ocular pruritus/irritation, allergic conjunctivitis/follicular conjunctivitis, dry mouth; may also cause fatigue/drowsiness and headache.

Safety & Warnings

Contraindications

Reactive airway disease (including bronchial asthma or history of asthma) or severe COPD; sinus bradycardia; sick sinus syndrome; sinoatrial block; 2nd/3rd-degree AV block (unless paced); overt cardiac failure; cardiogenic shock; hypersensitivity to components; concomitant MAO inhibitor therapy; infants <2 years.

Age Restriction

Contraindicated in children <2 years (neonates and infants); safety/efficacy not established in pediatric patients <18 years-use not recommended.

Special Populations

Children

Not approved for children under 2 years; contraindicated in neonates and infants due to risk of apnea and CNS depression from brimonidine. Use in children aged 2-17 years is not recommended due to insufficient safety and efficacy data

Storage & Patient Advice

Missed Dose

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

Overdose

Ocular overdose: rinse/flush the eye(s) with water or saline; systemic overdose may cause bradycardia, hypotension, AV block, bronchospasm/respiratory depression, and CNS depression-manage supportively (e.g., atropine for bradycardia, bronchodilators) and seek urgent medical care/poison center.

Patient Counseling

Use 1 drop in affected eye(s) twice daily ~12 hours apart; wash hands and avoid touching the dropper tip; remove contact lenses and wait ≥15 minutes before reinsertion; perform nasolacrimal occlusion for 1-2 minutes; separate other eye drops by ≥5 minutes; temporary blurred vision/drowsiness may occur-use caution driving; seek care for breathing difficulty, wheeze, fainting, very slow pulse, or severe/persistent eye redness/swelling; do not stop without prescriber advice.

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual field as clinically indicated; also monitor for systemic beta-blocker effects (heart rate, blood pressure, and respiratory symptoms) in at-risk patients (e.g., cardiovascular disease, COPD/asthma history).

Pharmacology

Mechanism of Action

Brimonidine (alpha-2 agonist) lowers IOP by decreasing aqueous humor production and increasing uveoscleral outflow; timolol (nonselective beta-blocker) lowers IOP primarily by reducing aqueous humor production from the ciliary body.

Duration of Effect

Approximately 12 hours per dose (supports twice-daily dosing).

Bioavailability

Both brimonidine and timolol can be systemically absorbed after ophthalmic administration, with measurable plasma concentrations possible (reduced by nasolacrimal occlusion).

Excretion

Brimonidine: primarily eliminated in urine, mainly as metabolites. Timolol: eliminated primarily by the kidney as metabolites with a small fraction excreted unchanged in urine.

Protein Binding

Brimonidine: approximately 29%; Timolol: approximately 60%

Product Information

Available Dosage Forms

Ophthalmic solution (eye drops).

Composition per Dose

Each 1 mL: Brimonidine tartrate 2 mg (0.2%) + Timolol maleate 5 mg (0.5% as timolol); preservative: benzalkonium chloride 0.05 mg/mL

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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