XALACOM EYE DROPS 2.5ML @

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Open-angle glaucoma or ocular hypertension: instill 1 drop in the affected eye(s) once daily, preferably in the evening; do not use more than once daily.

Initial Dose

One drop in the affected eye(s) once daily in the evening

Maintenance Dose

One drop in the affected eye(s) once daily in the evening

Maximum Dose

One drop in the affected eye(s) once daily; do not use more frequently (may reduce IOP-lowering effect).

Children's Dosage

Not approved for children under 18 years; safety and efficacy not established in pediatric patients

How to Take

Ophthalmic use: instill 1 drop into the conjunctival sac of the affected eye(s) once daily, preferably in the evening; avoid touching the dropper tip; close the eye and perform nasolacrimal occlusion (press inner canthus) for 1-2 minutes; if using other eye drops, separate by at least 5 minutes; remove contact lenses before use and reinsert after 15 minutes.

Side Effects

Common Side Effects

Common: conjunctival hyperemia; eye irritation/burning/stinging/itching; foreign body sensation; blurred vision; increased iris pigmentation; eyelash changes (increased length/thickness/darkening); headache.

Side Effect Frequency

Very common (>10%): increased iris pigmentation; Common (1-10%): conjunctival hyperemia and ocular irritation (burning/stinging/itching), eye pain; Other known effects include eyelash/eyelid changes and systemic beta-blocker effects (e.g., bradycardia/bronchospasm) at lower frequencies.

Safety & Warnings

Warnings & Precautions

Warn about permanent iris pigmentation and possible eyelid/periorbital darkening and eyelash changes; systemic absorption of timolol-use caution/avoid in asthma/COPD and in bradycardia/heart block/heart failure; caution in diabetes (masks hypoglycemia), hyperthyroidism (masks symptoms), and severe peripheral vascular disease; history of herpetic keratitis-use caution; benzalkonium chloride-remove contact lenses and reinsert after ~15 minutes; inform anesthesiologist before surgery.

Age Restriction

Not recommended in patients <18 years (safety/efficacy not established).

Special Populations

Children

Not approved for children under 18 years; safety and efficacy not established in pediatric patients

Elderly

Standard adult dosing; exercise caution regarding systemic timolol effects (cardiovascular, pulmonary) which may be more pronounced in elderly patients

Storage & Patient Advice

Missed Dose

If a dose is missed, take the next dose at the usual time (the next evening); do not double the dose.

Patient Counseling

Use 1 drop once daily (preferably evening) and do not exceed once daily; remove contact lenses and reinsert after 15 minutes; if using other eye drops, separate by ≥5 minutes; perform nasolacrimal occlusion for 1-2 minutes; expect possible temporary blurred vision; possible permanent iris darkening and eyelash/periorbital changes; seek care for wheeze/shortness of breath, fainting, or slow heartbeat; store unopened in refrigerator 2-8°C per verified API data (follow local label for in-use storage/discard time).

Monitoring Requirements

Monitor intraocular pressure and optic nerve/visual fields periodically; assess for ocular surface effects and iris/eyelash/periorbital changes; in at-risk patients monitor for systemic beta-blocker effects (heart rate, blood pressure, bronchospasm).

Pharmacology

Mechanism of Action

Latanoprost (prostaglandin F2α analogue) lowers IOP by increasing uveoscleral outflow; timolol (non-selective beta-blocker) lowers IOP by reducing aqueous humor production-together provide greater IOP reduction than either alone.

Duration of Effect

Approximately 24 hours (supports once-daily dosing).

Product Information

Available Dosage Forms

Eye drops, solution (2.5 ml dropper container)

Composition per Dose

Each 1 ml of solution: Latanoprost 0.05 mg (50 mcg) + Timolol maleate 6.83 mg equivalent to Timolol 5 mg; preservative: benzalkonium chloride 0.2 mg/ml

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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