XALATAN 0.005% EYE DROPS 2.5ML @

Indications

Approved Uses

Reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dosage & Administration

Dosing by Condition

Open-angle glaucoma or ocular hypertension: 1 drop in the affected eye(s) once daily in the evening; do not exceed once-daily dosing.

Initial Dose

1 drop (approximately 1.5 mcg) 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

Maximum: 1 drop in the affected eye(s) once daily (do not exceed once daily).

Children's Dosage

Pediatric dosage: Use and dose must be determined by physician. Safety and efficacy have not been established in children; the standard adult dose of 1 drop once daily should not be assumed without medical evaluation.

How to Take

Wash hands; remove contact lenses; instill 1 drop into the conjunctival sac of the affected eye(s) once daily in the evening; close eye gently and perform nasolacrimal occlusion (press inner canthus) for ~1 minute; if using other ophthalmic products, separate by at least 5 minutes; wait at least 15 minutes before reinserting contact lenses; do not use more than once daily.

Side Effects

Common Side Effects

Conjunctival hyperemia (eye redness), ocular irritation/stinging/foreign body sensation, increased iris pigmentation (brown discoloration), eyelash changes (increased length/thickness/darkening), periocular/eyelid skin darkening, blurred vision; may also cause dry eye or increased tearing.

Side Effect Frequency

Very common (≥10%): conjunctival hyperemia. Common (1-10%): eye irritation/foreign body sensation (burning/stinging/itching), eye pain, blurred vision, blepharitis, dry eye, photophobia, eyelid/periorbital changes.

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to latanoprost or any excipients (including benzalkonium chloride).

Warnings & Precautions

May cause permanent increased brown iris pigmentation; eyelash changes and periorbital skin darkening; caution in patients at risk of macular edema (aphakia/pseudophakia/posterior capsule tear); caution with intraocular inflammation and history of herpetic keratitis (avoid in active herpetic keratitis); contains benzalkonium chloride-remove contact lenses and reinsert after ~15 minutes.

Drug Interactions

Drug Interactions

Avoid using two or more prostaglandin analogs concurrently (may reduce effect or paradoxically increase IOP); separate from thimerosal-containing drops by at least 5 minutes due to precipitation; NSAIDs may reduce IOP-lowering effect in some patients.

Interaction Severity

MODERATE: Concomitant use with other prostaglandin analogs/prostaglandins (may reduce IOP-lowering effect or cause paradoxical IOP increase; generally avoid). MINOR: Thimerosal-containing ophthalmic products (precipitation-separate by ≥5 minutes). POSSIBLE/MINOR: Topical NSAIDs may reduce IOP-lowering effect in some patients.

Food Interaction

No restriction

Special Populations

Children

Pediatric dosage: Use and dose must be determined by physician. Safety and efficacy have not been established in children; the standard adult dose of 1 drop once daily should not be assumed without medical evaluation.

Elderly

Standard adult dosing.

Storage & Patient Advice

Storage Conditions

Store unopened bottle in refrigerator (2°C to 8°C). Once opened, may be stored at room temperature up to 25°C for 6 weeks.

Missed Dose

If a dose is missed, skip it and instill the next dose at the usual time the following evening; do not double the dose.

Stopping the Medicine

Do not stop without consulting the prescriber; stopping can lead to loss of IOP control and glaucoma progression risk.

Overdose

Ocular overdose: irritation, conjunctival hyperemia; systemic overdose is unlikely but accidental ingestion may cause GI symptoms and flushing/sweating-treat symptomatically/supportively and seek medical advice.

Patient Counseling

Use 1 drop in affected eye(s) once daily in the evening; do not use more than once daily. Remove contact lenses and reinsert after 15 minutes. If using other eye drops, separate by at least 5 minutes. After instillation, close the eye and press the inner corner for ~1 minute. Expect possible eye redness/irritation and potential permanent iris color darkening; eyelashes/periocular skin may darken or lashes may grow. Store unopened in refrigerator (2-8°C) per SFDA; after opening, store at room temperature (per product labeling) and discard after 6 weeks. Seek care for significant eye pain, vision changes, or signs of infection/inflammation.

Monitoring Requirements

Monitor intraocular pressure regularly; periodically assess for iris pigmentation changes and eyelash/periocular changes, and monitor for uveitis/iritis or macular edema in at-risk patients (e.g., aphakia/pseudophakia with torn posterior capsule).

Pharmacology

Mechanism of Action

Selective prostanoid FP receptor agonist (prostaglandin F2α analogue) that lowers intraocular pressure primarily by increasing uveoscleral outflow of aqueous humor.

Onset of Action

Onset of IOP reduction typically within 3-4 hours after instillation.

Metabolism

Latanoprost is an isopropyl ester prodrug that is hydrolyzed by esterases in the cornea to the biologically active latanoprost acid. It is then metabolized in the liver via fatty acid beta-oxidation.

Excretion

Metabolites are eliminated mainly via the kidneys; approximately 88% of a dose is recovered in the urine (as metabolites).

Product Information

Available Dosage Forms

Eye drops, solution (ophthalmic solution).

Composition per Dose

Each mL: 50 mcg (0.05 mg) latanoprost; preservative: benzalkonium chloride 0.02%; excipients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, water for injections

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Target Organ

Eye

Preservative Free

No

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