Xalatan®

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Latanoprost 0.005% · ophthalmic solution

Antiglaucoma

Approved uses

Open-angle glaucoma or ocular hypertension

One drop in the affected eye(s) once daily in the evening; not to exceed once daily.

IOP falls 3 to 4 hours after dosing, peaks at 8 to 12 hours, and lasts 24 hours with a 6.7 mmHg drop.

OFF-LABELNot in the FDA label for this product

Chronic angle-closure glaucoma

0.005% solution, one drop once daily at 9 PM (trial regimen), 12 weeks.

RCT · n=275

Randomized, double-masked, multicenter 12-week trial in chronic angle-closure glaucoma (latanoprost n=137, timolol n=138): mean change in daily IOP was -8.2 mmHg versus -5.2 mmHg with timolol BID, difference -3.0 mmHg (95% CI -4.0 to -2.1, P<0.001), favoring latanoprost, and more patients reached each prespecified target IOP. The formulation studied was the preserved 0.005% solution.

Chew PT, Aung T, Aquino MV, Rojanapongpun P. Intraocular pressure-reducing effects and safety of latanoprost versus timolol in patients with chronic angle-closure glaucoma. Ophthalmology. 2004;111(3):427-434. PMID 15019314

Pediatric glaucoma

0.005% solution, one drop once daily at 8 PM (trial regimen, ages 0 to 18 years), 12 weeks.

RCT · n=137 · not superior

Phase 3, randomized, double-masked, 12-week multicenter trial, 137 treated (primary congenital and non-congenital glaucoma): mean IOP reduction at week 12 was 7.2 mmHg versus 5.7 mmHg with timolol, difference 1.5 mmHg (95% CI -0.8 to 3.7, P=0.21), meeting the noninferiority margin without demonstrating superiority; responder rates 60% versus 52% (P=0.33) and both agents well tolerated over 3 months. This label states pediatric safety and effectiveness are not established.

Maeda-Chubachi T, Chi-Burris K, Simons BD, et al. Comparison of latanoprost and timolol in pediatric glaucoma: a phase 3, 12-week, randomized, double-masked multicenter study. Ophthalmology. 2011;118(10):2014-2021. PMID 21680022

Contraindications

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredient in this product.

Available Forms

0.005% (50 mcg/mL) ophthalmic solution, 2.5 mL fill in a 5 mL bottle, package of 1 bottle

Mechanism of Action

Prostaglandin F2alpha analogue supplied as an isopropyl ester prodrug that corneal esterases hydrolyze to the active acid; IOP falls mainly through increased uveoscleral outflow, which class reviews attribute to matrix metalloproteinase remodeling that widens the spaces between ciliary muscle fibers. Onset is 3 to 4 hours after instillation, maximum effect at 8 to 12 hours, and IOP reduction persists at least 24 hours.

Warnings & Precautions

Iris pigmentation: Brown pigmentation spreads concentrically from the pupil and increases as long as dosing continues, from increased melanin content in melanocytes rather than more melanocytes; it is likely permanent after discontinuation, so examine these patients regularly. Nevi and freckles of the iris appear unaffected, and the change may take months to years to become noticeable.
Periorbital and lash changes: Eyelid skin darkening plus increased eyelash and vellus hair length, thickness, pigmentation, number, and misdirected growth in the treated eye; periorbital tissue pigmentation reported reversible in some patients, eyelash changes usually reversible upon discontinuation.
Intraocular inflammation: Caution with a history of iritis or uveitis, and generally not for use with active intraocular inflammation, which may be exacerbated.
Macular edema: Macular edema including cystoid macular edema has been reported; caution in aphakia, in pseudophakia with a torn posterior lens capsule, and with other known risk factors.
Herpetic keratitis: Reactivation of herpes simplex keratitis has been reported; caution with a history of it, and avoid in active herpes simplex keratitis, which may be exacerbated.
Bacterial keratitis: Reported with inadvertently contaminated multiple-dose containers, in most cases in patients with concurrent corneal disease or a disrupted ocular epithelial surface.
Benzalkonium chloride: Preserved with 0.02% benzalkonium chloride, which may be absorbed by contact lenses; remove lenses before instillation and reinsert 15 minutes after.
Prostaglandin duplication: Dosing more than once daily, or combining two or more prostaglandins or prostaglandin analogs, may decrease the IOP lowering effect or cause paradoxical IOP elevation.
Thimerosal-containing drops: Precipitation occurs in vitro when thimerosal drops are mixed with this solution; separate concurrent topical drops by at least 5 minutes.

Common Side Effects

Ocular, 5% to 15%: foreign body sensation 13%, punctate keratitis 10%, stinging 9%, conjunctival hyperemia 8%, blurred vision 8%, itching 8%, burning 7%, increased iris pigmentation 7% (n=460 vs timolol n=369 in three controlled trials).
Ocular, 1% to 5%: excessive tearing 4%, eyelid discomfort or pain 4%, dry eye 3%, eye pain 3%, eyelid margin crusting 3%, eyelid erythema 3%, photophobia 2%, eyelid edema 1%, blepharitis 1%.
Discontinuation: fewer than 1% stopped therapy for intolerance to conjunctival hyperemia.
Ocular, postmarketing: intraocular inflammation (iritis/uveitis), macular edema including cystoid macular edema, herpes keratitis, keratitis, corneal edema and erosions, deepening of the eyelid sulcus, trichiasis, iris cyst, eyelid skin darkening, conjunctivitis, pseudopemphigoid of the conjunctiva.
Systemic, 1% to 3%: upper respiratory infection, nasopharyngitis or influenza 3%, myalgia, arthralgia or back pain 1%, rash or allergic skin reaction 1%.
Systemic, postmarketing: asthma and exacerbation of asthma, dyspnea, headache, dizziness, angina including unstable angina, palpitations, chest pain, nausea, vomiting, pruritus, toxic epidermal necrolysis.

Pregnancy & Lactation

Pregnancy: No adequate and well-controlled studies in pregnant women. IV latanoprost given to pregnant rabbits and rats through organogenesis produced malformations, embryofetal lethality, and spontaneous abortion at clinically relevant doses, with post-implantation loss in rabbits at 1.3 times the maximum recommended human ophthalmic dose and cleft palate in rats at 3.2 times.

Lactation: Excretion in human milk is unknown; weigh the benefits of breastfeeding against maternal need and potential effects on the breastfed child.

Pediatric Use

Safety and effectiveness not established in pediatric patients.