Xelpros®
Latanoprost 0.005% · ophthalmic emulsion
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 begins to fall 3 to 4 hours after dosing, peaks at 8 to 12 hours, and lasts at least 24 hours.
Contraindications
Known hypersensitivity to latanoprost or any other ingredient in this product.
Available Forms0.005% (50 mcg/mL) ophthalmic emulsion, 2.5 mL fill in a 5 mL bottle, package of 1 bottle, multi-pack of 3 bottles
Mechanism of ActionProstaglandin 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 long-term effects of increased pigmentation are not known.
- Periorbital and lash changes: Eyelid skin darkening plus increased eyelash and vellus hair length, thickness, pigmentation, number, and misdirected growth in the treated eye; reported reversible in some patients after 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 with latanoprost products; 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 with latanoprost; 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.
- Contact lens wear: 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 emulsion; separate concurrent topical drops by at least 5 minutes.
Common Side Effects
- Ocular, 5% or more: eye pain or stinging on instillation 55%, ocular hyperemia 41%, conjunctival hyperemia 15%, eye discharge 12%, growth of eyelashes 11%, eyelash thickening 8%, ocular itching 5% (N=448; any eye disorder 73%).
- Ocular, 1% to 4%: reduced visual acuity 4%, dry eye 3%, eyelid erythema 3%, foreign body sensation 2%, eyelid edema 2%, punctate keratitis 1%, eyelash discoloration 1%, conjunctival edema 1%.
- Discontinuation: fewer than 1% stopped therapy for intolerance to eye pain or stinging or to ocular hyperemia.
- Ocular, latanoprost class postmarketing: intraocular inflammation (iritis/uveitis), macular edema including cystoid macular edema, herpes keratitis, corneal edema and erosions, deepening of the eyelid sulcus, trichiasis, iris cyst, eyelid skin darkening, conjunctivitis, pseudopemphigoid of the conjunctiva.
- Systemic, latanoprost class postmarketing: asthma and exacerbation of asthma, dyspnea, headache, dizziness, angina including unstable angina, palpitations, chest pain, nausea, vomiting, pruritus, toxic epidermal necrolysis.
Pregnancy & LactationPregnancy: 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 UseSafety and effectiveness not established in pediatric patients.