Xalatan^®

Abbreviated Prescribing Information:¹

Formulation/presentation: Xalatan^® (Latanoprost) Ophthalmic solution available in pack size: 1 × 2.5 mL. 1 mL solution contains 50 μg of latanoprost and benzalkonium chloride 0.2 mg/mL. One drop contains approximately 1.5 μg of latanoprost. Each bottle contains 2.5 mL eye drops corresponding to approximately 80 drops of solution. Indications: Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, chronic angle closure glaucoma, and ocular hypertension. Reduction of elevated intraocular pressure in pediatric patients with elevated intraocular pressure and pediatric glaucoma. Dosage: Use in adults (including the elderly); one drop in the affected eye(s) once daily. Optimal effect is obtained if latanoprost is administered in the evening. If one dose is missed, treatment should continue with the next dose as normal. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. Pediatric population: Latanoprost eye drops may be used in pediatric patients at the same dosage as in adults. No data is available for preterm infants (<36 weeks gestational age) and data is minimal for age group <1 year. Contraindications: Known hypersensitivity to latanoprost or any other component of the product. Special warnings and precautions: This product contains benzalkonium chloride, which may be absorbed by contact lenses. Latanoprost may gradually increase the brown pigment of the iris. Eyelid skin darkening, which may be reversible. Latanoprost may gradually change eyelashes and vellus hair in the treated eye. The potential for heterochromia exists in patients receiving unilateral treatment. Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost, history of herpetic keratitis, avoided in cases of active herpes simplex keratitis and recurrent herpetic keratitis. There is limited experience with latanoprost in the treatment of inflammatory neovascular glaucoma. Latanoprost has no effects towards fertility; while for pregnant women, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Latanoprost and its metabolites may pass into breast milk, thus need to use it with caution. Side effects/adverse effects: Herpetic keratitis, dizziness, and headache. Eye irritation (burning, grittiness, itching, stinging and foreign body sensation), blepharitis, conjunctival hyperemia, eye pain, increased pigmentation of the iris, transient punctate epithelial erosions, eyelid edema and skin rash, corneal edema and erosions; eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); iritis/uveitis; keratitis; macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; vision blurred, photophobia, periorbital and lid changes resulting in deepening of the eyelid sulcus. Angina, palpitations, angina unstable, chest pain, asthma, dyspnea, asthma aggravation, acute asthma attacks, rash, myalgia, and arthralgia. Vomiting and nausea. In two short-term clinical trials (≤12 weeks), involving 93 (25 and 68) pediatric patients the safety profile was similar to that in adults and no new adverse events were identified. Shelf-life: Shelf-life after opening container: 4 weeks. Special precautions for storage: Store unopened bottle under refrigeration at 2°C to 8°C (36°F to 46°F). When a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 4 weeks. Protect from light.

API-XALATAN-0622

Full prescribing information is available upon request.¹

Reference: 1. Xalatan^® Malaysia Prescribing Information dated 1 June 2022.