Xalacom Eye Drops

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. (1)

• The recommended dosage is one drop in the affected eye(s) once daily in the evening
• If one dose is missed, treatment should continue with the next dose as normal
• The dosage of latanoprost ophthalmic solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including latanoprost ophthalmic solution is not recommended
• It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP
• Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours
• Latanoprost ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower IOP
• In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost ophthalmic solution
• If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart
• Contact lenses should be removed prior to the administration of latanoprost ophthalmic solution, and may be reinserted 15 minutes after administration
• One drop in the affected eye(s) once daily in the evening

Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%). Ophthalmic solution containing latanoprost 50 mcg/mL (0.005%). (3)

• Safety and effectiveness
• In pediatric patients have not been established

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

• Potential for Pigmentation Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent
• Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of latanoprost ophthalmic solution [see Warnings and Precautions ]
• Potential for Eyelash Changes Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with latanoprost ophthalmic solution
• These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. …

• Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product
• Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product

Pigmentation : Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent. (5.1) Eyelash Changes : Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible. (5.2) 5.1 Pigmentation Latanoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered. …

The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: Iris pigmentation changes [see Warnings and Precautions (5.1) ] Eyelid skin darkening [see Warnings and Precautions (5.1) ] Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ] Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ] Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4) ] Most common adverse reactions (5-15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, …

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of latanoprost ophthalmic solution administration in pregnant women.to inform drug-associated risks. In animal reproduction studies, intravenous (IV) administration of latanoprost to pregnant rabbits and rats throughout the period of organogenesis produced malformations, embryofetal lethality and spontaneous abortion at clinically relevant doses [see Data] . …

IV infusion of up to 3 mcg/kg of latanoprost in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment with latanoprost ophthalmic solution and no adverse reactions were observed. IV dosages of 5.5 to 10 mcg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating. If overdosage with latanoprost ophthalmic solution occurs, treatment should be symptomatic.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.