Xalatan Special Precautions

Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since this drug contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Contact Lenses: Patients should be advised not to wear a contact lens if their eye is red. This drug should not be used to treat contact lens related irritation. The preservative in this drug, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling this drug before they insert their contact lenses.
Iris pigmentation changes: Xalatan may gradually change the eye colors by increasing the amount of brown pigment in the iris. This effect has predominantly been seen in patients with mixed coloured irides, i.e., blue-brown, grey-brown, green-brown or yellow-brown, and is due to increased melanin content in the stromal melanocytes of the iris. A permanent heterochromia can happen. Typically the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. In patients with homogenously blue, grey, green or brown eyes, the change has only rarely seen during two years of treatment in clinical trials. The change in iris color occurs slowly and may not be noticeable for several months to years. It has not been associated with any symptom or pathological changes in clinical trials. No further increase in brown iris pigment has been observed after discontinuation of treatment, but the resultant color change may be permanent.
The potential for heterochromia exists for patients receiving unilateral treatment.
Until further long term data is obtained it is recommended that in patients with mixed colored irides only those who are intolerant or insufficiently responsive to another intraocular lowering medication be treated.
Neither nevi nor freckles of the iris have been affected by treatment. Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed in clinical trials, but until further long term experience about increased iris pigmentation is available, patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased iris pigmentation ensues.
Before treatment is instituted patients should be informed of the possibility of a change in eye color.
Glaucoma: There is no experience of Xalatan in inflammatory, neovascular, angle closure or congenital glaucoma and only limited experience in open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. Xalatan has no or little effect on the pupil but there is no experience in accurate attacks of closed angle glaucoma. Therefore it is recommended that Xalatan should be used with caution in these conditions until more experience is obtained.
Macular edema: Macular edema, including cystoid macular edema, has been reported during treatment with Xalatan. These reports have mainly occurred in aphakic patients, in pseudophakic patients with torn posterior lens capsule, or in patients with known risk factors for macular oedema. Xalatan should be used with caution in these patients.
Xalatan contains benzalkonium chloride which may be absorbed by contact lenses. The contact lenses should be removed before instillation of the eye drops and maybe reinserted after 15 minutes (see PRECAUTIONS). Xalatan should not be administered while wearing contact lenses. Xalatan has not been studied in patients with renal or hepatic impairment and should therefore be used with caution in such patients.
Herpetic keratitis: Xalatan should be used with caution in patients with a history of herpetic keratitis, and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues.
Effects on Ability to Drive and Use of Machines: In common with other preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.