Product Dossier

XALATAN

Product Dossier for XALATAN (latanoprost, Aspen Pharmacare). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

XALATAN is an eye drops solution containing 50 micrograms of latanoprost per mL. The solution is clear and colourless. Each bottle contains 2.5 mL of eye drop solution corresponding to a minimum of 80 drops of solution. One drop contains approximately 1.5 micrograms latanoprost.

Approved indications

— Reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to prostaglandins or other intraocular pressure lowering medications.

Dosing overview

The recommended therapy for adults (including the elderly) is one eye drop in the affected eye or eyes once daily. If more than one topical ophthalmic drug is being used, the eye drop products should be administered at least 5 minutes apart. Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.

Key safety warnings

Latanoprost may gradually change the eye colour by increasing the amount of brown pigment in the iris, predominantly in patients with mixed coloured irides such as green-brown, yellow-brown or blue-grey-brown, due to increased melanin content in the stromal melanocytes of the iris. The change in iris colour occurs slowly and may not be noticeable for several months to years and it has not been associated with any symptom or pathological changes. No further increase in brown iris pigment has been observed after discontinuation of treatment, but the resultant colour change may be permanent. Before treatment is instituted patients should be informed of the possibility of a change in eye colour. Eyelid skin darkening, which may be reversible, has been reported in association with the use of latanoprost. Latanoprost may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, and number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment. Macular oedema, including cystoid macular oedema, has been reported during treatment with latanoprost, mainly in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular oedema. Latanoprost eye drops should be used with caution in these patients.

Contraindications

Known hypersensitivity to latanoprost or any of the excipients in XALATAN.

PBS listing

XALATAN eye drops 50 micrograms per mL in 2.5 mL bottles are listed on the PBS with 3 items, with restriction type unrestricted, at an ex-manufacturer price of A$4.00.

Regulatory history

XALATAN was first listed on the Australian Register of Therapeutic Goods on 23 July 1997.