One drop contains approximately 1.5 micrograms latanoprost.
Benzalkonium chloride 0.2 mg/mL is included as a preservative.
Sodium dihydrogen phosphate monohydrate (E339i) 7.70 mg/mL.
Disodium phosphate anhydrous (E339ii) 1.55 mg/mL.
Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension in adults (including the elderly).
Reduction of elevated IOP in paediatric patients with elevated IOP and paediatric glaucoma.
Posology and method of administration
Posology
Adults (including the elderly)
Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Xalatan is administered in the evening.
The dosage of Xalatan should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
Paediatric population
Xalatan Eye drops, solution may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group < 1 year (4 patients) are limited (see section 5.1).
Method of administration
As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart.
4.3 Contraindications
Hypersensitivity to latanoprost or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Xalatan may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia.
This change in eye colour has predominantly been seen in patients with mixed coloured irides, i.e. blue-brown, grey-brown, yellow-brown and green-brown. In studies with latanoprost, the onset of the change is usually within the first 8 months of treatment, rarely during the second or third year, and has not been seen after the fourth year of treatment. The rate of progression of iris pigmentation decreases with time and is stable for five years. The effect of increased pigmentation beyond five years has not been evaluated. In an open 5-year latanoprost safety study, 33% of patients developed iris pigmentation (see section 4.8). The iris colour change is slight in the majority of cases and often not observed clinically. The incidence in patients with mixed colour irides ranged from 7 to 85%, with yellow-brown irides having the highest incidence. In patients with homogeneously blue eyes, no change has been observed and in patients with homogeneously grey, green or brown eyes, the change has only rarely been seen.
The colour change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. 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. No further increase in brown iris pigment has been observed after discontinuation of treatment. It has not been associated with any symptom or pathological changes in clinical trials to date.
Neither naevi 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. Based on 5 years clinical experience, increased iris pigmentation has not been shown to have any negative clinical sequelae and Xalatan can be continued if iris pigmentation ensues. However, patients should be monitored regularly and if the clinical situation warrants, Xalatan treatment may be discontinued.
There is limited experience of Xalatan in chronic angle closure glaucoma, open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. There is no experience of Xalatan in inflammatory and neovascular glaucoma or inflammatory ocular conditions. Xalatan has no or little effect on the pupil, but there is no experience in acute attacks of closed angle glaucoma. Therefore, it is recommended that Xalatan should be used with caution in these conditions until more experience is obtained.
There are limited study data on the use of Xalatan during the peri-operative period of cataract surgery. Xalatan should be used with caution in these patients.
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.
Reports of macular oedema have occurred (see section 4.8) mainly in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema (such as diabetic retinopathy and retinal vein occlusion). Xalatan should be used with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.
In patients with known predisposing risk factors for iritis/uveitis, Xalatan can be used with caution.
There is limited experience from patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported in post marketing experience. Asthmatic patients should therefore be treated with caution until there is sufficient experience, see also section 4.8.
Periorbital skin discolouration has been observed, the majority of reports being in Japanese patients. Experience to date shows that periorbital skin discolouration is not permanent and in some cases has reversed while continuing treatment with Xalatan.
Latanoprost may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.
Preservative
Xalatan contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. From the limited data available, there is no difference in the adverse event profile in children compared to adults. Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
Contact lenses
Contact lenses may absorb benzalkonium chloride and these should be removed before applying Xalatan but may be reinserted after 15 minutes (see section 4.2).
Paediatric population
Efficacy and safety data in the age group < 1 year (4 patients) are very limited (see section 5.1). No data are available for preterm infants (less than 36 weeks gestational age).
In children from 0 to < 3 years old that mainly suffer from primary congenital glaucoma (PCG), surgery (e.g. trabeculotomy/goniotomy) remains the first line treatment.
Long-term safety in children has not yet been established.
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