Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Upjohn UK Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
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.
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.
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).
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.
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if Xalatan is overdosed.
If Xalatan is accidentally ingested the following information may be useful: One bottle contains 125 micrograms latanoprost. More than 90% is metabolised during the first pass through the liver. Intravenous infusion of 3 micrograms/kg in healthy volunteers induced no symptoms, but a dose of 5.5-10 micrograms/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In monkeys, latanoprost has been infused intravenously in doses of up to 500 micrograms/kg without major effects on the cardiovascular system.
Intravenous administration of latanoprost in monkeys has been associated with transient bronchoconstriction. However, in patients with moderate bronchial asthma, bronchoconstriction was not induced by latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of Xalatan.
If overdosage with Xalatan occurs, treatment should be symptomatic.
Before first opening: 2 years.
After first opening of container: 4 weeks.
Do not store above 25°C.
After first opening: Use within 4 weeks (see section 6.3).
Keep the bottle in the outer carton in order to protect from light.
Dropper container (5 mL) of polyethylene with a screw cap and tamper evident overcap of polyethylene.
Each dropper container contains 2.5 mL Eye drops, solution corresponding to approximately 80 drops of solution.
Pack sizes: 1 × 2.5 mL, 3 × 2.5 mL, 6 × 2.5 mL.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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