Regulatory Information
VIATRIS PRIVATE LIMITED
VIATRIS PRIVATE LIMITED
Therapeutic
Prescription Only
Formulation Information
SOLUTION
**4.2 Posology and method of administration** Use in adults (including the elderly) One drop in the affected eye(s) once daily. Optimal effect is obtained if latanoprost is administered in the evening. The dosage of latanoprost 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. Latanoprost may be used concomitantly with other classes of topical ophthalmic drug products to lower IOP. 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 before instillation of the eye drops and may be reinserted after fifteen minutes (see section **4.4** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Paediatric population Xalatan eye drops 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** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
OPHTHALMIC
Medical Information
**4.1 Therapeutic indications** Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. It may also be used for the reduction of elevated intraocular pressure as an adjunct medical therapy in patients with primary chronic angle closure glaucoma. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
**4.3 Contraindications** Known hypersensitivity to latanoprost or any other component of the product.
S01EE01
latanoprost
Manufacturer Information
VIATRIS PRIVATE LIMITED
PFIZER MANUFACTURING BELGIUM NV
Active Ingredients
Documents
Package Inserts
Xalatan Eye Drops PI.pdf
Approved: June 2, 2022