Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
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. The use of Xalacom may be considered in patients who require both timolol and latanoprost, but it is unknown whether patients who are adequately controlled with timolol given twice daily plus latanoprost given once daily will be as well controlled with Xalacom given once daily. Xalacom should be used for the reduction of intraocular pressure in patients with open angle glaucoma and ocular hypertension who are insufficiently responsive to another intraocular lowering pressure medication. Xalacom should not be used more than once daily because latanoprost is most effective when given once daily. If there is an insufficient response to Xalacom, then consideration should be given to using the individual agents with timolol dosed twice daily. If one dose is missed, treatment should continue with the next dose as planned. The dose should not exceed one drop in the affected eye(s) daily. If more than one topical ophthalmic drug is being used, they 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_). When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity. Use in children: Safety and effectiveness in children and adolescents have not been established.
OPHTHALMIC
Medical Information
**4.1. Therapeutic Indications** Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to another topical IOP lowering agent.
**4.3. Contraindications** Latanoprost-timolol maleate is contraindicated in patients with: - Reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease. - Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, or cardiogenic shock. - Known hypersensitivity to latanoprost, timolol maleate, or any other component of the product.
S01ED51
timolol, combinations
Manufacturer Information
VIATRIS PRIVATE LIMITED
PFIZER MANUFACTURING BELGIUM NV
Active Ingredients
Documents
Package Inserts
Xalacom Eye Drops PI.pdf
Approved: June 2, 2022