Xalacom

XALACOM^®

Abbreviated Prescribing Information¹

Formulation/presentation: Xalacom (Latanoprost and Timolol) Eye solution is available in pack sizes: 1 × 2.5 mL. 1 mL solution contains latanoprost 50 mg and timolol maleate 6.8 mg equivalent to 5 mg timolol. Indications: Reduction of intraocular pressure (lOP) in patients with open-angle glaucoma and ocular hypertension who are insufficiently responsive to topical beta-blockers. Dosage: One drop in the affected eye(s) once daily. Contraindications: Reactive airway disease, including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, sick sinus syndrome, sinoatrial block, second or third-degree atrioventricular block not controlled with a pacemaker, overt cardiac failure, cardiogenic shock and hypersensitivity to the active substances or to any of the excipients. Special warnings and precautions: Patients with concomitant use of two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives, history of heart disease, coronary heart disease, Prinzmetal angina and cardiac failure, on hypotension therapy with beta-blockers, peripheral circulatory disturbance/disorders (i.e. severe forms of Raynaud’s disease or Raynaud’s syndrome), chronic obstructive pulmonary disease (COPD), asthma, corneal diseases, spontaneous hypoglycaemia, diabetes, patients already receiving a systemic beta-blocking agent, history of atopy or a history of a severe anaphylactic reaction, choroidal detachment, surgical anaesthesia, latanoprost may gradually change the eye colour. history of herpetic keratitis, macular oedema and use of contact lenses. Side effects/adverse effects: Increased iris pigmentation, eye irritation (stinging, tearing, redness, burning and itching), eye pain, herpetic keratitis, eyelash and vellus hair changes (increased length, thickness, pigmentation and number), punctate epithelial erosions, periorbital oedema, iritis/uveitis, macular oedema, dry eye, keratitis, corneal oedema and erosions, misdirected eyelashes sometimes resulting in eye irritation and iris cyst, photophobia, periorbital and lid changes resulting in deepening of the eyelid sulcus. Ocular irritation includes hallucinations, keratitis, blepharitis, decreased corneal sensitivity, dry eyes, blurred visions, diplopia, ptosis, corneal erosion and choroidal detachment (following filtration surgery).

API-XALACOM-0122

Full prescribing information is available upon request.

Reference:

1. XALACOM Malaysia Prescribing Information dated 11 January 2022.

Market Authorization Holder:
Viatris Sdn. Bhd.
Reg. No: 201801018158 (1280174-H)
15-03 & 15-04, Level 15, Imazium, No. 8, Jalan SS 21/37, Damansara
Uptown, 47400, Petaling Jaya, Selangor, Malaysia. Tel: 603-7733 8005

For Healthcare Professionals Only