Xalacom Ophthalmic Solution

This preparation is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufftciently responsive to β-blockers, prostaglandins or other IOP lowering agents.

Latanoprost is an analogue of prostaglandin F2α, it reduces intraocular pressure (IOP) by increasing outflow of aqueous humour.

Timolol is a non-selective adrenergic blocker. It lowers IOP by decreasing the formation of aqueous by the ciliary epithelium.

Adult or elderly: The recommended adult (including the elderly) dosage of is one drop in the affected eye(s) once daily. If one dose is missed, treatment should continue with the next dose as normal.

Children: Safety and effectiveness in children has not been established. This is therefore is not recommended for use in children.

No specific interaction studies have been performed with this preparation. Patients who are receiving treatment with this preparation and an oral β-adrenergic blocking agent should be observed for potential additive effects of β-blockade, both systemic and on lntraocular pressure The concomitant use of two topical β-adrenergic blocking agents is not recommended. Although this preparation alone has little or no effect on pupil size, mydriasis has occasionally been reported when Timolol is given with epinephrine. β-blockers may increase the hypoglycemic effect of antidiabetic agents. In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with Benzalkonium chloride, the preservative used in this preparatlon. If such drugs are used they should be administered with an interval of at least 5 minutes between applications. Similarly, several contact lens soakinq solutions contain thimerosal.

This combination is contraindicated in patients with Known hypersensitivity to Latanoprost, Timolol and benzalkonium chloride or any other ingredient in the product. This combination is also contraindicated for the following conditions such as reactive airway disease including bronchial asthma, history of bronchial asthma or severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.

This combination is generally well tolerated. The most frequent findings of increased iris pigmentation were in patients with green-brown, yellow-brown and blue/grey/brown irides. In patients with homogeneously blue, grey, green or brown eyes, the change was only rarely seen. Darkening, thickening and lengthening of the eye lashes have been reported. The most frequently reported undesirable effects in clinical trials were irritation of the eye, including stinging, burning and ,itching, eye hyperaemia, corneal disorders, coniunctivitis blepharitis, eye pain, headache and skin rash.

No reproduction toxicity studies have been conducted with this combination.This combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Latanoprost and its metabolites may pass into breast milk. Timolol maleate has been detected in human milk following ocular administration. Because of the potential serious adverse reactions in nursing infants, this preparation should be used with caution in nursing women.

This preparation should be used with caution in patients with macular edema, aphakic patients, pseudophakic parients with a torn posterior lens capsule or in patients with known risk factors for macular edema.It should be administered with caution in patients subjected to spontaneous hypoglycaemia or to diabetic patients who are receiving insulin or oral hypoglycaemic agents.Caution should also be exercised to patients wearing contact lenses or drive and use machines.

There is no human data available on over dosage with this preparation.Symptoms of systemic Timolol over dosage are bradycardia, hypotenslon, bronchospasm, and cardiac arrest. If such symptoms occur,treatment should be symptomatic and supportive. The ocular effects of Latanoprost administered at high doses are not known. If overdose with this preparation occurs, treatment should be symptomatic.

Drugs for miotics and glaucoma.

Store at 2-8° C. For opened bottles, may store below 25° C.