ARISTOMOL Eye drops

Therapeutic Class

Antiglaucoma Preparation

Indications

Ocular hypertension Chronic open-angle glaucoma Aphakic glaucoma

Chemical Composition

Timolol BP 0.50 %

Packaging

Each plastic dropper bottle contains 5 ml drops.

Dosage & Administration

The usual starting dose is one drop of Aristomol 0.50% in the affected eye twice a day. If necessary the physician may institute a concomitant therapy: Either a sympathomimetic or parasympathomimetic antiglaucoma ophthalmic solution, Or systemically administered carbonic anhydrase inhibitors, in order to obtain a better response. Since in some patients the pressure-lowering response to Aristomol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Aristomol. If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day.

Contraindications

Absolute bronchial asthma, bronchospasm, history of bronchial asthma or severe chronic obstructive pulmonary disease. Uncontrolled congestive cardiac insufficiency, cardiogenic shock High atrioventricular block (without apparatus) Raynaud phenomena, High bradycardia (pulse rate < 45 to 50 pulses/min.), Hypersensitivity to any component, relative combination with amiodarone.

Side Effects

Aristomol is generally well tolerated. In clinical studies of Timolol Maleate the adverse reactions reported were-mainly: Ocular: Symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, corneal hypoesthesis, visual disturbances including refractive changes, diplopia and ptosis. Cardiovascular: Bradicardia, arrhythmia, hypotension, syncope, heart block, cerebrovascular accident, cerebral ischemia, congestive heart failure, palpitation, cardiac arrest. Respiratory: Bronchospasm, respiratory failure, dyspnea. Systemic: Headache, asthenia, nausea, dizziness, depression, fatique.

Drug Interaction

Those of beta-blocking agents. Calcium inhibitors, catecholamine depending drugs, beta-blocking agents may lead to hypotension and/or severe bradycardia, and when combined with Aristomol may produce additive effects. Ophthalmic supervision is required in case of concomitant therapy with eye drops containing adrenaline (mydriasis may occur).