TIMOPTOL

What it is

Timoptol contains timolol maleate. It is supplied as eye drops, solution. Timoptol is available in two strengths: 0.25% containing 3.4 mg of timolol maleate per mL, and 0.5% containing 6.8 mg of timolol maleate per mL.

Approved indications

Timoptol is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension, patients with chronic open-angle glaucoma, and aphakic patients with glaucoma. — Ocular hypertension — Chronic open-angle glaucoma — Aphakic glaucoma

Dosing overview

Recommended therapy is one drop of 0.25% solution in the affected eye twice a day. If clinical response is not adequate, dosage may be changed to one drop of 0.5% solution in each affected eye twice a day. Evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment, and if the intraocular pressure is maintained at satisfactory levels, many patients can be placed on once-a-day therapy.

Key safety warnings

This medicine may be absorbed systemically, and the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. Respiratory complications, including exacerbation of asthma and death due to bronchospasm in patients with asthma, and cardiac complications, including rarely death in association with cardiac failure, have been reported following administration of timolol. Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition may precipitate more severe failure. Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, timolol should be discontinued, and cardiac failure should be adequately controlled before beginning therapy. Patients with a history of cardiovascular disease, including cardiac failure should be watched for signs of deterioration of these diseases, and pulse rates should be checked. Timolol has been reported rarely to increase muscle weakness in some patients with myasthenic symptoms. Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients who are receiving insulin or oral hypoglycemic agents, as they may mask the signs and symptoms of acute hypoglycemia.

Contraindications

Timoptol is contraindicated in the following conditions: reactive airway disease, bronchospasm, bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease ; sinus bradycardia, sino-atrial block, second and third degree atrioventricular block, overt cardiac failure, and cardiogenic shock ; and hypersensitivity to Timoptol or any component of this product.

PBS listing

Timoptol 5 mg (as maleate) per mL eye drops are listed on the PBS in two pack sizes: 2.5 mL with three PBS items at an ex-manufacturer price of A$9.40, and 5 mL with three PBS items at an ex-manufacturer price of A$7.69. Restriction types include both restricted and unrestricted listings.

Regulatory history

Timoptol 0.25% and 0.5% eye drops were first listed on the Australian Register of Therapeutic Goods on 30 October 1991.