TRUSOPT

What it is

TRUSOPT contains dorzolamide hydrochloride and timolol maleate . It is supplied as eye drops, solution . Each millilitre of TRUSOPT contains 20.00 mg (2.0% w/v) dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5.00 mg (0.5% w/v) timolol (6.83 mg of timolol maleate) as the active ingredients .

Approved indications

— Treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate .

Dosing overview

The dose is one drop of TRUSOPT in the affected eye(s) two times daily . If another topical ophthalmic agent is being used, TRUSOPT and the other agent should be administered at least ten minutes apart .

Key safety warnings

The timolol component is a beta-blocker and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of beta-blockers may occur with topical administration . Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. In patients without a history of cardiac 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, TRUSOPT eye drops should be discontinued . The dorzolamide component is a sulfonamide and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of sulfonamides may occur with topical administration, such as Stevens-Johnson syndrome and toxic epidermal necrolysis . Respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma and rarely death in association with cardiac failure, have been reported following administration of timolol maleate ophthalmic solution . Ophthalmic beta-blockers may induce dryness of eyes. Patients with corneal disease should be treated with caution .

Contraindications

TRUSOPT is contraindicated in patients with: reactive airway disease, bronchial asthma or 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, overt cardiac failure, cardiogenic shock; hypersensitivity to any component of this product . Dorzolamide has not been studied in patients with severe renal impairment (CrCl < 30 millilitre/min) or with hyperchloremic acidosis. Because dorzolamide hydrochloride and its metabolite are excreted predominantly by the kidney, dorzolamide is therefore contraindicated in such patients .

PBS listing

TRUSOPT eye drops 20 mg (as hydrochloride) per mL is listed on the PBS with 3 items at an ex-manufacturer price of A$4.93 .

Regulatory history

TRUSOPT was first registered on the ARTG on 18 April 1996 .