AZOPT

What it is

AZOPT eye drops suspension contains 10 mg/1 mL (1%) brinzolamide and also 0.1 mg/1 mL benzalkonium chloride as a preservative. AZOPT is a white to off-white uniform suspension.

Approved indications

— Decrease of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension for whom monotherapy with either component provides insufficient IOP reduction.

Dosing overview

The recommended dosage is one drop of AZOPT in the conjunctival sac of the affected eye(s) twice daily. Patients should be instructed to shake the bottle well before use. Nasolacrimal occlusion and closing the eyelid for two minutes after instillation are recommended. If more than one topical ophthalmic medicine is being used, the medicines must be administered at least 5 minutes apart. Patients must be instructed to remove soft contact lenses prior to application of AZOPT and to wait fifteen minutes after instillation of the dose before reinsertion.

Key safety warnings

AZOPT contains brinzolamide, a sulphonamide. The same types of undesirable effects that are attributable to sulphonamides may occur with topical administration. Hypersensitivity reactions reported with sulphonamide derivatives, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), can occur in patients receiving AZOPT as it is absorbed systemically. At the time of prescription, patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs of serious reactions or hypersensitivity occur, discontinue use of this medicine immediately. Due to the beta-adrenergic component, timolol, the same types of cardiovascular and pulmonary adverse reactions as seen with systemic beta-adrenergic blocking agents may occur. 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. AZOPT should be used with caution in patients with risk of renal impairment because of the possible risk of metabolic acidosis. AZOPT has not been studied in patients with narrow-angle glaucoma and its use is not recommended in these patients.

Contraindications

A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication is a contraindication. Reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease contraindicate AZOPT. Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock, sino-atrial block, and sick sinus syndrome contraindicate use. Severe allergic rhinitis and bronchial hyperreactivity and hyperchloraemic acidosis contraindicate AZOPT. AZOPT is contraindicated in patients with severe renal impairment. AZOPT is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.

PBS listing

AZOPT 10 mg per mL eye drops, 5 mL is listed on the PBS with 3 items with mixed restriction status, at an ex-manufacturer price of A$15.38.

Regulatory history

AZOPT 1.0% brinzolamide 10 mg/mL eye drops was first listed on the ARTG on 6 November 2000. The date of first approval was 5 February 2010.