ALPHAGAN

What it is

ALPHAGAN P 1.0 is brimonidine tartrate eye drops, with each millilitre containing brimonidine tartrate 1.0 mg (equivalent to 0.66 mg as brimonidine free base). Brimonidine tartrate is an alpha-2 adrenergic agonist that is 1000-fold more selective for the alpha-2 adrenoreceptor than the alpha-1 adrenergic receptor.

Approved indications

— Lowering elevated intraocular pressure in patients with chronic open angle glaucoma or ocular hypertension.

Dosing overview

The recommended dose for ALPHAGAN P 1.0 is one drop applied to the affected eye(s) twice a day at approximately 12-hour intervals. If more than one topical ophthalmic medicine is to be used, other eye drops should not be used within five to ten minutes of using ALPHAGAN P 1.0 eye drops. In order to minimise systemic absorption of ALPHAGAN P 1.0 eye drops, apply pressure to the tear duct immediately following administration.

Key safety warnings

ALPHAGAN P 1.0 eye drops should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. The IOP-lowering efficacy observed with brimonidine eye drops during the first month of therapy may not always reflect the long-term level of IOP reduction, and patients prescribed IOP-lowering medication should be routinely monitored for IOP. As with other alpha-agonists, brimonidine can potentially cause fatigue and/or drowsiness in some patients, and patients who engage in hazardous activities requiring mental alertness, such as driving and operating machinery, should be cautioned of the potential for a decrease in mental alertness. ALPHAGAN P 1.0 may also cause blurred vision or visual disturbance in some patients, and the patient should wait until these symptoms have cleared before driving or using machinery. Delayed ocular hypersensitivity reactions have been reported with ALPHAGAN, with some reported be associated with an increase in IOP.

Contraindications

ALPHAGAN P 1.0 eye drops are contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. This product is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. ALPHAGAN P 1.0 eye drops are contraindicated in infants and children less than 2 years of age.

PBS listing

ALPHAGAN P 1.0 (brimonidine tartrate 1 mg per mL, 5 mL) has 3 PBS items with mixed restriction status and an ex-manufacturer price of A$7.16.

Regulatory history

ALPHAGAN P 1.0 brimonidine tartrate 1 mg/mL eye drop was first listed on the Australian Register of Therapeutic Goods on 23 October 2024. The date of first approval was 23 October 2024.