ENIDIN

What it is

ENIDIN is an eye drop solution containing brimonidine tartrate 1.0 mg per mL (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. Topical administration of brimonidine solution decreases intraocular pressure (IOP) in humans.

Approved indications

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

Dosing overview

The recommended dose for ENIDIN is one drop applied to the affected eye(s) twice a day at approximately 12-hour intervals. In order to minimise systemic absorption, apply pressure to the tear duct immediately following administration.

Key safety warnings

Brimonidine can potentially cause fatigue and/or drowsiness in some patients. 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. ENIDIN may also cause blurred vision or visual disturbance in some patients. The patient should wait until these symptoms have cleared before driving or using machinery. ENIDIN should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans. Although ENIDIN had minimal effect on blood pressure and heart rate of patients in clinical studies, caution should be observed in treating patients receiving ENIDIN with severe, uncontrolled cardiovascular disease. Delayed ocular hypersensitivity reactions have been reported with ENIDIN, with some reported to be associated with an increase in IOP. Children 2 years of age and above, especially those weighing ≤20 kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence.

Contraindications

ENIDIN is contraindicated in patients with hypersensitivity to brimonidine tartrate or any component of this medication. ENIDIN is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. ENIDIN is contraindicated in infants and children under 2 years of age.

Regulatory history

ENIDIN brimonidine tartrate 2 mg/mL eye drop was first registered on the Australian Register of Therapeutic Goods on 24 April 2002. ENIDIN P 1.5 brimonidine tartrate 0.15% eye drop was subsequently registered on 18 June 2010. ENIDIN 1.0 received initial approval on 23 October 2024.