Brimonidine 0.2% Eye Drops (5ml)

Misc (Generics)

Ophthalmic prescription medicine

Anti-glaucoma alpha-2 adrenergic agonist eye drops

UK MHRA marketing authorisation for Brimonidine Tartrate 0.2% w/v Eye Drops (PL 15872/0018).
Classified as a Prescription Only Medicine (POM) in the United Kingdom.
ATC code S01EA05 (sympathomimetics in glaucoma therapy).
Manufactured and released in accordance with Good Manufacturing Practice (GMP) for medicinal products.

UK MHRA marketing authorisation for Brimonidine Tartrate 0.2% w/v Eye Drops (PL 15872/0018).
Classified as a Prescription Only Medicine (POM) in the United Kingdom.
ATC code S01EA05 (sympathomimetics in glaucoma therapy).
Manufactured and released in accordance with Good Manufacturing Practice (GMP) for medicinal products.

Anti-glaucoma alpha-2 adrenergic agonist eye drops

Description

Brimonidine 0.2% Eye Drops (5ml) contain brimonidine tartrate 0.2% w/v (2 mg/ml), an alpha-2 adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The solution is a clear, greenish-yellow, preserved eye-drop formulation supplied in a 5 ml low-density polyethylene dropper bottle. It is used as monotherapy when topical beta-blockers are contraindicated, or as adjunctive therapy when additional intraocular pressure lowering is required, and is available as a UK prescription-only medicine.

Bnefits

Lowers elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Can be used alone when topical beta-blocker therapy is contraindicated.
Provides additional intraocular pressure reduction when used in combination with other ocular hypotensive agents.
Rapid onset of action with peak ocular hypotensive effect around 2 hours after dosing.
Demonstrated intraocular pressure reduction of approximately 4–6 mmHg in long-term clinical studies.
Minimal effect on cardiovascular and pulmonary parameters at therapeutic doses when used as directed.

Indications

Reduction of elevated intraocular pressure in patients with open-angle glaucoma.
Reduction of elevated intraocular pressure in patients with ocular hypertension.
Monotherapy in patients in whom topical beta-blocker therapy is contraindicated.
Adjunctive therapy to other intraocular pressure-lowering medications when target intraocular pressure is not achieved with a single agent.

Composition

Active ingredient: Brimonidine tartrate 0.2% w/v (2.0 mg/ml).
Preservative: Benzalkonium chloride 0.005% w/v.
Other excipients: Polyvinyl alcohol, sodium citrate, citric acid anhydrous, sodium chloride, sodium hydroxide (to adjust pH), water for injection.

Formulation

Eye drops, solution.
Clear, greenish-yellow, preserved aqueous solution for ocular (topical eye) use.

Packaging

5 ml low-density polyethylene (LDPE) dropper bottle with polystyrene cap.
Supplied as 1 x 5 ml vial per pack.

Usage

For adults including the elderly: instil one drop into the affected eye(s) twice daily, approximately 12 hours apart, or as directed by a prescriber.
Wash hands before use. Tilt head back, pull down the lower eyelid to form a pouch, and instil one drop into the conjunctival sac without touching the eye or surrounding structures with the dropper tip.
After instillation, gently press a finger over the inner corner of the eye (punctal occlusion) at the medial canthus for about one minute to reduce systemic absorption.
If using other topical ophthalmic medicines, administer them at least 5–15 minutes apart.
Soft contact lenses should be removed before instillation and reinserted no earlier than 15 minutes after using the drops due to the benzalkonium chloride preservative.
Use exactly as prescribed. Do not stop treatment abruptly without medical advice, as intraocular pressure may rise again.

Contraindications

Hypersensitivity to brimonidine tartrate or to any of the excipients in the formulation.
Use in neonates and infants (less than 2 years of age).
Concomitant treatment with monoamine oxidase (MAO) inhibitors.
Concomitant treatment with antidepressants that affect noradrenergic transmission (e.g. certain tricyclic antidepressants and related agents such as mianserin).

Adverse Effects

Very common: ocular irritation and allergic reactions (including conjunctival hyperaemia, burning, stinging, pruritus, foreign body sensation, conjunctival follicles), blurred vision, allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reactions; oral dryness; headache; drowsiness; fatigue.
Common: local eye irritation (eyelid hyperaemia and oedema, blepharitis, conjunctival oedema and discharge, ocular pain and tearing), photophobia, corneal erosion or staining, ocular dryness, conjunctival blanching, abnormal vision, conjunctivitis; dizziness, abnormal taste; upper respiratory symptoms; gastrointestinal symptoms; asthenia.
Uncommon: palpitations or arrhythmias (including bradycardia and tachycardia); nasal dryness; systemic allergic reactions; depression.
Very rare: iritis (anterior uveitis), miosis; hypertension or hypotension; syncope; insomnia.
Post-marketing (frequency not known): iridocyclitis, eyelid pruritus, skin reactions including erythema, facial oedema, pruritus, rash and vasodilation.
In children, particularly 2–7 years of age or weighing ≤20 kg, somnolence (including severe cases) has been reported frequently when used as adjunctive therapy.

Storage Conditions

Do not store above 25°C.
Keep the bottle tightly closed when not in use.
Shelf life before first opening: typically 2 years (refer to pack for exact expiry date).
After first opening: discard any remaining solution 28 days after opening.
Keep out of the sight and reach of children.
Do not use if the solution becomes discoloured, cloudy, or if the seal is broken before first use.

Duration

Long-term, chronic therapy as directed by an ophthalmologist or prescribing clinician, with periodic review of intraocular pressure and clinical response.

Onset

Rapid onset; peak ocular hypotensive effect typically occurs around 2 hours after dosing, with sustained intraocular pressure reduction during continued twice-daily use.