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Brimonidine 0.2% Eye Drops (5ml)

Brimonidine 0.2% Eye Drops (5ml)

Misc (Generics)

Ophthalmic prescription medicine
  • 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.

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