Brimonidine Tartrate 2 mg/ml Eye Drops, solution

Misc (Generics)

Ophthalmic prescription medicine

Anti-glaucoma alpha-2 adrenergic agonist eye drops

UK Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorisation (PL 04569/0853) for Brimonidine Tartrate 2 mg/ml Eye Drops, Solution.
Classified as a Prescription Only Medicine (POM) in the United Kingdom.
Pharmacotherapeutic group: sympathomimetics in glaucoma therapy, ATC code S01EA05.
Manufactured and controlled in accordance with Good Manufacturing Practice (GMP) for medicinal products.

UK Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorisation (PL 04569/0853) for Brimonidine Tartrate 2 mg/ml Eye Drops, Solution.
Classified as a Prescription Only Medicine (POM) in the United Kingdom.
Pharmacotherapeutic group: sympathomimetics in glaucoma therapy, ATC code S01EA05.
Manufactured and controlled in accordance with Good Manufacturing Practice (GMP) for medicinal products.

Anti-glaucoma alpha-2 adrenergic agonist eye drops

Description

Brimonidine Tartrate 2 mg/ml Eye Drops, solution is a preserved ophthalmic solution containing brimonidine tartrate 2 mg/ml (equivalent to 1.3 mg/ml brimonidine), an alpha-2 adrenergic receptor agonist. It is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, either as monotherapy when topical beta-blocker therapy is contraindicated or as adjunctive therapy when additional IOP lowering is required. The solution is clear, slightly greenish-yellow, with a pH between 5.5–6.5 and osmolality 275–315 mOsm/kg, supplied in 5 ml LDPE dropper bottles for ocular use.

Bnefits

Reduces elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Can be used as monotherapy when topical beta-blocker eye drops are contraindicated.
Provides an additional intraocular pressure-lowering effect when used as adjunctive therapy to other ocular hypotensive agents.
Rapid onset of action, with peak ocular hypotensive effect around two hours after dosing.
Demonstrated long-term intraocular pressure reduction of approximately 4–6 mmHg in clinical studies with continued twice-daily use.
Topical administration with generally minimal effects on cardiovascular and pulmonary parameters when used as directed.

Indications

Reduction of elevated intraocular pressure (IOP) 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 IOP is not achieved with a single agent.

Composition

Active ingredient: Brimonidine tartrate 2 mg/ml (equivalent to 1.3 mg/ml brimonidine).
Excipient with known effect: Benzalkonium chloride 0.05 mg/ml (preservative).
Other excipients: Poly(vinyl) alcohol, sodium chloride, sodium citrate, citric acid monohydrate, purified water, hydrochloric acid (dilute, for pH adjustment), sodium hydroxide (for pH adjustment).

Formulation

Eye drops, solution.
Clear, slightly greenish-yellow, preserved aqueous ophthalmic solution with pH 5.5–6.5 and osmolality 275–315 mOsm/kg.

Packaging

5 ml solution in low-density polyethylene (LDPE) dropper bottles with LDPE dropper tip (approximately 35 microlitre drop) and high-density polyethylene (HDPE) cap.
Pack sizes: 1 × 5 ml, 3 × 5 ml, or 6 × 5 ml bottles (not all pack sizes may be marketed).

Usage

Adults (including the elderly): instil one drop into the affected eye(s) twice daily, approximately 12 hours apart, or as directed by the prescribing clinician.
Wash hands before use. Tilt the head back, gently pull down the lower eyelid to form a pouch and instil one drop into the conjunctival sac, taking care not to touch the eye or surrounding structures with the dropper tip.
After instillation, gently press a finger on the inner corner of the eye (medial canthus) to occlude the lacrimal sac for about one minute to reduce systemic absorption.
If more than one topical ophthalmic medicinal product is being used, administer each at least 5–15 minutes apart.
Soft contact lenses should be removed before instillation and may be reinserted after at least 15 minutes, as benzalkonium chloride may be absorbed by and discolour soft lenses.
Use exactly as prescribed. Do not stop treatment without consulting the doctor, as intraocular pressure may rise again.

Contraindications

Hypersensitivity to brimonidine tartrate or to any of the excipients listed in the product.
Use in neonates and infants (less than 2 years of age).
Patients receiving monoamine oxidase (MAO) inhibitor therapy.
Patients taking antidepressants that affect noradrenergic transmission, such as tricyclic antidepressants or mianserin.

Adverse Effects

Very common: headache, drowsiness; ocular irritation (including hyperaemia, burning and stinging, pruritus, foreign body sensation, conjunctival follicles); blurred vision; allergic blepharitis, allergic blepharoconjunctivitis, allergic conjunctivitis, ocular allergic reactions; oral dryness; fatigue.
Common: dizziness, abnormal taste; local eye irritation (eyelid hyperaemia and oedema, blepharitis, conjunctival oedema and discharge, ocular pain and tearing); photophobia; corneal erosion and staining; ocular dryness; conjunctival blanching; abnormal vision; conjunctivitis; upper respiratory symptoms; gastrointestinal symptoms; asthenia.
Uncommon: systemic allergic reactions; depression; palpitations or arrhythmias (including bradycardia and tachycardia); nasal dryness.
Rare: dyspnoea.
Very rare: insomnia; iritis; miosis; hypertension; hypotension.
Frequency not known (post-marketing): iridocyclitis (anterior uveitis); eyelid pruritus; skin reactions including erythema, facial oedema, pruritus, rash and vasodilation.
Paediatric population: in children aged 2–7 years, particularly those weighing ≤20 kg, a high incidence of somnolence (including severe cases) has been reported when used as adjunctive therapy; serious systemic adverse effects including CNS depression have been reported following accidental ingestion in children.

Storage Conditions

This medicinal product does not require any special storage conditions (store in accordance with local guidance and product packaging).
Keep the bottle tightly closed when not in use.
Shelf life before first opening: 4 years (check expiry date on the pack).
After first opening: use within 28 days and discard any remaining solution after this time.
Keep out of the sight and reach of children.
Do not use the eye drops if the solution becomes discoloured, cloudy, or if the seal is broken before first use.

Duration

Intended for long-term, chronic treatment of open-angle glaucoma or ocular hypertension as directed by an ophthalmologist or prescribing clinician, with periodic review of intraocular pressure and ongoing benefit\u2013risk.

Onset

Rapid onset with peak ocular hypotensive effect typically at about 2 hours after topical administration; sustained intraocular pressure reduction of approximately 4\u20136 mmHg with continued twice-daily use.