IOPIDINE 5 mg/ml Eye Drops, Solution

Iopidine

Prescription Medicine

Ophthalmic antiglaucoma alpha-adrenergic agonist

UK MHRA Authorised prescription Only medicinal product (POM)
Classified under ATC code S01EA03 (sympathomimetics in glaucoma therapy)
Manufactured and released in accordance with EU/UK Good Manufacturing Practice (GMP) for medicinal products

UK MHRA Authorised prescription Only medicinal product (POM)
Classified under ATC code S01EA03 (sympathomimetics in glaucoma therapy)
Manufactured and released in accordance with EU/UK Good Manufacturing Practice (GMP) for medicinal products

Ophthalmic antiglaucoma alpha-adrenergic agonist

Description

IOPIDINE 5 mg/ml Eye Drops, Solution is a clear, colourless to pale yellow ophthalmic solution containing apraclonidine 5 mg/ml (as hydrochloride), an alpha-adrenergic agonist. It is used as short-term adjunctive therapy in patients with chronic glaucoma who are already on maximally tolerated medical treatment but require additional intraocular pressure (IOP) reduction to help delay laser therapy or glaucoma surgery. By reducing aqueous humour production and increasing outflow, it lowers raised pressure inside the eye.

Bnefits

Provides additional intraocular pressure reduction in patients already on maximally tolerated glaucoma therapy
Helps delay the need for pressure-relieving laser treatment or glaucoma surgery in chronic glaucoma
Topical ophthalmic use with targeted action on the eye
Onset of IOP-lowering effect usually within about one hour, with maximal effect around three to five hours after instillation
Can be used alongside other ocular glaucoma medications (with appropriate spacing between drops)
Supplied in multi-dose bottle with dropper tip for accurate dosing
Clear, colourless to pale yellow solution allowing visual inspection before use

Indications

Short-term adjunctive therapy of chronic glaucoma in patients already receiving maximally tolerated medical therapy who require additional intraocular pressure reduction
Use in conjunction with other antiglaucoma medications to control raised intraocular pressure and delay laser treatment or glaucoma surgery, as prescribed by a specialist

Composition

Active substance: apraclonidine 5 mg/ml (as apraclonidine hydrochloride)
Benzalkonium chloride 0.1 mg/ml (preservative)
Sodium chloride
Sodium acetate trihydrate
Hydrochloric acid and/or sodium hydroxide (to adjust pH)
Purified water

Formulation

Sterile, clear, colourless to pale yellow eye drops, solution
Multi-dose preserved formulation for topical ocular use

Packaging

5 ml plastic bottle with screw cap and dropper tip, in an outer carton
10 ml plastic bottle with screw cap and dropper tip, in an outer carton

Usage

For ocular use only.
Usual dose: 1 drop into the affected eye(s) three times daily, or as directed by the prescribing doctor.
Wash hands before use.
Remove the tamper-evident collar when the bottle is first opened if present.
Tilt the head back, gently pull down the lower eyelid to form a pocket and instil one drop into the conjunctival sac without touching the eye, eyelids or any surface with the dropper tip.
After instillation, gently press a finger into the corner of the eye by the nose for about 1 minute (nasolacrimal occlusion) to reduce systemic absorption.
If using other ophthalmic medicines, leave at least 5 minutes between products; eye ointments should be applied last.
If a drop misses the eye, instil another drop.
If a dose is missed, apply the next dose as soon as remembered unless it is nearly time for the next dose; do not use a double dose.
Contact lenses: remove soft contact lenses before instillation and wait at least 15 minutes after dosing before reinsertion.
Use only for the duration recommended by the treating ophthalmologist (commonly up to one month due to tachyphylaxis).

Contraindications

Hypersensitivity to apraclonidine, clonidine, or any excipient in the formulation (including benzalkonium chloride)
History of severe or unstable and uncontrolled cardiovascular disease, including severe uncontrolled arterial hypertension
Use in children
Concurrent treatment with monoamine oxidase inhibitor (MAOI) antidepressants
Concurrent treatment with tricyclic antidepressants
Concurrent treatment with systemic sympathomimetic medicines taken orally or by injection

Adverse Effects

Very common ocular: conjunctivitis, eye itching (pruritus), ocular hyperaemia (increased redness/inflammation)
Common ocular: ocular discomfort, increased tearing (lacrimation), eyelid oedema, foreign-body sensation, dry eye, eyelid crusting
Uncommon ocular: swelling of the eye, abnormal or reduced vision, eye pain or irritation, corneal surface damage/erosion, photophobia, blurred vision, mydriasis, blepharitis, ptosis, eyelid erythema, conjunctival oedema, various conjunctival vascular changes, discharge or whitening of the eye
Allergic/ocular intolerance reactions: combination of redness, itching, discomfort, watery eyes, abnormal sensation, eyelid and conjunctival swelling; may require discontinuation
Common systemic: dry mouth, nasal dryness or inflammation, dermatitis, weakness, headache, unusual or altered taste (dysgeusia)
Uncommon systemic: chest pain, peripheral oedema, irregular heartbeat, constipation, nausea, fatigue or malaise, sore throat, runny nose, muscle aches, dizziness, somnolence, tingling sensations, nervousness, depression, insomnia, shortness of breath or difficulty breathing, facial swelling, irritability, vasodilation
Very rare or not known: hypersensitivity reactions, potential bradycardia and systemic hypotension particularly if systemically absorbed or in susceptible patients

Storage Conditions

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not refrigerate or freeze.
Keep the bottle tightly closed and store in the outer carton to protect from light.
Do not use after the expiry date stated on the bottle and carton.
Discard 4 weeks after first opening the bottle to reduce the risk of contamination.
Do not dispose of via wastewater or household waste; ask a pharmacist how to dispose of unused medicine.

Duration

Intended for short-term adjunctive use; maximum recommended duration is approximately one month due to loss of effect (tachyphylaxis), although some patients may benefit for longer under close specialist supervision.

Onset

Onset of intraocular pressure reduction usually within about 1 hour, with maximum IOP-lowering effect typically occurring 3\u20135 hours after a single dose.