Intended for UK Healthcare Professionals only. This website contains promotional information.

Adverse events and prescribing information can be found at the bottom of the page

Unmanaged IOP in patients with chronic glaucoma on maximally tolerated medical therapy before surgery can lead to damage in optic nerves and visual acuity loss.1

IOPIDINE® 5 mg/ml is indicated for short-term adjunctive therapy of chronic glaucoma in patients on maximally tolerated medical therapy who require additional IOP reduction to delay laser treatment or glaucoma surgery.2

What is apraclonidine?

Apraclonidine is a potent and relatively selective α2-adrenergic receptor agonist.1 Several studies show that apraclonidine lowers IOP by decreasing aqueous production through its action on a2-adrenoreceptors of the nonpigmented ciliary epithelium.1

A picture of the IOPIDINE® 5 mg/ml bottle in between a blue and orange curved line

Benefits of IOPIDINE® 5 mg/ml

IOPIDINE® 5 mg/ml is a proven and efficacious way to control intra-ocular pressure and delay surgical intervention1,3

IOPIDINE® 5 mg/ml helps to delay the requirement for surgical intervention by enabling satisfactory intraocular pressure control to be regained.2

IOPIDINE® 5 mg/ml is effective in short-term use. The onset of action of IOPIDINE® 5 mg/ml can usually be noted within one hour and the maximum intraocular pressure reduction usually occurs three to five hours after application of a single dose.2

The maximum recommended duration of therapy is one month, but some patients may benefit from longer treatment.2,4 In clinical studies, IOPIDINE® 5 mg/ml can be effective up to 24 months.4

IOPIDINE® in clinical trials

In a prospective placebo-controlled study, IOPIDINE® 5 mg/ml delayed or prevented surgery by at least 90 days, in 60% of patients (n=52).3

IOPIDINE® 5 mg/ml demonstrated a 19–26% reduction in IOP from baseline in a real-world study.4

A close up photo of an elderly patients eye
A photo of a sphygmomanometer taking a blood pressure reading

Additional benefits of IOPIDINE® 5 mg/ml

IOPIDINE® 5 mg/ml does not cross the blood-brain barrier.1

IOPIDINE® lowers IOP with minimal CNS side effects.1 Based on a real-world study, use of topical apraclonidine showed to have no significant effect on blood pressure and heart rate.5†

†Study investigating IOP elevations after anterior segment laser surgery (n=66).

A photo of a the IOPIDINE® 5 mg/ml bottle and it's packaging

Safety information

IOPIDINE® 5mg/mL is contraindicated in patients with a history of severe or unstable and uncontrolled cardiovascular disease including severe uncontrolled arterial hypertension.2

IOPIDINE® 5mg/mL is contraindicated in children.2

IOPIDINE® 5 mg/mL is contraindicated in patients with hypersensitivity to any component of the formulation or to systemic clonidine and in patients receiving monoamine oxidase inhibitors, systemic sympathomimetics or tricyclic antidepressants.2

In clinical trials using IOPIDINE® the most common adverse reactions were ocular hyperaemia, eye pruritus, and conjunctivitis, occurring in approximately 12% to 23% of patients.2

Regulatory approval

Apraclonidine is recommended by NICE and within the European Glaucoma Society (EGS) guidelines as a IOP-lowering therapy in glaucoma.6,7

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Essential Pharma at essentialpharmaUK@EU.ProPharmaGroup.com.

Prescribing Information Iopidine® 0.5%
Prescribing Information Iopidine® 1%
References
  1. Scuderi G et al. Expert Rev Ophthalmol. 2008;3:149–153.
  2. IOPIDINE 5 mg/ml Solution Summary of Product Characteristics https://www.medicines.org.uk/emc/product/14408/smpc/print December 2022.
  3. Robin AL et al. Am J Ophthalmol. 1995;120:423–432.
  4. Gross RL et al. J Glaucoma. 1997;6:298–302.
  5. Yüksel N et al. Int Ophthalmol. 1992;16:337–342
  6. European Glaucoma Society Terminology and Guidelines for Glaucoma, 5th Edition. Br J Ophthalmol. 2020;105(Suppl 1):1–169.

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IOPIDINE® 5 mg/ml Safety information

Very Common side effects (≥1/10) include conjunctivitis, eye pruritus and ocular hyperaemia.2

Common side effects (≥1/100 to >1/10) include rhinitis, headache, dysgeusia, eyelid oedema, dry eye, conjunctival follicles, foreign body sensation in eyes, eyelid margin crusting, lacrimation increased, ocular discomfort, nasal dryness, dry mouth, dermatitis and asthenia.2

Other less common side effects include chest pain, oedema peripheral, arrhythmia, depression, asthma, malaise, mydriasis, keratitis, keratopathy, and reduced visual acuity.2

Warnings and precautions:2

The possibility of a vasovagal attack should be considered in patients with a history of such.

Caution should be used in patients with a history of angina, severe coronary insufficiency, recent myocardial infarction, overt cardiac failure, hypertension, cardiovascular disease, including apoplexy, cerebrovascular disease, Parkinson’s syndrome, chronic renal failure, disease or thromboangiitis obliterans.

Apraclonidine has been rarely associated with depression, caution and monitoring of depressed patients is advised.

In end-stage glaucoma, if reduction in vision occurs immediately following IOPIDINE therapy, treatment should be suspended.

Discontinue treatment if intraocular pressure rises significantly in glaucoma patients on maximally tolerated therapy. The loss of effect which occurs over time should be closely monitored.

Such patients should have visual fields evaluated periodically.

Monitoring of patients with impaired renal or hepatic function is advised; close monitoring of cardiovascular parameters in patients with impaired liver function as the systemic dosage form of clonidine is partly metabolised in the liver.

Use can result in an ocular intolerance reaction including: ocular hyperaemia, eye pruritus, ocular discomfort, lacrimation increased abnormal sensation, and oedema of the lids and conjunctival oedema. Therapy should be discontinued if any occurs. Repeated use may cause contact sensitization in patients. Ocular intolerance responses are more common in patients treated for more than one month.

Discontinuation of therapy in the event of rising intraocular pressure should coincide with the initiation of alternative therapy, or pressure-relieving surgery.

Patients who develop an exaggerated reduction in intraocular pressure should be closely monitored. Contact with soft contact lenses should be avoided.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

Please consult the Iopidine 5mg/ml Summary of Product Characteristics for further information.