Apraclonidine

Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha2-Agonists; Monoamine Oxidase Inhibitors.

• Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly.

• Apraclonidine ophthalmic solution 0.5% is contraindicated in patients with hypersensitivity to apraclonidine or any other component of this medication, as well as systemic clonidine. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitors.contraindicated

One to two drops of apraclonidine ophthalmic solution 0.5% should be instilled in the affected eye(s) three times daily. Since apraclonidine ophthalmic solution 0.5% will be used with other ocular glaucoma therapies, an approximate 5 minute interval between instillation of each medication should be practiced to prevent washout of the previous dose. NOT FOR INJECTION INTO THE EYE. NOT FOR ORAL INGESTION.

Not for injection or oral ingestion. FOR EYE USE ONLY.

In clinical studies the overall discontinuation rate related to apraclonidine ophthalmic solution 0.5% was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation. The following adverse reactions (incidences) were reported in clinical studies of apraclonidine ophthalmic solution 0.5% as being possibly, probably, or definitely related to therapy: Ocular The following adverse reactions were reported in 5% to 15% of the patients: discomfort, hyperemia, and pruritus. The following adverse reactions were reported in 1% to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema, and tearing. The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, and photophobia. Nonocular Dry mouth occurred in approximately 10% of the patients.

Pregnancy Apraclonidine HCl has been shown to have an embryocidal effect in rabbits when given in an oral dose of 3.0 mg/kg (60 times the maximum recommended human dose). Dose related maternal toxicity was observed in pregnant rats at 0.3 mg/kg (6 times the maximum recommended human dose). There are no adequate and well controlled studies in pregnant women. Apraclonidine ophthalmic solution 0.5% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Ingestion of apraclonidine ophthalmic solution 0.5% has been reported to cause bradycardia, drowsiness, and hypothermia. Accidental or intentional ingestion of oral clonidine has been reported to cause apnea, arrhythmias, asthenia, bradycardia, conduction defects, diminished or absent reflexes, dryness of the mouth, hypotension, hypothermia, hypoventilation, irritability, lethargy, miosis, pallor, respiratory depression, sedation or coma, seizure, somnolence, transient hypertension, and vomiting. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Hemodialysis is of limited value since a maximum of 5% of circulating drug is removed.

• Dec 31, 1987NDANDA019779Harrow Eye
• Jul 30, 1993NDANDA020258Harrow Eye

1. 1Drug Ineffective2120%
2. 2Off Label Use76.6%
3. 3Somnolence76.6%
4. 4Eyelid Ptosis65.7%
5. 5Vision Blurred65.7%
6. 6Constipation54.7%
7. 7Dry Mouth54.7%
8. 8Dyspnoea54.7%
9. 9Eye Pain54.7%
10. 10Sinus Bradycardia54.7%
11. 11Tenderness54.7%
12. 12Urinary Retention54.7%
13. 13Visual Acuity Reduced54.7%
14. 14Acute Kidney Injury43.8%
15. 15Angle Closure Glaucoma43.8%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Apraclonidine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults
  Not yet recruiting · Phase 3 · Interventional · 178 enrolled · Alcon Research
  NCT07578363updated 2026-06-10
• Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults
  Not yet recruiting · Phase 3 · Interventional · 230 enrolled · Alcon Research
  NCT07531043updated 2026-06-10
• A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness
  Completed · Phase 3 · Interventional · 159 enrolled · Alcon Research
  NCT06444529updated 2025-10-23
• Efficacy of Topical Apraclonidine for the Treatment of Ocular Synkinesis
  Withdrawn · Phase 4 · Interventional · 0 enrolled · University of Alabama at Birmingham
  NCT05167760updated 2024-07-19
• Micropulse Laser Trabeculoplasty (MLT) Versus Selective Laser Trabeculoplasty (SLT) for Treatment of Open Angle Glaucoma
  Completed · Interventional · 81 enrolled · David Belyea
  NCT01956942updated 2023-06-13
• Efficacy of Apraclonidine Eye Drops in the Treatment of Ptosis Secondary to Myasthenia Gravis
  Completed · Phase 2 · Interventional · 10 enrolled · American University of Beirut Medical Center
  NCT05045248updated 2021-09-16
• Impact Post-operative Treatment on Intraocular Pressure Post-SLT on Patients With Primary Open-angle Glaucoma
  Completed · Interventional · 67 enrolled · CHU de Quebec-Universite Laval
  NCT01058278updated 2016-02-29
• Randomized Prospective Study of Selective Laser Trabeculoplasty (SLT) Versus Argon Trabeculoplasty (ALT) in Patients With Pseudoexfoliation Glaucoma and Ocular Hypertension
  Completed · Phase 3 · Interventional · 25 enrolled · University of Calgary
  NCT01126203updated 2010-05-24
• Comparison of the Alpha-2 Agonists for Prevention of Intraocular Pressure Elevation After Selective Laser Trabeculoplasty
  Unknown · Interventional · 43 enrolled · Walter Reed Army Medical Center
  NCT00567411updated 2007-12-05

Frequently asked questions

How does Apraclonidine work?

Mechanism-of-action classes: Adrenergic alpha-Agonists; Adrenergic alpha2-Agonists; Monoamine Oxidase Inhibitors.

What is Apraclonidine used for?

According to FDA labeling, Apraclonidine carries indications including: Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Apraclonidine?

Apraclonidine is classified as Sympathomimetics in glaucoma therapy, alpha-Adrenergic Agonist, Adrenergic alpha-Agonists, Adrenergic alpha2-Agonists, Monoamine Oxidase Inhibitors, Decreased Intraocular Fluid Pressure.

What are the brand names for Apraclonidine?

Apraclonidine is marketed under brand names including Iopidine.

What are the contraindications for Apraclonidine?

Apraclonidine labeling lists contraindications including: Apraclonidine ophthalmic solution 0.5% is contraindicated in patients with hypersensitivity to apraclonidine or any other component of this medication, as well as systemic clonidine. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitors.. Always consult the full prescribing information and a clinician.