IOPIDINE 1%

IOPIDINE 1% is an FDA-registered drug product whose active ingredient is APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION. It is labelled by Harrow Eye, LLC taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 82667-200, application NDA019779, label effective 20260508. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing APRACLONIDINE HYDROCHLORIDE OPHTHALMIC SOLUTION are most often described in connection with: argon laser, usage iopidine, ophthalmic solution, indicated control, prevent post-surgical, elevations iop, occur patients, iridotomy yag. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.

DOSAGE AND ADMINISTRATION One drop of IOPIDINE* 1% Ophthalmic Solution should be instilled in the scheduled operative eye one hour before initiating anterior segment laser surgery and a second drop should be instilled to the same eye immediately upon completion of the laser surgical procedure. Use a separate container for each single‑drop dose and discard each container after use.

CONTRAINDICATIONS IOPIDINE 1% Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine.

WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. Not for injection or oral ingestion. Topical administration of apraclonidine have been reported to cause cardiovascular collapse requiring intubation and ventilation in pediatric patients 6 years and younger, including neonates. Systemic adverse reactions such as prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, pallor have also been reported. Appropriate monitoring in a clinical setting should be in place.

ADVERSE REACTIONS The following adverse events, occurring in less than 2% of patients, were reported in association with the use of IOPIDINE 1% Ophthalmic Solution in laser surgery: ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis. The following adverse events were observed in investigational studies dosing IOPIDINE 1% Ophthalmic Solution once or twice daily for up to 28 days in non‑laser studies: Ocular Conjunctival blanching, upper lid elevation, mydriasis, burning, discomfort, foreign body sensation, dryness, itching, hypotony, blurred or dimmed vision, allergic response, conjunctival microhemorrhage. Gastrointestinal Abdominal pain, diarrhea, stomach discomfort, emesis Cardiovascular Bradycardia, vasovagal attack, palpitations, orthostatic episode Central Nervous System Insomnia, dream disturbances, irritability, decreased libido. Other Taste abnormalities, dry mouth, nasal burning or dryness, headache, head cold sensation, chest heaviness or burning, clammy or sweaty palms, body heat sensation, shortness of breath, increased pharyngeal secretion, extremity pain or numbness, fatigue, paresthesia, pruritus not associated with rash. Clinical Practice The following events have been identified during postmarketing use of IOPIDINE 1% Ophthalmic Solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to IOPIDINE 1% Ophthalmic Solution, or a combination of these factors, include • Hypersensitivity. • Cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine.

What is IOPIDINE 1% used for?
INDICATIONS AND USAGE IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.

Who makes IOPIDINE 1%?
Harrow Eye, LLC is the labeler of record for IOPIDINE 1%.

What form does IOPIDINE 1% come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is IOPIDINE 1% prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has IOPIDINE 1% been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.