IOPIDINE 1% apraclonidine hydrochloride ophthalmic solution 10 mg/mL Solution/ Drops
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the alpha-Adrenergic Agonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Apraclonidine 0.5% eye drops are used for the short-term treatment of glaucoma (a condition that can cause damage to the optic nerve and vision loss, usually due to increased pressure in the eye) in people who are taking other medications for this condition and still have increased pressure in the eye. Apraclonidine 1% eye drops are used to prevent or reduce increased pressure in the eye during and after certain types of laser eye surgery. Apraclonidine is in a class of medications called alpha-2-adrenergic agonists. It lowers the pressure in the eye by decreasing the amount of fluid produced...
Read the full MedlinePlus article ↗- Apraclonidine 0.5% eye drops are used to help lower the pressure inside your eye — called intraocular pressure, or IOP. They're meant as a short-term add-on for people with glaucom...
- What exactly is apraclonidine eye drops used for?
- That's an important question. For many people, the benefit lasts less than a month. Some patients find the drops stop working as well over time — this is called tachyphylaxis. It c...
- How long will these eye drops keep working for me?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $26.705 | $640.92 / 24 vials |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Iopidine 1% 10 mg/mLthis 82667-0200-01 | Harrow | 12 pouches | $26.705 | — | Availability likely | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 82667-0200-01 You're viewing this | 12 POUCH in 1 CARTON (82667-200-01) / 2 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE | $26.70 / ea | $640.92 | 2023-08-01 | Active |
| 82667-0200-05 | 5 POUCH in 1 CARTON (82667-200-05) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .1 mL in 1 VIAL, SINGLE-DOSE | — | — | 2026-05-01 | Active |
Pack size FAQ
What quantity is in NDC 82667-0200-01?
What NDC number is used to bill for this package of IOPIDINE 1% apraclonidine hydrochloride ophthalmic solution 10 mg/mL Solution/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
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 ▾
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.
🔄 Drug Interactions ▾
DRUG INTERACTIONS Interactions with other agents have not been investigated.
🤰 Pregnancy ▾
PREGNANCY Apraclonidine HCl has been shown to have an embryocidal effect in rabbits when given in an oral dose of 3 mg/kg/day (150 times the maximum recommended human dose). Dose related maternal toxicity was observed in pregnant rats at 0.3 mg/kg/day (15 times the maximum recommended human dose). There are no adequate and well controlled studies in pregnant women.
IOPIDINE* 1% Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established. During postmarketing surveillance, cardiovascular collapse requiring intubation and ventilation, prolonged lethargy and unresponsiveness, apnea, hypoxia, respiratory failure, bradycardia, hypertension, hypotension, hypothermia, hypotonia, and pallor have been reported in pediatric patients 6 years and younger, including neonates, following topical administration of apraclonidine (see WARNINGS).
🧓 Geriatric Use ▾
GERIATRIC USE No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Ingestion of IOPIDINE* 0.5% Ophthalmic Solution 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Apraclonidine is a relatively selective, alpha adrenergic agonist and does not have significant membrane stabilizing (local anesthetic) activity. When instilled into the eye, IOPIDINE 1% (apraclonidine hydrochloride ophthalmic solution) has the action of reducing intraocular pressure (IOP). Ophthalmic apraclonidine has minimal effect on cardiovascular parameters.
Optic nerve head damage and visual field loss may result from an acute elevation in IOP that can occur after argon or Nd:YAG laser surgical procedures. Elevated IOP, whether acute or chronic in duration, is a major risk factor in the pathogenesis of visual field loss. The higher the peak or spike of IOP, the greater the likelihood of visual field loss and optic nerve damage especially in patients with previously compromised optic nerves.
The onset of action with IOPIDINE 1% Ophthalmic Solution can usually be noted within one hour and the maximum IOP reduction usually occurs three to five hours after application of a single dose. The precise mechanism of the ocular hypotensive action of IOPIDINE 1% Ophthalmic Solution is not completely established at this time. Aqueous fluorophotometry studies in man suggest that its predominant action may be related to a reduction of aqueous formation.
Controlled clinical studies of patients requiring argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy showed that IOPIDINE 1% Ophthalmic Solution controlled or prevented the post-surgical IOP rise typically observed in patients after undergoing those procedures. After surgery, the mean IOP was 1.2 to 4 mmHg below the corresponding pre-surgical baseline pressure before IOPIDINE Ophthalmic Solution treatment. With placebo treatment, post-surgical pressures were 2.5 to 8.4 mmHg higher than their corresponding pre-surgical baselines.
Overall, only 2% of patients treated with IOPIDINE* 1% Ophthalmic Solution had severe IOP elevations (spike greater than or equal to 10 mmHg) during the first three hours after laser surgery, whereas 23% of placebo-treated patients responded with severe pressure spikes (Table 1). Of the patients that experienced a pressure spike after surgery, the peak IOP was above 30 mmHg in most patients (Table 2) and was above 50 mmHg in seven placebo-treated patients and one IOPIDINE 1% Ophthalmic Solution-treated patient. Table 1: Incidence of IOP Spikes Greater Than or Equal to 10 mmHg Study Laser Procedure Treatment Apraclonidine Placebo P‑Value a N (%) a N (%) 1 Trabeculoplasty <0.05 0/40 (0%) 6/35 (17%) 2 Trabeculoplasty =0.06 2/41 (5%) 8/42 (19%) 1 Iridotomy <0.05 0/11 (0%) 4/10 (40%) 2 Iridotomy =0.05 0/17 (0%) 4/19 (21%) 1 Nd:YAG Capsulotomy <0.05 3/80 (4%) 19/83 (23%) 2 Nd:YAG Capsulotomy <0.05 0/83 (0%) 22/81 (27%) a N = Number Spikes/Number Eyes.
Table 2: Magnitude of Post-surgical IOP in Trabeculoplasty, Iridotomy and Nd:YAG Capsulotomy Patients With Severe Pressure Spikes Greater than or Equal to 10 mmHg Maximum Postsurgical IOP (mmHg) Treatment Total Spikes 20-29 mmHg 30-39 mmHg 40-49 mmHg > 50 mmHg IOPIDINE 8 1 4 2 1 Placebo 78 16 47 8 7
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED IOPIDINE 1% Ophthalmic Solution as base is a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied as follows: 0.1 mL in plastic ophthalmic dispensers, packaged two per pouch. These dispensers are enclosed in a foil overwrap as an added barrier to evaporation.
12 pouches per carton NDC 82667‑200‑01 5 pouches per carton NDC 82667‑200‑05 Storage: Store at 2°C to 25°C (36°F‑77°F). Protect from light. Manufactured for: Harrow Eye, LLC™ Nashville, TN 37215 USA Revised: March 2026
📋 Description ▾
DESCRIPTION IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha adrenergic agonist, in a sterile isotonic solution for topical application to the eye. Apraclonidine hydrochloride is a white to off‑white powder and is highly soluble in water. Its chemical name is 2-[(4‑amino-2,6 dichlorophenyl)imino] imidazolidine monohydrochloride with an empirical formula of C 9 H 11 Cl 3 N 4 and a molecular weight of 281.6.
The chemical structure of apraclonidine hydrochloride is: Each mL of IOPIDINE 1% Ophthalmic Solution contains: Actives : apraclonidine hydrochloride 11.5 mg equivalent to apraclonidine base 10 mg. Inactives: sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4‑7.8), purified water and benzalkonium chloride 0.01% (preservative). Osmolality is 260‑320 mOsm.
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💬 Information for Patients ▾
INFORMATION FOR PATIENTS Apraclonidine can cause dizziness and somnolence. Patients who engage in hazardous activities requiring mental alertness should be warned of the potential for a decrease in mental alertness on the day of surgery.