Apraclonidine

FDA label, Harrow Eye, LLC, ophthalmic, effective 2026-05-08. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation 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.

Drug interactions

Check apraclonidine against a medication list
Label text (1 paragraph)

Interactions with other agents have not been investigated.

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.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for apraclonidine. Check the label's hepatic warnings.

Pregnancy and lactation

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.

Lactation

It is not known if topically applied IOPIDINE 1% Ophthalmic Solution is excreted in human milk. Decision should be made to discontinue nursing temporarily for the one day on which IOPIDINE 1% Ophthalmic Solution is used.

Breastfeeding (LactMed)

No information is available on the use of apraclonidine during breastfeeding. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue. One manufacturer recommends avoiding breastfeeding on the one day on which it is used for argon laser trabeculoplasty, argon laser iridotomy or posterior capsulotomy.

Source: LactMed: Apraclonidine (NICHD, public domain)Revised Sep 20, 2021

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Not the price at the counter
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