Apraclonidine Ophthalmic

Apraclonidine Ophthalmic

Apraclonidine Ophthalmic Recall

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Questions & Answers

Side Effects & Adverse Reactions

Not for injection or oral ingestion.

FOR TOPICAL OPHTHALMIC USE ONLY.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Apraclonidine 0.5% Ophthalmic Solution 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 to delay surgery should have frequent follow-up examinations and treatment should be discontinued if the intraocular pressure rises significantly.

The addition of Apraclonidine Ophthalmic Solution to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because Apraclonidine Ophthalmic Solution is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP.

The IOP lowering efficacy of Apraclonidine Ophthalmic Solution diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.

History

There is currently no drug history available for this drug.

Other Information

Apraclonidine 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 C9H11Cl3N4 and a molecular weight of 281.57. The chemical structure of apraclonidine hydrochloride is:

Chemical Structure

Each mL of Apraclonidine 0.5% Ophthalmic Solution contains:
Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg;
Preservative: benzalkonium chloride 0.01%.
Inactives: sodium acetate, sodium chloride, sodium hydroxide and/or hydrochloric acid may be added to adjust pH (4.4 to 7.8) and water for injection.

Apraclonidine Ophthalmic Manufacturers


  • Akorn Inc.
    Apraclonidine Ophthalmic (Apraclonidine Hydrochloride) Solution/ Drops [Akorn Inc.]

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