Friday 6 April 2012

Apraclonidine Hydrochloride


Class: EENT Drugs, Miscellaneous
ATC Class: S01EA03
VA Class: OP900
Molecular Formula: C9H10Cl2N4•HCl
CAS Number: 73218-79-8
Brands: Iopidine

Introduction

Relatively selective α2-adrenergic agonist;1 4 7 12 19 43 62 65 imidazoline-derivative sympathomimetic amine.a


Uses for Apraclonidine Hydrochloride


Inhibition of Perioperative IOP Increases


Apraclonidine 1% is used prophylactically to prevent or reduce intraoperative and postoperative increases in intraocular pressure (IOP) before and after ocular laser surgery (e.g., argon laser trabeculoplasty, argon laser iridotomy, neodymium yttrium aluminum garnet [Nd:YAG] laser posterior capsulotomy).1 2 16 17 18 19 20


Glaucoma


Apraclonidine 0.5% is used for short-term (<1 month) adjunctive therapy in patients with open-angle glaucoma receiving maximally tolerated drug therapy (i.e., a topical β-adrenergic blocking agent in conjunction with a systemically administered carbonic anhydrase inhibitor and a sympathomimetic and/or a parasympathomimetic agent) who require additional reduction in IOP.62 65


Apraclonidine Hydrochloride Dosage and Administration


Administration


For topical ophthalmic use only.62 Not for injection or oral use.62


Ophthalmic Administration


Apply topically to the affected eye(s) as an ophthalmic solution.1 2 16 17 18 19 20 54 62


Avoid contamination of the solution container.34 62


If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.c


1% solution is for single use only; use a separate container for each single-drop dose of 1% solution and discard each container after use.b


Dosage


Available as apraclonidine hydrochloride; dosage expressed in terms of apraclonidine.1 a


Adults


Inhibition of Perioperative IOP Increases

Ophthalmic

Apraclonidine 1% solution: 1 drop in the eye undergoing surgery 1 hour before surgery; instill 1 drop in the same eye immediately upon completion of surgery.1 16 17 18 19


Glaucoma

Ophthalmic

Apraclonidine 0.5% solution: 1 or 2 drops in the affected eye(s) 3 times daily.62 65 Benefit of therapy for most patients is <1 month.62 65 (See Tachyphylaxis under Cautions.)


Special Populations


No special population dosage recommendations at this time.b c


Cautions for Apraclonidine Hydrochloride


Contraindications


Concomitant use with an MAO inhibitor.62 (See Specific Drugs under Interactions.)


Known hypersensitivity to apraclonidine, clonidine, or to any ingredient in the formulation.1 62


Warnings/Precautions


Sensitivity Reactions


Hypersensitivity Reactions

Topical hypersensitivity reactions (e.g., hyperemia, pruritus, discomfort, tearing, foreign body sensation, eyelid swelling) reported.36 62 65 c If hypersensitivity reaction occurs, discontinue apraclonidine.c


General Precautions


Systemic Effects

Perioperative use of apraclonidine hydrochloride ophthalmic solution to date has been associated with a low potential for causing adverse systemic effects;1 2 16 17 18 19 29 36 48 however, continuous (e.g., up to 12 weeks) use of apraclonidine ophthalmic solution has been associated with a higher incidence of adverse systemic effects.62


Cardiovascular Effects

Possible adverse cardiovascular effects (e.g., bradycardia,1 29 chest heaviness or burning,1 palpitation,1 reduced systolic and diastolic BP,2 29 orthostatic hypotension).1 57


Use with caution in patients with severe uncontrolled cardiac disease (e.g., hypertension), coronary insufficiency, recent MI, cerebrovascular disease, Raynaud's disease, or thromboangitis obliterans.1 62 65


Use with caution in patients with a history of vasovagal attacks; 1 possible vasovagal attacks during laser surgery.1 17


Depressive Episodes

Carefully supervise patients with a history of mental depression; may be subject to further depressive episodes.62


CNS Effects

Possible dizziness and somnolence; performance of activities requiring mental alertness and physical coordination may be impaired.62


Tachyphylaxis

IOP-lowering efficacy may diminish during therapy with 0.5% ophthalmic solution; careful monitoring recommended.c


Patient Monitoring

Closely monitor patients who develop excessive IOP reduction.1


Periodic visual field tests and frequent follow-up examinations recommended in patients receiving maximally tolerated drug therapy and 0.5% apraclonidine for glaucoma to delay surgery;62 discontinue therapy if IOP increases substantially.62


Ocular Effects

Abnormal vision, pain, keratitis, keratopathy, blepharitis, blepharoconjunctivitis, photophobia, corneal staining, corneal erosion, corneal infiltrate, and irritation reported rarely.62 65


Specific Populations


Pregnancy

Category C.b c


Lactation

Not known whether apraclonidine is distributed into milk.1 62 Caution advised if 0.5% ophthalmic solution is used.62 Temporarily discontinue nursing during the day that 1% ophthalmic solution is used for inhibition of perioperative IOP increases.1


Pediatric Use

Safety and efficacy not established in children <21 years of age.1 57


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.b c


Hepatic Impairment

Closely monitor cardiovascular parameters in patients with impaired liver function.c


Renal Impairment

Elimination may be decreased; closely monitor cardiovascular parameters in severe renal impairment.62


Use with caution in patients with chronic renal impairment.c


Common Adverse Effects


0.5% solution: Discomfort, hyperemia, pruritus, tearing, lid edema, dry mouth, foreign body sensation, blanching, blurred vision, conjunctivitis, discharge, dry eye.c


1% solution: Ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, mydriasis.b


Interactions for Apraclonidine Hydrochloride


Specific Drugs






























Drug



Interaction



Comments



Antidepressants, tricyclic (imipramine, desipramine)



Potential decrease in IOP-lowering effect62



Use concomitantly with caution62



Antipsychotic agents



Possible additive hypotensive effects62



Reported with concomitant systemic clonidine therapy; not evaluated with concomitant apraclonidine therapy1 62



Cardiac glycosides



Possible decrease in heart rate and BP62



Use concomitantly with caution62



CNS depressants (e.g., barbiturates, opiates, anesthetics, sedatives, alcohol)



Possible additive CNS effects62



Hypotensive agents



Possible decrease in heart rate and BP62



Use concomitantly with caution62



MAO inhibitors



Possible excess of circulating catecholamines with withdrawal of apraclonidine62



Concomitant use contraindicatedb c


No data available on the circulating plasma concentrations of catecholamines following apraclonidine withdrawal62



Ocular hypotensive agents



Additive IOP-lowering effect16 17



Used to therapeutic advantage16 17 18


Apraclonidine Hydrochloride Pharmacokinetics


Absorption


Bioavailability


Some systemic absorption occurs following topical administration.1 2 15 29 62


Onset


Following topical application of a 1% solution, reduction in IOP usually occurs within 1 hour and reaches a maximum within 3–5 hours.1 2 16 17 62


Duration


Reduction in IOP persists for at least 12 hours.1 2 16 17 62


Distribution


Extent


Distribution into both ocular and systemic human tissues is unknown.52


Not known whether apraclonidine crosses the placenta or is distributed into milk.1 57 62


Elimination


Metabolism


Metabolic fate not fully elucidated.57 58 62


Elimination Route


Elimination characteristics not fully elucidated.57 58 62


Half-life


0.5% solution: 8 hours.62 65


Stability


Storage


Ophthalmic


Solution

0.5% solution: Tight, light-resistant container at 2–27°C; do not freeze.62


1% solution: Tight, light-resistant container at 2–25°C.1 b


ActionsActions



  • Stimulates α2-receptors; also may stimulate, to a lesser extent, α1-receptors.2 13




  • Inhibits the production of cyclic adenosine monophosphate (AMP) by inhibition of adenylate cyclase.4 6 13 43




  • Reduces both elevated1 16 17 18 19 48 54 62 65 and normal2 29 36 62 65 IOP in patients with or without glaucoma1 16 17 18 19 48 54 via peripheral (e.g., local) effects.2 61




  • Exact mechanism(s) of action not clearly established,1 3 8 9 10 19 56 65 but predominant effect appears to be reduced aqueous humor formation.1 3 10 19 55 56 62 65 resulting from constriction of afferent ciliary process vessels.2 3 10 53 56




  • Produces local vasoconstriction and reduction in blood flow in the eye.2 33 62



Advice to Patients



  • Importance of learning and adhering to proper administration techniques to avoid contamination of the solution container.c If more than one topical ophthalmic drug is used, importance of administering at least 5 minutes apart.c




  • Importance of delaying insertion of soft contact lenses for at least 15 minutes after apraclonidine instillation, since benzalkonium chloride preservative in the solution may be absorbed by soft lenses.c




  • Risk of dizziness or fatigue; use caution when driving or operating machinery.62




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.c




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.c




  • Importance of informing patients of other important precautionary information. (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


















Apraclonidine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Ophthalmic



Solution



0.5% (of apraclonidine)



Iopidine (with benzalkonium chloride)



Alcon



1% (of apraclonidine)



Iopidine (with benzalkonium chloride)



Alcon


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Iopidine 0.5% Solution (ALCON VISION): 10/$189.99 or 30/$540


Iopidine 0.5% Solution (ALCON VISION): 5/$104.99 or 15/$295.96


Iopidine 1% Solution (ALCON VISION): 24/$335.99 or 72/$950



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



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a. AHFS drug information 2006. McEvoy GK, ed. Apraclonidine. Bethesda, MD: American Society of Health-System Pharmacists; 2830-3.



b. Alcon Laboratories. Iopidine (apraclonidine hydrochloride ophthalmic solution) 1% prescribing information. Fort Worth, TX; 2004 Dec.



c. Alcon Laboratories. Iopidine (apraclonidine ophthalmic solution) 0.5% prescribing information. Fort Worth, TX; 2003 Dec.



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