Iopidine Side Effects

Generic Name: apraclonidine ophthalmic

Note: This page contains information about the side effects of apraclonidine ophthalmic. Some of the dosage forms included on this document may not apply to the brand name Iopidine.

Not all side effects for Iopidine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to apraclonidine ophthalmic: ophthalmic solution

In addition to its needed effects, some unwanted effects may be caused by apraclonidine ophthalmic (the active ingredient contained in Iopidine). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking apraclonidine ophthalmic, check with your doctor or nurse as soon as possible:

For 0.5% apraclonidineMore common
  • Allergic reaction (redness, itching, tearing of eye)
Less common or rare
  • Blurred vision or change in vision
  • chest pain
  • clumsiness or unsteadiness
  • depression
  • dizziness
  • eye discharge, irritation, or pain
  • irregular heartbeat
  • numbness or tingling in fingers or toes
  • raising of upper eyelid
  • rash around eyes
  • redness of eyelid, or inner lining of eyelid
  • swelling of eye, eyelid, or inner lining of eyelid
  • swelling of face, hands, or feet
  • wheezing or troubled breathing
For 1% apraclonidineLess common or rare
  • Allergic reaction (redness of eye or inner lining of eyelid, swelling of eyelid, watering of eye)
  • irregular heartbeat

Some of the side effects that can occur with apraclonidine ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

For 0.5% apraclonidineMore common
  • Dryness of mouth
  • eye discomfort
Less common or rare
  • Change in taste or smell
  • constipation
  • crusting or scales on eyelid or corner of eye
  • discoloration of white part of eye
  • drowsiness or sleepiness
  • dry nose or eyes
  • general feeling of discomfort or illness
  • headache
  • increased sensitivity of eyes to light
  • muscle aches
  • nausea
  • nervousness
  • paleness of eye or inner lining of eyelid
  • runny nose
  • sore throat
  • tiredness or weakness
  • trouble in sleeping
For 1% apraclonidineMore common
  • Increase in size of pupil of eye
  • paleness of eye or inner lining of eyelid
  • raising of upper eyelid
Less common or rare
  • Runny nose

For Healthcare Professionals

Applies to apraclonidine ophthalmic: ophthalmic solution

Ocular

Many ocular side effects are transient and may not be observed until 5 to 7 hours after dosing.

A 66-year-old man with proliferative diabetic retinopathy and increased intraocular pressure (IOP) successfully underwent trabeculoplasty. He received one drop of apraclonidine 1% in the left eye one hour before and immediately after the procedure. At one and two hours postoperatively, the intraocular pressures in his left eye were 8 and 6 mm Hg, respectively. After examination, the patient was discharged. On postoperative days one and four, the intraocular pressures in his left eye were 10 and 28 mm Hg, respectively. The authors believed that the use of apraclonidine almost certainly contributed to low intraocular pressure in this patient, although trabeculoplasty itself can result in an acute decrease in intraocular pressure.[Ref]

Ocular side effects have included hyperemia and pruritus in 10% to 13% of patients. Ocular discomfort and tearing have been reported in 4% to 6% of patients. Lid edema, blurred vision, foreign body sensation, dry eye, conjunctivitis, discharge and blanching have been reported in 1% to 5% of patients. Lid margin crusting, conjunctival follicles, conjunctival edema, edema, abnormal vision, ocular pain, lid disorder, keratitis, blepharitis, photophobia, corneal staining, lid erythema, blepharoconjunctivitis, irritation, corneal erosion, corneal infiltrate, keratopathy, lid scales, and lid retraction have been reported in less than 1% of patients. Follicular conjunctivitis and hypotony have been reported rarely. Mydriasis has also been reported.[Ref]

Hypersensitivity

In one study in which approximately 40 patients received apraclonidine for 90 days, allergic reactions tended to occur 30 to 60 days after treatment began and resolved on discontinuation of the drug. Although up to 20% of patients developed allergic symptoms, only two patients elected to discontinue therapy for this reason.

In one double blind placebo controlled study (n=171) 12.9% of the 84 patients treated with apraclonidine 0.5% one to two drops in affected eye(s) 3 times a day discontinued treatment due to hypersensitivity side effects.[Ref]

Hypersensitivity side effects have been reported the most frequently in up to 20% of patients. They have included discomfort, hyperemia, pruritus, tearing, edema of the lids and conjunctiva, and foreign body sensation.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth (10%) and dysgeusia (3%). Abdominal pain, diarrhea, constipation, gastric discomfort, nausea, dyspepsia, and vomiting have also been reported.[Ref]

Nervous system

Lethargy has been reported in 14% of patients who have been on apraclonidine for up to four weeks.

Insomnia, dream disturbances, irritability, headache, dizziness, fatigue, paresthesia, numbness or pain of the extremities, and decreased libido have been reported in nonlaser patients using apraclonidine for up to 4 weeks.[Ref]

Nervous system side effects have included lethargy (up to 14%). Abnormal coordination, asthenia, dizziness, headache, insomnia, malaise, nervousness, paresthesia, and somnolence have been reported in up to 3% of patients. Decreased libido, dream disturbances, fatigue, irritability, and numbness or pain of extremities have also been reported.[Ref]

Cardiovascular

Although long-term studies have not been done, systemic side effects from apraclonidine are expected to be relatively infrequent relative to clonidine since apraclonidine is far less lipophilic. The relative hydrophilia of apraclonidine markedly reduces the risk of central alpha-adrenergic stimulation. In one double-blinded, crossover study of 20 healthy female volunteers, the use of apraclonidine 0.25% or 0.5% did not produce any significant changes in resting or exercise heart rate or blood pressure relative to placebo. This study did not address chronic use of apraclonidine in the elderly or in patients with glaucoma.

A single case of syncope and chest tightness has been associated with apraclonidine. A 67-year-old woman with a history of hypertension, diabetes, and renal calculi was scheduled to undergo argon laser iridotomy. She had no known history of coronary artery disease or arrhythmias. Her native medications included insulin, furosemide, and metoprolol. Approximately ten minutes after the instillation of one drop of 1% apraclonidine to the right eye (to prevent elevated intraocular pressure), she complained of chest tightness. Her pulse was "strong and regular." Within one to two minutes, her pulse was undetectable and the patient lost consciousness. Her rhythm was sinus. She was successfully resuscitated after aggressive intravenous fluid therapy. Her blood glucose was 180 mg/dL, and her ECG was normal. The patient subsequently underwent successful argon laser iridotomy without the use of apraclonidine.

After topical application, apraclonidine does not significantly alter heart rate or blood pressure.

Irregular heart beats have been reported in less than 2% of patients undergoing laser surgery.

There have been occasional reports of bradycardia, chest heaviness or burning, palpitations, reduced blood pressure, and orthostatic hypotension when apraclonidine 1% is administered once or twice a day for 4 weeks to individuals not undergoing laser surgery.

In one study, blood pressure reduction averaged 6%, and was not considered clinically significant, although occasionally blood pressure decreased by 20%. Heart rate changes ranged from a 42% decrease to a 44% increase.[Ref]

Cardiovascular side effects have included arrhythmias and peripheral edema in less than 3% of patients. Bradycardia, chest heaviness or burning, palpitations, reduced blood pressure, orthostatic hypotension, flushing, heat sensation, and clammy palms have also been reported.[Ref]

Respiratory

Respiratory side effects have included nasal congestion (<2%). Rhinitis, dyspnea, pharyngitis, and asthma have been reported rarely. Increased pharyngeal secretions, nasal burning or dryness, and head cold sensations have also been reported.[Ref]

Nonlaser patients on apraclonidine therapy for up to 4 weeks have reported increased pharyngeal secretions, nasal burning or dryness, and head cold sensations.[Ref]

Psychiatric

Psychiatric side effects have rarely included depression (<1%).[Ref]

Dermatologic

Dermatological side effects have included contact dermatitis and dermatitis (<3%), and pruritus.[Ref]

Musculoskeletal

Musculoskeletal side effects have rarely included myalgia (0.2%).[Ref]

Other

Other side effects have included chest pain, dry nose, facial edema, taste perversion, and parosmia in less than 3% of patients.[Ref]

General

A 15% discontinuation rate has been reported. The most common side effects listed as causes for discontinuation of therapy, in decreasing order of frequency, are hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation.[Ref]

References

1. Stewart WC, Ritch R, Shin DH, Lehman RP, Shrader CE, van Buskirk EM "The efficacy of apraclonidine as an adjunct to timolol therapy." Arch Ophthalmol 113 (1995): 287-92

2. Wilkerson M, Lewis RA, Shields MB "Follicular conjunctivitis associated with apraclonidine." Am J Ophthalmol 111 (1991): 105-6

3. "Product Information. Iopidine (apraclonidine)." Alcon Laboratories Inc, Fort Worth, TX.

4. Robin AL "Questions concerning the role of apraclonidine in the management of glaucoma." Arch Ophthalmol 113 (1995): 712-4

5. Jampel HD "Hypotony following instillation of apraclonidine for increased intraocular pressure after trabeculoplasty." Am J Ophthalmol 108 (1989): 191-2

6. Robin AL "Short-term effects of unilateral 1% apraclonidine therapy." Arch Ophthalmol 106 (1988): 912-5

7. Morrison JC, Robin AL "Adjunctive glaucoma therapy: a comparison of apraclonidine to dipivefrin when added to timolol maleate." Ophthalmology 96 (1989): 3-7

8. Gharagozloo NZ, Relf SJ, Brubaker RF "Aqueous flow is reduced by the alpha-adrenergic agonist, apraclonidine hydrochloride (ALO 2145)." Ophthalmology 95 (1988): 1217-20

9. Robin AL, Ritch R, Shin DH, Smythe B, Mundorf T, Lehmann RP, Brotherman D, Camras C, Derick R, Garrett DT, Gross R, Kapetans "Short-term efficacy of apraclonidine hydrochloride added to maximum-tolerated medical therapy for glaucoma." Am J Ophthalmol 120 (1995): 423-32

10. Nagasubramanian S, Hitchings RA, Demailly P, Chuniaud M, Pannarale MR, Pecori-Giraldi J, Stodtmeister R, Parsons DG "Comparison of apraclonidine and timolol in chronic open-angle glaucoma. A three-month study." Ophthalmology 100 (1993): 1318-23

11. Sridharrao B, Badrinath SS "Efficacy and safety of apraclonidine in patients undergoing anterior segment laser surgery." Br J Ophthalmol 73 (1989): 884-7

12. Feibel RM "High incidence of topical allergic reactions to 1% apraclonidine." Arch Ophthalmol 113 (1995): 1579

13. Butler P, Mannschreck M, Lin S, Hwang I, Alvarado J "Clinical experience with the long-term use of 1% apraclonidine: incidence of allergic reactions." Arch Ophthalmol 113 (1995): 293-6

14. Butler PJ, Alvarado JA "High incidence of topical allergic reactions to 1% apraclonidine - reply." Arch Ophthalmol 113 (1995): 1579-80

15. Jampel HD, Robin AL, Quigley HA, Pollack IP "Apraclonidine. A one-week dose-response study." Arch Ophthalmol 106 (1988): 1069-73

16. Robin AL "The role of apraclonidine hydrochloride in laser therapy for glaucoma." Trans Am Ophthalmol Soc 87 (1989): 729-61

17. Abrams DA, Robin AL, Crandall AS, Caldwell DR, Schnitzer DB, Pollack IP, Rader JE, Reaves TA Jr "A limited comparison of apraclonidine's dose response in subjects with normal or increased intraocular pressure." Am J Ophthalmol 108 (1989): 230-7

18. Yarwood J, Bartholomew K "Systemic effects of topical ophthalmic agents." Br J Anaesth 105 (2010): 238-9

19. King MH, Richards DW "Near syncope and chest tightness after administration of apraclonidine before argon laser iridotomy." Am J Ophthalmol 110 (1990): 308-9

20. Coleman AL, Robin AL, Pollack IP, Rudikoff MT, Enger C, Mayer PR "Cardiovascular and intraocular pressure effects and plasma concentrations of apraclonidine." Arch Ophthalmol 108 (1990): 1264-7

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