Iopidine Eye

DRUG DESCRIPTION

IOPIDINE® 0.5% 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:

Each mL of IOPIDINE 0.5% Ophthalmic Solution contains

Active: apraclonidine hydrochloride 5.75 mg equivalent to apraclonidine base 5 mg; Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, sodium acetate, sodium hydroxide and/or hydrochloric acid (pH 4.4-7.8) and purified water.

What are the possible side effects of apraclonidine ophthalmic (Iopidine)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • slow or uneven heart rate;
  • pounding heartbeats or fluttering in your chest;
  • shallow breathing, feeling like you might pass out;
  • severe swelling, redness, or discomfort in or around your eye;
  • eye pain or increased watering; or
  • ...

Read All Potential Side Effects and See Pictures of Iopidine Eye »

What are the precautions when taking apraclonidine (Iopidine Eye)?

Before using apraclonidine, tell your doctor or pharmacist if you are allergic to it; or to clonidine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., cerebrovascular disease, Raynaud's disease), high blood pressure, heart problems (e.g., recent heart attack), kidney disease, mental/mood disorders (e.g., depression).

After you apply this drug, your vision may become temporarily blurred or unstable. It may also infrequently make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness...

Read All Potential Precautions of Iopidine Eye »


Iopidine Eye Consumer (continued)

SIDE EFFECTS: Eye discomfort/redness/burning, blurred vision, dry mouth/nose, dizziness, drowsiness, upset stomach, or unusual tiredness may occur. Eye itching/watering or eyelid swelling may be symptoms of an allergic reaction of the eye. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, irritability), slow/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using apraclonidine, tell your doctor or pharmacist if you are allergic to it; or to clonidine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood vessel disease (e.g., cerebrovascular disease, Raynaud's disease), high blood pressure, heart problems (e.g., recent heart attack), kidney disease, mental/mood disorders (e.g., depression).

After you apply this drug, your vision may become temporarily blurred or unstable. It may also infrequently make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.


Iopidine Eye Patient Information Including Side Effects

Brand Names: Iopidine

Generic Name: apraclonidine ophthalmic (Pronunciation: a pra KLAH ni deen)

  • What is apraclonidine ophthalmic (Iopidine Eye)?
  • What are the possible side effects of apraclonidine ophthalmic (Iopidine Eye)?
  • What is the most important information I should know about apraclonidine ophthalmic (Iopidine Eye)?
  • What should I discuss with my healthcare provider before using apraclonidine ophthalmic (Iopidine Eye)?
  • How should I use apraclonidine ophthalmic (Iopidine Eye)?
  • What happens if I miss a dose (Iopidine Eye)?
  • What happens if I overdose (Iopidine Eye)?
  • What should I avoid while using apraclonidine ophthalmic (Iopidine Eye)?
  • What other drugs will affect apraclonidine ophthalmic (Iopidine Eye)?
  • Where can I get more information?

What is apraclonidine ophthalmic (Iopidine Eye)?

Apraclonidine reduces the amount of fluid in the eye, which decreases pressure inside the eye.

Apraclonidine ophthalmic is used to treat or prevent high pressure inside the eye caused by certain types of eye surgery or procedures.

Apraclonidine ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of apraclonidine ophthalmic (Iopidine Eye)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • slow or uneven heart rate;
  • pounding heartbeats or fluttering in your chest;
  • shallow breathing, feeling like you might pass out;
  • severe swelling, redness, or discomfort in or around your eye;
  • eye pain or increased watering; or
  • numbness or tingly feeling in your hands or feet.

Less serious side effects may include:

  • burning, itching, or dryness of your eyes;
  • feeling like something is in your eye;
  • blurred or dimmed vision;
  • redness of the eye or eyelid;
  • mildly swollen or puffy eyes;
  • nausea, stomach pain, diarrhea;
  • headache, sleep problems (insomnia);
  • dry or stuffy nose, burning in your nose;
  • a dry mouth; or
  • unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about apraclonidine ophthalmic (Iopidine Eye)?

Do not use apraclonidine ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before using apraclonidine ophthalmic, tell your doctor if you have kidney or liver disease, heart disease, high blood pressure, or a history of fainting or low blood pressure. Also tell your doctor if you are using any medications to treat high blood pressure or a heart rhythm disorder.

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