Pronunciation:

a-pra-KLON-i-deen

Brand Names:

• Iopidine

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiglaucoma

Pharmacologic—

Alpha-2 Adrenergic Agonist

Uses of This Medicine:

Apraclonidine 0.5% eye drops is used to treat glaucoma when the medications you have been using for glaucoma do not reduce your eye pressure enough.

Apraclonidine 1% eye drops is used just before and after certain types of eye surgery (argon laser trabeculoplasty, argon laser iridotomy, and Nd:YAG laser posterior capsulotomy). The medicine is used to control or prevent a rise in pressure within the eye (ocular hypertension) that can occur after this type of surgery.

Apraclonidine 0.5% and 1% are available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of apraclonidine eye drops in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of apraclonidine eye drops in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iobenguane I 131

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart attack, history of or
• Heart or blood vessel disease (eg, Raynaud's disease, thromboangiitis obliterans) or
• High blood pressure or
• Kidney disease or
• Stroke, history of or
• Vasovagal attack (rapid decrease in heart rate and blood pressure that can lead to fainting), history of—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

This medicine is available in 2 forms: apraclonidine 0.5% eye drops and apraclonidine 1% eye drops. Ask your doctor or pharmacist if you have any questions.

Apraclonidine 0.5% eye drops:

• Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.
• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.
• If your doctor ordered two different eye drops to be used together, wait at least 10 minutes between the times you apply the medicines. This will help to keep the second medicine from washing out the first one.

Apraclonidine 1% eye drops:

• A doctor or other trained health professional will give you this medicine.
• You will receive one drop of this medicine in the affected eye 1 hour before surgery, then one drop in the same eye immediately after surgery.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form:
  • For glaucoma (0.5% apraclonidine):
    • Adults—Use one drop in each eye two or three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Apraclonidine 0.5% eye drops may be stored in the refrigerator.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not use this medicine if you are also taking a MAO inhibitor (MAOI).

Apraclonidine 0.5% eye drops may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

For 0.5% apraclonidine

More common

Allergic reaction (redness, itching, tearing of the eye)

Less common

Blurred vision or change in vision

chest pain

clumsiness or unsteadiness

depression

dizziness

eye discharge, irritation, or pain

irregular heartbeat

numbness or tingling in the fingers or toes

raising of the upper eyelid

rash around the eyes

redness of the eyelid or inner lining of the eyelid

swelling of the eye, eyelid, or inner lining of the eyelid

swelling of the face, hands, or feet

For 1% apraclonidine

Less common

Blurred vision

diarrhea

dry mouth

eye redness

fainting

feeling cold or sleepy

irregular heartbeat

lightheadedness

redness, swelling, or whitening of the eyelids

slow heartbeat

stomach pain

stuff or runny nose

swelling of the eyelid

trouble sleeping

unusual dreams

unusual taste in the mouth

vomiting

watering of eye

Get emergency help immediately if any of the following symptoms of overdose occur:

For 1% apraclonidine

Symptoms of overdose

Confusion

clumsiness

drowsiness

low body temperature

muscle aches

muscle weakness

shivering

sleepiness

slow heartbeat

tiredness

weak or feeble pulse

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For 0.5% apraclonidine

More common

Dryness of the mouth

eye discomfort

Less common

Change in taste or smell

constipation

crusting or scales on the eyelid or corner of the eye

discoloration of white part of the eye

drowsiness or sleepiness

dry nose or eyes

general feeling of discomfort or illness

headache

increased sensitivity of the eyes to light

muscle aches

nausea

nervousness

paleness of the eye or inner lining of the eyelid

runny nose

sore throat

tiredness or weakness

trouble in sleeping

For 1% apraclonidine

More common

Increase in size of the pupil of the eye

paleness of the eye or inner lining of the eyelid

Less common

Runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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