Apraclonidine Ophthalmic

WHY is this medicine prescribed?

Apraclonidine 0.5% eye drops are used for the short-term treatment of glaucoma (a condition that can cause damage to the optic nerve and vision loss, usually due to increased pressure in the eye) in people who are taking other medications for this condition and still have increased pressure in the eye. Apraclonidine 1% eye drops are used to prevent or reduce increased pressure in the eye during and after certain types of laser eye surgery. Apraclonidine is in a class of medications called alpha-2-adrenergic agonists. It lowers the pressure in the eye by decreasing the amount of fluid produced within the eye.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Apraclonidine comes as a 0.5% solution (liquid) and a 1% solution to instill in the eye. The 0.5% solution is usually instilled in the affected eye(s) three times a day. The 1% solution is usually instilled in the eye that is being treated 1 hour before laser eye surgery and again immediately after the surgery. If you are using apraclonidine eye drops regularly, use them at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use apraclonidine eye drops exactly as directed. Do not use more or less of them or use them more often than prescribed by your doctor.

Apraclonidine eye drops are only for use in the eye. Do not swallow the eye drops.

Apraclonidine 0.5% eye drops may not continue to control your eye pressure after you have used them for a period of time, usually less than 1 month. Your doctor will examine you often while you are using apraclonidine 0.5% eye drops to see whether the eye drops are still working for you.

Apraclonidine 0.5% eye drops help to control glaucoma for a short period of time but do not cure the condition. Continue to use apraclonidine 0.5% eye drops even if you feel well. Do not stop using apraclonidine 0.5% eye drops without talking to your doctor.

To instill the eye drops, follow these steps:

1. Wash your hands thoroughly with soap and water.
2. Check the dropper tip to make sure that it is not chipped or cracked.
3. Avoid touching the dropper tip against your eye or anything else; eyedrops and droppers must be kept clean.
4. While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
5. Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it.
6. Brace the remaining fingers of that hand against your face.
7. While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
8. Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
9. Place a finger on the tear duct and apply gentle pressure.
10. Wipe any excess liquid from your face with a tissue.
11. If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop.
12. If you are using the 0.5% eye drops, replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip. If you are using the 1% eye drops, discard the bottle and use a new bottle for your second dose.
13. Wash your hands to remove any medication.

What SPECIAL PRECAUTIONS should I follow?

Before using apraclonidine eye drops,

• tell your doctor and pharmacist if you are allergic to apraclonidine, clonidine (Catapres, Catapres TTS, in Clorpres, Duraclon) or any other medications.

• Tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) and tranylcypromine (Parnate).

• Some medications should not be used with apraclonidine eye drops. Other medications may cause dosing changes or extra monitoring when used with apraclonidine eye drops. Make sure you have discussed any medications you are currently taking or plan to take before using apraclonidine eye drops with your doctor and pharmacist. Before starting, stopping, or changing any medications while using apraclonidine eye drops, please get the advice of your doctor or pharmacist.

• if you are using other eye medications, instill them at least 5 minutes before or after you instill apraclonidine eye drops

• tell your doctor if you recently had a heart attack and if you have or have ever had depression; diabetes; high blood pressure; a stroke or ministroke; Raynaud's disease (condition that causes sudden tightening of the blood vessels in the fingers and toes); thromboangiitis obliterans (inflammation of the blood vessels in the arms and legs); fainting; or heart, liver, or kidney disease.

• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while you are using apraclonidine eye drops, call your doctor.

• tell your doctor if you are breast-feeding. If you will be using apraclonidine 1% drops on the day you have laser eye surgery, your doctor will probably tell you not to breast-feed that day.

• you should know that apraclonidine eye drops may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are using apraclonidine eye drops. Alcohol can make the side effects from apraclonidine worse.

• you should know that using apraclonidine eye drops may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Instill the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill extra drops to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Apraclonidine eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• red, swollen, itchy, or teary eyes
• eye discomfort
• feeling that something is in the eye
• irregular, slow, or pounding heartbeat
• blurred vision
• pale eyes
• dry eyes
• widened pupils (dark circles in the center of the eyes)
• raised eyelids
• lack of usual coordination
• lack of energy
• sleepiness
• difficulty falling asleep or staying asleep
• unusual dreams
• dizziness
• headache
• depression
• irritability
• pain, burning, or tingling in the hands or feet
• changed sense of taste or smell
• dry mouth
• nausea
• vomiting
• stomach pain
• constipation
• diarrhea
• dry or burning nose
• chest heaviness or burning
• skin redness
• rash
• itching
• feeling hot
• clammy or sweaty palms
• decreased sexual desire

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fainting
• swelling of the face, eyes, arms, hands, feet, ankles, or lower legs
• shortness of breath

Apraclonidine eye drops may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

If someone swallows apraclonidine eye drops, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• slowed pulse
• sleepiness
• chills

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.