Brimonidine Ophthalmic

Brimonidine ophthalmic (eye) drops is used alone or together with other medicines to treat increased pressure in the eye that is caused by open-angle glaucoma or a condition called hypertension of the eye (ocular hypertension). brimonidine is an alpha-adrenergic agonist.

brimonidine is available only with your doctor's prescription.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Some of these products are not for use if you are wearing contact lenses. Be sure you know if you need to avoid wearing contact lenses while using this product.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eyelid swelling.

(bri MOE ni deen)

Elevated intraocular pressure:

US labeling: Ophthalmic: Instill 1 drop in affected eye(s) 3 times/day (approximately every 8 hours)

Canadian labeling: Ophthalmic:

Solution 0.15%: Instill 1 drop in affected eye(s) 3 times/day (approximately every 8 hours)

Solution 0.2%: Instill 1 drop in affected eye(s) 2 times/day (approximately every 12 hours)

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

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

Call your doctor at once if you have:

• eye pain or increased watering; or

• severe swelling, redness, burning, or discomfort in or around your eye.

Common side effects may include:

• drowsiness, tired feeling;

• dry mouth, blurred vision;

• mild itching, redness, or irritation of your eyes; or

• mild stinging or burning when using the eye drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This medication is used to treat open-angle glaucoma or high fluid pressure in the eye. Lowering high fluid pressure in the eye reduces the risk of vision loss, nerve damage, or blindness. This medication lowers pressure by allowing better fluid drainage from within the eye and also by reducing the amount of fluid formed in the eye. It is known as an alpha agonist.

This drug is not recommended for use in children less than 2 years of age due to an increased risk of serious side effects such as very slowed breathing. Ask the doctor or pharmacist for details.

How to use Brimonidine TARTRATE Drops

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

If you are wearing contact lenses, remove them before using this medication. After applying this medication, wait at least 15 minutes before putting in your contact lens.

Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and insert one drop, usually three times daily, or as directed by your doctor. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. Try not to blink and do not rub your eye. This will prevent the medication from draining out. Repeat these steps for your other eye if so directed by your doctor.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying the other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

It is important to continue this medication even if you do not have any symptoms. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. Do not stop using this medication without consulting your doctor.

Inform your doctor if your condition worsens.

Applies to brimonidine ophthalmic: ophthalmic solution

Along with its needed effects, brimonidine ophthalmic 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 while taking brimonidine ophthalmic:

• Blurred or loss of vision
• burning, dry, or itching eyes
• discharge or excessive tearing
• disturbed color perception
• double vision
• halos around lights
• headache
• itching of the eye
• night blindness
• overbright appearance of lights
• redness of the eye or inner lining of the eyelid
• swelling of the eyelid
• tearing of the eye
• tunnel vision

• Ache or pain in the eye
• blindness
• bloody eye
• blurred vision or other change in vision
• change in color vision
• confusion
• decreased vision
• difficult or labored breathing
• difficulty seeing at night
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drainage from the eye
• fainting
• fast heartbeat
• feeling of something in the eye
• gradual blurring or loss of vision
• increased blood pressure
• increased sensitivity of the eye to light
• mental depression
• muscle pain
• nausea or vomiting
• oozing in the eye
• redness, swelling, or itching of the eye or eyelid
• runny or stuffy nose
• seeing flashes or sparks of light
• seeing floating dark spots or material before eyes
• seeing floating spots before the eyes or a veil or curtain appearing across part of vision
• shortness of breath
• skin rash
• sneezing
• sweating
• swelling of the eye
• tightness in the chest
• unusual tiredness or weakness
• watery eyes
• wheezing

• Bluish lips or skin
• chest pain or discomfort
• confusion
• fast, pounding, or irregular heartbeat or pulse
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• irregular, fast, slow, or shallow breathing
• low body temperature
• muscle aches or weakness
• shivering
• slow or irregular heartbeat
• weak or feeble pulse
• weight gain

Some side effects of brimonidine ophthalmic 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:

• Burning, stinging, or tearing of the eye
• drowsiness or tiredness
• dryness of the mouth

• Acid or sour stomach
• anxiety
• bad, unusual, or unpleasant (after) taste
• belching
• body aches or pain
• change in taste
• chills
• congestion
• cough
• cough producing mucus
• crusting on eyelid or corner of eye
• diarrhea
• difficulty breathing
• discoloration of white part of the eye
• dryness of the eye
• dryness or soreness of the throat
• fever
• general feeling of discomfort or illness
• hoarseness
• indigestion
• joint pain
• lack or loss of strength
• large amounts of cholesterol in the blood
• lid disorder
• loss of appetite
• muscle aches and pains
• pain or tenderness around the eyes and cheekbones
• paleness of the eye or inner lining of the eyelid
• passing of gas
• pounding heartbeat
• rash
• shivering
• sleepiness or unusual drowsiness
• sleeplessness
• sneezing
• sore throat
• stomach discomfort, fullness, upset, or pain
• tender, swollen glands in the neck
• trouble with sleeping
• trouble with swallowing
• troubled breathing
• unable to sleep
• voice changes

• Constricted, pinpoint, or small pupils (black part of the eye)
• redness of the skin
• sensitivity to light
• throbbing pain
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual weak feeling
• unusually warm skin

2 years or older:
1 drop in the affected eye(s) 3 times per day, approximately 8 hours apart

Comments:
-This drug may be used concomitantly with other topical ophthalmic drugs.
-If more than one topical ophthalmic drug is being used, the products should be administered at least 5 minutes apart.

Use: To lower intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Safety and efficacy have not been established in patients younger than 2 years.

Consult WARNINGS section for additional precautions.