Pronunciation:

bri-MOE-ni-deen

Brand Names:

• Alphagan P
• Lumify

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antiglaucoma

Pharmacologic—

Alpha-2 Adrenergic Agonist

Uses of This Medicine:

Brimonidine eye drops is used alone or together with other medicines to lower pressure inside the eye that is caused by open-angle glaucoma or ocular (eye) hypertension. This medicine is an alpha-adrenergic agonist.

Brimonidine eye drops is also used to relieve redness of the eye caused by minor eye irritations.

This medicine is 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Alphagan® P eye drops in children 2 years of age and older. Because of brimonidine's toxicity, use in children younger than 2 years of age is not recommended.

Appropriate studies have not been performed on the relationship of age to the effects of Lumify™ eye drops in children younger than 5 years of age. 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 brimonidine eye drops in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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.

• Amphetamine
• Dextroamphetamine
• Iobenguane I 131
• Lisdexamfetamine

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:

• Depression or
• Heart attack, history of or
• Heart disease or
• Orthostatic hypotension (low blood pressure when standing up) or
• Raynaud disease (blood vessel disease) or
• Stroke, history of or
• Thromboangiitis obliterans (blood vessel disease)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

If your doctor ordered two different eye drops to be used together, wait at least 5 minutes after you put the first medicine in your eye to use the second medicine. This will prevent the second medicine from “washing out” the first one.

To use the eye drops:

• Wash your hands with soap and water before and after using this medicine.
• Shake the eye drops well just before each use.
• Tilt your head back and press 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, repeat the directions with a second drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed when you are not using the drops.
• If germs get in the bottle, your eye could become infected. Serious eye infections can cause blindness.
• The eye drops will normally be a clear liquid with a greenish-yellow color. If the color changes or the liquid becomes cloudy, do not use the medicine. Get a new bottle from the pharmacy.

You should not use the eye drops if you have contact lenses in your eyes. Remove your contact lenses before you use this medicine. Wait at least 10 minutes after you use the medicine before putting the contact lenses back in.

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 dosage form (eye drops):
  • For glaucoma or ocular hypertension:
    • Adults and children 2 years of age and older—One drop in the affected eye 3 times a day, about 8 hours apart.
    • Children younger than 2 years of age—Use is not recommended.
  • For redness of the eye:
    • Adults and children 5 years of age and older—One drop in the affected eye every 6 to 8 hours.
    • Children younger than 5 years of age—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.

Precautions While Using This Medicine:

It is very important that your eye doctor (ophthalmologist) check your or your child's progress at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

If itching, redness, swelling, or other signs of eye or eyelid irritation occur, check with your doctor.

If you or your child have an eye injury or infection, or need to have eye surgery, talk with your doctor right away. You may need to change the medicine or stop using it.

This medicine may cause some people to become lightheaded, dizzy, drowsy, tired, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for allergies, sedatives or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Brimonidine 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:

More common

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

Less common

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

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

skin rash

sneezing

sweating

swelling of the eye

tightness in the chest

unusual tiredness or weakness

vomiting

watery eyes

Incidence not known

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 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:

More common

Burning, stinging, or tearing of the eye

drowsiness or tiredness

dryness of the mouth

Less common

Anxiety

bad, unusual, or unpleasant (after) taste

belching

body aches or pain

change in taste

chills

congestion

cough

cough producing mucus

crusting on the eyelid or on the corner of the eye

diarrhea

difficulty breathing

discoloration of the 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

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

Incidence not known

Constricted, pinpoint, or small pupils (black part of the eye)

redness of the skin

sensitivity to light

throbbing pain

unusual drowsiness, dullness, or feeling of sluggishness

unusual weak feeling

unusually warm skin

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.