Apo-Brimonidine: Uses, Side Effects and Dosage

What is APO-BRIMONIDINE used for?

• APO-BRIMONIDINE eye drops are used to reduce high pressure in the eye in adult patients with:

  • chronic open-angle glaucoma (a condition that causes damage to the optic nerve of your eye).
  • ocular hypertension (high pressure in the eye).

How does APO-BRIMONIDINE work?

APO-BRIMONIDINE is an eye drop solution that reduces the amount of fluid flowing into the eye and increases the amount of fluid flowing out of the eye. This reduces the pressure inside the eye. It contains a preservative.

What are the ingredients in APO-BRIMONIDINE?

Medicinal ingredient: Brimonidine Tartrate

Non-medicinal ingredients: Benzalkonium chloride (0.005% as a preservative), citric acid, hydrochloric acid and/or sodium hydroxide to adjust pH, polyvinyl alcohol, sodium chloride, sodium citrate and water for injection.

APO-BRIMONIDINE comes in the following dosage forms:

Ophthalmic solution, 0.2% w/v

Do not use APO-BRIMONIDINE if:

• you are allergic to brimonidine tartrate, any of the other ingredients, or to any component of the APO-BRIMONIDINE container (See What are the ingredients in APO-BRIMONIDINE?).
• you are receiving monoamine oxidase (MAO) inhibitor therapy (used to treat depression).
• APO-BRIMONIDINE should not be used in children under the age of 2 years.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-BRIMONIDINE. Talk about any health conditions or problems you may have, including if you:

• are breastfeeding a baby, pregnant or intend to become pregnant.

• have or have had heart and blood vessel problems.
• have or have had circulation problems which make the toes and fingers numb and pale. This is called Raynaud’s phenomenon.
• have or have had low blood pressure.
• are taking or intend to take other medicines. This is particularly important if you are taking medicine to lower blood pressure or to treat heart disease.
• have or have had liver problems.
• have or have had kidney problems.
• have or have had depression.
• have or have had eye surgery.
• develop an eye condition due to infection or injury.
• wear contact lenses. The preservative in APO-BRIMONIDINE may be absorbed by soft (hydrophilic) contact lenses. Lenses should be removed before using APO-BRIMONIDINE and kept out for 15 minutes after use.

Other warnings you should know about:

Immediately tell your healthcare professional if you:

• have or have had eye surgery.
• develop an eye condition due to infection or injury.

Ask your healthcare professional for their advice on whether you should continue to use the

APO-BRIMONIDINE bottle.

Driving and using machines:

APO-BRIMONIDINE may cause drowsiness and fatigue or blurred vision. Do not drive, use heavy machinery or participate in dangerous activities or activities requiring you to be alert, until these conditions have passed.

Children (2 to 18 years of age): The use of APO-BRIMONIDINE is currently not recommended in children, as several serious side effects have been reported with the use of brimonidine tartrate ophthalmic solution 0.2% in children.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with APO-BRIMONIDINE:

• antihypertensives (medicines used to treat high blood pressure).
• cardiac glycoside (medicines used to treat heart failure and irregular heartbeats).
• central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics).
• clonidine (medicine used to treat high blood pressure and attention deficit hyperactivity disorder [ADHD]).
• heart and blood pressure medications such as alpha-agonists.
• medication such as beta-blockers (ophthalmic and/or systemic, used to treat high blood pressure and irregular heartbeats).
• tricyclic antidepressants (medicines used to treat depression).

How to take APO-BRIMONIDINE:

• APO-BRIMONIDINE contains a preservative called benzalkonium chloride which may change the colour of soft contact lenses. If you wear contact lenses, remove them before using APO-BRIMONIDINE. Wait 15 minutes after using the drops before you put your lenses back in.
• Always use APO-BRIMONIDINE exactly as your healthcare professional has told you to.
• If you use APO-BRIMONIDINE with other eye drops, wait at least five minutes between putting in APO-BRIMONIDINE and the other drops.
• To help prevent infections, do not let the tip of the bottle touch your eye or anything else. Put the cap back on and close the bottle immediately after you have used it.

Follow the steps below to help you use APO-BRIMONIDINE properly:

1. 1. Wash your hands. Tilt your head back and look at the ceiling. (See image 1)
2. 2. Gently pull down the lower eyelid to create a small pocket. (See image 2)
3. 3. Turn the bottle upside down and squeeze it gently to release one drop into the eyelid pocket. If a drop misses your eye, try again. (See image 3)
4. 4. Let go of the lower lid and close your eye for 30 seconds. (See image 4)

1. 5. Repeat steps 1 to 4 in the other eye if both eyes need treatment.

Usual dose:

Following the instructions for use above, put one drop of APO-BRIMONIDINE in the affected eye, twice daily, about 12 hours apart.

Overdose:

If you accidentally use too many drops, just go back to your regular twice a day dosing the next day. If you have any concerns, talk to your doctor or pharmacist.

Missed Dose:

If you forget to apply your eye drops at your normal time, simply apply them as soon as you remember. Then go back to the original schedule as directed by your healthcare professional. Do not try to catch up on missed drops by applying more than one dose at a time.

What are possible side effects from using APO-BRIMONIDINE?

These are not all the possible side effects you may have when taking APO-BRIMONIDINE. If you experience any side effects not listed here, tell your healthcare professional.

• abnormal taste
• abnormal vision
• allergic reaction
• blurred vision
• cold-like symptoms
• constriction of eye’s pupil
• depression
• dizziness
• drowsiness
• dry mouth
• dry nose
• erosion on the surface of the eye and staining
• eye discharge
• eye irritation
• eye dryness
• fainting
• general weakness
• headache
• irritation of the eye (eye redness, burning, stinging, a feeling of something in the eye)
• itchy eyes
• local irritation (inflammation and swelling of the eyelid, pain and tearing)
• sensitivity to light
• skin reaction
• symptoms involving the stomach and digestion
• swelling of eye’s pupil
• tiredness or sleepiness

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

APO-BRIMONIDINE should be stored at controlled room temperature (15^oC to 30^oC). Protect from light. Discard unused portion 28 days after opening container.

Keep out of sight and reach of children.

If you want more information about APO-BRIMONIDINE:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.

Last Revised JAN 2, 2024