Ratio-Brimonidine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

ratio-BRIMONIDINE eye drops are used to reduce high pressure in the eye in patients with chronic open-angle glaucoma or ocular hypertension.

What it does:

ratio-BRIMONIDINE is a preserved 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.

When it should not be used:

Do not use ratio-BRIMONIDINE:

• If you are allergic to brimonidine tartrate or any of the

  other ingredients (See what the nonmedicinal ingredients are)

• If you are receiving monoamine oxidase (MAO)

  inhibitor therapy

• In neonates and infants below the age of 2 years

What the medicinal ingredient is:

Brimonidine tartrate

What the important nonmedicinal ingredients are:

0.005% benzalkonium chloride, as preservative, citric acid, polyvinyl alcohol, purified water, sodium chloride and sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

What dosage forms it comes in:

Ophthalmic solution, brimonidine tartrate 0.2%, w/v

WARNINGS AND PRECAUTIONS

ratio-BRIMONIDINE may cause drowsiness and fatigue or blurred vision. Do not drive, use heavy machinery or engage in hazardous activities or activities requiring mental alertness, until these conditions have passed.

BEFORE you use ratio-BRIMONIDINE talk to your doctor or pharmacist if:

• you are breastfeeding a baby, pregnant or intend to

  become pregnant.

  • you have any allergies to this drug, or to similar drugs (ask your doctor) or to ratio-

    BRIMONIDINE’s ingredients or components of its container

  • you are taking or intend to take other prescription or non-prescription drugs. This is particularly important if you are taking medicine to lower blood pressure or to treat heart disease.

  • you wear contact lenses. The preservative in ratio-

    BRIMONIDINE (benzalkonium chloride) may be absorbed by soft (hydrophilic) contact lenses. Lenses should be removed prior to using ratio-BRIMONIDINE and kept out for 15 minutes after use.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with brimonidine tartrate include^:

Central nervous system depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics), heart and blood pressure medications such as alpha-agonists, medication such as beta-blockers (ophthalmic and/or systemic), antihypertensives, cardiac glycoside, tricyclic antidepressants and clonidine.

Drug interactions studies have not been done for brimonidine tartrate.

PROPER USE OF THIS MEDICATION

Usual adult dose:

Normally, you should put one drop of ratio-BRIMONIDINE in each eye that needs treatment, twice every day, about 12 hours apart, following the instructions for use below.

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

Follow the following steps to help you use ratio-BRIMONIDINE properly:

1. 1. Wash your hands. Tilt your head back and look at the ceiling.
2. 2. Gently pull down the lower eyelid to create a small pocket.
3. 3. Turn the bottle upside down and squeeze it gently to release one drop into each eye that needs treatment.
4. 4. Let go of the lower lid, and close your eye for 30 seconds.

If a drop misses your eye, try again.

ratio-BRIMONIDINE contains a preservative called benzalkonium chloride which may discolour soft contact lenses. If you wear contact lenses, remove them before using ratio-BRIMONIDINE. Wait 15 minutes after using the drops before you put your

lenses back in.

Always use ratio-BRIMONIDINE exactly as your doctor has instructed you. If you use ratio-BRIMONIDINE with another eye drop, leave at least five minutes between putting in ratio-BRIMONIDINE and then 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.

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.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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 doctor. Do not try to catch up on missed drops by applying more than one dose at a time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The following side effects may be seen with ratio-BRIMONIDINE. If these persist or cause you concern, consult your doctor.

Very common:

• Dry mouth

• Irritation of the eye (eye redness, burning, stinging, a

  feeling of something in the eye)

• Blurred vision
• Headache
• Tiredness, sleepiness or drowsiness

Common:

• Local irritation (inflammation and swelling of the eyelid,

  pain and tearing)

• Sensitivity to light

  • Erosion on the surface of the eye and staining
  • Eye dryness
  • Abnormal vision
  • Dizziness
  • Cold-like symptoms
  • Symptoms involving the stomach and digestion
  • Abnormal taste
  • General weakness

This is not a complete list of side effects. For any unexpected effects while taking ratio-BRIMONIDINE, contact your doctor or pharmacist.

HOW TO STORE IT

ratio-BRIMONIDINE should be stored in the original container at 15° C to 25°C. Discard unused solution at the end of treatment.

Do not use the drops after the expiry date (marked “Exp”) on the bottle and the box.

Keep out of reach of children.

REPORTING SIDE EFFECTS

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting

  Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON

    K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available

at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document, plus the full product monograph, prepared for health professionals, can be found by contacting the sponsor, Teva Canada Limited:

1-800-268-4127 ext 1255005 (English)

1-877-777-9117 (French)

or druginfo@tevacanada.com

Toronto, Ontario

Canada, M1B 2K9.

Last revised: November 6, 2014.