Dorzolamide-Timolol (Alcon Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Dorzolamide 2%-Timolol 0.5% ophthalmic solution is the name for the medication dorzolamide and timolol maleate available only on prescription through your doctor. Dorzolamide 2%-Timolol 0.5% ophthalmic solution is a combination of an ophthalmic carbonic anhydrase inhibiting drug and an ophthalmic beta-blocking drug, both of which lower the pressure in the eye in different ways.

Remember – This medicine is prescribed for the particular condition that you have.

Do not give this medicine to other people, nor use it for any other condition.

When it should not be used:

Do not use this medicine after the date shown on the container.

Do not use Dorzolamide 2%-Timolol 0.5% ophthalmic solution if you:

• are allergic to any of its components. See “What the

  important nonmedicinal ingredients are.”

• have asthma or have ever had asthma
• have chronic obstructive lung disease
• have certain heart diseases or conditions
• have severe kidney problems
• are taking oral carbonic anhydrase inhibitors

• are breast feeding or intend to breast feed.

What the medicinal ingredients are:

Each mL contains 20 mg dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate) as the active ingredients.

What the important nonmedicinal ingredients are:

Hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection. Benzalkonium chloride is added as a preservative.

What dosage form it comes in:

Dorzolamide 2%-Timolol 0.5% ophthalmic solution is a sterile eye drop.

WARNINGS AND PRECAUTIONS

This medicine may not be suitable for some patients. So tell your doctor if you think any of the following applies to you:

• If you have any medical problems now or have had any in the past, especially asthma and other lung problems or heart problems;
• If you have any allergies to any medications;
• Dorzolamide 2%-Timolol 0.5% ophthalmic solution contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your doctor before using Dorzolamide 2%-Timolol 0.5% ophthalmic solution. Do not administer while wearing (soft) contact lenses. Remove lenses before application and re-insert no earlier than 15 minutes after use.
• If you are pregnant or intend to become pregnant;
• If you are breast feeding or intend to breast feed;
• If you have now or have had in the past kidney problems.
• If you have liver or thyroid problems.
• If you are diabetic or have suffered spontaneous hypoglycaemia (low blood sugar).
• If you have certain eye problems (i.e. corneal defects) or history of eye surgery.
• If you are planning major surgery, including eye surgery.

• If you are taking any other medications see

  INTERACTIONS WITH THIS MEDICATION.

If the following occur during treatment, consult your doctor immediately:

• allergic reaction such as skin rash or itching.
• develop any eye infection, swelling of the eyelid, redness or irritation.

• you have any eye surgery or suffer eye injury.

• severe skin reactions with symptoms such as blisters,

  peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat

DORZOLAMIDE-TIMOLOL OPHTHALMIC SOLUTION IS NOT RECOMMENDED FOR CHILDREN.

In studies with Dorzolamide 2%-Timolol 0.5% ophthalmic solution, the effect of Dorzolamide 2%-Timolol 0.5% ophthalmic solution was similar in both elderly and younger adult patients.

INTERACTIONS WITH THIS MEDICATION

Your doctor also needs to know about drugs (including eye drops) that you are using or plan to use, including drugs obtained without a prescription. This is particularly important if you are taking medicine to lower blood pressure (i.e. calcium channel blockers, clonidine), or to treat heart disease (i.e. quinidine, beta-blockers), or depression (i.e. selective serotonin reuptake inhibitors, SSRI’s). Also tell your doctor if you are taking large doses of acetylsalicylic acid or sulfa drugs.

PROPER USE OF THIS MEDICATION

Read the following information carefully. If you need any explanations, or further information, ask your doctor or pharmacist.

• Do not start taking any other medicines unless you have

  discussed the matter with your doctor.

• If you are using Dorzolamide 2%-Timolol 0.5%

  ophthalmic solution with another eyedrop, the drops should be instilled at least 10 minutes apart.

• Do not change the dosage of the drug without consulting

  your doctor. If you must stop treatment, contact your doctor immediately.

• Do not allow the tip of the container to touch the eye or

  areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, keep the tip of the container away from contact with any surface.

Usual Adult Dose:

The appropriate dosage and duration of treatment will be established by your doctor.

The usual dose is one drop in the affected eye(s) in the morning and in the evening.

Missed Dose:

It is important to apply Dorzolamide 2%-Timolol 0.5% ophthalmic solution as prescribed by your doctor. If you miss a dose, apply it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule.

Overdose

For management of a suspected drug overdose, particularly oral ingestion, contact your Regional Poison Control Centre even if there are no symptoms.

If you feel you have taken too much Dorzolamide 2%-Timolol 0.5% ophthalmic solution and symptoms may include shortness of breath, low heartbeat, dizziness, headache, etc., seek medical help.

INSTRUCTIONS FOR USE

How to use the DROP-TAINER^® BOTTLE

The DROP-TAINER® bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER® bottle, read the complete instructions carefully.

1. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after Dorzolamide 2%-Timolol 0.5% ophthalmic solution.
2. 2. Wash hands before use.
3. 3. Before using the mediation for the first time, be sure the Safety Seal on the bottle is unbroken.
4. 4. Tear off of the Safety Seal to break the seal.
5. 5. Before each use, shake once and remove the screw cap.

1. 6.

   Invert the bottle and hold the bottle between your

   thumb and middle finger, with the tips of the fingers pointing towards you.

2. 7.

   Tilt your head back and position the bottle above the

   affected eye.

3. 8.

   With the opposite hand, place a finger under the eye.

   Gently pull down until a “V” pocket is made between your eye and lower lid.

DO NOT TOUCH YOUR EYE WITH THE DROPPER TIP.

1. 9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication. DO NOT SQUEEZE THE SIDES OF THE BOTTLE. KEEP YOUR HEAD TILTED BACKWARD AND CLOSE YOUR EYE TO ALLOW ABSORPTION OF THE MEDICATION INTO THE EYE.
2. 10. Repeat 6, 7, 8, 9 with other eye if instructed to do so.
3. 11. Replace screw cap by turning until firmly touching the bottle.

Ophthalmic medications, if handled improperly, can become contaminated by common bacteria known to cause eye infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic medications. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately concerning continued use of this bottle.

The dispenser tip is designed to provide a pre-measured drop; therefore, do NOT enlarge the hole of the dispenser tip. After you have used all doses, there will be some Dorzolamide 2%-Timolol 0.5% ophthalmic solution left in the bottle. You should not be concerned since an extra amount of Dorzolamide 2%-Timolol 0.5% ophthalmic solution has been added and you will get the full amount of Dorzolamide 2%-Timolol 0.5% ophthalmic solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• Any medicine may have unintended or undesirable effects, so-called side effects.
• You may experience eye symptoms such as burning and stinging, blurred vision, itching, tearing, redness of the eye(s). You may sense a bitter taste after putting in your eye drops. Kidney stones and rarely, rash may also occur.
• Also, other side effects that have been observed with the separate active ingredients in Dorzolamide 2%-Timolol 0.5% ophthalmic solution include: headache, nosebleed, dry mouth, nausea, tiredness, swelling or crusting of the eyelids.

• Other side effects may also occur rarely, and some of

  these may be serious. These may include shortness of breath, severe skin reactions, visual changes, an irregular heartbeat and a slowing of your heart rate. If you develop a severe skin reaction with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat, stop taking this medication immediately and contact your physician.

• Your doctor or pharmacist has a complete list of the

  possible side effects from this medication. Please tell your doctor or pharmacist promptly about any unusual symptom.

• Possible side effects such as visual disturbances may

  affect the ability to drive and use machines.

• If the contents of the container are swallowed, you should

  contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking Dorzolamide 2%-Timolol 0.5% ophthalmic solution, contact your physician or pharmacist.

HOW TO STORE IT

Store at 2°C to 25°C. Protect from light.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Call toll-free at 1-866-234-2345
• Report online at www.healthcanada.gc.ca/medeffect

• Complete a Canada Vigilance Reporting form and:

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

  • Mail to: Canada Vigilance Program

    Health Canada

    Postal Locator 0701C

    Ottawa, ON,

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on MedEffect^™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effects, please contact your health care provider before notifying Canada Vigilance. 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 at:

http://www.alcon.ca

or by contacting the sponsor ALCON Canada Inc. at: 1-800-613-2245.

Date of Preparation: October 1, 2010

DROP-TAINER^® is a registered trademark of Alcon Manufacturing, Ltd.