Teva-Dorzotimol: Uses, Side Effects and Dosage

What the medication is used for:

TEVA-DORZOTIMOL (dorzolamide hydrochloride and timolol maleate) is available only on prescription through your doctor. TEVA-DORZOTIMOL® 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 TEVA-DORZOTIMOL 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 ingredient is:

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

What the important nonmedicinal ingredients are:

Hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide (pH adjustment), and water for injection. Benzalkonium chloride is only added as a preservative to TEVA-DORZOTIMOL Ophthalmic Solution.

What dosage forms it comes in:

Teva-Dorzotimol (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution is sterile eye drops.

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;
• TEVA-DORZOTIMOL Ophthalmic Solution contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your doctor before using TEVA-DORZOTIMOL. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert 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.

TEVA-DORZOTIMOL IS NOT

RECOMMENDED FOR CHILDREN.

In studies with dorzolamide hydrochloride and timolol maleate, the effect of dorzolamide hydrochloride and timolol maleate 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 TEVA-DORZOTIMOL

  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 TEVA-DORZOTIMOL 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

If you feel you have taken too much TEVA-DORZOTIMOL and symptoms may include shortness of breath, low heartbeat, dizziness, headache, etc, consult a physician immediately.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

INSTRUCTIONS FOR USE

1. 1.

   Get the bottle of TEVA-DORZOTIMOL

   Solution ready, along with a mirror, if needed.

2. 2. Wash your hands.
3. 3. Take the bottle and twist off the cap, being careful not to touch the dropper tip.
4. 4. Hold the bottle, pointing it down, between your thumb and middle finger.
5. 5.

   Tilt your head back and look at the ceiling.

   Pull down your eyelid with a clean finger, until there is a “pocket” between the eyelid and your eye. The drop will go in there.

6. 6. Bring the bottle tip close to the eye. Use the mirror if it helps.
7. 7. Gently press the bottom of the bottle with your forefinger to release one drop at a time. Don’t touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect the drops left in the bottle. Don’t squeeze the bottle: it is designed so that just a gentle press on the bottom is needed.
8. 8.

   If you use drops in both eyes, repeat the

   steps for the other eye.

9. 9.

   Put the bottle cap firmly back on

   immediately after use.

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 hydrochloride and timolol maleate 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 TEVA-DORZOTIMOL with preservative formulation, contact your physician or pharmacist.

HOW TO STORE IT

Store at room temperature 15°C - 25°C. Protect from light.

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: January 24, 2012

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:

$ Report online at

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

$ 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 the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.