Apo-Dorzolamide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for;

APO-DORZOLAMIDE is the brand name for the medication dorzolamide hydrochloride available only on prescription through your physician. APO-DORZOLAMIDE is an ophthalmic carbonic anhydrase inhibitor. APO-DORZOLAMIDE is prescribed to lower the raised pressure in your eye(s) because you have increased pressure in your eye(s) or glaucoma.

What it does;

APO-DORZOLAMIDE inhibits the enzyme carbonic anhydrase to reduce production of the watery secretion of the eye, which helps reduce the pressure in your eye.

Remember: This medication is prescribed for the particular condition that you have. Never give this medication to others. Do not 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 APO-DORZOLAMIDE if you:

• are allergic to any of its components (see; What the important

  nonmedicinal ingredients are).

• have severe kidney problems.
• are taking oral carbonic anhydrase inhibitors.

What the medicinal ingredient is;

2% dorzolamide present as the hydrochloride salt, a sulfonamide-related compound.

What the important nonmedicinal ingredients are; hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide and water for injection. Benzalkonium chloride is only added as a preservative to APO-DORZOLAMIDE Ophthalmic Solution.

What dosage forms it comes in;

APO-DORZOLAMIDE (dorzolamide hydrochloride) ophthalmic solution 2% are sterile eye drops.

WARNINGS AND PRECAUTIONS

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

If you have any medical problems now or have had any in the past, including eye (corneal) defects, or previous eye surgery while using dorzolamide:

• If you are using any other medications (see INTERACTIONS WITH THIS MEDICATION).
• If you have any allergies to any medications;
• APO-DORZOLAMIDE contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your physician before using APO-DORZOLAMIDE. 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 or liver problems;

If any of the following occur during treatment with APO-DORZOLAMIDE, consult your physician immediately:

• if you suspect that APO-DORZOLAMIDE is causing an allergic reaction such as skin rash or itching or other reactions in the eye, such as conjunctivitis;
• if you develop any eye infection or any eye irritation or any new eye problem such as redness of the eye or swelling of the eyelids;
• if you have any eye surgery or suffer eye injury.
• if you have severe skin reactions with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat

APO-DORZOLAMIDE IS NOT RECOMMENDED FOR CHILDREN.

In studies with dorzolamide hydrochloride ophthalmic solution, the effect of dorzolamide hydrochloride ophthalmic solution was similar in both elderly and younger adult patients.

INTERACTIONS WITH THIS MEDICATION

Your physician also needs to know about drugs (including eye drops) that you are using or plan to use, including drugs obtained without a prescription, in particular, large doses of ASA (acetylsalicylic acid) or sulfa drugs.

PROPER USE OF THIS MEDICATION

• Do not start taking any other medicines unless you have discussed the matter with your physician.
• If more than one topical ophthalmic drug is being utilized, the drugs should be administered at least ten minutes apart.

• If your physician has recommended you use APO-

  DORZOLAMIDE with a beta-blocker eye drop to lower eye pressure, then the dose is one drop of APO-DORZOLAMIDE in the affected eye(s) in the morning and in the evening.

• Do not change the dosage of the drug without consulting your

  physician. If you must stop treatment, contact your physician 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 physician.

When APO-DORZOLAMIDE is used alone, the dose is one drop in the affected eye(s) in the morning, in the afternoon and in the evening.

Missed Dose;

It is important to apply APO-DORZOLAMIDE as prescribed by your physician. 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:

INSTRUCTIONS FOR USE

APO-DORZOLAMIDE Ophthalmic Solution

1. 1.

   Before using the medication for the first time, be sure the

   Sealing Tape on the bottle is unbroken.

   1. 2. To open the bottle, unscrew the cap by turning as indicated by the arrows.
   2. 3. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
   3. 4. Invert the bottle and press lightly with the thumb and index finger until a single drop is dispensed into the eye as directed by your doctor. DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
   4. 5. Repeat steps 3 & 4 with the other eye if instructed to do so by your doctor.
   5. 6. Replace the cap by turning until it is firmly touching the bottle. Do not over tighten the cap.
   6. 7.

      The dispenser tip is designed to provide a pre-measured drop;

      therefore, do NOT enlarge the hole of the dispenser tip.

   7. 8.

      After you have used all doses, there will be some APO-

      DORZOLAMIDE left in the bottle. You should not be concerned since an extra amount of APO-DORZOLAMIDE has been added and you will get the full amount of APO-DORZOLAMIDE that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.

   8. 9. 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.

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), eye pain, or swelling or crusting of the eyelids. You may sense a bitter taste after putting in your eye drops.

Other side effects may include headache, nosebleed, dry mouth, nausea, tiredness, kidney stones and rarely, rash such as severe skin reactions. 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.

For management of a suspected drug overdose, particularly oral ingestion, contact your doctor, go to the nearest emergency room, or contact the nearest poison control centre for advice immediately.

Cap

Sealing tape

Bottle

There have been post-marketing experience reports of allergic reactions to dorzolamide hydrochloride ophthalmic solution with symptoms such as tissue swelling, difficulty in breathing, itching, and urticaria (raised skin rash). If this occurs, stop taking this medication and contact your physician.

Your physician or pharmacist has a complete list of the possible side effects from this medication. Please tell your physician 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 physician immediately.

This is not a complete list of side effects. For any unexpected effects while taking APO-DORZOLAMIDE, contact your physician or pharmacist.

HOW TO STORE IT

Store at room temperature between 15-30ºC (59-86ºF). Protect from light.

Keep all medicines safely away from children.

MORE INFORMATION

If you have any questions about the medication(s) you are taking talk to your doctor or pharmacist.

You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

This leaflet plus the full product monograph, prepared for health professionals can be found by contacting DISpedia, Apotex’s Drug Information Service, at: 1-800-667-4708, or by e-mail dispedia@apotex.com.

Last Revised: October 25, 2010

REPORTING SUSPECTED SIDE EFFECTS

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

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free to 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 0701D

    Ottawa, ON K1A 0K9

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

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.