Riva-Dorzolamide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RIVA-DORZOLAMIDE is the brandname for the medication dorzolamide hydrochloride available only on prescription through your physician. RIVA-DORZOLAMIDE is an ophthalmic carbonic anhydrase inhibitor. RIVA-

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:

RIVA-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 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 RIVA-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, sodium hydroxide and water for injection. Benzalkonium chloride is only added as a preservative to RIVA-DORZOLAMIDE Ophthalmic Solution.

What dosage forms it comes in:

RIVA-DORZOLAMIDE 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;
• RIVA-DORZOLAMIDE contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your physician before using RIVA-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 RIVA-DORZOLAMIDE, consult your physician immediately:

• if you suspect that RIVA-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

RIVA-DORZOLAMIDE IS NOT RECOMMENDED FOR CHILDREN.

In studies with dorzolamide hydrochloride, the effect of dorzolamide hydrochloride 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 RIVA-

  DORZOLAMIDE with a beta-blocker eye drop to lower eye pressure, then the dose is one drop of RIVA-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 RIVA-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 RIVA-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:

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

INSTRUCTIONS FOR USE

RIVA-DORZOLAMIDE Ophthalmic Solution

1. 1.

   Before using the medication for the first time, be sure

   the safety seal on the bottle is unbroken.

2. 2.

   Tear off the safety seal to break the seal.

   1. 3. To open the bottle, unscrew the cap by turning the cap. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
   2. 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
   3. 5. Invert the bottle and press lightly with the thumb or index finger (as shown) 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.

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.

1. 6. If drop dispensing is difficult after opening for the first time, replace the cap on the bottle and tighten (DO NOT OVERTIGHTEN) and then remove by turning the cap in the opposite direction.
2. 7. Repeat steps 4 & 5 with the other eye if instructed to do so by your doctor.
3. 8. Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.
4. 9. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
5. 10.

   After you have used all doses, there will be some

   RIVA-DORZOLAMIDE left in the bottle. You should not be concerned since an extra amount of RIVA-DORZOLAMIDE has been added and you will get the full amount of RIVA-DORZOLAMIDE 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), 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.

There have been post-marketing experience reports of allergic reactions to dorzolamide hydrochloride 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 RIVA-DORZOLAMIDE, contact your physician or pharmacist.

HOW TO STORE IT

RIVA-DORZOLAMIDE Ophthalmic Solution: Store at 15 - 30°C. Protect from light.

Once opened, the bottle may be stored at 15 - 30°C for up to 40 days. Discard unused portion 40 days after opening.

Keep all medicines safely away from 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 Patient 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 Patient 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, Laboratoire Riva Inc., at: 1-800-363-7988 or at www.labriva.com

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Québec, Canada.

J7C 3V4

www.labriva.com

Last revised: December 06, 2016