Dorzolamide Hydrochloride Ophthalmic Solution: Uses, Side Effects and Dosage

What is DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION used for?

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION lowers the pressure in the eye for conditions such as ocular hypertension or open-angle glaucoma.

How does DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION work?

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION belongs to a group of medicines called carbonic anhydrase inhibitors. DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION works by reducing the production of liquid in the eye. This helps lower the pressure in the eye.

What are the ingredients in DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION?

Medicinal ingredient: dorzolamide (present as the hydrochloride salt)

Non-medicinal ingredients: Hydroxyethyl Cellulose, Mannitol, Sodium Citrate Dihydrate, Sodium Hydroxide and Water for Injection. Benzalkonium Chloride is only added as a preservative to DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION.

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION comes in the following dosage forms:

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION 2% are sterile eye drops.

Do not use DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION if:

• you are allergic to any of its components (see: What are the ingredients in DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION).
• you have severe kidney problems.
• you are taking oral carbonic anhydrase inhibitors.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION. Talk about any health conditions or problems you may have, including if you:

• have any medical problems now or have had any in the past, including eye (corneal) problems, or previous eye surgery;
• have any allergies to any medications;
• DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your healthcare professional before using DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION. Do not use DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use.

• are pregnant or intend to become pregnant;

• are breast feeding or intend to breast feed;
• have now or have had in the past liver problems;
• have now or have had in the past kidney problems.

Other warnings you should know about:

You may find that your vision is blurred for a time just after you put DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION in your eye. Do

not drive or use any tools or machines until your vision is clear.

DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION is not recommended for children under 18 years of age.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION:

• Other drugs (including eye drops) that you are using or plan to use;
• Other drugs obtained without a prescription;
• Other carbonic anhydrase inhibitors;
• Large dose of ASA (acetylsalicylic acid);
• A group of drugs known as “sulfa drugs”.

How to take DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION:

• Do not start taking any other medicines unless you have discussed the matter with your
• healthcare professional.
• If you use other eye drops, they should be used at least ten minutes apart.
• If you use DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION with a beta-blocker eye drop, then the dose is one drop of DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION in the affected eye(s) in the morning and in the evening.
• Do not change how you take this drug without talking to your healthcare professional. If you
• must stop taking this drug, contact your healthcare professional immediately.

Usage Instructions:

1. 1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION.
2. 2. Wash hands before each use.
3. 3. To open the bottle, unscrew the cap by turning as indicated by the arrows on the top of 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. To open the bottle, remove the shrink neck band and unscrew the cap by turning counterclockwise.

1. 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.

1. 5. Gently press the bottle to release one drop at a time. Instill drops as directed by your doctor.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.

Eye droppers can become contaminated with bacteria from touching the eye or around the eye area. This can cause eye infections leading to serious damage of the eye, even loss of vision. If you think your bottle may be contaminated, or if you develop an eye infection, contact your healthcare professional immediately concerning continued use of this bottle.

1. 6. Repeat steps 4 & 5 with the other eye if instructed to do so by your healthcare professional.
2. 7. Put the bottle cap firmly back on immediately after use.

Usual dose:

Your doctor will tell you the right dose and length of time to use DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION.

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

Overdose:

Missed Dose:

It is important to apply DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION 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.

What are possible side effects from using DORZOLAMIDE HYDROCHLORIDE

OPHTHALMIC SOLUTION?

These are not all the possible side effects you may feel when taking DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION. If you experience any side effects not listed here, contact your healthcare professional.

You may experience eye symptoms such as:

• Burning and stinging
• Blurred vision
• Itching
• Tearing
• Redness of the eye (s)
• Eye pain
• Swelling of the eyelids
• Crusting of the eyelids
• Eyelid irritation
• Sensitivity to light
• A feeling of something in the eye

Other side effects may include:

• Bitter taste after putting in your eye drops
• Headache
• Nosebleed
• Dry mouth
• Throat irritation
• Nausea
• Tiredness
• Dizziness
• Numbness or tingling of the skin
• Itchy skin

If the contents of the container are swallowed, you should contact your healthcare professional immediately.

Serious side effects and what to do about them

This is not a complete list of side effects. For any unexpected effects while taking DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION, contact your doctor or pharmacist.

Reporting Side Effects

Storage:

• Store at 15°-25°C (59° - 77°F).
• After first opening store at 15°-25°C (59° - 77°F) for up to 28 days.
• Protect from light.
• Keep out of reach and sight of children.

If you want more information about DORZOLAMIDE HYDROCHLORIDE OPHTHALMIC SOLUTION:

• Talk to your healthcare professional
• Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.bauschlomb.ca, or by calling 1-800-361-4261.

Bausch & Lomb Incorporated

1400 North Goodman Street

Rochester NY, USA

14609

www.bauschlomb.ca

Imported and Distributed by:

Bausch + Lomb Corporation

520 Applewood Crescent

Vaughan, Ontario

L4K 4B4

Last Revised: June 14, 2022