AG-Dorzolamide Timolol: Uses, Side Effects and Dosage

What is AG-Dorzolamide Timolol used for?

AG-Dorzolamide Timolol is used to treat high pressure in the eye in patients with the following conditions:

• Ocular hypertension
• Open-angle glaucoma

It is used along with other medicines.

How does AG-Dorzolamide Timolol work?

AG-Dorzolamide Timolol contains a combination of two medicines. One is called a carbonic anhydrase inhibiting medicine. The other is called a beta-blocking medicine. Each one works in a different way to lower the pressure in the eye.

What are the ingredients in AG-Dorzolamide Timolol?

Medicinal ingredients: Dorzolamide (as dorzolamide hydrochloride) and timolol (as timolol maleate)

Non-medicinal ingredients: Hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, and water for injection.

Benzalkonium chloride is only added as a preservative to AG-Dorzolamide Timolol.

AG-Dorzolamide Timolol comes in the following dosage forms:

Solution: 20 mg / mL dorzolamide (as dorzolamide hydrochloride) and 5 mg / mL timolol (as timolol maleate).

Do not use AG-Dorzolamide Timolol if you:

• are allergic to AG-Dorzolamide Timolol or any of its ingredients. See “What are the ingredients in AG-Dorzolamide Timolol?”
• have serious breathing problems such as asthma
• have chronic obstructive lung disease
• have certain heart conditions such as slow or irregular heartbeats or heart failure
• have severe kidney problems
• are taking medicines called carbonic anhydrase inhibitors by mouth
• are less than 18 years of age

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AG-Dorzolamide Timolol. Talk about any health conditions or problems you may have, including if you:

• have lung or breathing problems such as chronic obstructive lung disease.
• have muscle weakness of the eye.
• have had heart problems such as heart failure in the past.
• have a heart condition called a first-degree heart block.
• have an allergy to any medication.

• are pregnant or planning to become pregnant.

• are breastfeeding or planning to breastfeed.
• have or have had kidney problems.
• have or have had liver problems.
• have or have had thyroid problems.
• have or have had blood circulation problems such as Raynaud’s syndrome.
• have or have had diabetes or other blood sugar problems.
• have certain eye problems like corneal defects or have had eye surgery in the past.
• are planning to have major surgery, including eye surgery, as AG-Dorzolamide Timolol may change the effects of some medicines during anesthesia.

Other warnings you should know about:

Contact lenses

If you wear contact lenses, consult your doctor before using AG-Dorzolamide Timolol. AG-Dorzolamide Timolol contains the preservative benzalkonium chloride. It can deposit in soft contact lenses. This means that you must remove your contact lenses before you apply AG-Dorzolamide Timolol. Wait 15 minutes before putting your contact lenses back in your eyes. Driving and using machines

Wait until you can see clearly before driving or operating machines after applying AG-Dorzolamide Timolol.

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 AG-Dorzolamide Timolol:

• Other drugs (including eye drops) that you are using or plan to use.
• Medicines used to lower blood pressure, called calcium channel blockers or clonidine.
• Medicines used to treat heart problems such as quinidine and medicines called beta blockers.
• Medicines used to treat diabetes such as insulin or oral hypoglycemic agents.
• Medicines used to treat depression called selective serotonin reuptake inhibitors.
• Acetylsalicylic acid used to reduce fever and pain.
• Medicines called sulfa drugs used to treat bacterial infections.

How to take AG-Dorzolamide Timolol:

• Take AG-Dorzolamide Timolol exactly as your healthcare professional has told you to.
• If you are using AG-Dorzolamide Timolol with another eye drop, the drops should be applied at least 10 minutes apart.
• Be careful not to touch your eye, the area around your eye, or any other surface with the tip of the container. It may become contaminated with bacteria. This can cause eye infections. This could lead to serious damage of the eye including loss of vision. Keep the tip of the container away from contact with any surface. Contact your healthcare professional if you think the bottle might be contaminated or if you think you might have an eye infection.
• If you cannot apply AG-Dorzolamide Timolol to yourself a family member or caregiver may help you.

AG-Dorzolamide Timolol

1. 1. Before using AG-Dorzolamide Timolol for the first time, be sure the safety seal on the bottle is unbroken.
2. 2. The safety seal is broken upon twisting the cap.
3. 3. To open the bottle, unscrew the cap by turning. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
4. 4. Tilt your head back and pull your lower eyelid down slightly to form a pocket between your eyelid and your eye.
5. 5. Invert the bottle and press lightly with the thumb or index finger (as shown) until a single drop is dispensed into the eye.

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

1. 6. After using AG-Dorzolamide Timolol, press a finger into the corner of your eye, by the nose (as shown) for 2 minutes. This helps keep AG-Dorzolamide Timolol in your eye.
2. 7. If drop dispensing is difficult after you open the bottle for the first time, replace the cap on the bottle and tighten. Then, remove by turning the cap in the opposite direction.
3. 8. Repeat steps 4, 5 and 6 with the other eye if instructed to do so by your healthcare professional.
4. 9. Replace the cap by turning until it is firmly touching the bottle. Do not tighten the cap too much. This may damage the bottle and cap.
5. 10. The dispenser tip is designed to provide a single drop; therefore, do NOT enlarge the hole of the dispenser tip.
6. 11. After you have used all doses, there will be some AG-Dorzolamide Timolol left in the bottle. You should not be concerned since an extra amount of AG-Dorzolamide Timolol has been added to the bottle and you will still get the full amount of AG-Dorzolamide Timolol that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.

Usual dose:

The usual dose is one drop in the affected eye(s) twice a day.

Your healthcare professional will tell you exactly how much AG-Dorzolamide Timolol you should apply and for how long you should apply it.

Overdose:

If you feel you have used too much AG-Dorzolamide Timolol, symptoms may include shortness of breath, low heartbeat, dizziness, headache, etc., seek medical help.

If you think you, or a person you are caring for, have used too much AG-Dorzolamide Timolol, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

It is important to apply AG-Dorzolamide Timolol 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. Do not apply a double dose.

What are possible side effects from using AG-Dorzolamide Timolol?

These are not all the possible side effects you may have when using AG-Dorzolamide Timolol. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• Burning, stinging, itching or redness of the eye.
• Watery eyes.
• Blurred vision.
• Swelling or crusting of the eyelids.
• Altered sense of taste including a bitter taste.
• Muscle pain.
• Abdominal pain.
• Headache.
• Nosebleed.
• Dry mouth.
• Nausea.
• Tiredness.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting

  (https://www.canada.ca/en/health-canada/services/drugs-health- products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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.

Storage:

Store at 15-25⁰C, in upright position. Protect from light. Discard 28 days after opening.

Keep out of reach and sight of children.

If you want more information about AG-Dorzolamide Timolol:

• 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); or by calling 450-449-9272.

Angita Pharma Inc.

1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Revised: SEP 09, 2024