Patient Medication Information: uses, side effects, how to take - Apo-Dorzo-Timop
What is APO-DORZO-TIMOP used for?
APO-DORZO-TIMOP 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 APO-DORZO-TIMOP work?
APO-DORZO-TIMOP 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 APO-DORZO-TIMOP?
Medicinal ingredients: Dorzolamide hydrochloride and timolol maleate
Non-medicinal ingredients: Hydroxyethyl cellulose, mannitol, sodium citrate dihydrate, sodium hydroxide solution, and water for injection.
Benzalkonium chloride is only added as a preservative to APO-DORZO-TIMOP.
APO-DORZO-TIMOP 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 APO-DORZO-TIMOP if you:
- are allergic to APO-DORZO-TIMOP or any of its ingredient. See “What are the ingredients in APO-DORZO-TIMOP?”
- 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 APO-DORZO-TIMOP. 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 breast-feeding or planning to breast-feed.
- 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 APO-DORZO-TIMOP 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 APO-DORZO-TIMOP. APO-DORZO-TIMOP contains the preservative benzalkonium chloride. It can deposit in soft contact lenses. This means that you must remove your contact lenses before you apply APO-DORZO-TIMOP. 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 APO-DORZO-TIMOP.
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 APO-DORZO-TIMOP:
- 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 APO-DORZO-TIMOP:
- Take APO-DORZO-TIMOP exactly as your healthcare professional has told you to.
- If you are using APO-DORZO-TIMOP 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 APO-DORZO-TIMOP to yourself a family member or caregiver may help you.
APO-DORZO-TIMOP
- 1. Before using APO-DORZO-TIMOP for the first time, be sure the safety seal on the front of the bottle is not broken. A gap between the bottle and the cap is normal for an unopened bottle.

- 2. Tear off the safety seal to break the seal.

- 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.

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

- 5. Invert the bottle and press lightly with the thumb or index finger over the “Finger Push Area” (as shown) until a single drop is dispensed into the eye.

DO NOT TOUCH YOUR EYE OR EYELID WITH THE DROPPER TIP.
- 6. After application, close your eye and press the inner corner of the eye with your finger (as shown) for about two minutes. This helps to stop the medicine from getting into the rest of the body.

- 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 it by turning the cap in the opposite direction as shown by the arrows on the top of the cap.
- 8. Repeat steps 4, 5 and 6 with the other eye if instructed to do so by your healthcare professional.
- 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.
- 10. The dispenser tip is designed to provide a single drop into your eye; do not enlarge the hole of the dispenser tip.
- 11. After you have used all doses, there will be some APO-DORZO-TIMOP left in the bottle. You should not be concerned since an extra amount of APO-DORZO-TIMOP has been added to the bottle and you will still get the full amount of APO-DORZO-TIMOP 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 APO-DORZO-TIMOP you should apply and for how long you should apply it.
Overdose:
If you feel you have taken too much APO-DORZO-TIMOP and 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 taken too much APO-DORZO-TIMOP, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
It is important to apply APO-DORZO-TIMOP 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 APO-DORZO-TIMOP?
These are not all the possible side effects you may have when taking APO-DORZO-TIMOP. 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
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Slow heartbeat. | ✓ | ||
| RARE | |||
| Heart problems: irregular heartbeat, heart block, low blood pressure. | ✓ | ||
| Toxic Epidermal Necrolysis (severe skin reaction): redness, blistering and/or peeling of large areas of the skin. | ✓ | ||
| Allergic Reactions: rash, hives, swelling of the mouth, throat, and lips, difficulty breathing, blue skin, shock, loss of consciousness, low blood pressure. | ✓ | ||
| Stevens-Johnson syndrome (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal | ✓ | ||
| passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands. | |||
| Urolithiasis (kidney stones): pain when urinating, severe pain in the side and back, below the ribs. | ✓ | ||
| UNKNOWN | |||
| Increased heart rate. | ✓ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, racing pulse or heart palpitations. | ✓ | ||
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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store at room temperature 15°C - 30°C. Protect from light.
Keep out of reach and sight of children.
If you want more information about APO-DORZO-TIMOP:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products), or by calling 1-800-667-4708.
