Patient Medication Information: uses, side effects, how to take - Duokopt
What is DUOKOPT® used for?
DUOKOPT® 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. DUOKOPT® is a preservative-free formulation and is used in patients who may be sensitive to a preservative.
DUOKOPT® is supplied in a multidose bottle (HDPE) equipped with a pump fitted with a delivery system helper and a security cap for the first opening. DUOKOPT® is available in 4 mL bottles. The DUOKOPT® container closure system is not made with natural rubber latex.
How does DUOKOPT® work?
DUOKOPT® 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 DUOKOPT®?
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.
DUOKOPT® 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 DUOKOPT® if you:
- are allergic to DUOKOPT® or any of its ingredients. See “What are the ingredients in DUOKOPT®?”
- 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 [Brand name]. 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 DUOKOPT® may change the effects of some medicines during anesthesia.
Other warnings you should know about:
Contact lenses
DUOKOPT® has not been studied in patients wearing contact lenses. If you wear soft contact lenses, you should consult your doctor before using DUOKOPT®.
Driving and using machines
Wait until you can see clearly before driving or operating machines after applying DUOKOPT®.
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 [Brand name]:
- 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 betablockers.
- 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 [Brand name]:
- Take DUOKOPT® exactly as your healthcare professional has told you to.
- If you are using DUOKOPT® 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 DUOKOPT® to yourself a family member or caregiver may help you.
DUOKOPT® Ophthalmic Solution
| Before using the medication for the first time, be sure the security cap on the bottle is unbroken. Hold the security cap firmly and unscrew it to open the bottle. |  | ||||
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| 1. | Before each use, wash your hands thoroughly and remove the cap from the bottle tip. Do not touch the bottle tip with your fingers. |  | |||
| To activate the pumping mechanism, press down several times with the bottle upside down until the first drop appears. This process is only required for the very first use and will not be necessary for the next administrations. | |||||
| 2. | Place your thumb on the tab at the top of the bottle and your index finger on the base of the bottle. Then place your middle finger on the second tab at the base of the bottle. Hold the bottle upside down. |  | |||
| 3. | Tilt your head back and with the index finger of your other hand, pull your lower eyelid down slightly to form a pocket between your eyelid and your eye. Do not allow the bottle tip to touch your eye or any area around your eye. Hold the bottle dropper vertically above your eye and press firmly on the bottle until a single drop is dispensed into the eye as directed by your doctor. Each pump of the bottle is designed to automatically release exactly one drop. |  | |||
| If the drop does not release from the bottle, gently shake the bottle in order to remove the remaining drop from the tip and repeat Step 3. | |||||
| 4. | After using DUOKOPT®, close your eye and press the inner corner of the eye with your finger (as shown) for about 2 minutes. This helps to stop the medicine from getting into the rest of the body. | |
|---|---|---|
| 5. | Replace the cap on the bottle immediately after use. Discard unused solution 28 days after opening. |
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 DUOKOPT® you should apply and for how long you should apply it.
Overdose:
If you feel you have taken too much DUOKOPT® 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 DUOKOPT®, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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Missed Dose:
It is important to apply DUOKOPT® 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 DUOKOPT®?
These are not all the possible side effects you may have when taking DUOKOPT®. 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 | |||
|---|---|---|---|
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| 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:
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. |
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Storage:
Store between 15°C to 25°C. Protect from light. Discard unused solution 28 days after opening.
Keep out of the reach and sight of children.
If you want more information about DUOKOPT®:
- 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/drugproduct-database.html); the manufacturer’s website https://www.theapharma.ca, or by calling 1-888-805-8432 .