Cosopt - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Glaucoma, Open Angle, Intraocular Hypertension|
|Class:||Ophthalmic glaucoma agents|
|Form:||Eye drops (ophthalmic)|
|Ingredients:||dorzolamide, timolol, hydroxyethyl cellulose, mannitol, sodium citrate, sodium hydroxide, water for injection|
About this Medication
What the Medication is Used For
COSOPT is the brandname for the medication dorzolamide hydrochloride and timolol maleate available only on prescription through your doctor. COSOPT is a combination of an ophthalmic carbonic anhydrase inhibiting drug and an ophthalmic beta-blocking drug, both of which lower the pressure in the eye in different ways.
COSOPT preservative-free formulation is indicated in patients who may be sensitive to a preservative, or for whom the use of a preservative-free formulation is otherwise advisable.
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 COSOPT if you:
- are allergic to any of its components. See “What the important nonmedicinal ingredients are”;
- have now or have had in the past certain serious breathing problems such as asthma;
- have chronic obstructive lung disease;
- have certain heart diseases or conditions (such as slow or irregular heartbeats);
- have severe kidney problems;
- are taking oral carbonic anhydrase inhibitors; are breast feeding or intend to breast feed.
What the Medicinal Ingredient is
Each mL contains 20 mg dorzolamide (as dorzolamide hydrochloride) and 5 mg of timolol (as timolol maleate).
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 COSOPT Ophthalmic Solution.
What Dosage Forms It Comes in
COSOPT and COSOPT preservative-free formulation (dorzolamide hydrochloride and timolol maleate) Ophthalmic Solution are sterile eye drops.
Warnings and Precautions
This medicine may not be suitable for some patients. So, tell your doctor if you think any of the following applies to you:
- If you have any medical problems now or have had any in the past, lung or breathing (such as asthma or chronic obstructive lung disease) problems or heart problems (such as coronary heart disease, heart failure or low blood pressure).
- If you have any allergies to any medications.
- COSOPT Ophthalmic Solution contains the preservative benzalkonium chloride. If you wear contact lenses, you should consult your doctor before using COSOPT. Do not administer while wearing (soft) contact lenses. Remove lenses before application and reinsert no earlier than 15 minutes after use. COSOPT preservative-free formulation has not been studied in patients wearing contact lenses.
- 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 problems.
- If you have now or have had in the past liver or thyroid problems.
- If you have now or have had in the past heart rate disturbances (such as slow or irregular heartbeats).
- If you have now or have had in the past poor blood circulation problems (such as Raynaud’s syndrome).
- If you have now or have had in the past diabetes or other blood sugar problems.
- If you have certain eye problems (i.e. corneal defects) or history of eye surgery.
- If you are planning major surgery, including eye surgery, as COSOPT may change the effects of some medicines during anesthesia.
If you are taking any other medications see INTERACTIONS WITH THIS MEDICATION.
If the following occur during treatment, consult your doctor immediately:
- allergic reaction such as skin rash or itching;
- develop any eye infection, swelling of the eyelid, redness or irritation;
- you have any eye surgery or suffer eye injury;
- severe skin reactions with symptoms such as blisters, peeling skin, red/purple rash, skin lesions and sores, and associated fever, sore throat.
COSOPT IS NOT RECOMMENDED FOR CHILDREN.
In studies with COSOPT, the effect of COSOPT was similar in both elderly and younger adult patients
Interactions With This Medication
Your doctor also needs to know about drugs (including eye drops) that you are using or plan to use, including drugs obtained without a prescription. This is particularly important if you are taking medicine to lower blood pressure (i.e. calcium channel blockers, clonidine), or to treat heart disease (i.e. quinidine, beta-blockers), diabetes, or depression (i.e. selective serotonin reuptake inhibitors, SSRI’s). Also tell your doctor if you are taking large doses of acetylsalicylic acid or sulfa drugs.
Proper Use of this Medication
Read the following information carefully. If you need any explanations, or further information, ask your doctor or pharmacist.
- Do not start taking any other medicines unless you have discussed the matter with your doctor.
- If you are using COSOPT with another eye drop, the drops should be instilled at least 10 minutes apart.
- Do not change the dosage of the drug without consulting your doctor. If you must stop treatment, contact your doctor 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.
When using COSOPT preservative-free formulation Ophthalmic Solution, the container and any remaining contents must be discarded after each treatment.
Usual Adult Dose
The appropriate dosage and duration of treatment will be established by your doctor.
The usual dose is one drop in the affected eye(s) in the morning and in the evening.
It is important to apply COSOPT 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 double dose.
|In case of drug overdose, particularly oral ingestion, contact your health care professional, hospital emergency department or regional poison control centre, even if there are no symptoms|
If you feel you have taken too much COSOPT and symptoms may include shortness of breath, low heartbeat, dizziness, headache, etc., seek medical help.
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). You may sense a bitter taste after putting in your eye drops. Kidney stones and rarely, rash may also occur.
- Also, other side effects that have been observed with the separate active ingredients in COSOPT include: muscle pain, abdominal pain, headache, nosebleed, dry mouth, nausea, tiredness, swelling or crusting of the eyelids.
Other side effects may also occur rarely, and some of these may be serious. These may include shortness of breath, severe skin reactions, visual changes, an irregular heartbeat and a slowing of your heart rate. 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.
- Your doctor or pharmacist has a complete list of the possible side effects from this medication. Please tell your doctor or pharmacist promptly about any unusual symptom.
- If you have blurred vision or tiredness, do not drive until the effects pass.
- If the contents of the container are swallowed, you should contact your doctor immediately.
Serious Side Effects, How Often They Happen and What to Do About Them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Rare||Heart effects such as irregular heartbeat, heart block, low blood pressure||✓|
|Allergic reactions with symptoms such as swelling of the mouth and throat, shortness of breath, hives, severe itching and rash||✓|
This is not a complete list of side effects. For any unexpected effects while taking COSOPT and COSOPT preservative-free formulation, contact your physician or pharmacist.
How to Store It
Store at room temperature 15 °C–25 °C. Protect from light.
COSOPT preservative-free formulation pipettes should be stored in protective foil pouch.
KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN.
Reporting Suspected Side Effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance program by one of the following 3 ways:
- Call toll-free at 1-866-234-2345
- Report online at www.healthcanada.gc.ca/medeffect Complete a Canada Vigilance Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, Ontario K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect
Or at Merck Canada Inc., by one of the following 2 ways:
- Call toll-free at 1-800-567-2594
- Complete a Canada Vigilance Reporting Form and
- Fax toll-free to: 1-800-369-3090
- Mail to: Merck Canada Inc.
16750, route Transcanadienne
Kirkland, Québec H9H 4M7
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program or Merck do not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.merck.ca
or by contacting the sponsor, Merck Canada Inc., at: 1-800-567-2594.