Coumadin - Consumer Medicine Information
|Condition:||Antiphospholipid Syndrome, Chronic Central Venous Catheterization, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis, First Event, Deep Vein Thrombosis, Recurrent Event, Heart Attack (Myocardial Infarction), Heart Failure (Congestive Heart Failure), Pulmonary Embolism, Recurrent Event, Pulmonary Embolism, First Event, Protein S Deficiency, Prosthetic Heart Valves, Tissue Valves - Thrombosis Prophylaxis, Prosthetic Heart Valves, Mechanical Valves - Thrombosis Prophylaxis, Prosthetic Heart Valves - Thrombosis Prophylaxis, Prevention of Thromboembolism in Atrial Fibrillation, Thromboembolic Stroke Prophylaxis|
|Class:||Anticoagulants, Coumarins and indandiones|
|Ingredients:||warfarin sodium, magnesium stearate, lactose anhydrous, pregelatinized tapioca starch, and colour dye which varies in each tablet strength|
What is COUMADIN
- COUMADIN is an anticoagulant drug. "Anti" means against, and "coagulant" refers to blood clotting. An anticoagulant helps reduce clots from forming in the blood.
- COUMADIN is a narrow therapeutic index drug, which means that there is a narrow margin between too much and too little of the drug. Too much drug may cause you to bleed more. Too little drug may let a harmful clot form.
How does COUMADIN work
- COUMADIN partially blocks the re-use of vitamin K in your liver. Vitamin K is needed to make clotting factors that help the blood to clot and prevent bleeding. Vitamin K is found naturally in foods such as leafy, green vegetables and certain vegetable oils.
- COUMADIN begins to reduce blood clotting within 24 hours after taking the drug. The full effect may take 72 to 96 hours to occur. The anti-clotting effects of a single dose of COUMADIN last 2 to 5 days, but it is important for you to take your dose every day.
What should I tell my healthcare provider before starting COUMADIN
Tell your healthcare provider about all of your health conditions, including if you:
- have bleeding problems
- fall often
- have liver or kidney problems
- have high blood pressure
- have a heart problem called congestive heart failure
- have diabetes
- plan to have any surgery or a dental procedure
- have any other medical conditions
- drink alcohol or have problems with alcohol abuse. Alcohol can affect your COUMADIN dose and should be avoided.
- are pregnant or planning to become pregnant.
- are breastfeeding. COUMADIN may increase bleeding in your baby. Talk to your doctor about the best way to feed your baby. If you choose to breastfeed while taking COUMADIN, both you and your baby should be carefully monitored for bleeding problems.
Tell all of your healthcare providers and dentists that you are taking COUMADIN. They should talk to the healthcare provider who prescribed COUMADIN for you before you have any surgery or dental procedure. Your COUMADIN may need to be stopped for a short time or you may need your dose adjusted.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Some of your other medicines may affect the way COUMADIN works. Certain medicines may increase your risk of bleeding. See “What should I avoid while taking COUMADIN?”
What is the most important information I should know when taking COUMADIN
- Like all prescription drugs, COUMADIN may cause side effects. The most common side effect of COUMADIN is bleeding, which may be serious and life-threatening. However, the risk of serious bleeding is low when the effect of COUMADIN is within a range that is right for your specific medical condition. Notify your health care provider right away of any unusual bleeding or if signs or symptoms of bleeding occur (see “What are the possible side effects of COUMADIN”).
- Do not take COUMADIN during pregnancy. Use effective measures to avoid pregnancy while taking COUMADIN. This is very important because your unborn baby could be seriously harmed if you take COUMADIN while you are pregnant. Your baby could be born with birth defects or could die.
- The dose of COUMADIN may be different for each patient. For example, older patients (age 60 years of age or older) appear to have a greater-than-expected response to COUMADIN so that as patient age increases, a lower dose of COUMADIN may be Your health care provider will decide what dose is best for you. This dose may change from time to time.
- To decide on the dosage of COUMADIN you need, your health care provider will take a small amount of your blood to find out your prothrombin time, protime, or PT, for short. Protimes are often recorded as an INR (International Normalized Ratio), a standard way of reporting protimes.
- PT/INR tests are very important. They help your health care provider see how fast your blood is clotting and whether your dosage of COUMADIN should change.
- When you start taking COUMADIN, you may have PT/INR tests every day for a few days, then perhaps one time every week. These PT/INR tests and regular visits to a health care provider are very important for the success of therapy with COUMADIN.
- PT/INR tests will be needed at periodic intervals (such as one time per month) throughout your course of therapy to keep your PT/INR in the best range for your medical condition. Discuss with your health care provider the range that is right for you.
- Eat a normal balanced diet maintaining a consistent level of green, leafy vegetables that contain high amounts of Vitamin K since the amount of vitamin K in your daily diet may affect COUMADIN
- Call your healthcare provider right away if you take too much COUMADIN.
- Report right away any illness, such as throwing up (vomiting), loose or runny stools (diarrhea), an infection or fever, to your health care provider.
- Call your healthcare provider right away if you fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you.
- Tell anyone giving you medical or dental care that you are taking COUMADIN.
- Tell your healthcare provider about any planned surgeries, medical or dental procedures. Your COUMADIN may have to be stopped for a short time or you may need your dose adjusted.
- Carry identification stating that you are taking COUMADIN.
How should I take COUMADIN
- Take COUMADIN exactly the way your health care provider tells you and take it at the same time every day. You can take COUMADIN either with food or on an empty Your dosage may change from time to time depending on your response to COUMADIN.
- If you miss a dose of COUMADIN, notify your health care provider right away. Take the dose as soon as possible on the same day, but do not take a double dose of COUMADIN the next day to make up for a missed dose.
What are the possible side effects of COUMADIN
Your health care provider can tell you about possible side effects of COUMADIN, which include bleeding and allergic reactions. To lower the risk of bleeding, your PT/INR should be kept within a range that is right for you.
Please contact your health care provider right away if you experience any of the following signs or symptoms of bleeding problems.
- headache, dizziness, or weakness
- fatigue, feeling tired, general feeling of illness (malaise)
- bleeding from shaving or other cuts that does not stop
- bleeding of gums when brushing your teeth
- coughing up blood
- vomiting blood or material that looks like coffee grounds
- unusual bruising (black-and-blue marks on your skin) for unknown reasons
- pink or dark brown urine
- red or black color in your stool
- more bleeding than usual when you get your menstrual period or unexpected bleeding from the vagina
- unusual pain or swelling
Serious, but rare, side effects of COUMADIN include skin necrosis (death of skin tissue), calciphylaxis and “purple toe syndrome,” either of which may require removal of unhealthy tissue and/or amputation of the affected area. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body or if you have pain in your legs or toes and they look purple or dark in color. You may need medical care right away. Talk with your health care provider for further information on these side effects.
Hypersensitivity/allergic reactions are reported infrequently. Signs or symptoms of these reactions may range from mild reactions (rash, itching, hives) to more severe reactions (trouble breathing, throat tightening or constriction, facial swelling, swollen lips or tongue, sudden low blood pressure).
These are not all of the side effects of COUMADIN. For more information, ask your healthcare provider or pharmacist.
What should I avoid while taking COUMADIN
- Do not start, stop, or change any medicine except on advice of your health care provider. COUMADIN interacts with many different drugs, including aspirin and aspirin-containing ointments and skin creams as well as natural medicines (e.g., bromelains, coenzyme Q10, danshen (Colocasia antiquorum), dong quai (Angelica sinensia), garlic, ginkgo biloba, ginseng and St. John’s wort). Tell your health care provider about any prescription and non-prescription (over-the-counter) drugs that you are taking including occasional use of headache medications.
- Do not take any other medicines that contain warfarin. Warfarin is the active ingredient in COUMADIN
- Do not make drastic changes in your diet, such as eating large amounts of green, leafy vegetables. The amount of vitamin K in your daily diet may affect therapy with COUMADIN.
- Avoid intake of cranberry juice or any other cranberry products. Notify your healthcare provider if any of these products are part of your normal diet.
- Do not attempt to change your weight by dieting, without first checking with your health care provider.
- Avoid alcohol consumption.
- Do not participate in any activity or sport that may result in serious injury.
- Avoid cutting yourself.
What does COUMADIN look like
COUMADIN Tablets are available in many strengths and each strength has a unique tablet color:
|Tablet Strength||Tablet Color|
|10 mg||White (Dye free)|
Each round, single-scored tablet is imprinted on one side with the word “COUMADIN” and the numeric strength of the tablet.
Be sure to check that the tablet shows “COUMADIN” and the right numeric strength before you take it.
How to Store COUMADIN
- Store the tablets at room temperature (15°C to 30°C).
- Protect from light and moisture.
- Keep out of reach and sight of children.
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website at: http://www.bmscanada.ca or by contacting the sponsor, Bristol-Myers Squibb Canada at: 1-866-463-6267.