Jantoven

It is used to decrease the clotting ability of the blood and to help prevent harmful clots from forming in the blood vessels . It is often used to prevent or treat deep venous thrombosis, a condition in which harmful blood clots form in the blood vessels of the legs. These blood clots can travel to the lungs and cause a condition called pulmonary embolism. Warfarin is also used to prevent or treat blood clots that are caused by certain heart conditions or open-heart surgery. It may be used after a heart attack to prevent blood clots from forming. Although it will not dissolve blood clots that have already formed, warfarin may keep the clots from becoming larger and causing more serious problems .

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of warfarin in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of warfarin in the elderly. However, elderly patients may require an adjustment in the dose, especially those who are at risk of bleeding.

Pregnancy

Breastfeeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Tamoxifen

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab


• Acenocoumarol


• Alteplase, Recombinant


• Amiodarone


• Ancrod


• Anisindione


• Anistreplase


• Antithrombin III Human


• Aprepitant


• Ardeparin


• Aspirin


• Bivalirudin


• Capecitabine


• Carboplatin


• Celecoxib


• Certoparin


• Chamomile


• Cilostazol


• Citalopram


• Clopidogrel


• Cyclophosphamide


• Dalteparin


• Danaparoid


• Defibrotide


• Dermatan Sulfate


• Desvenlafaxine


• Dicumarol


• Doxorubicin


• Duloxetine


• Enoxaparin


• Eptifibatide


• Escitalopram


• Etoposide


• Etravirine


• Fenofibrate


• Fenofibric Acid


• Fish Oil


• Fluconazole


• Fluorouracil


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Garlic


• Ginkgo


• Heparin


• Imatinib


• Influenza Virus Vaccine


• Ketoprofen


• Lamifiban


• Leflunomide


• Levofloxacin


• Lycium


• Marijuana


• Mechlorethamine


• Methotrexate


• Methyl Salicylate


• Metronidazole


• Milnacipran


• Moxifloxacin


• Nadroparin


• Nandrolone


• Naproxen


• Nilotinib


• Noscapine


• Oxandrolone


• Papaya


• Parnaparin


• Paroxetine


• Pentosan Polysulfate Sodium


• Phenindione


• Phenprocoumon


• Pomegranate


• Prasugrel


• Procarbazine


• Proguanil


• Reteplase, Recombinant


• Reviparin


• Ropinirole


• Sertraline


• Sibrafiban


• Simvastatin


• Sitaxsentan


• St John`s Wort


• Streptokinase


• Sulfamethoxazole


• Sulfisoxazole


• Tan-Shen


• Tenecteplase


• Testosterone


• Tinzaparin


• Tirofiban


• Torsemide


• Urokinase


• Venlafaxine


• Vincristine


• Vindesine


• Voriconazole


• Xemilofiban

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose


• Acemetacin


• Acetaminophen


• Allopurinol


• Aminoglutethimide


• Amitriptyline


• Amoxicillin


• Amprenavir


• Apazone


• Avocado


• Azathioprine


• Azithromycin


• Benorilate


• Benzbromarone


• Black Tea


• Bosentan


• Bromfenac


• Butabarbital


• Butalbital


• Carbamazepine


• Carbimazole


• Cefamandole


• Cefazolin


• Chitosan


• Chloral Hydrate


• Cholestyramine


• Choline Salicylate


• Chondroitin


• Cimetidine


• Ciprofloxacin


• Cisapride


• Clarithromycin


• Coenzyme Q10


• Colesevelam


• Curcumin


• Cyclosporine


• Danazol


• Darunavir


• Dexamethasone


• Dexlansoprazole


• Dextrothyroxine


• Dicloxacillin


• Diflunisal


• Disopyramide


• Disulfiram


• Dong Quai


• Doxepin


• Enoxacin


• Erlotinib


• Erythromycin


• Esomeprazole


• Eterobarb


• Ethinyl Estradiol


• Etonogestrel


• Exenatide


• Felbamate


• Fluoxymesterone


• Fluvastatin


• Gefitinib


• Gemcitabine


• Gemfibrozil


• Ginger


• Ginseng


• Glucagon


• Glucosamine


• Glyburide


• Green Tea


• Griseofulvin


• Ifosfamide


• Indomethacin


• Indoprofen


• Isoniazid


• Isoxicam


• Itraconazole


• Ivermectin


• Ketoconazole


• Lactulose


• Lansoprazole


• Lepirudin


• Levamisole


• Levonorgestrel


• Levothyroxine


• Liothyronine


• Lopinavir


• Lornoxicam


• Melatonin


• Meloxicam


• Menthol


• Mephobarbital


• Mercaptopurine


• Mesalamine


• Mesna


• Mestranol


• Methimazole


• Methylprednisolone


• Methyltestosterone


• Methylthiouracil


• Miconazole


• Mitotane


• Moricizine


• Nafcillin


• Nalidixic Acid


• Nevirapine


• Nilutamide


• Nimesulide


• Norelgestromin


• Norethindrone


• Norfloxacin


• Norgestrel


• Ofloxacin


• Omeprazole


• Orlistat


• Oxyphenbutazone


• Pantoprazole


• Phenobarbital


• Phenylbutazone


• Phytonadione


• Piracetam


• Polyacrylamide


• Potassium Iodide


• Prednisone


• Primidone


• Propafenone


• Propoxyphene


• Propylthiouracil


• Quetiapine


• Ranitidine


• Rifabutin


• Rifampin


• Rifapentine


• Ritonavir


• Rofecoxib


• Rosuvastatin


• Roxithromycin


• Salicylamide


• Salicylic Acid


• Salsalate


• Saquinavir


• Secobarbital


• Sodium Salicylate


• Sodium Thiosalicylate


• Soybean


• Soy Isoflavones


• Soy Protein


• Stanozolol


• Sucralfate


• Sulfinpyrazone


• Sulindac


• Tenidap


• Terbinafine


• Thyroglobulin


• Thyroid


• Tibolone


• Ticlopidine


• Tigecycline


• Tolterodine


• Tramadol


• Trastuzumab


• Trolamine Salicylate


• Valdecoxib


• Vancomycin


• Vitamin A


• Vitamin E


• Vorinostat


• Zafirlukast


• Zileuton

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Enteral Nutrition


• High Protein Food


• Noni Juice


• Vitamin K Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or


• Mental disorders (e.g., psychosis or senility)a€”Patients with these conditions or those who cannot cooperate should not be given warfarin.

• Blood disease or bleeding problems or


• Heart infection or


• High blood pressure or


• Spinal anesthesia, recent or


• Stomach or intestinal ulcer (active) or


• Stroke or


• Surgery, recent or scheduled (e.g., surgery of the eye, brain, or spine) or


• Threatened miscarriagea€”Warfarin should not be used in patients with any of these conditions. The risk of bleeding from warfarin may be increased .

• Catheter insertion or


• Congestive heart failure or


• Deep venous thrombosis, heparin-induced or


• Diabetes mellitus (sugar diabetes) or


• Falls or blows to the body or head or


• Infection or


• Kidney disease or


• Liver disease or


• Major surgery, any type or


• Thrombocytopenia, heparin-induceda€”Use with caution. This medicine may increase your risk of having serious problems .

Proper Use

Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.

Carefully follow your doctor`s instructions about any special diet. This medicine works best when you eat about the same amount of vitamin K in your food every day. Avoid big changes in how much vitamin K you eat. Some foods that have a high amount of vitamin K are asparagus, broccoli, brussels sprouts, cabbage, green leafy vegetables (such as collards, turnip greens, mustard greens, spinach, and salad greens), plums, rhubarb, and certain vegetable oils (such as soybean oil and canola oil).

Do not drink alcohol while you are using this medicine. Also avoid drinking cranberry juice or eating cranberry products .

You may take the tablets on a full or empty stomach.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  
  
  • For prevention or treatment of blood clots:
    
    
    
    • Adulta€”At first, 2 milligrams (mg) to 5 mg per day. Your doctor will then adjust your dose up to a maximum of 10 mg per day depending on your condition.
    
    
    • Childrena€”Use and dose must be determined by your doctor . .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly. Blood tests, such as INR, are needed to check for proper dosage and unwanted side effects. Be sure to keep all appointments.

Using this medicine while you are pregnant can harm your unborn baby . Use an effective form of birth control to keep from getting pregnant . If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not stop taking any of your medicines or start any new medicines unless they have been discussed with your doctor . Keep a list of your medicines with you at all times. This includes prescription medicines, nonprescription (over-the-counter [OTC]) medicines, and herbal or vitamin supplements.

Do not take other medicines that also contain warfarin. Using too much warfarin may cause serious bleeding problems .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.

Check with your doctor immediately if you start to have diarrhea, fever, or any signs of infection.

Call your doctor right away if you have pain in your toes and they look purple or dark in color. Also tell your doctor right away if you have pain, a color change, or a temperature change to any area of your body . These could be signs of a serious medical problem .

This medicine may increase your chance of bleeding. Check with your doctor right away if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin . Avoid picking your nose. If you need to blow your nose, blow it gently.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters. Avoid contact sports or other situations where bruising or injury could occur.

It is recommended that you carry identification that says you are using warfarin. If you have any questions about what kind of identification to carry, check with your doctor .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

Less common

• Abdominal or stomach pain with cramping


• Bleeding gums


• Blood in the urine


• Bloody stools


• Blurred vision


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain or discomfort


• Confusion


• Coughing up blood


• Difficulty with breathing or swallowing


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Excessive bruising


• Headache


• Increased menstrual flow or vaginal bleeding


• Nosebleeds


• Paralysis


• Peeling of the skin


• Prolonged bleeding from cuts


• Red or black, tarry stools


• Red or dark brown urine


• Shortness of breath


• Sweating


• Unexplained swelling


• Unusual tiredness or weakness

Rare

• Arm, back, or jaw pain


• Blue or purple toes


• Change in consciousness


• Chest tightness or heaviness


• Chills


• Clay-colored stools


• Diarrhea


• Dizziness


• Fainting or loss of consciousness


• Fast or irregular breathing


• Fast or irregular heartbeat


• Fever


• Itching


• Light-colored stools


• Loss of appetite


• Nausea and vomiting


• Pain in the toes


• Pale skin


• Skin blisters


• Skin rash


• Small red or purple spots on the skin


• Stomach pain


• Swelling of the eyes or eyelids


• Tightness in the chest and/or wheezing


• Troubled breathing with exertion


• Unpleasant breath odor


• Unusual bleeding or bruising


• Upper right abdominal pain


• Vomiting of blood


• Yellow eyes and skin

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Joint pain


• Muscle pain

Rare

• Bloated


• Change in taste, or bad, unusual, or unpleasant (after) taste


• Cold intolerance


• Excess air or gas in the stomach or intestines


• Full feeling


• General feeling of discomfort or illness


• Hair loss or thinning of the hair


• Hives or welts


• Lack or loss of strength


• Pain


• Passing gas


• Red, sore, or itching skin


• Sores, welting, or blisters


• Unusual drowsiness, dullness, or feeling of sluggishness

Incidence not known

• Painful or prolonged erection of the penis

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.