Warfarin Sodium

INDICATIONS & USAGE

WARFARIN SODIUM CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

• ●     Bromelains, danshen, dong quai (Angelica sinensis), garlic, Ginkgo biloba, ginseng, and cranberry products are associated most often with an INCREASE in the effects of warfarin sodium.

• ●     Coenzyme Q10 (ubidecarenone) and St. John's wort are associated most often with a DECREASE in the effects of warfarin sodium.

INFORMATION FOR PATIENTS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

PEDIATRIC USE

GERIATRIC USE

WARFARIN SODIUM ADVERSE REACTIONS

• ●     Treatment.)

• ●     Bleeding which occurs when the PT/INR is within the therapeutic range warrants diagnostic investigation since it may unmask a previously unsuspected lesion, e.g., tumor, ulcer, etc.

• ●     Necrosis of skin and other tissues. (SeeWARNINGS.)

• ●     Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, including anaphylactic reactions, systemic cholesterol microembolization, purple toes syndrome, hepatitis, cholestatic hepatic injury, jaundice, elevated liver enzymes, hypotension, vasculitis, edema, anemia, pallor, fever, rash, dermatitis, including bullous eruptions, urticaria, angina syndrome, chest pain, abdominal pain including cramping, flatulence/bloating, fatigue, lethargy, malaise, asthenia, nausea, vomiting, diarrhea, pain, headache, dizziness, loss of consciousness, syncope, coma, taste perversion, pruritus, alopecia, cold intolerance, and paresthesia including feeling cold and chills.

OVERDOSAGE

DOSAGE & ADMINISTRATION

• ●     Clinical factors including age, race, body weight, sex, concomitant medications, and comorbidities and

• ●     Genetic factors (CYP2C9 and VKORC1 genotypes).

• ●     5 hours after the last IV bolus dose of heparin, or

• ●     4 hours after cessation of a continuous IV infusion of heparin, or

• ●     24 hours after the last subcutaneous heparin injection.

HOW SUPPLIED

STORAGE AND HANDLING

INFORMATION FOR PATIENTS

• ●     Tell their physician if they fall often as this may increase their risk for complications.

• ●     Strictly adhere to the prescribed dosage schedule. Do not take or discontinue any other drug, including salicylates (e.g., aspirin and topical analgesics), other over-the-counter drugs, and botanical (herbal) products except on advice of your physician.

• ●     Notify their physician immediately if any unusual bleeding or symptoms occur. Signs and symptoms of bleeding include: pain, swelling or discomfort, prolonged bleeding from cuts, increased menstrual flow or vaginal bleeding, nosebleeds, bleeding of gums from brushing, unusual bleeding or bruising, red or dark brown urine, red or tar black stools, headache, dizziness, or weakness.

• ●     Contact their doctor

• ●     Avoid any activity or sport that may result in traumatic injury.

• ●     Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy.

• ●     Carry identification stating that they are taking warfarin sodium.

• ●     If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses.

• ●     Eat a normal, balanced diet to maintain a consistent intake of vitamin K. Avoid drastic changes in dietary habits, such as eating large amounts of leafy, green vegetables.

• ●     Contact their physician to report any serious illness, such as severe diarrhea, infection, or fever.

• ●     Be aware that if therapy with warfarin sodium is discontinued, the anticoagulant effects of warfarin sodium may persist for about 2 to 5 days.

SPL MEDGUIDE

• ●     You may have a higher risk of bleeding if you take warfarin sodium and:

• ●               are 65 years of age or older

• ●               have a history of stomach or intestinal bleeding

• ●               have high blood pressure (hypertension)

• ●               have a history of stroke, or "mini-stroke" (transient ischemic attack or TIA)

• ●               have serious heart disease

• ●               have a low blood count or cancer

• ●               have had trauma, such as an accident or surgery

• ●               have kidney problems

• ●               take other medicines that increase your risk of bleeding, including:

• ●                    a medicine that contains heparin

• ●                    other medicines to prevent or treat blood clots

• ●                    nonsteroidal anti-inflammatory drugs (NSAIDs)

• ●               take warfarin sodium for a long time. Warfarin sodium is the active ingredient in Warfarin Sodium Tablets, USP.

• ●     Get your regular blood test to check for your response to warfarin sodium. This blood test is called an INR test. The INR test checks to see how fast your blood clots. Your healthcare provider will decide what INR numbers are best for you. Your dose of warfarin sodium will be adjusted to keep your INR in a target range for you.

• ●      Call your healthcare provider right away if you get any of the following signs or symptoms of bleeding problems:

• ●               pain, swelling, or discomfort

• ●               headaches, dizziness, or weakness

• ●               unusual bruising (bruises that develop without known cause or grow in size)

• ●               nosebleeds

• ●               bleeding gums

• ●               bleeding from cuts takes a long time to stop

• ●               menstrual bleeding or vaginal bleeding that is heavier than normal

• ●               pink or brown urine

• ●               red or black stools

• ●               coughing up blood

• ●               vomiting blood or material that looks like coffee grounds

• ●      Some foods and beverages can interact with warfarin sodium and affect your treatment and dose.

• ●               Eat a normal, balanced diet. Talk to your healthcare provider before you make any diet changes. Do not eat large amounts of leafy, green vegetables. Leafy, green vegetables contain vitamin K. Certain vegetable oils also contain large amounts of vitamin K. Too much vitamin K can lower the effect of warfarin sodium.

• ●     Always tell all of your healthcare providers that you take warfarin sodium.

• ●     Wear or carry information that you take warfarin sodium.

• ●     your chance of having bleeding problems is higher than the possible benefit of treatment. Your healthcare provider will decide if warfarin sodium is right for you. Talk to your healthcare provider about all of your health conditions.

• ●      you are pregnant unless you have a mechanical heart valve.Warfarin sodium may cause birth defects, miscarriage, or death of your unborn baby.

• ●      you are allergic to warfarin or any of the other ingredients in Warfarin Sodium Tablets, USP. See the end of this leaflet for a complete list of ingredients in Warfarin Sodium Tablets, USP.

• ●     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

• ●     are pregnant or plan to become pregnant. See "Who should not take warfarin sodium?"

• ●     are breast-feeding. You and your healthcare provider should decide if you will take warfarin sodium and breast-feed.

• ●      Take warfarin sodium exactly as prescribed.Your healthcare provider will adjust your dose from time to time depending on your response to warfarin sodium.

• ●      You must have regular blood tests and visits with your healthcare provider to monitor your condition.

• ●      If you miss a dose of warfarin sodium, call your healthcare provider.Take the dose as soon as possible on the same day.Do nottake a double dose of warfarin sodium the next day to make up for a missed dose.

• ●     Call your healthcare provider right away if you:

• ●               take too much warfarin sodium

• ●               are sick with diarrhea, an infection, or have a fever

• ●               fall or injure yourself, especially if you hit your head. Your healthcare provider may need to check you

• ●     Do not do any activity or sport that may cause a serious injury.

• ●     See "What is the most important information I should know about warfarin sodium?"

• ●                Death of skin tissue (skin necrosis or gangrene).This can happen soon after starting warfarin sodium. It happens because blood clots form and block blood flow to an area of your body. Call your healthcare provider right away if you have pain, color, or temperature change to any area of your body. You may need medical care right away to prevent death or loss (amputation) of your affected body part.

• ●                "Purple toes syndrome."Call your healthcare provider right away if you have pain in your toes and they look purple in color or dark in color.

• ●     Store warfarin sodium at 68to 77(20to 25

• ●     Keep warfarin sodium in a tightly closed container, and keep warfarin sodium out of the light.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION