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 tablets.

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

INFORMATION FOR PATIENTS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

PEDIATRIC USE

GERIATRIC USE

WARFARIN SODIUM ADVERSE REACTIONS

• ●     OVERDOSAGE: 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).

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

REFERENCES

SPL MEDGUIDE

• ●     Take your warfarin sodium tablets exactly as prescribed to lower the chance of blood clots forming in your body (seeWhat is warfarin sodium?).

• ●     Warfarin sodium tablets are very important for your health, but it can cause serious and life-threatening bleeding problems. To benefit from warfarin sodium tablets and also lower your chance for bleeding problems, you must:

• ●      Many other medicines, including prescription and non-prescription medicines, vitamins and herbal supplements can interact with warfarin sodium tablets and:

• ●     Do not take other medicines that contain warfarin.Warfarin is the active ingredient in warfarin sodium tablets.

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

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

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

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

• ●      you are pregnant or plan to become pregnant.Warfarin sodium tablets can cause death or birth defects to an unborn baby. Use effective birth control if you can get pregnant.

• ●      you are allergic to warfarin or to anything else in warfarin sodium tablets.

• ●     have bleeding problems

• ●     fall often

• ●     have liver or kidney problems

• ●     have high blood pressure

• ●     have a heart problem called congestive heart failure

• ●     have diabetes

• ●     drink alcohol or have problems with alcohol abuse. Alcohol can affect your warfarin sodium dose and should be avoided.

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

• ●      are breastfeeding.Warfarin sodium tablets 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 warfarin sodium tablets, both you and your baby should be carefully monitored for bleeding problems.

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

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

• ●      Take warfarin sodium tablets at the same time every day.You can take warfarin sodium tablets either with food or on an empty stomach.

• ●      If you miss a dose of warfarin sodium tablets, call your healthcare provider.Take the dose as soon as possible on the same day. Do not take a double dose of warfarin sodium tablets the next day to make up for a missed dose.

• ●      Call your healthcare provider right away if you take too much warfarin sodium tablets.

• ●     Call your healthcare provider if you are sick with diarrhea, an infection, or have a fever.

• ●     Tell your healthcare provider about any planned surgeries, medical or dental procedures.Your warfarin sodium tablets may have to be stopped for a short time or you may need your dose adjusted.

• ●      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.

• ●      Do not start, stop, or change any medicine without talking with your healthcare provider.

• ●     Do not make changes in your diet, such as eating large amounts of green, leafy vegetables.

• ●     Do not change your weight by dieting, without first checking with your healthcare provider.

• ●     Avoid drinking alcohol.

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

• ●      Warfarin sodium is very important for your health, but it can cause serious and life-threatening bleeding problems (see "What is the most important information I should know about warfarin sodium tablets?").

• ●      Serious side effects of warfarin sodium tablets also include:

• ●      Store warfarin sodium tablets at 20- 25(68- 77[see USP Controlled Room Temperature]. Protect from light.

• ●      Keep warfarin sodium tablets and all medicines out of the reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION