Warfarin Sodium Tablets

Signs and Symptoms

Suspected or overt abnormal bleeding (e.g., appearance of blood in stools or urine, hematuria, excessive menstrual bleeding, melena, petechiae, excessive bruising or persistent oozing from superficial injuries) are early manifestations of anticoagulation beyond a safe and satisfactory level.

Treatment

Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing Jantoven® Tablets (Warfarin Sodium Tablets, USP) therapy and if necessary, by administration of oral or parenteral vitamin K1 . (Please see recommendations accompanying vitamin K1 preparations prior to use.)8,9

Such use of vitamin K1 reduces response to subsequent Jantoven (warfarin sodium tablets) ® Tablets therapy. Patients may return to a pretreatment 1 thrombotic status following the rapid reversal of a prolonged PT/INR. Resumption of Jantoven® Tablets (warfarin sodium tablets) administration reverses the effect of vitamin K, and a therapeutic PT/INR can again be obtained by careful dosage adjustment. If rapid anticoagulation is indicated, heparin may be preferable for initial therapy.

If minor bleeding progresses to major bleeding, give 5 to 25 mg (rarely up to 50 mg) parenteral vitamin K1 . In emergencysituations of severe hemorrhage, clotting factors can be returned to normal by administering 200 to 500 mL of fresh whole blood or fresh frozen plasma, or by giving commercial Factor IX complex.

A risk of hepatitis and other viral diseases is associated with the use of these blood products; Factor IX complex is also associated with an increased risk of thrombosis. Therefore, these preparations should be used only in exceptional or life-threatening bleeding episodes secondary to Jantoven® Tablets (warfarin sodium tablets) overdosage.

Purified Factor IX preparations should not be used because they cannot increase the levels of prothrombin, Factor VII and Factor X which are also depressed along with the levels of Factor IX as a result of Jantoven® Tablets (warfarin sodium tablets) treatment. Packed red blood cells may also be given if significant blood loss has occurred. Infusions of blood or plasma should be monitored carefully to avoid precipitating pulmonary edema in elderly patients or patients with heart disease.

Follow your doctor's instructions about taking warfarin while you are pregnant. Warfarin can harm an unborn baby or cause birth defects. However, the benefits of preventing blood clots in certain women may outweigh any risks to the baby.

Never take a double dose of this medication.

You should not take warfarin if you have a bleeding or blood cell disorder, blood in your urine or stools, an infection of the lining of your heart, stomach bleeding, bleeding in the brain, recent or upcoming surgery, or if you need a spinal tap or spinal anesthesia (epidural).

Warfarin may cause you to bleed more easily, especially if you have: a history of bleeding problems, high blood pressure or severe heart disease, kidney or liver disease, cancer, surgery or a medical emergency, a disease affecting the blood vessels in your brain, a history of stomach or intestinal bleeding, if you are 65 or older, or if you are severely ill or debilitated.

Many drugs (including some over-the-counter medicines and herbal products) can cause serious medical problems or death if you take them with warfarin. It is very important to tell your doctor about all medicines you have recently used.

Ask your doctor before taking any medicine for pain, arthritis, fever, or swelling. These medicines may affect blood clotting and may also increase your risk of stomach bleeding.

Any doctor, dentist, surgeon, or other medical care provider who treats you should know that you are taking this medication.

Avoid making any changes in your diet without first talking to your doctor.