ResoundingHealth
Search
  
Basic Drug Info
Drug Name:Warfarin Sodium
Manufacturer:BARR LABORATORIES, INC.
Other Info:MANUFACTURED BYBARR LABORATORIES, INC.POMONA, NY 10970 BR-831, 869, 832, 925, 874, 833, 926, 834, 835



Clinical Trials:


Indications and Usage
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Venous Thrombosis -- The formation or presence of a blood clot (THROMBUS) within a vein.

Pulmonary Embolism -- Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.

Complication -- Any disease or disorder that occurs during the course of (or because of) another disease.

Complication Aspects -- Used with diseases to indicate conditions that co-exist or follow, i.e., co-existing diseases, complications, or sequelae.

Atrial Fibrillation -- Abnormal cardiac rhythm that is characterized by rapid, uncoordinated firing of electrical impulses in the upper chambers of the heart (HEART ATRIA). In such case, blood cannot be effectively pumped into the lower chambers of the heart (HEART VENTRICLES). It is caused by abnormal impulse generation.

Myocardial Infarction -- NECROSIS of the MYOCARDIUM caused by an obstruction of the blood supply to the heart (CORONARY CIRCULATION).

Cerebrovascular accident -- sudden neurologic impairment due to a cerebrovascular disorder, either an arterial occlusion or an intracranial hemorrhage.

Contraindications
Anticoagulation is contraindicated in any localized or general physical condition or personal circumstance in which the hazard of hemorrhage might be greater than the potential clinical benefits of anticoagulation, such as:
Warnings

The most serious risks associated with anticoagulant therapy with warfarin sodium are hemorrhage in any tissue or organ and, less frequently (<0.1%), necrosis and/or gangrene of skin and other tissues.

The risk of hemorrhage is related to the level of intensity and the duration of anticoagulant therapy.

Hemorrhage and necrosis have in some cases been reported to result in death or permanent disability.

Necrosis appears to be associated with local thrombosis and usually appears within a few days of the start of anticoagulant therapy.

In severe cases of necrosis, treatment through debridement or amputation of the affected tissue, limb, breast or penis has been reported.

Careful diagnosis is required to determine whether necrosis is caused by an underlying disease.

Warfarin therapy should be discontinued when warfarin is suspected to be the cause of developing necrosis and heparin therapy may be considered for anticoagulation.

Although various treatments have been attempted, no treatment for necrosis has been considered uniformly effective.

See below for information on predisposing conditions.

These and other risks associated with anticoagulant therapy must be weighed against the risk of thrombosis or embolization in untreated cases.

It cannot be emphasized too strongly that treatment of each patient is a highly individualized matter.

Warfarin sodium, a narrow therapeutic range (index) drug, may be affected by factors such as other drugs and dietary Vitamin K.

Dosage should be controlled by periodic determinations of prothrombin time (PT)/International Normalized Ratio (INR) or other suitable coagulation tests.

Determinations of whole blood clotting and bleeding times are not effective measures for control of therapy.

Heparin prolongs the one-stage PT.

When heparin and warfarin sodium are administered concomitantly, refer below to Conversion From Heparin Therapy for recommendations.

Caution should be observed when warfarin sodium is administered in any situation or in the presence of any predisposing condition where added risk of hemorrhage, necrosis, and/or gangrene is present.

Anticoagulation therapy with warfarin sodium may enhance the release of atheromatous plaque emboli, thereby increasing the risk of complications from systemic cholesterol microembolization, including the “purple toes syndrome.” Discontinuation of warfarin sodium therapy is recommended when such phenomena are observed.

Systemic atheroemboli and cholesterol microemboli can present with a variety of signs and symptoms including purple toes syndrome, livedo reticularis, rash, gangrene, abrupt and intense pain in the leg, foot, or toes, foot ulcers, myalgia, penile gangrene, abdominal pain, flank or back pain, hematuria, renal insufficiency, hypertension, cerebral ischemia, spinal cord infarction, pancreatitis, symptoms simulating polyarteritis, or any other sequelae of vascular compromise due to embolic occlusion.

The most commonly involved visceral organs are the kidneys followed by the pancreas, spleen, and liver.

Some cases have progressed to necrosis or death.

Purple toes syndrome is a complication of oral anticoagulation characterized by a dark, purplish or mottled color of the toes, usually occurring between 3 to 10 weeks, or later, after the initiation of therapy with warfarin or related compounds.

Major features of this syndrome include purple color of plantar surfaces and sides of the toes that blanches on moderate pressure and fades with elevation of the legs; pain and tenderness of the toes; waxing and waning of the color over time.

While the purple toes syndrome is reported to be reversible, some cases progress to gangrene or necrosis which may require debridement of the affected area, or may lead to amputation.
Branded Drugs
The following US Branded drugs contain Warfarin Sodium


COUMADIN -- BRISTOL MYERS SQUIBB PHARMA CO

ATHROMBIN -- PHARMACEUTICAL RESEARCH ASSOC INC

JANTOVEN -- USL PHARMA INC

PANWARFIN -- ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV


This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.