Warfarin Sodium
Generic: WARFARIN SODIUM
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
73048ed9-242f-4f86-a8db-9c7547daa01d
Indications & Usage
1 INDICATIONS AND USAGE Warfarin sodium tablets are indicated for: • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
• Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
• Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets are a vitamin K antagonist indicated for: • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 ) • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1 ) • Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ( 1 ) Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
( 1 )
• Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
• Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
Warfarin sodium tablets are a vitamin K antagonist indicated for: • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1 ) • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1 ) • Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ( 1 ) Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling: • Hemorrhage [ see Boxed Warning , Warnings and Precautions ( 5.1 ) , and Overdosage ( 10 ) ] • Necrosis of skin and other tissues [ see Warnings and Precautions ( 5.2 ) ] • Systemic atheroemboli and cholesterol microemboli [ see Warnings and Precautions ( 5.3 ) ] Other adverse reactions to warfarin sodium include: • Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) • Vascular disorders: vasculitis • Hepatobiliary disorders: hepatitis, elevated liver enzymes.
Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine.
• Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating • Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia • Respiratory disorders: tracheal or tracheobronchial calcification • General disorders: chills Most common adverse reactions to warfarin sodium are fatal and nonfatal hemorrhage from any tissue or organ.
( 6 )To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine.
• Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating • Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia • Respiratory disorders: tracheal or tracheobronchial calcification • General disorders: chills Most common adverse reactions to warfarin sodium are fatal and nonfatal hemorrhage from any tissue or organ.
( 6 )To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.