WARFARIN SODIUM

Anticoagulant (Vitamin K antagonist)

Brand names: Warfarin Sodium

Oral

Mechanism of Action

12.1 Mechanism of Action Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K-dependent clotting factors. Vitamin K promotes the biosynthesis of γ-carboxyglutamic acid residues in the proteins that are essential for biological activity. Warfarin is thought to interfere with clotting factor synthesis by inhibition of the C1 subunit of vitamin K epoxide reductase (VKORC1) enzyme complex, thereby reducing the regeneration of vitamin K 1 epoxide [see Clinical Pharmacology ( 12.5 )] .

Indications

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

Contraindications

• 4 CONTRAINDICATIONS Warfarin sodium is contraindicated in: Pregnancy Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves
• fatal fetal hemorrhage
• and an increased risk of spontaneous abortion and fetal mortality. If warfarin sodium is used during pregnancy or if the patient becomes pregnant while taking this drug
• or traumatic surgery resulting in large open surfaces [see Warnings and Precautions ( 5.8 )] Bleeding tendencies associated with: − Active ulceration or overt bleeding of the gastrointestinal
• genitourinary

FDA Warnings

5 WARNINGS AND PRECAUTIONS Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation
2 ) Calciphylaxis: Fatal and serious cases have occurred
4 ) Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death
5 ) Heparin-induced thrombocytopenia (HIT): Initial therapy with warfarin sodium in HIT has resulted in cases of amputation and death

Known Side Effects

9 documented side effects by frequency

Shortness of Breath

>10%

Fatigue

1-10%

Nausea

1-10%

Diarrhea

1-10%

Dizziness

1-10%

Drug Not Working

1-10%

Falls

1-10%

Headache

1-10%

Weakness

1-10%

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Compare With

1 available comparisons

vs WARFARIN

Formulations

Dosage Forms

Tablet

Route

Oral