Warfarin Sodium
Generic Name: warfarin sodium
Brand Names:
Warfarin Sodium
11 DESCRIPTION Warfarin sodium tablets, USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R - and S -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows: C 19 H 15 NaO 4 M.W.
Overview
11 DESCRIPTION Warfarin sodium tablets, USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R - and S -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows: C 19 H 15 NaO 4 M.W.
Uses
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.
Dosage
2 DOSAGE AND ADMINISTRATION Individualize dosing regimen for each patient, and adjust based on INR response. ( 2.1 , 2.2 ) Knowledge of genotype can inform initial dose selection. ( 2.3 ) Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. ( 2.4 ) Review conversion instructions from other anticoagulants. ( 2.8 ) 2.1 Individualized Dosing The dosage and administration of warfarin sodium tablets must be individualized for each patient according to the patient’s International Normalized Ratio (INR) response to the drug. Adjust the dose based on the patient’s INR and the condition being treated.
Side Effects
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 )] Tissue Necrosis [see Warnings and Precautions ( 5.2 )] Calciphylaxis [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury [see Warnings and Precautions ( 5.4 )] Systemic Atheroemboli and Cholesterol Microemboli [see Warnings and Precautions ( 5.5 )] Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions ( 5.6 )] Other Clinical Settings with Increased Risks [see Warnings and Precautions ( 5.8 )] Other adverse reactions to warfarin sodium include: Immune system disorders: hypersensitivity/allergic reactions (includ...
Interactions
7 DRUG INTERACTIONS Concomitant use of drugs that increase bleeding risk, antibiotics, antifungals, botanical (herbal) products, and inhibitors and inducers of CYP2C9, 1A2, or 3A4. ( 7 ) Consult labeling of all concurrently used drugs for complete information about interactions with warfarin sodium or increased risks for bleeding. ( 7 ) 7.1 General Information Drugs may interact with warfarin sodium through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with warfarin sodium are synergism (impaired hemostasis, reduced clotting factor synthesis), competitive antagonism (vitamin K), and alteration of the physiologic control loop for vitamin K metabolism (hereditary resistance).
Warnings
WARNING: BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of INR in all treated patients [see Dosage and Administration ( 2.1 )] . Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions ( 7 )] . 5 WARNINGS AND PRECAUTIONS Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue warfarin sodium and consider alternative anticoagulants if necessary. ( 5.2 ) Calciphylaxis: Fatal and serious cases have occurred. Discontinue warfarin sodium and consider alternative anticoagulation therapy. ( 5.3 ) Acute kidney injury may occur during episodes of excessive anticoagulation and hematuria. ( 5.4 ) Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue warfarin sodium if such emboli occur. ( 5.5 ) Heparin-induced thrombocytopenia (HIT): Initial therapy with warfarin sodium in HIT has resulted in cases of amputation and death. 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, who are at high risk of thromboembolism [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] . Warfarin sodium can cause fetal harm when administered to a pregnant woman.
Pregnancy
8.1 Pregnancy Risk Summary Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see Warnings and Precautions ( 5.7 )] . Warfarin sodium can cause fetal harm. Exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Warfarin sodium tablets USP, 7.5 mg are available as yellow, capsule-shaped, biconvex scored tablets, debossed with TV/71/2 on the scored side and 1719 on the other side containing 7.5 mg warfarin sodium, USP, packaged in NDC: 70518-1467-00 PACKAGING: 30 in 1 BLISTER PACK Dispense in a tight, light-resistant container as defined in the USP, with a child-resista...
Frequently Asked Questions
What is Warfarin Sodium used for?▼
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.
What are the side effects of Warfarin Sodium?▼
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 )] Tissue Necrosis [see Warnings and Precautions ( 5.2 )] Calciphylaxis [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury [see Warnings and Precautions ( 5.4 )] Systemic Atheroemboli and Cholesterol Microemboli [see Warnings and Precautions ( 5.5 )] Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions ( 5.6 )] Other Clinical Settings with Increased Risks [see Warnings and Precautions ( 5.8 )] Other adverse reactions to warfarin sodium include: Immune system disorders: hypersensitivity/allergic reactions (includ...
Can I take Warfarin Sodium during pregnancy?▼
8.1 Pregnancy Risk Summary Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of warfarin sodium may outweigh the risks [see Warnings and Precautions ( 5.7 )] . Warfarin sodium can cause fetal harm. Exposure to warfarin during the first trimester of pregnancy caused a pattern of congenital malformations in about 5% of exposed offspring.
What are the important warnings for Warfarin Sodium?▼
WARNING: BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of INR in all treated patients [see Dosage and Administration ( 2.1 )] . Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions ( 7 )] . 5 WARNINGS AND PRECAUTIONS Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue warfarin sodium and consider alternative anticoagulants if necessary. ( 5.2 ) Calciphylaxis: Fatal and serious cases have occurred. Discontinue warfarin sodium and consider alternative anticoagulation therapy. ( 5.3 ) Acute kidney injury may occur during episodes of excessive anticoagulation and hematuria. ( 5.4 ) Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue warfarin sodium if such emboli occur. ( 5.5 ) Heparin-induced thrombocytopenia (HIT): Initial therapy with warfarin sodium in HIT has resulted in cases of amputation and death. 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, who are at high risk of thromboembolism [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] . Warfarin sodium can cause fetal harm when administered to a pregnant woman.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.