Warfarin sodium is the generic equivalent of the brand-name drug Warfarin Sodium. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Warfarin sodium through Premier Pharma with same-day fulfillment on in-stock SKUs.
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FDA Boxed Warning
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) ]. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information (17) ]. WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Warfarin sodium can cause major or fatal bleeding. ( 5.1 ) Perform regular monitoring of INR in all treated patients. ( 2.1 ) Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium…
Source: FDA prescribing information. For licensed professionals only.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Warfarin sodium tablets, USP 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. Warfarin sodium is 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 fibrillati…
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) ].
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY 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…
Contraindications & Precautions
4 CONTRAINDICATIONS Warfarin sodium tablets, USP are contraindicated in: Pregnancy Warfarin sodium tablets, USP are 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. Warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of…
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) ] 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,…
Drug 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 intera…
Dosage & Administration
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 must be…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Instructions for Patients Advise patients to: Strictly adhere to the prescribed dosage schedule [see Dosage and Administration (2.1) ]. If the prescribed dose of warfarin sodium is missed, take the dose as soon as possible on the same day but do not take a double dose of warfarin sodium the next day to make up for missed doses [see Dosage and Administration (2.6) ]. Obtain prothrombin time tests and make regular visits to their physician or clinic to monitor therapy [see Dosage an…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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