Warfarin 5 mg Tablets — Generic For Coumadin — Amneal

These highlights do not include all the information needed to use WARFARIN SODIUM TABLETS safely and effectively. See full prescribing information for WARFARIN SODIUM TABLETS.

WARFARIN SODIUM tablets (crystalline), for oral use

Initial U.S. Approval: 1954

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 therapy. (7)

Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding. (17)

Indications And Usage

Warfarin sodium tablets are 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)

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)

Dosage Forms And Strengths

Scored tablets: 1, 2, 2-1/2, 3, 4, 5, 6, 7-1/2, or 10 mg (3)

Contraindications

Pregnancy, except in women with mechanical heart valves. (4, 5.7, 8.1)

Hemorrhagic tendencies or blood dyscrasias. (4)

Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces. (4, 5.8)

Bleeding tendencies associated with certain conditions. (4)

Threatened abortion, eclampsia, and preeclampsia. (4)

Unsupervised patients with potential high levels of non-compliance. (4)

Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding. (4)

Hypersensitivity to warfarin or any component of the product. (4)

Major regional or lumbar block anesthesia. (4)

Malignant hypertension. (4)

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. Warfarin sodium may be considered after platelet count has normalized. (5.6)
• Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. (5.7)

• 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. Warfarin sodium may be considered after platelet count has normalized. (5.6)
• Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. (5.7)

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. Warfarin sodium may be considered after platelet count has normalized. (5.6)

Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. (5.7)

Adverse Reactions

Most common adverse reactions to warfarin sodium are fatal and nonfatal hemorrhage from any tissue or organ. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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)

Use In Specific Populations

Pregnant women with mechanical heart valves: warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. (8.1)

Lactation: Monitor breastfeeding infants for bruising or bleeding. (8.2)

Renal Impairment: Instruct patients with renal impairment to frequently monitor their INR. (8.6)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 11/2022