Warfarin Sodium

WARFARIN SODIUM- warfarin sodium tablet
RedPharm Drug, Inc.

HIGHLIGHTS OF PRESCRIBING INFORMATION

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, for oral use
Initial U.S. Approval: 1954

WARNING: BLEEDING RISK
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

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Warfarin sodium can cause major or fatal bleeding. ( 5.1)
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Perform regular monitoring of INR in all treated patients. ( 2.1)
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Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. ( 7)
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Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding. ( 17)

RECENT MAJOR CHANGES

Warnings and Precautions, Calciphylaxis (5.3) 9/2016

INDICATIONS AND USAGE

Warfarin sodium tablets are a vitamin K antagonist indicated for:

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Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ( 1)
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Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ( 1)
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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

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Individualize dosing regimen for each patient, and adjust based on INR response. ( 2.1, 2.2)
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Knowledge of genotype can inform initial dose selection. ( 2.3)
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Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. ( 2.4)
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Review conversion instructions from other anticoagulants. ( 2.8)

DOSAGE FORMS AND STRENGTHS

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Scored tablets: 1, 2, 2.5, 3, 4, 5, 6, 7.5, or 10 mg ( 3)

CONTRAINDICATIONS

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Pregnancy, except in women with mechanical heart valves ( 4, 5.6, 8.1)
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Hemorrhagic tendencies or blood dyscrasias ( 4)
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Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces ( 4, 5.7)
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Bleeding tendencies associated with certain conditions ( 4)
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Threatened abortion, eclampsia, and preeclampsia ( 4)
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Unsupervised patients with potential high levels of non-compliance ( 4)
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Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding ( 4)
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Hypersensitivity to warfarin or any component of the product ( 4)
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Major regional or lumbar block anesthesia ( 4)
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Malignant hypertension ( 4)

WARNINGS AND PRECAUTIONS

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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)
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Calciphylaxis: Fatal and serious cases have occurred. Discontinue warfarin sodium and consider alternative anticoagulation therapy. ( 5.3)
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Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue warfarin sodium if such emboli occur. ( 5.4)
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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. ( 5.5)
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Pregnant women with mechanical heart valves: warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. ( 5.6)

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 Teva Pharmaceuticals USA, Inc. at 1-866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

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Concomitant use of drugs that increase bleeding risk, antibiotics, antifungals, botanical (herbal) products, and inhibitors and inducers of CYP2C9, 1A2, or 3A4. ( 7)
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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

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Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. ( 8.1)
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Lactation: Monitor breastfeeding infants for bruising or bleeding. ( 8.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 10/2016

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: BLEEDING RISK
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Individualized Dosing
2.2 Recommended Target INR Ranges and Durations for Individual Indications
2.3 Initial and Maintenance Dosing
2.4 Monitoring to Achieve Optimal Anticoagulation
2.5 Missed Dose
2.7 Treatment During Dentistry and Surgery
2.8 Conversion From Other Anticoagulants
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hemorrhage
5.2 Tissue Necrosis
5.3 Calciphylaxis
5.4 Systemic Atheroemboli and Cholesterol Microemboli
5.5 Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS
5.6 Use in Pregnant Women with Mechanical Heart Valves
5.7 Other Clinical Settings with Increased Risks
5.8 Endogenous Factors Affecting INR
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 CYP450 Interactions
7.2 Drugs that Increase Bleeding Risk
7.3 Antibiotics and Antifungals
7.4 Botanical (Herbal) Products and Foods
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
10.1 Signs and Symptoms
10.2 Treatment
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.5 Pharmacogenomics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Atrial Fibrillation
14.2 Mechanical and Bioprosthetic Heart Valves
14.3 Myocardial Infarction
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Warfarin Sodium Tablets USP 1 mg 100s Label Text
Warfarin Sodium Tablets USP 2 mg 100s Label Text
Warfarin Sodium Tablets USP 2.5 mg 100s Label Text
Warfarin Sodium Tablets USP 3 mg 100s Label Text
Warfarin Sodium Tablets USP 4 mg 100’s Label Text
Warfarin Sodium Tablets USP 5 mg 100s Label Text
Warfarin Sodium Tablets USP 6mg 100s Label Text
Warfarin Sodium Tablets USP 7.5 mg 100s Label Text
Warfarin Sodium Tablets USP 10 mg 100s Label Text

*
Sections or subsections omitted from the full prescribing information are not listed.

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.