Warfarin (oral)

Warfarin (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gerald Chi

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Black Box Warning

WARNING: BLEEDING RISK See full prescribing information for complete Boxed Warning. * Coumadin can cause major or fatal bleeding. Perform regular monitoring of INR in all treated patients. Drugs, dietary changes, and other factors affect INR levels achieved with Coumadin therapy. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding.

Overview

Warfarin (oral) is an anticoagulant that is FDA approved for the {{{indicationType}}} of venous thromboembolism, pulmonary embolism, thromboembolic complications associated with atrial fibrillation, cardiac valve replacement, and/or myocardial infarction. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hemorrhage, necrosis of skin and other tissues, and systemic atheroemboli and cholesterol microemboli.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Individualized Dosing

• The dosage and administration of COUMADIN must be individualized for each patient according to the patient’s INR response to the drug. Adjust the dose based on the patient’s INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines from the American College of Chest Physicians (ACCP) to assist in the determination of the duration and intensity of anticoagulation with COUMADIN [see References (15)].
• An INR of greater than 4.0 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding.

Venous Thromboembolism

• Dosing Information

• Adjust the warfarin dose to maintain a target INR of 2.5 (INR range, 2.0-3.0) for all treatment durations. The duration of treatment is based on the indication as follows:

• For patients with a DVT or PE secondary to a transient (reversible) risk factor, treatment with warfarin for 3 months is recommended.
• For patients with an unprovoked DVT or PE, treatment with warfarin is recommended for at least 3 months. After 3 months of therapy, evaluate the risk-benefit ratio of long-term treatment for the individual patient.
• For patients with two episodes of unprovoked DVT or PE, long-term treatment with warfarin is recommended. For a patient receiving long-term anticoagulant treatment, periodically reassess the risk-benefit ratio of continuing such treatment in the individual patient.

Atrial Fibrillation

• Dosing Information

• In patients with non-valvular AF, anticoagulate with warfarin to target INR of 2.5 (range, 2.0-3.0).

• In patients with non-valvular AF that is persistent or paroxysmal and at high risk of stroke (i.e., having any of the following features: prior ischemic stroke, transient ischemic attack, or systemic embolism, or 2 of the following risk factors: age greater than 75 years, moderately or severely impaired left ventricular systolic function and/or heart failure, history of hypertension, or diabetes mellitus), long-term anticoagulation with warfarin is recommended.
• In patients with non-valvular AF that is persistent or paroxysmal and at an intermediate risk of ischemic stroke (i.e., having 1 of the following risk factors: age greater than 75 years, moderately or severely impaired left ventricular systolic function and/or heart failure, history of hypertension, or diabetes mellitus), long-term anticoagulation with warfarin is recommended.
• For patients with AF and mitral stenosis, long-term anticoagulation with warfarin is recommended.
• For patients with AF and prosthetic heart valves, long-term anticoagulation with warfarin is recommended; the target INR may be increased and aspirin added depending on valve type and position, and on patient factors.

Mechanical and Bioprosthetic Heart Valves

• Dosing Information

• For patients with a bileaflet mechanical valve or a Medtronic Hall (Minneapolis, MN) tilting disk valve in the aortic position who are in sinus rhythm and without left atrial enlargement, therapy with warfarin to a target INR of 2.5 (range, 2.0-3.0) is recommended.
• For patients with tilting disk valves and bileaflet mechanical valves in the mitral position, therapy with warfarin to a target INR of 3.0 (range, 2.5-3.5) is recommended.
• For patients with caged ball or caged disk valves, therapy with warfarin to a target INR of 3.0 (range, 2.5-3.5) is recommended.
• For patients with a bioprosthetic valve in the mitral position, therapy with warfarin to a target INR of 2.5 (range, 2.0-3.0) for the first 3 months after valve insertion is recommended. If additional risk factors for thromboembolism are present (AF, previous thromboembolism, left ventricular dysfunction), a target INR of 2.5 (range, 2.0-3.0) is recommended.

Post-Myocardial Infarction

• Dosing Information

• For high-risk patients with MI (e.g., those with a large anterior MI, those with significant heart failure, those with intracardiac thrombus visible on transthoracic echocardiography, those with AF, and those with a history of a thromboembolic event), therapy with combined moderate-intensity (INR, 2.0-3.0) warfarin plus low-dose aspirin (≤100 mg/day) for at least 3 months after the MI is recommended.

Recurrent Systemic Embolism and Other Indications

• Dosing Information

• Oral anticoagulation therapy with warfarin has not been fully evaluated by clinical trials in patients with valvular disease associated with AF, patients with mitral stenosis, and patients with recurrent systemic embolism of unknown etiology. However, a moderate dose regimen (INR 2.0-3.0) may be used for these patients.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Warfarin (oral) in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Warfarin (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Warfarin (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Warfarin (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Warfarin (oral) in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING: BLEEDING RISK See full prescribing information for complete Boxed Warning. * Coumadin can cause major or fatal bleeding. Perform regular monitoring of INR in all treated patients. Drugs, dietary changes, and other factors affect INR levels achieved with Coumadin therapy. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Warfarin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Warfarin (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Warfarin (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Warfarin (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Warfarin (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Warfarin (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Warfarin (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Warfarin (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Warfarin (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Warfarin (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Warfarin (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Warfarin (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Warfarin (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Warfarin (oral) in the drug label.

Condition1

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Warfarin (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Warfarin (oral) in the drug label.

Pharmacology

There is limited information regarding Warfarin (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Warfarin (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Warfarin (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Warfarin (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Warfarin (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Warfarin (oral) in the drug label.

Condition1

• Description

How Supplied

Storage

There is limited information regarding Warfarin (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Warfarin (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Warfarin (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Coumadin®
• Jantoven®

Look-Alike Drug Names

• Coumadin® - Avandia®
• Coumadin® - Cardura®
• Jantoven® - Janumet®
• Jantoven® - Januvia®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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