COUMADIN- warfarin sodium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

warfarin sodium (UNII: 6153CWM0CL) (warfarin - UNII:5Q7ZVV76EI)

Available from:

Physicians Total Care, Inc.

INN (International Name):

warfarin sodium

Composition:

warfarin sodium 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

COUMADIN® is 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 COUMADIN has 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. - Pregnancy COUMADIN 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 (5.5) and Use in Specific Populations (8.1) ]. C

Product summary:

COUMADIN tablets are single-scored, with one face imprinted numerically with 1, 4, 5, 6, 7-1/2 superimposed and inscribed with with “COUMADIN” and with the opposite face plain. COUMADIN is available with potencies and colors as follows:

Authorization status:

New Drug Application

Patient Information leaflet

Physicians Total Care, Inc.
----------
MEDICATION GUIDE
COUMADIN® (COU-ma-din)
(warfarin sodium)
Read this Medication Guide before you start taking COUMADIN (warfarin
sodium) and each time you
get a refill. There may be new information. This Medication Guide does
not take the place of talking to
your healthcare provider about your medical condition or treatment.
You and your healthcare provider
should talk about COUMADIN when you start taking it and at regular
checkups.
What is the most important information I should know about COUMADIN?
COUMADIN can cause bleeding which can be serious and sometimes lead to
death. This is because
COUMADIN is a blood thinner medicine that lowers the chance of blood
clots forming in your body.
•
You may have a higher risk of bleeding if you take COUMADIN and:
•
are 65 years of age or older
•
have a history of stomach or intestinal bleeding
•
have high blood pressure (hypertension)
•
have a history of stroke, or "mini-stroke" (transient ischemic attack
or TIA)
•
have serious heart disease
•
have a low blood count or cancer
•
have had trauma, such as an accident or surgery
•
have kidney problems
•
take other medicines that increase your risk of bleeding, including:
•
a medicine that contains heparin
•
other medicines to prevent or treat blood clots
•
nonsteroidal anti-inflammatory drugs (NSAIDs)
•
take warfarin sodium for a long time. Warfarin sodium is the active
ingredient in
COUMADIN.
Tell your healthcare provider if you take any of these medicines. Ask
your healthcare provider if you are
not sure if your medicine is one listed above.
Many other medicines can interact with COUMADIN and affect the dose
you need or increase
COUMADIN side effects. Do not change or stop any of your medicines or
start any new medicines
before you talk to your healthcare provider.
Do not take other medicines that contain warfarin sodium while taking
COUMADIN.
•
Get your regular blood test to check for your response to COUMADIN.
This blood test is called
an INR test. The IN

Summary of Product characteristics

COUMADIN - WARFARIN SODIUM TABLET
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COUMADIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR COUMADIN.
COUMADIN (WARFARIN SODIUM) TABLETS, FOR ORAL USE
COUMADIN (WARFARIN SODIUM) FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1954
WARNING: BLEEDING RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
COUMADIN 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 COUMADIN THERAPY. (7)
INSTRUCT PATIENTS ABOUT PREVENTION MEASURES TO MINIMIZE RISK OF
BLEEDING AND TO REPORT SIGNS AND
SYMPTOMS OF BLEEDING. (17)
RECENT MAJOR CHANGES
Contraindications (4) 10/2011
Warnings and Precautions, Use in Pregnant Women with Mechanical Heart
Valves (5.5) 10/2011
INDICATIONS AND USAGE
COUMADIN 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 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)
LIMITATION OF USE
COUMADIN has 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)
For injection: