WARFARIN SODIUM- 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:

A-S Medication Solutions

INN (International Name):

WARFARIN SODIUM

Composition:

WARFARIN SODIUM 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Warfarin sodium tablets are indicated for: 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. Warfarin sodium is contraindicated in: Warfarin sodium 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 (5.7) 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 spontaneous abortion and fetal mortality. If warfarin sodium is

Product summary:

Product: 50090-1756 NDC: 50090-1756-0 30 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

A-S Medication Solutions
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MEDICATION GUIDE
Warfarin (WAR-far-in) Sodium (SO-dee-um) Tablets
What is the most important information I should know about warfarin
sodium tablets?
Warfarin sodium tablets can cause bleeding which can be serious and
sometimes lead to death. This is
because warfarin sodium tablets are 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 warfarin sodium
tablets and:
o
are 65 years of age or older
o
have a history of stomach or intestinal bleeding
o
have high blood pressure (hypertension)
o
have a history of stroke, or “mini-stroke” (transient ischemic
attack or TIA)
o
have serious heart disease
o
have a low blood count or cancer
o
have had trauma, such as an accident or surgery
o
have kidney problems
o
take other medicines that increase your risk of bleeding, including:
▪
a medicine that contains heparin
▪
other medicines to prevent or treat blood clots
▪
non-steroidal anti-inflammatory drugs (NSAIDs)
o
take warfarin sodium for a long time. Warfarin sodium is the active
ingredient in warfarin sodium
tablets.
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 warfarin sodium tablets and
affect the dose you need or increase
warfarin sodium tablets 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
warfarin sodium tablets.
•
Get your regular blood test to check for your response to warfarin
sodium tablets. This blood test is
called an INR test. The INR test checks to see how fast your blood
clots. Your healthcare provider
will decide what INR numbers are best for you. Your dose of warfarin
sodium tablets will be
adjusted to keep your INR in a target range for you.
•
Call your healthcare provider r

Summary of Product characteristics

WARFARIN SODIUM- WARFARIN SODIUM TABLET
A-S MEDICATION SOLUTIONS
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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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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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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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•
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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•
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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)
Dosage and Administration, Renal Impairment (2.5) 5/2017
Warnings and Precautions, Acute kidney injury (5.4) 5/2017
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)
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)
Rev