WARFARIN SODIUM tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)

Tillgänglig från:

Cardinal Health 107, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Warfarin sodium tablets, USP are indicated for: Limitations of Use Warfarin sodium 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. Warfarin sodium tablets, USP are contraindicated in: Warfarin sodium tablets, USP are 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 fet

Produktsammanfattning:

Warfarin Sodium Tablets, USP are single-scored, flat, beveled, capsule-shaped tablets, engraved numerically with 2, 2½, or 5 on one side and engraved with "WARFARIN" on top of "TARO" on the other side. They are packaged with potencies and colors as follows: 2.5 mg Green: Overbagged with 10 tablets per bag, NDC 55154-4696-0 Protect from light and moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. Store the hospital unit-dose blister packages in the carton until contents have been used. Special Handling Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see References (15) ]. Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see Use in Specific Populations (8.1) ].

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Cardinal Health 107, LLC
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MEDICATION GUIDE
8000813/0718
Warfarin (war' far in) Sodium Tablets, USP
Read this Medication Guide before you start taking 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
warfarin sodium when you start taking it and at regular checkups.
What is the most important information I should know about warfarin
sodium tablets?
Warfarin sodium can cause bleeding which can be serious and sometimes
lead to death. This is
because warfarin sodium 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 warfarin sodium
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 warfarin sodium
tablets, USP.
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 and affect the
dose you need or increase
warfarin sodium 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, USP.
•
Get your regular

Produktens egenskaper

WARFARIN SODIUM- WARFARIN SODIUM TABLET
CARDINAL HEALTH 107, LLC
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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._
•
•
•
•
RECENT MAJOR CHANGES
Dosage and Administration, Renal Impairment ( 2.5)
5/2017
Warnings and Precautions, Calciphylaxis ( 5.3)
9/2016
Warnings and Precautions, Acute kidney injury ( 5.4)
5/2017
INDICATIONS AND USAGE
Warfarin sodium is a vitamin K antagonist indicated for:
•
•
•
LIMITATIONS OF USE
Warfarin sodium has no direct effect on an established thrombus, nor
does it reverse ischemic tissue
damage. ( 1)
DOSAGE AND ADMINISTRATION
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•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
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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)
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)
Review