WARFARIN SODIUM tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals,Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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. Warfarin Sodium is contraindicated in: - Pregnancy Warfarin sodium tablets are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembo

Descriptif du produit:

Warfarin sodium tablets, USP are supplied as follows: • 1 mg Tablets: Light pink, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "1" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-119-90), 100's count ( NDC 57237-119-01) and 1000's count ( NDC 57237-119-99) • 2 mg Tablets: Lavender, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "2" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-120-90), 100's count ( NDC 57237-120-01) and 1000's count ( NDC 57237-120-99) • 2.5 mg Tablets: Green, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "21/2" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-121-90) 100's count ( NDC 57237-121-01) and 1000's count ( NDC 57237-121-99) • 3 mg Tablets: Tan, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "3" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-122-90) 100's count ( NDC 57237-122-01) and 1000's count ( NDC 57237-122-99) • 4 mg Tablets: Blue, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "4" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-123-90) 100's count ( NDC 57237-123-01) and 1000's count ( NDC 57237-123-99) • 5 mg Tablets: Peach, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "5" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-124-90), 100's count ( NDC 57237-124-01) and 1000's count ( NDC 57237-124-99) • 6 mg Tablets: Teal, Round, Flat Beveled edge tablets de-bossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "6" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-125-90), 100's count ( NDC 57237-125-01) and 1000's count ( NDC 57237-125-99) • 7.5 mg Tablets: Yellow, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "71/2" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-126-90), 100's count ( NDC 57237-126-01) and 1000's count ( NDC 57237-126-99) • 10 mg Tablets: White, Round, Flat Beveled edge tablets debossed "I" on the left side of bisect and "G" on the right side of bisect on one side and "W" on the top and "10" on the bottom of other side, supplied in bottles of 90's count ( NDC 57237-127-90), 100's count ( NDC 57237-127-01) and 1000's count ( NDC 57237-127-99) Storage: Store at 20° to 25°C (68° F to 77° F). [see USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. 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)].

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

NuCare Pharmaceuticals,Inc.
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MEDICATION GUIDE
Warfarin Sodium Tablets, USP ( (war' far in soe' dee um)
What is the most important information I should know about warfarin
sodium?
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.
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.
•
Get your regular blood test to check for your response to warfarin
sodium. 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
will be adjusted to keep
your INR in a target range for you.
•
Call your healthcare provider right away if you get any of the
followi

Résumé des caractéristiques du produit

WARFARIN SODIUM- WARFARIN SODIUM TABLET
NUCARE PHARMACEUTICALS,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._
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)
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 tablets are 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)
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
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