WARFARIN SODIUM tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

St Marys Medical Park Pharmacy

INN (Mezinárodní Name):

WARFARIN SODIUM

Složení:

WARFARIN SODIUM 2 mg

Druh předpisu:

PRESCRIPTION DRUG

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

WARFARIN SODIUM- WARFARIN SODIUM TABLET
ST MARYS MEDICAL PARK PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
WARFARIN SODIUM SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR WARFARIN SODIUM.
INITIAL U.S. APPROVAL: 1954
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WARNING: BLEEDING RISK
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
Contraindications (4) 10/2011
Warnings and Precautions, Use in Pregnant Women with Mechanical
Heart Valves (5.5) 10/2011
INDICATIONS AND USAGE
Warfarin sodium tablets, USP are 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
Warfarin sodium tablets, USP 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, 2, 2.5, 3, 4, 5, 6, 7.5, or 10 mg (3)
CONTRAINDICATIONS
Pregnancy, except in women