Country: United States
Language: English
Source: NLM (National Library of Medicine)
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)
Bryant Ranch Prepack
WARFARIN SODIUM
WARFARIN SODIUM 7.5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
WARFARIN SODIUM- WARFARIN SODIUM TABLET BRYANT RANCH PREPACK ---------- 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. WARFARIN SODIUM TABLETS, USP 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) 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) LIMITATIONS 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 with mechanical heart valves (4, 5.5, 8.1) Hemorrhagic tendencies or blood dyscrasias (4)) Recent or contemplated surgery of the Read the complete document