Country: United States
Language: English
Source: NLM (National Library of Medicine)
WARFARIN SODIUM (UNII: 6153CWM0CL) (WARFARIN - UNII:5Q7ZVV76EI)
Unit Dose Services
WARFARIN SODIUM
WARFARIN SODIUM 6 mg
ORAL
PRESCRIPTION DRUG
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: 50436-6364 NDC: 50436-6364-1 30 TABLET in a BOTTLE
Abbreviated New Drug Application
Unit Dose Services ---------- MEDICATION GUIDE Warfarin (WAR-far-in) Sodium (SO-dee-um) Tablets The 7.5 mg tablets contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. 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 f Read the complete document
WARFARIN SODIUM- WARFARIN SODIUM TABLET UNIT DOSE SERVICES ---------- 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 tablets are a vitamin K antagonist indicated for: • • • 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 • • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • • • • 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. Read the complete document