WARFARIN SODIUM tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

REMEDYREPACK INC.

INN (Nama Internasional):

WARFARIN SODIUM

Komposisi:

WARFARIN SODIUM 1 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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 is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism

Ringkasan produk:

Warfarin sodium tablets USP, 1 mg are available as pink, capsule-shaped, biconvex scored tablets, debossed with TV/1 on the scored side and 1712 on the other side containing 1 mg warfarin sodium, USP, packaged in NDC: 70518-0279-00 PACKAGING: 30 in 1 BLISTER PACK Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light. Keep tightly closed. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. 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)]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status otorisasi:

Abbreviated New Drug Application

Selebaran informasi

REMEDYREPACK INC.
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MEDICATION GUIDE
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
[phone]
Warfarin (war' far in) Sodium (soe' dee um) Tablets
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:
•
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
•
non-steroidal 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 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 for your response to warfarin
sodium tablets. 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 war

Karakteristik produk

WARFARIN SODIUM- WARFARIN SODIUM TABLET
REMEDYREPACK INC.
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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._
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 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 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, 5.7, 8.1)
Hemorrhagic tendencies or blood dyscrasias ( 4)
Recent or c