COUMADIN- warfarin sodium tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

A-S Medication Solutions

INN (nume internaţional):

WARFARIN SODIUM

Compoziție:

WARFARIN SODIUM 5 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

COUMADIN® is indicated for: Limitations of Use COUMADIN has 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. COUMADIN is contraindicated in: • Pregnancy COUMADIN 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)] . COUMADIN can cause fetal harm when administered to a pregnant woman. COUMADIN 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 COUMADIN is used during pregnancy or if the patient becomes pregn

Rezumat produs:

Product: 50090-0028 NDC: 50090-0028-0 30 TABLET in a BOTTLE

Statutul autorizaţiei:

New Drug Application

Prospect

A-S Medication Solutions
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MEDICATION GUIDE
COUMADIN® (COU-ma-din)
(warfarin sodium) tablets
What is the most important information I should know about COUMADIN?
COUMADIN can cause bleeding which can be serious and sometimes lead to
death. This is because
COUMADIN 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 COUMADIN 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
COUMADIN.
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 COUMADIN and affect the dose
you need or increase
COUMADIN 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
COUMADIN.
•
Get your regular blood test to check for your response to COUMADIN.
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 COUMADIN 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
following signs or symptoms of
bleeding problems:
•
pain, swelling, or discomfort
•
headaches,

Caracteristicilor produsului

COUMADIN- WARFARIN SODIUM TABLET
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
COUMADIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR COUMADIN.
COUMADIN (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
Dosage and Administration, Intravenous Route of Administration (2.7)
Removed 8/2017
Warnings and Precautions, Calciphylaxis (5.3) 9/2016
Warnings and Precautions, Acute kidney injury (5.4) 5/2017
INDICATIONS AND USAGE
COUMADIN is 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
COUMADIN has 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, 2-1/2, 3, 4, 5, 6, 7-1/2, 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 contemplated surgery of the central nervous system (CNS) or
eye, or traumatic surgery resultin