WARFARIN SODIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northwind Pharmaceuticals, LLC

INN (International Name):

WARFARIN SODIUM

Composition:

WARFARIN SODIUM 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Warfarin Sodium Tablets USP 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 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. 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 [see Warnings and Precautions (5.5) and Use in Specifi

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

WARFARIN SODIUM- WARFARIN SODIUM TABLET
Northwind Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Warfarin sodium
Read this Medication Guide before you start taking warfarin sodium and
each time you get a refill. There
may be new information. This Medication Guide does not take the place
of talking to your healthcare
provider about your medical condition or treatment. You and your
healthcare provider should talk about
warfarin sodium when you start taking it and at regular checkups.
What is the most important information I should know about warfarin
sodium?
Warfarin sodium can cause bleeding which can be serious and sometimes
lead to death. This is because
warfarin sodium 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 warfarin sodium
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 warfarin sodium.
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 and affect the
dose you need or increase
warfarin sodium 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.
Get your regular blood test to check for your response to warfarin
sodium.
This blood test is called

Summary of Product characteristics

WARFARIN SODIUM- WARFARIN SODIUM TABLET
NORTHWIND PHARMACEUTICALS, LLC
----------
WARFARIN SODIUM
BOXED WARNING
WARNING: BLEEDING RISK
-Warfarin sodium can cause major or fatal bleeding [see Warnings and
Precautions (5.1)].
-Perform regular monitoring of INR in all treated patients [see Dosage
and Administration (2.1)].
-Drugs, dietary changes, and other factors affect INR levels achieved
with warfarin sodium
therapy [see Drug Interactions (7)].
-Instruct patients about prevention measures to minimize risk of
bleeding and to report signs and
symptoms of bleeding [see Patient Counseling Information (17)].
INDICATIONS & USAGE
Warfarin Sodium Tablets USP 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 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.
DOSAGE & ADMINISTRATION
2.1 Individualized Dosing
The dosage and administration of warfarin sodium must be
individualized for each patient according to
the patient’s INR response to the drug. Adjust the dose based on the
patient’s INR and the condition
being treated. Consult the latest evidence-based clinical practice
guidelines from the American College
of Chest Physicians (ACCP) to assist in the determination of the
duration and intensity of anticoagulation
with warfarin sodium [see References (15)].
2.2 Recommended Target INR Ranges and Durations for Individual
Indications
An INR of greater than 4 ap