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:

NuCare Pharmaceuticals Inc.

INN (International Name):

WARFARIN SODIUM

Composition:

WARFARIN SODIUM 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 [

Product summary:

Warfarin Sodium Tablets USP, 5 mg are available as peach, capsule-shaped, biconvex scored tablets, debossed with TV/5 on the scored side and 1721 on the other side containing 5 mg warfarin sodium, USP, packaged in bottles of 30 (NDC 66267-268-30)tablets. 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 Special Populations ( 8.1) ]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NuCare Pharmaceuticals, Inc
----------
MEDICATION GUIDE
Warfarin (WAR-far-in) Sodium (SO-dee-um) Tablets USP
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.
Read this Medication Guide before you start taking warfarin sodium
tablets 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 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 i

Summary of Product characteristics

WARFARIN SODIUM- WARFARIN SODIUM TABLET
NUCARE PHARMACEUTICALS, INC
----------
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, 5.5, 8.1)
Hemorrhagic tendencies or blood dyscrasias ( 4)
R