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:

REMEDYREPACK INC.

INN (International Name):

WARFARIN SODIUM

Composition:

WARFARIN SODIUM 7.5 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, 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 bottles of 100 (NDC 0093-1712-01) and 1000 (NDC 0093-1712-10) tablets. Warfarin Sodium Tablets USP, 2 mg are available as lavender, capsule-shaped, biconvex scored tablets, debossed with TV/2 on the scored side and 1713 on the other side containing 2 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1713-01) and 1000 (NDC 0093-1713-10) tablets. Warfarin Sodium Tablets USP, 2.5 mg are available as green, capsule-shaped, biconvex scored tablets, debossed with TV/2 1 / 2 on the scored side and 1714 on the other side containing 2.5 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1714-01) and 1000 (NDC 0093-1714-10) tablets. Warfarin Sodium Tablets USP, 3 mg are available as tan, capsule-shaped, biconvex scored tablets, debossed with TV/3 on the scored side and 1715 on the other side containing 3 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1715-01) tablets. Warfarin Sodium Tablets USP, 4 mg are available as blue, capsule-shaped, biconvex scored tablets, debossed with TV/4 on the scored side and 1716 on the other side containing 4 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1716-01) and 1000 (NDC 0093-1716-10) tablets. 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 100 (NDC 0093-1721-01) and 1000 (NDC 0093-1721-10) tablets. Warfarin Sodium Tablets USP, 6 mg are available as teal, capsule-shaped, biconvex scored tablets, debossed with TV/6 on the scored side and 1718 on the other side containing 6 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1718-01) tablets. Warfarin Sodium Tablets USP, 7.5 mg are available as yellow, capsule-shaped, biconvex scored tablets, debossed with TV/7 1 / 2 on the scored side and 1719 on the other side containing 7.5 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1719-01) tablets. Warfarin Sodium Tablets USP, 10 mg are available as white, capsule-shaped, biconvex scored tablets, debossed with TV/10 on the scored side and 1720 on the other side containing 10 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1720-01) 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 Specific Populations ( 8.1)] . KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
----------
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:
•
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

Summary of Product characteristics

WARFARIN SODIUM- WARFARIN SODIUM TABLET
REMEDYREPACK 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)
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:
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 tablet