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:

RedPharm Drug, Inc.

INN (International Name):

WARFARIN SODIUM

Composition:

WARFARIN SODIUM 3 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 hig

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/21/2 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/71/2 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

WARFARIN SODIUM- warfarin sodium tablet
RedPharm Drug, Inc.
----------
MEDICATION GUIDE
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.
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:
o
are 65 years of age or older
o
have a history of stomach or intestinal bleeding
o
have high blood pressure (hypertension)
o
have a history of stroke, or “mini-stroke” (transient ischemic
attack or TIA)
o
have serious heart disease
o
have a low blood count or cancer
o
have had trauma, such as an accident or surgery
o
have kidney problems
o
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)
o
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 no

Summary of Product characteristics

WARFARIN SODIUM- WARFARIN SODIUM TABLET
REDPHARM DRUG, INC.
----------
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)].
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
Warnings and Precautions, Calciphylaxis (5.3) 9/2016
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 ADMINIS