WARFARIN SODIUM tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aidarex Pharmaceuticals LLC

INN (International Name):

WARFARIN SODIUM

Sammensætning:

WARFARIN SODIUM 2 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

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 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. Repackaged by: Aidarex Pharmaceuticals, LLC Corona, CA 92880

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

Aidarex Pharmaceuticals LLC
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SPL MEDGUIDE SECTION
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:
•
oare 65 years of
age or older
•
ohave a history of
stomach or
intestinal bleeding
•
ohave high blood
pressure
(hypertension)
•
ohave a history of
stroke, or “mini-
stroke” (transient
ischemic attack or
TIA)
•
ohave serious
heart disease
•
ohave a low blood
count or cancer
•
ohave had trauma,
such as an
accident or
surgery
•
ohave kidney
problems
•
otake 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)
•
otake 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 provide

Produktets egenskaber

WARFARIN SODIUM- WARFARIN SODIUM TABLET
AIDAREX PHARMACEUTICALS LLC
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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 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