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:

Camber Pharmaceuticals

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: Limitations of Use Warfarin sodium tablets, USP 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 tablets are 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 Specific Populations (8.1)] . Warfarin sodium tablets can cause fetal harm when administered to a pregnant woman. Warfarin sodium tablets exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If warfarin sodium tablets

Product summary:

Warfarin sodium tablets, USP are supplied as follows: 1 mg Tablets:   Light pink, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘327 ’ on other, supplied in bottles of 100’s count (NDC 31722-327-01) and 1000’s count (NDC 31722-327-10) 2 mg Tablets:   Lavender, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘328 ’ on other, supplied in bottles of 100’s count (NDC 31722-328-01) and 1000’s count (NDC 31722-328-10) 2.5 mg Tablets: Green, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘329 ’ on other, supplied in bottles of 100’s count (NDC 31722-329-01) and 1000’s count (NDC 31722-329-10). 3 mg Tablets: Tan, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘330 ’ on other, supplied in bottles of 100’s count (NDC 31722-330-01) and 1000’s count (NDC 31722-330-10). 4 mg Tablets: Blue, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘331 ’ on other, supplied in bottles of 100’s count (NDC 31722-331-01) and 1000’s count (NDC 31722-331-10) 5 mg Tablets: Peach, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘332 ’ on other, supplied in bottles of 100’s count (NDC 31722-332-01) and 1000’s count (NDC 31722-332-10). 6 mg Tablets: Teal, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘333 ’ on other, supplied in bottles of 100’s count (NDC 31722-333-01) and 1000’s count (NDC 31722-333-10) 7.5 mg Tablets: Yellow, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘334 ’ on other, supplied in bottles of 100’s count (NDC 31722-334-01) and 1000’s count (NDC 31722-334-10). 10 mg Tablets: White, Round, Flat Beveled edge tablets de-bossed ‘I ’ on the left side of bisect and ‘G ’ on the right side of bisect on one side and ‘335 ’ on other, supplied in bottles of 100’s count (NDC 31722-335-01) and 1000’s count (NDC 31722-335-10). Storage: Store at 20° to 25°C (68° F to 77° F). [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

WARFARIN SODIUM - WARFARIN SODIUM TABLET
Camber Pharmaceuticals
----------
MEDICATION GUIDE
Warfarin Sodium Tablets, USP
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, USP 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 ch

Summary of Product characteristics

WARFARIN SODIUM - WARFARIN SODIUM TABLET
CAMBER PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
WARFARIN SODIUM TABLETS, USP FOR ORAL USE
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
WARFARIN SODIUM SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR WARFARIN SODIUM.
WARFARIN SODIUM (WARFARIN SODIUM) TABLET 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
Contraindications (4) - 10/2011
Warnings and Precautions, Use in Pregnant Women with Mechanical
Heart Valves (5.5) - 10/2011
INDICATIONS AND USAGE
Warfarin sodium tablets, USP are 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)
LIMITATION OF USE
Warfarin sodium tablets, USP 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