JANTOVEN- warfarin sodium tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

Warfarin Sodium (UNII: 6153CWM0CL) (Warfarin - UNII:5Q7ZVV76EI)

可用日期:

Upsher-Smith Laboratories, LLC

INN（国际名称）:

Warfarin Sodium

组成:

Warfarin Sodium 1 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

JANTOVEN® is 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 has 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. JANTOVEN is contraindicated in: - Pregnancy JANTOVEN is 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 (5.7) and

產品總結:

Tablets JANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2½, 3, 4, 5, 6, 7½, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit dose blister packages with potencies and colors as follows: 1 mg – Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01). 2 mg – Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01). 2½ mg – Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01). 3 mg – Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01). 4 mg – Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01). 5 mg – Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01). 6 mg – Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01). 7½ mg – Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01). 10 mg – Compressed tablet, white (dye-free), round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01). Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure. 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) ].

授权状态:

Abbreviated New Drug Application

资料单张

Upsher-Smith Laboratories, LLC
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MEDICATION GUIDE
JANTOVEN® (JAN-TO-VEN) TABLETS
(WARFARIN SODIUM TABLETS, USP)
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised 0917
What is the most important information I should know about JANTOVEN?
JANTOVEN can cause bleeding which can be serious and sometimes lead to
death. This is because
JANTOVEN 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 JANTOVEN 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 is the active
ingredient in
JANTOVEN.
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 JANTOVEN and affect the dose
you need or increase
JANTOVEN 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
JANTOVEN.
•
Get your regular blood test to check for your response to JANTOVEN.
This blood test is called an
INR test. The INR test checks to see how fast your blood clots. Your
healthcare provider will
decide what INR numbers are best for you. Your dose of JANTOVEN will
be adjusted to keep
your INR in a target range for you.
•
Call your healthcare provider right away if you get

产品特点

JANTOVEN- WARFARIN SODIUM TABLET
UPSHER-SMITH LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JANTOVEN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JANTOVEN.
JANTOVEN TABLETS (WARFARIN SODIUM TABLETS, USP), 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
JANTOVEN is 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 has 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, 2½, 3, 4, 5, 6, 7½, or 10 mg