WARFARIN SODIUM tablet

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Rebel Distributors Corp

INN (इंटरनेशनल नाम):

WARFARIN SODIUM

रचना:

WARFARIN SODIUM 1 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism. Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement. Warfarin sodium tablets are indicated to reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Anticoagulation is contraindicated in any localized or general physical condition or personal circumstance in which the hazard of hemorrhage might be greater than the potential clinical benefits of anticoagulation, such as: Warfarin sodium tablets are contraindicated in women who are or may become pregnant because the drug passes through the placental barrier and may cause fatal hemorrhage to the fetus in utero. Furthermore, there have been reports of birth malformations in children born to mothers who

उत्पाद समीक्षा:

Warfarin Sodium Tablets, 1 mg are pink, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘1’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-672-30 in bottles of 30 tablets Warfarin Sodium Tablets, 2 mg are lavender, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘2’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-673-30 in bottles of 30 tablets NDC 21695-673-60 in bottles of 60 tablets Warfarin Sodium Tablets, 2.5 mg are green, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘2½’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-674-30 in bottles of 30 tablets Warfarin Sodium Tablets, 3 mg are tan, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘3’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-675-30 in bottles of 30 tablets Warfarin Sodium Tablets, 4 mg are blue, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘4’ and bisect on one side and plain on other side and are supplied as follows: NDC: 21695-939-30 in bottles of 30 tablets Warfarin Sodium Tablets, 5 mg are peach, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘5’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-677-30 in bottles of 30 tablets Warfarin Sodium Tablets, 7.5 mg are yellow, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘7½’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-940-30 in bottles of 30 tablets Warfarin Sodium Tablets, 10 mg are white to off white, oval, flat, beveled edge, uncoated tablets debossed with the logo of ‘WAR’, ‘10’ and bisect on one side and plain on other side and are supplied as follows: NDC 21695-801-30 in bottles of 30 tablets Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

Rebel Distributors Corp
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MEDICATION GUIDE
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 tablets when you start taking it and at
regular checkups.
What is the most important information I should know about warfarin
sodium tablets?
•
Take your warfarin sodium tablets exactly as prescribed to lower the
chance of blood clots
forming in your body (see What is warfarin sodium?).
•
Warfarin sodium tablets are very important for your health, but it can
cause serious and life-
threatening bleeding problems. To benefit from warfarin sodium tablets
and also lower your
chance for bleeding problems, you must:
•
Get your regular blood test to check for your response to warfarin
sodium tablets. This blood test
is called a PT/INR test. The PT/INR test checks to see how fast your
blood clots. Your healthcare
provider will decide what PT/INR numbers are best for you. Your dose
of warfarin sodium tablets
will be adjusted to keep your PT/INR in a target range for you.
•
Call your healthcare provider right away if you get any of the
following signs or symptoms of
bleeding problems:
•
pain, swelling or discomfort
•
headaches, dizziness, or weakness
•
unusual bruising (bruises that develop without known cause or grow in
size)
•
nose bleeds
•
bleeding gums
•
bleeding from cuts takes a long time to stop
•
menstrual bleeding or vaginal bleeding that is heavier than normal
•
pink or brown urine
•
red or black stools
•
coughing up blood
•
vomiting blood or material that looks like coffee grounds
•
Many other medicines, including prescription and non-prescription
medicines, vitamins
and herbal supplements can interact with warfarin sodium tablets and:
•
affect the dose you need, or increase warfarin sodium tablets sid

उत्पाद विशेषताएं

WARFARIN SODIUM- WARFARIN SODIUM TABLET
REBEL DISTRIBUTORS CORP
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WARFARIN SODIUM TABLETS, USP
_ANTICOAGULANT_
WARNING: BLEEDING RISK
Warfarin sodium can cause major or fatal bleeding. Bleeding is more
likely to occur during the
starting period and with a higher dose (resulting in a higher INR).
Risk factors for bleeding
include high intensity of anticoagulation (INR >4.0), age ≥65,
highly variable INRs, history of
gastrointestinal bleeding, hypertension, cerebrovascular disease,
serious heart disease, anemia,
malignancy, trauma, renal insufficiency, concomitant drugs (see
PRECAUTIONS) and long
duration of warfarin therapy. Regular monitoring of INR should be
performed on all treated
patients. Those at high risk of bleeding may benefit from more
frequent INR monitoring, careful
dose adjustment to desired INR, and a shorter duration of therapy.
Patients should be instructed
about prevention measures to minimize risk of bleeding and to report
immediately to physicians
signs and symptoms of bleeding (see PRECAUTIONS: INFORMATION FOR
PATIENTS).
DESCRIPTION
Warfarin sodium tablet (crystalline warfarin sodium) is an
anticoagulant, which acts by inhibiting vitamin
K-dependent coagulation factors. Chemically, it is
3-(α-acetonylbenzyl)-4-hydroxycoumarin and is a
racemic mixture of the _R_- and _S_-enantiomers. Crystalline warfarin
sodium is an isopropanol clathrate.
The crystallization of warfarin sodium virtually eliminates trace
impurities present in amorphous
warfarin. Its molecular formula is C
H NaO , and its structural formula may be represented by the
following:
Crystalline warfarin sodium occurs as a white crystalline powder,
odorless or practically odorless.
Each warfarin sodium tablet intended for oral administration contains
warfarin sodium clathrates
equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg
or 7.5 mg or 10 mg of warfarin
sodium. In addition each tablet contains the inactive ingredients
hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate and pregelatinized s