Coumadin (Warfarin Sodium) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Coumadin

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Introduction to deep vein thrombosis (DVT)

Arteries have thin muscles within their walls to be able to withstand the pressure of the heart pumping blood to the far reaches of the body. Veins don't have a significant muscle lining, and there is nothing pumping blood back to the heart except physiology. Blood returns to the heart because the body's large muscles squeeze the veins as they contract in their normal activity of moving the body. The normal activities of moving the body returns the blood back to the heart.

There are two types of veins in the leg; superficial veins and deep veins. Superficial veins lie just below the skin and are easily seen on the surface. Deep veins, as their name implies, are located deep within the muscles of the leg. Blood flows from the superficial veins into the deep venous system through small perforator veins. Superficial and perforator veins have one-way valves within them that allow blood to flow only in the direc...

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COUMADIN® TABLETS
(warfarin sodium) Tablets, USP Crystalline

COUMADIN® FOR INJECTION
(warfarin sodium) for Injection, 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 PATIENT INFORMATION).

DRUG DESCRIPTION

COUMADIN (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 empirical formula is C19H15NaO4, and its structural formula may be represented by the following:

COUMADIN® (crystalline warfarin sodium) Structural Formula Illustration

Crystalline warfarin sodium occurs as a white, odorless, crystalline powder, is discolored by light and is very soluble in water; freely soluble in alcohol; very slightly soluble in chloroform and in ether.

COUMADIN (warfarin sodium) Tablets for oral use also contain:

All strengths:	Lactose, starch and magnesium stearate
1 mg:	D&C Red No. 6 Barium Lake
2 mg:	FD&C Blue No. 2 Aluminum Lake and
2 mg:	FD&C Red No. 40 Aluminum Lake
2-½ mg:	D&C Yellow No. 10 Aluminum Lake and
2-½ mg:	FD&C Blue No. 1 Aluminum Lake
3 mg:	FD&C Yellow No. 6 Aluminum Lake,
	FD&C Blue No. 2 Aluminum Lake and
	FD&C Red No. 40 Aluminum Lake
4 mg:	FD&C Blue No. 1 Aluminum Lake
5 mg:	FD&C Yellow No. 6 Aluminum Lake
6 mg:	FD&C Yellow No. 6 Aluminum Lake and
6 mg:	FD&C Blue No. 1 Aluminum Lake
7-½ mg:	D&C Yellow No. 10 Aluminum Lake and
7-½ mg:	FD&C Yellow No. 6 Aluminum Lake
10 mg:	Dye Free

COUMADIN (warfarin sodium) for Injection is supplied as a sterile, lyophilized powder, which, after reconstitution with 2.7 mL sterile Water for Injection, contains:

Warfarin Sodium	2 mg/mL
Sodium Phosphate, Dibasic, Heptahydrate	4.98 mg/mL
Sodium Phosphate, Monobasic, Monohydrate	0.194 mg/mL
Sodium Chloride	0.1 mg/mL
Mannitol	38.0 mg/mL
Sodium Hydroxide, as needed for pH adjustment to	8.1 to 8.3

What are the possible side effects of warfarin (Coumadin, Jantoven)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

skin changes or discoloration anywhere on your body;
purple toes or fingers;
pain in your stomach, back, or sides;
low fever, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
diarrhea, fever, chills, body aches, flu...

Read All Potential Side Effects and See Pictures of Coumadin »

What are the precautions when taking warfarin sodium (Coumadin)?

Before taking warfarin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders (such as anemia, hemophilia), bleeding problems (such as bleeding of the stomach/intestines, bleeding in the brain), blood vessel disorders (such as aneurysms), recent major injury/surgery, liver disease, alcohol use, mental/mood disorders (including memory problems), frequent falls/injuries.

It is important that all your doctors and dentists know that you take warfarin. Before having surgery or any...

Read All Potential Precautions of Coumadin »

Last reviewed on RxList: 1/3/2011
This monograph has been modified to include the generic and brand name in many instances.