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

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May 16, 2012

Jantoven

Drug Side Effects Explained »

Drug Side Effects: Types

Side effects fall into several categories. Allergic reactions can happen with any drug and can range from itching and rash all the way up to a life-threatening anaphylactic reaction.

Other side effects simply â€œcome with the territory.â€ Some drugs can't help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (also known by the brand name Benadryl). Though it eases allergy symptoms, it also suppresses the activity of the body chemical acetylcholine, and that leads to drowsiness and a host of other side effects, including dry mouth.

Some drugs have barely noticeable side effects when dosed properly. For example, Warfarin (Jantoven, Coumadin) used to prevent blood clots, is usually well tolerated, but serious internal bleeding can occur.

Side effects may only pop up when certain drugs are mixed with certain other things. These might also be con...

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JANTOVEN® TABLETS
(warfarin sodium) Tablets, USP

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).

DRUG DESCRIPTION

Jantoven® Tablets (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:

Jantoven (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.

Jantoven® Tablets (Warfarin Sodium Tablets, USP) for oral use contain: 1 mg, 2 mg, 2½ mg, 3 mg, 4 mg, 5 mg, 6 mg, 7½mg or 10 mg of crystalline warfarin sodium, USP. They also contain:

All Strengths: Lactose monohydrate, magnesium stearate, povidone, and pregelatinized starch (corn).

1 mg: FD&C Red #40 Aluminum Lake
2 mg: FD&C Blue #2 Aluminum Lake and FD&C Red #40 Aluminum Lake 2½ mg: D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake
3 mg: Brown #75 Synthetic Brown Iron Oxide
4 mg: FD&C Blue #1 Aluminum Lake
5 mg: FD&C Yellow #6 Aluminum Lake
6 mg: Yellow #10 Synthetic Yellow Iron Oxide, Black #85 Synthetic Black Iron Oxide and FD&C Blue #1 Aluminum Lake 7½ mg: D&C Yellow #10 Aluminum Lake and FD&C Yellow #6 Aluminum Lake
10 mg: Dye Free.

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...

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What are the precautions when taking warfarin sodium tablets (Jantoven)?

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...

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Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.