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(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).
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:
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:
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; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using warfarin and call your doctor at once if you have a serious side effect such as:
- pain, swelling, hot or cold feeling, skin changes, or discoloration anywhere on your body;
- sudden and severe leg or foot pain, foot ulcer, purple toes or fingers;
- sudden headache, dizziness, or weakness;
- unusual bleeding (nose, mouth, vagina, or rectum), bleeding from wounds or needle...
Last reviewed on RxList: 3/24/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Jantoven Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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