Coumadin
COUMADIN® TABLETS
(warfarin sodium) Tablets, USP Crystalline
COUMADIN® FOR INJECTION
(warfarin sodium) for Injection, 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
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:
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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 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 FD&C Red No. 40 Aluminum Lake |
| 2-1/2 mg: | D&C Yellow No. 10 Aluminum Lake and 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 FD&C Blue No. 1 Aluminum Lake |
| 7-1/2 mg: | D&C Yellow No. 10 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake |
| 10 mg: | Dye Free |
COUMADIN 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
Generic Name: Warfarin Sodium
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