Healthcare Provider Information
The following Healthcare Provider information is designed to help you feel confident and informed about Mallinckrodt’s Warfarin Sodium Tablets, USP. The below brochure contains product information including images of the tablets, labels, and bottles. A comparison chart illustrates the physical appearance of Mallinckrodt’s Warfarin tablets against each of the competitor’s tablets. The bioequivalency information will show how precisely Mallinckrodt’s Warfarin tablets match the brand, Coumadin®*. Finally, full prescribing information can be found in the brochure.
Mallinckrodt has also included a substantial amount of information on this website directed to your patients, helping educate them and feel comfortable with this product.
Important Safety Information
Warfarin sodium tablets are indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, and pulmonary embolism.
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 in full prescribing information), 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 in full prescribing information).
Anticoagulation is contraindicated in any localized or general physical condition or personal circumstance in which the hazard of hemorrhage might be greater that the potential clinical benefits of anticoagulation, such as: in women who are or may become pregnant, because Warfarin may cause fatal hemorrhage to the fetus and reports of birth malformations; recent or contemplated surgery of the central nervous system, eye or traumatic surgery with large open surfaces; bleeding tendencies associated with active ulceration; threatened abortion, inadequate laboratory facilities; unsupervised patients; spinal puncture.
*Coumadin
is a registered trademark of Bristol-Myers Squibb Company.
All trademarks are owned by Mallinckrodt Inc. unless otherwise noted.
