Patient Information
Mallinckrodt is a trusted expert in the pharmaceutical industry, committed to providing you quality medications. The patient brochure below will help answer questions related to Mallinckrodt’s Warfarin Sodium therapy. The brochure contains images of Mallinckrodt’s Wafarin Sodium tablets, comparing them to the brand, Coumadin®*. You will also find information about how the medication works, what do to if you miss a dose and about blood tests, diet, exercise, symptoms prompting you to contact your doctor, etc. In addition, a downloadable Warfarin Sodium ID card is available for you to print and carry in your wallet to ensure that healthcare providers are alerted to your therapy. We have also provided a downloadable calendar to help track your Warfarin Sodium Tablet usage, doctor appointments, dietary changes, and other aspects of your anticoagulation therapy program.
This patient brochure was designed to help you better understand your anticoagulation therapy and should not supersede any instructions or advice given by your healthcare provider.
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.
