Product Details
WARFARIN SODIUM 5 MG
Introduction : WARFARIN SODIUM 5 MG
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (1) ? Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement (1) ? Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction (1)
Indication : WARFARIN SODIUM 5 MG
Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE).
Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement.
Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
Storage : Store at a controlled room temperature between 15 and 30 degrees C (59 and 86 degrees F); protect from light and moisture
Mechanism of Action : Warfarin sodium is an anticoagulant that works by blocking the regeneration of vitamin K(1) epoxide, thus inhibiting synthesis of vitamin K-dependent clotting factors which include factors 2, 7, 9 and 10, and the anticoagulant proteins C and S
Therapeutic : Anticoagulant
Side Effects : pain, swelling, or discomfort
headaches, dizziness, or weakness
unusual bruising (bruises that develop without known cause or grow in size)
nosebleeds
bleeding gums
bleeding from cuts takes a long time to stop
menstrual bleeding or vaginal bleeding that is heavier than normal
pink or brown urine
red or black stools
coughing up blood
vomiting blood or material that looks like coffee grounds
Contraindications : Pregnancy, except in women with mechanical heart valves ? Hemorrhagic tendencies or blood dyscrasias
Recent or contemplated surgery of the central nervous system (CNS) or
eye, or traumatic surgery resulting in large open surfaces
? Bleeding tendencies associated with certain conditions
? Threatened abortion, eclampsia, and preeclampsia
? Unsupervised patients with potential high levels of non-compliance
? Spinal puncture and other diagnostic or therapeutic procedures with
potential for uncontrollable bleeding (4)
? Hypersensitivity to warfarin or any component of the product
? Major regional or lumbar block anesthesia
? Malignant hypertension
Safety Advice / Warnings : Warfarin can cause major or fatal bleeding. Regular monitoring of INR should be performed on all treated patients. Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding .
Using this medicine while you are pregnant can harm your unborn baby.
Check with your doctor immediately if you have diarrhea, fever, or any symptoms of an infection
Avoid use of this drug during pregnancy and prescribe an alternative. Evidence has demonstrated fetal abnormalities or risks when used during pregnancy. Advise women of childbearing potential of fetal risk.
This medicine may cause skin necrosis or gangrene. Call your doctor right away if you have pain, a color change, or a temperature change to any area of your body
Warfarin may increase your risk of having kidney problems, including acute kidney injury. Check with your doctor right away if you have blood in the urine, decreased urine output, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.
References : Label: JANTOVEN- warfarin sodium tablet
None Listed: The Warfarin Antiplatelet Vascular Evaluation Trial Investigators. Oral Anticoagulant and Antiplatelet Therapy and Peripheral Arterial Disease. N Engl J Med 2007; 357(3):217-227.
Product Information: COUMADIN(R) oral tablets, warfarin sodium oral tablets. Bristol-Myers Squibb Company (per manufacturer), Princeton, NJ, 2019.