Warfarin Sodium 2 mg/1
Warfarin · TABLET · Aphena Pharma Solutions - Tennessee, LLC
Warfarin is an oral blood thinner used to prevent blood clots and reduce the risk of stroke, heart attack, and other serious conditions caused by abnormal clotting. Your doctor will monitor you regularly with blood tests while taking this medication, as the dose needs to be carefully adjusted for your individual needs.
Key Facts
- Brand Name
- Warfarin Sodium
- Generic Name
- Warfarin
- NDC Code (Product)
43353-021- Manufacturer
- Aphena Pharma Solutions - Tennessee, LLC
- Strength
- 2 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090935
- Marketing Start
- 04/08/2015
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
RISING PHARMACEUTICALS
Failed Impurities/Degradation Specifications
Bristol-Meyers Squibb
Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic cellulose fiber particles found in retain vials
CARDINAL HEALTHCARE
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Aidapak Services, LLC
Labeling: Label Mixup; WARFARIN SODIUM, Tablet, 0.5 mg (1/2 of 1 mg) may be potentially mislabeled as SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD70636_1, EXP: 5/29/2014.
Zydus Pharmaceuticals USA Inc
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Taro Pharmaceuticals U.S.A., Inc.
Failed Content Uniformity Specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Warfarin sodium tablets are indicated for: 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. Limitations of Use Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. Warfarin sodium tablets are a vitamin K antagonist indicated for: 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 thromboemb…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Individualize dosing regimen for each patient, and adjust based on INR response. ( 2.1 , 2.2 ) Knowledge of genotype can inform initial dose selection. ( 2.3 ) Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. ( 2.4 ) Review conversion instructions from other anticoagulants. ( 2.8 ) 2.1 Individualized Dosing The dosage and administration of warfarin sodium tablets must be individualized for each patient according to the patient’s International Normalized Ratio (INR) response to the drug. Adjust the dose based on the patient’s INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines regarding the duration and intensity of anticoagulation for the indicated conditions. 2.2 Recommended Target INR Ranges and Durations for Individual Indications An INR of greater than 4 appears to provide no additional therapeutic benefit in most patients and is associated with a higher risk of bleeding. Venous Thromboembolism (including deep venous thrombosis [DVT] and PE) Adjust the warfarin dose to maintain a target INR of 2.5 …
Contraindications
4 CONTRAINDICATIONS Warfarin sodium is contraindicated in: Pregnancy Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see Warnings and Precautions ( 5.7 ) and Use in Specific Populations ( 8.1 )] . Warfarin sodium can cause fetal harm when administered to a pregnant woman. Warfarin sodium exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If warfarin sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations ( 8.1 )] . Warfarin sodium is contraindicated in patients with: Hemorrhagic tendencies or blood dyscrasias Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces [see Warnings and Precautions ( 5.8 )] Bleeding tendencies associated with: − Active ulceration or overt bleeding of the gastrointestinal, genitourina…
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of drugs that increase bleeding risk, antibiotics, antifungals, botanical (herbal) products, and inhibitors and inducers of CYP2C9, 1A2, or 3A4. ( 7 ) Consult labeling of all concurrently used drugs for complete information about interactions with warfarin sodium or increased risks for bleeding. ( 7 ) 7.1 General Information Drugs may interact with warfarin sodium through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with warfarin sodium are synergism (impaired hemostasis, reduced clotting factor synthesis), competitive antagonism (vitamin K), and alteration of the physiologic control loop for vitamin K metabolism (hereditary resistance). Pharmacokinetic mechanisms for drug interactions with warfarin sodium are mainly enzyme induction, enzyme inhibition, and reduced plasma protein binding. It is important to note that some drugs may interact by more than one mechanism. More frequent INR monitoring should be performed when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs, including drugs intended for short-term use (e.g., antibiotics, antifungals, cort…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling: Hemorrhage [see Boxed Warning, Warnings and Precautions (5.1), and Overdosage ( 10 )] Tissue Necrosis [see Warnings and Precautions ( 5.2 )] Calciphylaxis [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury [see Warnings and Precautions ( 5.4 )] Systemic Atheroemboli and Cholesterol Microemboli [see Warnings and Precautions ( 5.5 )] Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions ( 5.6 )] Other Clinical Settings with Increased Risks [see Warnings and Precautions ( 5.8 )] Other adverse reactions to warfarin sodium include: Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) Vascular disorders: vasculitis Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine. Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating Skin disorders: rash, dermatitis (including bu…
Frequently Asked Questions
What is Warfarin Sodium used for?
Warfarin is an oral blood thinner used to prevent blood clots and reduce the risk of stroke, heart attack, and other serious conditions caused by abnormal clotting. Your doctor will monitor you regularly with blood tests while taking this medication, as the dose needs to be carefully adjusted for your individual needs.
Is Warfarin Sodium a controlled substance?
Warfarin Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Warfarin Sodium?
The generic name for Warfarin Sodium is Warfarin. There are 1 other brand versions of Warfarin.
What is the NDC code for Warfarin Sodium 2 mg/1?
The NDC (National Drug Code) for Warfarin Sodium 2 mg/1 is 43353-021, listed by Aphena Pharma Solutions - Tennessee, LLC.
Other Warfarin Sodium Dosages
- Warfarin Sodium2.5 mg/176282-329
- Warfarin Sodium5 mg/10093-1721
- Warfarin Sodium2.5 mg/151407-343
- Warfarin Sodium5 mg/151407-346
- Warfarin Sodium7.5 mg/151407-791
- Warfarin Sodium2.5 mg/165162-763
- Warfarin Sodium1 mg/167046-2072
- Warfarin Sodium3 mg/170518-2380
- Warfarin Sodium10 mg/170518-4636
- Warfarin Sodium1 mg/170518-4637
Other Warfarin Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)