Warfarin Sodium (Coumadin)

Trade Name : COUMADIN

Bristol-Myers Squibb Pharma Company

TABLET

Strength 4 mg/1

WARFARIN SODIUM Vitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Warfarin Sodium (Coumadin) which is also known as COUMADIN and Manufactured by Bristol-Myers Squibb Pharma Company. It is available in strength of 4 mg/1 per ml. Read more

Warfarin Sodium (Coumadin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: BLEEDING RISK
  • See full prescribing information for complete boxed warning.
  • COUMADIN is indicated for:
  • Limitations of Use
  • COUMADIN has 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.
  • COUMADIN is a vitamin K antagonist indicated for:
  • u2022 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism n
  • u2022 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement n
  • u2022 Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarctionn
  • Limitations of Use
  • COUMADIN has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. n
  • u2022 Individualize dosing regimen for each patient, and adjust based on INR response. , n
  • u2022 Knowledge of genotype can inform initial dose selection. n
  • u2022 Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. n
  • u2022 Review conversion instructions from other anticoagulants. n
  • No data
  • Scored tablets: 1, 2, 2-1/2, 3, 4, 5, 6, 7-1/2, or 10 mg n
  • COUMADIN is contraindicated in:
  • u2022 Pregnancy
  • COUMADIN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism . COUMADIN can cause fetal harm when administered to a pregnant woman. COUMADIN 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 COUMADIN 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 .
  • COUMADIN is contraindicated in patients with:
  • u2022 Hemorrhagic tendencies or blood dyscrasias
  • u2022 Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces n n n
  • u2022 Bleeding tendencies associated with:
  • u00a0 -u00a0 Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract
  • u00a0 -u00a0 Central nervous system hemorrhage
  • u00a0 -u00a0 Cerebral aneurysms, dissecting aorta
  • u00a0 -u00a0 Pericarditis and pericardial effusions
  • u00a0 -u00a0 Bacterial endocarditis
  • u2022 Threatened abortion, eclampsia, and preeclampsia
  • u2022 Unsupervised patients with conditions associated with potential high level of non-compliance
  • u2022 Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding
  • u2022 Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis) n
  • u2022 Major regional or lumbar block anesthesia
  • u2022 Malignant hypertension
  • Pregnancy, except in women with mechanical heart valves , , n
  • Hemorrhagic tendencies or blood dyscrasias n
  • u00a0Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces , n
  • Bleeding tendencies associated with certain conditions n
  • Threatened abortion, eclampsia, and preeclampsia n
  • Unsupervised patients with potential high levels of non-compliance n
  • Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding n
  • Hypersensitivity to warfarin or any component of the product n
  • Major regional or lumbar block anesthesia n
  • Malignant hypertension n
  • No data
  • Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue COUMADIN and consider alternative anticoagulants if necessary. n
  • Calciphylaxis: Fatal and serious cases have occurred. Discontinue COUMADIN and consider alternative anticoagulation therapy. (5.3)
  • Acute kidney injury may occur during episodes of excessive anticoagulation and hematuria. (5.4)
  • Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue COUMADIN if such emboli occur. (5.5)
  • Heparin-induced thrombocytopenia (HIT): Initial therapy with COUMADIN in HIT has resulted in cases of amputation and death. COUMADIN may be considered after platelet count has normalized. (5.6)
  • Pregnant women with mechanical heart valves: COUMADIN may cause fetal harm; however, the benefits may outweigh the risks. (5.7)
  • The following serious adverse reactions to COUMADIN are discussed in greater detail in other sections of the labeling:
  • u2022 Hemorrhage n u2022 Tissue Necrosis n u2022 Calciphylaxis n u2022 Acute Kidney Injury n u2022 Systemic Atheroemboli and Cholesterol Microemboli n u2022 Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS n u2022 Other Clinical Settings with Increased Risks n
  • Other adverse reactions to COUMADIN include:
  • u2022 Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions)u2022 Vascular disorders: vasculitisu2022 Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of COUMADIN and ticlopidine.u2022 Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloatingu2022 Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopeciau2022 Respiratory disorders: tracheal or tracheobronchial calcificationu2022 General disorders: chills
  • Most common adverse reactions to COUMADIN are fatal and nonfatal hemorrhage from any tissue or organ. n
  • To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or .
  • Drugs may interact with COUMADIN through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with COUMADIN 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 COUMADIN 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, corticosteroids) .
  • Consult the labeling of all concurrently used drugs to obtain further information about interactions with COUMADIN or adverse reactions pertaining to bleeding.
  • Concomitant use of drugs that increase bleeding risk, antibiotics, antifungals, botanical (herbal) products, and inhibitors and inducers of CYP2C9, 1A2, or 3A4. n
  • Consult labeling of all concurrently used drugs for complete information about interactions with COUMADIN or increased risks for bleeding. (7)
  • u2022 Pregnant women with mechanical heart valves: COUMADIN may cause fetal harm; however, the benefits may outweigh the risks. n u2022 Lactation: Monitor breastfeeding infants for bruising or bleeding. n u2022 Renal Impairment: Instruct patients with renal impairment to frequently monitor their INR. n
  • No data
  • COUMADIN (warfarin sodium) tablets contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin Ku2011dependent coagulation factors. The chemical name of warfarin sodium is 3-(u03b1-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the - and -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is CHNaO, and its structural formula is represented by the following:
  • Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.
  • COUMADIN tablets for oral use also contain:
  • No data
  • Carcinogenicity, mutagenicity, or fertility studies have not been performed with warfarin.
  • No data
  • OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Instructions for Patients
  • Advise patients to:
  • Bleeding Risks
  • Advise patients to:
  • Concomitant Medications and Botanicals (Herbals)
  • Advise patients to:
  • Pregnancy and Nursing
  • Advise patients to:
  • Bristol-Myers Squibb Company
  • COUMADIN is a trademark of Bristol-Myers Squibb Pharma Company.
  • Copyright u00a9 Bristol-Myers Squibb Company 2017
  • Printed in USAn u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Revised December 2019
  • For more information, go to www.coumadin.com or call 1-800-321-1335.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • See section for a complete list of available packages of COUMADIN.
  • NDC 0056-0169-701 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0170-702 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0176-702u00bd mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0188-703 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0168-704 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0172-705 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0189-706 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0173-707u00bd mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS
  • NDC 0056-0174-7010 mg Rx onlyCOUMADINn (Warfarin Sodium Tablets, USP)Crystalline*DISPENSE WITH MEDICATION GUIDEHIGHLY POTENT ANTICOAGULANTWARNING: Serious bleeding results from overdosage. Do not use or dispense before reading directions and warnings in accompanying product information.DOSAGE: See package insert.100 TABLETS

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