Warfarin Sodium (Warfarin Sodium)

Trade Name : Warfarin Sodium

Teva Pharmaceuticals USA, Inc.

TABLET

Strength 1 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 (Warfarin Sodium) which is also known as Warfarin Sodium and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1 mg/1 per ml. Read more

Warfarin Sodium (Warfarin Sodium) 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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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
  • Dosage and Administration, Renal Impairment () 5/2017
  • Warnings and Precautions, Calciphylaxis () 9/2016
  • Warnings and Precautions, Acute kidney injury () 5/2017
  • WARNING: BLEEDING RISK
  • See full prescribing information for complete boxed warning.
  • Warfarin sodium can cause major or fatal bleeding. ()
  • Perform regular monitoring of INR in 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. ()
  • Warfarin sodium tablets are indicated for:
  • 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:
  • Limitations of Use
  • Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. ()
  • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism ()
  • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement ()
  • Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction ()
  • No data
  • Individualize dosing regimen for each patient, and adjust based on INR response. (, )
  • Knowledge of genotype can inform initial dose selection. ()
  • Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. ()
  • Review conversion instructions from other anticoagulants. ()
  • Warfarin Sodium Tablets USP, 1 mg are available as pink, capsule-shaped, biconvex scored tablets, debossed with TV/1 on the scored side and 1712 on the other side.
  • Warfarin Sodium Tablets USP, 2 mg are available as lavender, capsule-shaped, biconvex scored tablets, debossed with TV/2 on the scored side and 1713 on the other side.
  • Warfarin Sodium Tablets USP, 2.5 mg are available as green, capsule-shaped, biconvex scored tablets, debossed with TV/2/ on the scored side and 1714 on the other side.
  • Warfarin Sodium Tablets USP, 3 mg are available as tan, capsule-shaped, biconvex scored tablets, debossed with TV/3 on the scored side and 1715 on the other side.
  • Warfarin Sodium Tablets USP, 4 mg are available as blue, capsule-shaped, biconvex scored tablets, debossed with TV/4 on the scored side and 1716 on the other side.
  • Warfarin Sodium Tablets USP, 5 mg are available as peach, capsule-shaped, biconvex scored tablets, debossed with TV/5 on the scored side and 1721 on the other side.
  • Warfarin Sodium Tablets USP, 6 mg are available as teal, capsule-shaped, biconvex scored tablets, debossed with TV/6 on the scored side and 1718 on the other side.
  • Warfarin Sodium Tablets USP, 7.5 mg are available as yellow, capsule-shaped, biconvex scored tablets, debossed with TV/7/ on the scored side and 1719 on the other side.
  • Warfarin Sodium Tablets USP, 10 mg are available as white, capsule-shaped, biconvex scored tablets, debossed with TV/10 on the scored side and 1720 on the other side.
  • Scored tablets: 1, 2, 2.5, 3, 4, 5, 6, 7.5, or 10 mg ()
  • Warfarin sodium is contraindicated in:
  • Warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism . 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 .
  • Warfarin sodium is contraindicated in patients with:
  • 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 ()
  • Hypersensitivity to warfarin or any component of the product ()
  • Major regional or lumbar block anesthesia ()
  • Malignant hypertension ()
  • The 7.5 mg tablets contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
  • Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue warfarin sodium and consider alternative anticoagulants if necessary. ()
  • Calciphylaxis: Fatal and serious cases have occurred. Discontinue warfarin sodium and consider alternative anticoagulation therapy. ()
  • Acute kidney injury may occur during episodes of excessive anticoagulation and hematuria. ()
  • Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue warfarin sodium if such emboli occur. ()
  • Heparin-induced thrombocytopenia (HIT): Initial therapy with warfarin sodium in HIT has resulted in cases of amputation and death. Warfarin sodium may be considered after platelet count has normalized. ()
  • Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. ()
  • The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling:
  • Other adverse reactions to warfarin sodium include:
  • Most common adverse reactions to warfarin sodium are fatal and nonfatal hemorrhage from any tissue or organ. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Concomitant use of drugs that increase bleeding risk, antibiotics, antifungals, botanical (herbal) products, and inhibitors and inducers of CYP2C9, 1A2, or 3A4. ()
  • Consult labeling of all concurrently used drugs for complete information about interactions with warfarin sodium or increased risks for bleeding. ()
  • No data
  • Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. ()
  • Lactation: Monitor breastfeeding infants for bruising or bleeding. ()
  • Renal Impairment: Instruct patients with renal impairment to frequently monitor their INR. ()
  • No data
  • Warfarin sodium tablets USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent 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 structural formula may be represented as follows:
  • CHNaO M.W. 330.31
  • 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.
  • Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
  • 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.
  • Warfarin Sodium Tablets USP, 1 mg are available as pink, capsule-shaped, biconvex scored tablets, debossed with TV/1 on the scored side and 1712 on the other side containing 1 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1712-01) and 1000 (NDC 0093-1712-10) tablets.
  • Warfarin Sodium Tablets USP, 2 mg are available as lavender, capsule-shaped, biconvex scored tablets, debossed with TV/2 on the scored side and 1713 on the other side containing 2 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1713-01) and 1000 (NDC 0093-1713-10) tablets.
  • Warfarin Sodium Tablets USP, 2.5 mg are available as green, capsule-shaped, biconvex scored tablets, debossed with TV/2/ on the scored side and 1714 on the other side containing 2.5 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1714-01) and 1000 (NDC 0093-1714-10) tablets.
  • Warfarin Sodium Tablets USP, 3 mg are available as tan, capsule-shaped, biconvex scored tablets, debossed with TV/3 on the scored side and 1715 on the other side containing 3 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1715-01) tablets.
  • Warfarin Sodium Tablets USP, 4 mg are available as blue, capsule-shaped, biconvex scored tablets, debossed with TV/4 on the scored side and 1716 on the other side containing 4 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1716-01) and 1000 (NDC 0093-1716-10) tablets.
  • Warfarin Sodium Tablets USP, 5 mg are available as peach, capsule-shaped, biconvex scored tablets, debossed with TV/5 on the scored side and 1721 on the other side containing 5 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1721-01) and 1000 (NDC 0093-1721-10) tablets.
  • Warfarin Sodium Tablets USP, 6 mg are available as teal, capsule-shaped, biconvex scored tablets, debossed with TV/6 on the scored side and 1718 on the other side containing 6 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1718-01) tablets.
  • Warfarin Sodium Tablets USP, 7.5 mg are available as yellow, capsule-shaped, biconvex scored tablets, debossed with TV/7/ on the scored side and 1719 on the other side containing 7.5 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1719-01) tablets.
  • Warfarin Sodium Tablets USP, 10 mg are available as white, capsule-shaped, biconvex scored tablets, debossed with TV/10 on the scored side and 1720 on the other side containing 10 mg warfarin sodium, USP, packaged in bottles of 100 (NDC 0093-1720-01) tablets.
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Protect from light. Keep tightly closed.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Special Handling
  • Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published .
  • Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets .
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • 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:
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. D 8/2017
  • No data
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