Warfarin (Warfarin Sodium)

Trade Name : Warfarin Sodium

Aphena Pharma Solutions - Tennessee, LLC

TABLET

Strength 2 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 (Warfarin Sodium) which is also known as Warfarin Sodium and Manufactured by Aphena Pharma Solutions - Tennessee, LLC. It is available in strength of 2 mg/1 per ml. Read more

Warfarin (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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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
  • Warfarin sodium can cause major or fatal bleeding. n
  • Perform regular monitoring of INR in all treated patients.n
  • Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. n
  • Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding. n
  • FULL PRESCRIBING INFORMATION
  • Warfarin sodium tablets are indicated for:
  • Limitations of Use
  • Warfarin sodium tablets are vitamin K antagonist indicated for:
  • Limitation of Use
  • Warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. n
  • Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism n
  • Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement n
  • Reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction n
  • No data
  • Individualize dosing regimen for each patient, and adjust based on INR response. n n
  • Knowledge of genotype can inform initial dose selection. n
  • Monitoring: Obtain daily INR determinations upon initiation until stable in the therapeutic range. Obtain subsequent INR determinations every 1 to 4 weeks. n
  • Review conversion instructions from other anticoagulants. n
  • Warfarin sodium tablets, USP are supplied as follows:
  • Scored tablets: 1, 2, 2.5, 3, 4, 5, 6, 7.5, or 10 mg n
  • Warfarin sodium is contraindicated in:
  • Pregnancy, except in women with mechanical heart valves (, , )n
  • Hemorrhagic tendencies or blood dyscrasias n
  • Recent or contemplated surgery of the central nervous system (CNS) or eye, or traumatic surgery resulting in large open surfaces (n 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 warfarin sodium and consider alternative anticoagulants if necessary. n
  • Systemic atheroemboli and cholesterol microemboli: Some cases have progressed to necrosis or death. Discontinue warfarin sodium if such emboli occur. n
  • 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. n
  • Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. n
  • 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. n
  • To report SUSPECTED ADVERSE REACTIONS, contact Exelan Pharmaceuticals, Inc. at at 1-800-FDA-1088 or n
  • 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, corticosteroids) [see ].
  • Consult the labeling of all concurrently used drugs to obtain further information about interactions with warfarin sodium 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 warfarin sodium or increased risks for bleeding. n
  • No data
  • Pregnant women with mechanical heart valves: Warfarin sodium may cause fetal harm; however, the benefits may outweigh the risks. n
  • Lactation. Monitor breastfeeding infants for bruising or bleeding. n
  • No data
  • Warfarin sodium is an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. Chemically, it is 3-(u03b1-acetonylbenzyl)-4-hydroxycoumarin and is a racemic mixture of the - and -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its molecular 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.
  • Each warfarin sodium tablet intended for oral administration contains warfarin sodium clathrates equivalent to 1 mg or 2 mg or 2.5 mg or 3 mg or 4 mg or 5 mg or 6 mg or 7.5 mg or 10 mg of warfarin sodium. In addition each tablet contains the inactive ingredients lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each
  • 1 mg tablet contains: D&C Red # 30 aluminum lake
  • 2 mg tablet contains: FD&C Red # 40 aluminum lake and FD&C Blue#2
  • 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue # 2
  • 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue # 2 and FD&C Red # 40 aluminum lake
  • 4 mg tablet contains: FD&C Blue # 2
  • 5 mg tablet contains: FD&C Yellow # 6 aluminum lake
  • 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue # 2
  • 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake
  • 10 mg tablet is dye free
  • 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 are supplied as follows:
  • 1 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u20181u2019
  • 2 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u20182u2019
  • 2.5 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u201821/2u2019
  • 3 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u20183u2019
  • 4 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u20184u2019
  • 5 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u20185u2019
  • 6 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u20186u2019
  • 7.5 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u201871/2u2019
  • 10 mg Tablets:n- u2018Iu2019n- u2018Gu2019n- u2018Wu2019n- u201810u2019
  • Storage:
  • Special HandlingProcedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see ].n
  • Advise the patient to read the FDA-approved patient labeling ().
  • Advise patients to:
  • Rev: 04/2016
  • Warfarin Sodium Tablets, USPn- (war' far in soe' dee um)
  • Read this Medication Guide before you start taking warfarin sodium and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. You and your healthcare provider should talk about warfarin sodium when you start taking it and at regular checkups.
  • What is the most important information I should know about warfarin sodium?
  • Warfarin sodium can cause bleeding which can be serious and sometimes lead to death. This is because warfarin sodium is a blood thinner medicine that lowers the chance of blood clots forming in your body.
  • See u201cWhat are the possible side effects of warfarin sodium?u201d for more information about side effects.
  • What is warfarin sodium?
  • Warfarin sodium is prescription medicine used to treat blood clots and to lower the chance of blood clots forming in your body. Blood clots can cause a stroke, heart attack, or other serious conditions if they form in the legs or lungs.
  • Who should not take warfarin sodium?
  • Do not take warfarin sodium if:
  • What should I tell my healthcare provider before taking warfarin sodium?
  • Before you take warfarin sodium, tell your healthcare provider if you:
  • Tell all of your healthcare providers and dentists that you are taking warfarin sodium. They should talk to the healthcare provider who prescribed warfarin sodium for you before you have surgery or dental procedure. Your warfarin sodium may need to be stopped for a short time or your may need your dose adjusted.
  • Tell your healthcare provider about all the medicines you take,n- What is the most important information I should know about warfarin sodium?
  • Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
  • How should I take warfarin sodium?
  • What should I avoid while taking warfarin sodium?
  • Tell your healthcare provider if you have any side effect that bothers you or does not go away.
  • These are not all of the side effects of warfarin sodium. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store warfarin sodium tablets?
  • Keep warfarin sodium tablets and all medicines out of the reach of children.
  • General information about warfarin sodium.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use warfarin sodium for a condition for which it was not prescribed. Do not give warfarin sodium to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about warfarin sodium. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about warfarin sodium that is written for healthcare professionals.
  • If you would like more information,, talk to your healthcare provider or call Exelan Pharmaceuticals, Inc. at 1-855-295-7455.
  • What are the ingredients in warfarin sodium tablets, USP?
  • Active ingredient: Warfarin Sodium, USP
  • Inactive ingredients: Lactose monohydrate, starch, pregelatinised starch, Hydroxypropyl Cellulose, starlac and magnesium stearate. Additionally each:
  • 1 mg tablet contains: D&C Red #30 aluminum lake
  • 2 mg tablet contains: FD&C Red #40 aluminum lake and FD&C Blue#2
  • 2.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Blue#2
  • 3 mg tablet contains: FD&C Yellow # 6 aluminum lake, FD&C Blue#2 and FD&C Red # 40 aluminum lake
  • 4 mg tablet contains: FD&C Blue#2
  • 5 mg tablet contains: FD&C Yellow # 6 aluminum lake
  • 6 mg tablet contains: FD&C Yellow # 6 aluminum lake and FD&C Blue #2
  • 7.5 mg tablet contains: D&C Yellow # 10 aluminum lake and FD&C Yellow # 6 aluminum lake
  • 10 mg tablet is dye free.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured for:
  • Exelan Pharmaceuticals, Inc.
  • Lawrenceville, GA 30046
  • Manufactured By:
  • InvaGen Pharmaceuticals, Inc.
  • Hauppauge, NY 11788
  • Rev: 04/16
  • Rx only n Barcode: 335-04-2016
  • Please reference the section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
  • Store between 20u00b0-25u00b0C (68u00b0-77u00b0F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
  • Repackaged by:n n Cookeville, TN 38506n 20170622JH
  • NDC 43353-028-30
  • Warfarin Sodium Tablets, USP 1mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-021-30
  • Warfarin Sodium Tablets, USP 2mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-029-30
  • Warfarin Sodium Tablets, USP 2.5mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-030-30
  • Warfarin Sodium Tablets, USP 3mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-033-30
  • Warfarin Sodium Tablets, USP 4mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-023-30
  • Warfarin Sodium Tablets, USP 5mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-053-30
  • Warfarin Sodium Tablets, USP 7.5mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets
  • NDC 43353-054-30
  • Warfarin Sodium Tablets, USP 10mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient
  • Rx onlyu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a030 Tablets

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