Warfarin Sodium (Jantoven)

Trade Name : Jantoven

Upsher-Smith Laboratories, LLC

TABLET

Strength 1 mg/1

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

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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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 (Jantoven) which is also known as Jantoven and Manufactured by Upsher-Smith Laboratories, LLC. It is available in strength of 1 mg/1 per ml. Read more

Warfarin Sodium (Jantoven) 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

Packaging and Delivery

Validated Cold Chain Shipment

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
  • 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. ()
  • No data
  • JANTOVEN is indicated for:
  • Limitations of Use
  • Warfarin Sodium 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.
  • JANTOVEN is a vitamin K antagonist indicated for:
  • Limitations of Use
  • 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. ()
  • JANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2u00bd, 3, 4, 5, 6, 7u00bd, or 10 below the score and with 832 debossed on the opposite side.
  • JANTOVEN tablets are supplied in the following strengths:
  • Scored tablets: 1, 2, 2u00bd, 3, 4, 5, 6, 7u00bd, or 10 mg ()
  • JANTOVEN is contraindicated in:
  • JANTOVEN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism [see and ttttttt]. JANTOVEN can cause fetal harm when administered to a pregnant woman. JANTOVEN 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 JANTOVEN 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 ]. tttttt
  • JANTOVEN 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 ()
  • No data
  • Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation. Discontinue JANTOVEN and consider alternative anticoagulants if necessary. ()
  • Calciphylaxis: Fatal and serious cases have occurred. Discontinue JANTOVEN 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 JANTOVEN 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 JANTOVEN are discussed in greater detail in other sections of the labeling:
  • Other adverse reactions to JANTOVEN include:
  • Most common adverse reactions to Warfarin Sodium are fatal and nonfatal hemorrhage from any tissue or organ. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Upsher-Smith Laboratories, LLC at 1-855-899-9180 or FDA at 1-800-FDA-1088 or .
  • 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 JANTOVEN or increased risks for bleeding. ()
  • No data
  • Pregnant women with mechanical heart valves: JANTOVEN 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
  • JANTOVEN (Warfarin Sodium Tablets, USP) is 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 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.
  • JANTOVEN tablets for oral use contain: 1 mg, 2 mg, 2u00bd mg, 3 mg, 4 mg, 5 mg, 6 mg, 7u00bd mg or 10 mg of warfarin sodium, USP. They 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.
  • Tablets
  • JANTOVEN tablets are single scored, compressed tablets with one side scored and debossed with WRF above the score and 1, 2, 2u00bd, 3, 4, 5, 6, 7u00bd, or 10 below the score and with 832 debossed on the opposite side. JANTOVEN is available in bottles and unit dose blister packages with potencies and colors as follows:
  • 1 mg u2013 Compressed tablet, pink, round; in bottles of 100 (NDC 0832-1211-00) and 1000 (NDC 0832-1211-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1211-01).
  • 2 mg u2013 Compressed tablet, lavender, round; in bottles of 100 (NDC 0832-1212-00) and 1000 (NDC 0832-1212-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1212-01).
  • 2u00bd mg u2013 Compressed tablet, green, round; in bottles of 100 (NDC 0832-1213-00) and 1000 (NDC 0832-1213-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1213-01).
  • 3 mg u2013 Compressed tablet, tan, round; in bottles of 100 (NDC 0832-1214-00) and 1000 (NDC 0832-1214-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1214-01).
  • 4 mg u2013 Compressed tablet, blue, round; in bottles of 100 (NDC 0832-1215-00) and 1000 (NDC 0832-1215-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1215-01).
  • 5 mg u2013 Compressed tablet, peach, round; in bottles of 100 (NDC 0832-1216-00) and 1000 (NDC 0832-1216-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1216-01).
  • 6 mg u2013 Compressed tablet, teal, round; in bottles of 100 (NDC 0832-1217-00) and 1000 (NDC 0832-1217-10) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1217-01).
  • 7u00bd mg u2013 Compressed tablet, yellow, round; in bottles of 100 (NDC 0832-1218-00) and 500 (NDC 0832-1218-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1218-01).
  • 10 mg u2013 Compressed tablet, white (dye-free), round; in bottles of 100 (NDC 0832-1219-00) and 500 (NDC 0832-1219-50) and in unit dose cartons of 100 tablets (10 cards containing 10 tablets each) (NDC 0832-1219-01).
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). Excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container with a child-resistant closure.
  • Special Handling
  • Procedures for proper handling and disposal of potentially hazardous drugs should be considered. Guidelines on this subject have been published [see ].
  • Pharmacy and clinical personnel who are pregnant should avoid exposure to crushed or broken tablets [see ].
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • No data
  • NDC 0832-1211-00JANTOVENn Warfarin SodiumTablets, USP
  • 1 mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1212-00JANTOVENn Warfarin SodiumTablets, USP
  • 2 mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1213-00JANTOVENn Warfarin SodiumTablets, USP
  • 2u00bd mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1214-00JANTOVENn Warfarin SodiumTablets, USP
  • 3 mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1215-00JANTOVENn Warfarin SodiumTablets, USP
  • 4 mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1216-00JANTOVENn Warfarin SodiumTablets, USP
  • 5 mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1217-00JANTOVENn Warfarin SodiumTablets, USP
  • 6 mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1218-00JANTOVENn Warfarin SodiumTablets, USP
  • 7u00bd mg
  • PHARMACIST: Dispense the MedicationGuide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 100 Tabletsn n
  • UPSHER-SMITH
  • NDC 0832-1219-50JANTOVENn Warfarin SodiumTablets, USP
  • 10 mg
  • PHARMACIST: Dispense the Medication Guide provided separately to each patient.
  • HIGHLY POTENT ANTICOAGULANT WARNING:
  • 500 Tabletsn n
  • UPSHER-SMITH

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