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Argatroban (Argatroban)

Trade Name : Argatroban

Sandoz Inc

INJECTION

Strength 1 mg/mL

ARGATROBAN Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin 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 Argatroban (Argatroban) which is also known as Argatroban and Manufactured by Sandoz Inc. It is available in strength of 1 mg/mL per ml. Read more

Argatroban (Argatroban) 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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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
  • Argatroban in Sodium Chloride injection is a direct thrombin inhibitor indicated:
  • For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) n ()
  • As an anticoagulant in adult patients with or at risk of HIT undergoing percutaneous coronary intervention (PCI) n ()
  • Heparin-Induced Thrombocytopenia
  • The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusionn ()
  • Percutaneous Coronary Intervention
  • The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention is n started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous line over 3 to 5 minutes n ()
  • Injection: 50 mg per 50 mL (1 mg/mL) clear solution in a singleu2013dose vial. The solution is ready for intravenous infusion.
  • Injection: 50 mg per 50 mL (1 mg/mL) clear solution in single-dose vial ()
  • Argatroban in Sodium Chloride injection is contraindicated in:
  • Major bleeding ()
  • History of hypersensitivity to this product ()
  • No data
  • Risk of hemorrhage: Hemorrhage at any site can occur (unexplained fall in hematocrit or blood pressure or other unexplained n symptom may indicate hemorrhage). Use with caution in patients at risk, including those receiving antiplatelet agents, thrombolytics,n or other anticoagulants. ()
  • Use in hepatic impairment: Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic n impairment. Avoid use in PCI in patients with clinically significant hepatic impairment ()
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Adverse Events in Patients with HIT (With or Without Thrombosis)
  • Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The following safety information is based on all 568 patients treated with argatroban in Study 1 and Study 2. The safety profile of the patients from these studies is compared with that of 193 historical controls in which the adverse events were collected retrospectively. Adverse events are separated into hemorrhagic and non-hemorrhagic events.
  • Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease u22652 g/dL, that led to a transfusion of u22652 units, or that was intracranial, retroperitoneal, or into a major prosthetic joint. Minor bleeding was overt bleeding that did not meet the criteria for major bleeding.
  • Table 4
  • Table 5
  • Adverse Events in Patients with or at Risk for HIT Patients Undergoing PCI
  • The following safety information is based on 91 patients initially treated with argatroban and 21 patients subsequently n re-exposed to argatroban for a total of 112 PCIs with argatroban anticoagulation. Adverse events are separated into hemorrhagic n and non-hemorrhagic events.
  • Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease u22655 g/dL, that led to n transfusion of u22652 units, or that was intracranial, retroperitoneal, or into a major prosthetic joint.
  • The rate of major bleeding events in patients treated with argatroban in the PCI trials was 1.8%.
  • Table 7
  • There were 22 serious adverse events in 17 PCI patients (19.6% in 112 interventions).n lists the serious adverse events occurring in n argatroban-treated-patients with or at risk for HIT undergoing PCI.
  • Intracranial Bleeding In Other Populations
  • Increased risks for intracranial bleeding have been observed in investigational studies of argatroban for other uses. In a study n of patients with acute myocardial infarction receiving both argatroban and thrombolytic therapy (streptokinase or tissue plasminogen n activator), the overall frequency of intracranial bleeding was 1% (8 out of 810 patients). Intracranial bleeding was not observed in 317n subjects or patients who did not receive concomitant thrombolysis .
  • The safety and effectiveness of argatroban for cardiac indications other than PCI in patients with HIT have not been established.n Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of n acute stroke within 12 hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of 117 patients (4.3%) whon received argatroban at 1 to 3 mcg/kg/min and in none of the 54 patients who received placebo. Asymptomatic intracranial hemorrhage n occurred in 5 (4.3%) and 2 (3.7%) of the patients, respectively.
  • Allergic Reactions
  • One hundred fifty-six allergic reactions or suspected allergic reactions were observed in 1,127 individuals who were treated n with argatroban in clinical pharmacology studies or for various clinical indications. About 95% (148/156) of these reactions occurred n in patients who concomitantly received thrombolytic therapy (e.g., streptokinase) or contrast media.
  • Allergic reactions or suspected allergic reactions in populations other than patients with HIT (with or without thrombosis)n include (in descending order or frequency):
  • Limited data are available on the potential formation of drug-related antibodies. Plasma from 12 healthy volunteers treatedn with argatroban over 6 days showed no evidence of neutralizing antibodies. No loss of anticoagulant activity was noted with repeated n administration of argatroban to more than 40 patients.
  • To report SUSPECTED ADVERSE REACTIONS, contact Eagle Pharmaceuticals, Inc at 1-855-318-2170 or FDA atn 1-800-FDA-1088 or .
  • HIT patients: The most common (u22655%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac n arrest ()
  • PCI patients: The most common (u22655%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and n headache ()
  • No data
  • Heparin: Allow sufficient time for heparin's effect on aPTT to decrease before initiating Argatroban in Sodium Chloride injection therapy n ()
  • Warfarin: Concomitant use results in increased prolongation of PT and INR ()
  • Thrombolytic agents or glycoprotein IIb/IIIa antagonists: Safety and effectiveness of concomitant use with argatroban have not n been established (, )
  • No data
  • Lactation: Discontinue nursing or drug, taking into account the importance of the drug to the mother n ()
  • Pediatric Use: Safety and effectiveness have not been established ()
  • Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing argatroban or by decreasingn the argatroban dose. In clinical studies, anticoagulation parameters generally returned from therapeutic levels to baseline within 2 to 4 n hours after discontinuation of the drug. Reversal of anticoagulant effect may take longer in patients with hepatic impairment.
  • No specific antidote to argatroban is available; if life- threatening bleeding occurs and excessive plasma levels of argatroban are n suspected, discontinue argatroban immediately and measure aPTT and other coagulation parameters. When argatroban was administered as an continuous infusion (2 mcg/kg/min) prior to and during a 4-hour hemodialysis session, approximately 20% of Argatroban was cleared through n dialysis.
  • Single intravenous doses of argatroban at 200, 124, 150, and 200 mg/kg were lethal to mice, rats, rabbits, and dogs, respectively.n The symptoms of acute toxicity were loss of righting reflex, tremors, clonic convulsions, paralysis of hind limbs, and coma.
  • Argatroban is a synthetic direct thrombin inhibitor and the chemical name is 1-[5-[(aminoiminomethyl) amino]-1-oxo-2[[(1,2,3,4-tetrahydro-3-methyl-8-quinolinyl)sulfonyl]amino]pentyl]-4-methyl-2- piperidinecarboxylic acid, monohydrate. Argatroban has 4 n asymmetric carbons. One of the asymmetric carbons has an configuration (stereoisomer Type I) and n an configuration (stereoisomer Type II). Argatroban consists of a mixture of n and stereoisomers at a ratio of approximately 65:35.
  • The molecular formula of argatroban is CHNOSu2022HO. Its molecular n weight is 526.66 g/mol. The structural formula is:
  • Argatroban in Sodium Chloride injection is a sterile, non-pyrogenic, clear, colorless to pale yellow, aqueous solution. It is supplied in a single-dose, n clear glass vial containing 50 mg of argatroban in 50 mL solution. Each mL, contains 1 mg argatroban, 2 mg lactobionic acid, 2 mg L-methioninen USP, 8 mg sodium chloride USP, and sodium hydroxide NF (for pH adjustment) in water for injection USP. The pH of the solution is n approximately 8.8.
  • No data
  • Carcinogenicity studies with argatroban have not been performed.
  • Argatroban was not genotoxic in the Ames test, the Chinese hamster ovary cell (CHO/HGPRT) forward mutation test, the Chinese n hamster lung fibroblast chromosome aberration test, the rat hepatocyte, and WI-38 human fetal lung cell unscheduled DNA synthesis (UDS)n tests, or the mouse micronucleus test.
  • Argatroban at intravenous doses up to 27 mg/kg/day (0.3 times the recommended maximum human dose based on body surface area) n had no effect on fertility and reproductive function of male and female rats.
  • No data
  • Argatroban in Sodium Chloride injection is supplied in a single-dose vial containing 50 mg argatroban in 50 mL of aqueous solution (1 mg/mL).
  • NDC 0781-3314-91 u2013 Package containing one vial of Argatroban in Sodium Chloride injection (each vial contains 50 mg of argatroban).
  • NDC 0781-3314-95 u2013 Package containing 10 vials of Argatroban in Sodium Chloride injection (each vial contains 50 mg of argatroban).
  • Storage
  • Store the vials in original cartons at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F): excursion permitted between n 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F). Do not refrigerate or freeze. Protect from light and store in carton. Do not use if n solution is cloudy or contains a precipitate.
  • Inform patients of the risks associated with Argatroban in Sodium Chloride injection as well as the plan for regular monitoring during administrationn of the drug .
  • Specifically inform patients to report:
  • Manufactured by:Cipla Ltd., India forSandoz Inc.Princeton, NJ 08540
  • Principal Display Panel - Carton Label
  • NDC
  • Argatroban Injection
  • 50 mg per 50 mL(1 mg per mL)
  • For Intravenous Infusion Only
  • Rx only 10 Single Use Vials
  • SANDOZa Novartis Company
  • Principal Display Panel - Carton Label
  • NDC
  • ArgatrobanInjection
  • 50 mg per 50 mL
  • (1 mg per mL)
  • Do not dilute prior to administration
  • For Intravenous Infusion Only
  • Discard Unused Portion
  • Rx only
  • Single Use Vial
  • SANDOZa Novartis Company
  • Principal Display Panel - Vial Label
  • NDCn- Rx Only
  • Argatroban Injection
  • 50 mg per 50 mL
  • (1 mg per mL)

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