Argatroban (Argatroban)

Trade Name : Argatroban

West-Ward Pharmaceuticals Corp

INJECTION

Strength 50 mg/50mL

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 West-Ward Pharmaceuticals Corp. It is available in strength of 50 mg/50mL 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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Dosage and Administration, Dosing in Patients Undergoing Percutaneous Coronary Intervention () u00a0u00a0u00a0u00a0u00a05/2016

Argatroban is a direct thrombin inhibitor indicated:

u00a0For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).u00a0 () nn
u00a0As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI). u00a0()

Heparin-Induced Thrombocytopenia n
Percutaneous Coronary Intervention

Argatroban Injectionu00a0250 mg/2.5 mL (100 mg/mL) must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringeru2019s Injection to a final concentration of 1u00a0mg/mL. () nn
Argatroban Injection 50 mg/50 mL (1 mg/mL) is ready for intravenous infusion. Dilution is not required. ()

No data

Injection: 250 mg/2.5 mL (100 mg/mL) single-dose vial. u00a0nn
Injection: 50 mg/50 mL (1 mg/mL) ready for intravenous infusion single-dose vial. ()

Argatroban is contraindicated in:

Major bleeding n
u00a0History of hypersensitivity to this product u00a0

No data

The following adverse reaction is also discussed in other sections of the labeling:
Adverse Reactions in Patients with HIT (With or Without Thrombosis)
Because clinical trials are conducted under widely varying conditions, adverse reaction 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 adverseu00a0reactionsu00a0were collected retrospectively. Adverseu00a0reactions are separated into hemorrhagic and non-hemorrhagic reactions.
Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease u2265 2 g/dL, that led to a transfusion of u2265 2 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 gives an overview of the most frequently observed hemorrhagic reactions, presented separately by major and minor bleeding, sorted by decreasing occurrence among argatroban-treated patients with HIT (with or without thrombosis).
*u00a0u00a0with or without thrombosisa)u00a0 Patients may have experienced more than 1 adverse reaction.b)u00a0u00a0One patient experienced intracranial hemorrhage 4 days after discontinuation of argatroban and following therapy with urokinase andoral anticoagulation.c)u00a0 The historical control group consisted of patients with a clinical diagnosis of HIT (with or without thrombosis) that were considered eligible by an independent medical panel.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0DIC = disseminated intravascular coagulation.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0BKA = below the knee amputation.
Table 5 gives an overview of the most frequently observed non-hemorrhagicu00a0reactions sorted by decreasing frequency of occurrence (u22652%) among argatroban-treated HIT/HITTS patients.
a) Patients may have experienced more than 1 adverse reaction.b) With or without thrombosisc) The historical control group consisted of patients with a clinical diagnosis of HIT (with or without thrombosis) that were considered eligible by an independent medical panel.
Adverse Reactions 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 re-exposed to argatroban for a total of 112 PCIs with argatroban anticoagulation. Adverseu00a0reactions are separated into hemorrhagic (Table 6) and non-hemorrhagic (Table 7) reactions.
Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease u22655 g/dL, that led to a 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%.
a)u00a0u00a0Patients may have experienced more than 1 adverse reaction.b)u00a0u00a091 patients who underwent 112 interventions.u00a0u00a0u00a0u00a0 CABG = coronary artery bypass graft.
Table 7 gives an overview of the most frequently observed non-hemorrhagicu00a0adverse reactions u00a0(>2%), sorted by decreasing frequency of occurrence among argatroban-treated PCI patients.
a)u00a0u00a0Patients may have experienced more than 1 adverse reaction.b)u00a0u00a091 patients who underwent 112 interventions.
There were 22 serious adverseu00a0reactions in 17 PCI patients (19.6% in 112 interventions). Tableu00a08 lists the serious adverseu00a0reactions occurring in argatroban-treated patients with or at risk for HIT undergoing PCI.
a)u00a0u00a0Individualu00a0reactions may also have been reported elsewhere (see Table 6 and 7).b)u00a0u00a091 patients underwent 112 procedures. Some patients may have experienced more than 1 reaction.
Intracranial Bleeding in Other Populations
Increased risks for intracranial bleeding have been observed in investigational studies of argatroban for other uses.u00a0 In a study of patients with acute myocardial infarction receiving both argatroban and thrombolytic therapy (streptokinase or tissue plasminogen activator), the overall frequency of intracranial bleeding was 1% (8 out of 810 patients). u00a0Intracranial bleeding was not observed in 317 subjects or patients who did not receive concomitant thrombolysisn
The safety and effectiveness of argatroban for cardiac indications other than PCI in patients with HIT have not been established.u00a0 Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of acute stroke within 12u00a0hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of 117 patients (4.3%) who received argatroban at 1 to 3u00a0mcg/kg/min and in none of the 54 patients who received placebo. u00a0Asymptomatic intracranial hemorrhage 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 with argatroban in clinical pharmacology studies or for various clinical indications. About 95% (148/156) of these reactions occurred 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) include (in descending order of frequency):
Limited data are available on the potential formation of drug-related antibodies. Plasma from 12 healthy volunteers treated with argatroban over 6 days showed no evidence of neutralizing antibodies. No loss of anticoagulant activity was noted with repeated administration of argatroban to more than 40 patients.
To report SUSPECTED ADVERSE REACTIONS, contact
West-Ward Pharmaceuticals Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
.

HIT patients: The most common (>5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest.u00a0u00a0 nn
u00a0PCI patients: The most common (>5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache.u00a0u00a0u00a0u00a0

No data

No data

Excessive anticoagulation, with or without bleeding, may be controlled by discontinuing argatroban or by decreasing the argatroban dose. In clinical studies, anticoagulation parameters generally returned from therapeutic levels to baseline within 2 to 4 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 suspected, discontinue argatroban immediately and measure aPTT and other coagulation parameters. When argatroban was administered as a continuous infusion (2 mcg/kg/min) prior to and during a 4-hour hemodialysis session, approximately 20% of argatroban was cleared through dialysis.
Single intravenous doses of argatroban at 200, 124, 150, and 200 mg/kg were lethal to mice, rats, rabbits, and dogs, respectively. 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 asymmetric carbons. One of the asymmetric carbons has an R configuration (stereoisomer Type I) and an S configuration (stereoisomer Type II). Argatroban consists of a mixture of R and S stereoisomers at a ratio of approximately 65:35.
The molecular formula of Argatroban is CHNOSu2022HO. Its molecular weight is 526.66 g/mol. The structural formula is shown below:
Argatroban is a white, odorless crystalline powder that is freely soluble in glacial acetic acid, slightly soluble in ethanol, and insoluble in acetone, ethyl acetate, andu00a0ether.
Argatrobanu00a0Injectionu00a0250 mg/2.5 mL (100 mg/mL) is a sterile clear, colorless to pale yellow, slightly viscous solution. u00a0Argatroban 250 mg/2.5 mL (100 mg/mL) is available in 250-mg (in 2.5-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 100 mg Argatroban. Inert ingredients (per vial): 1300 mg Propylene glycol,u00a0760 mg Dehydrated alcohol.
Argatroban Injection 50 mg/50 mL (1 mg/mL) is a sterile clear, colorless to pale yellow, solution. u00a0Argatroban 50 mg/50 mL (1 mg/mL) is available in 50-mg (in 50-mL) single-dose amber vials, with white flip-top caps. Each mL of sterile, nonpyrogenic solution contains 1 mg Argatroban. Inert ingredients (per vial): 260 mg Propylene glycol,u00a0152 mg Dehydrated alcohol, and 450 mg Sodium Chloride.

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 hamster lung fibroblast chromosome aberration test, the rat hepatocyte, and WI-38 human fetal lung cell unscheduled DNA synthesis (UDS) tests, or the mouse micronucleus test.
Argatroban at intravenous doses up to 27u00a0mg/kg/day (0.3u00a0times the recommended maximum human dose based on body surface area) had no effect on fertility and reproductive function of male and female rats.

No data

Argatroban Injection is available in packages as follows: u00a0
NDCu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Strengthu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Packaged
0143-9674-01u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 250 mg/2.5 mL (100 mg/mL)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Single Dose Vial
0143-9559-01u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 50 mg/50 mL (1 mg/mL)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Single Dose Vial
Storage and Handling
Store the vials in original carton at 20u00b0 - 25u00b0 C (68u00b0 - 77u00b0 F) [See USP Controlled Room Temperature].u00a0 Do not freeze.u00a0 Retain in the original carton to protect from light. If the solution is cloudy, or if an insoluble precipitate is noted, the vial should be discarded.

Inform patients of the risks associated with Argatroban Injection as well as the plan for regular monitoring during administration of the drug.u00a0 Specifically, inform patients to report:
Manufactured by:u00a0 n
Distributed by:u00a0 n
Revisedu00a0October 2016

Single-Use VialNDC 0143-9674-01Discard Unused Portionn n n n Rx ONLY

NDC 0143-9559-01u00a0u00a0 Rx onlyn n n 50 mL Single Dose Vialn n
NDC 0143-9559-01u00a0u00a0 Rx onlyn n n n n n 50 mL Single Dose Vialn n
u00a0

No data

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Argatroban (Argatroban)

Trade Name : Argatroban

INJECTION

Delivery Process

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Argatroban (Argatroban)

Trade Name : Argatroban

INJECTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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