Argatroban (Argatroban)

Trade Name : ARGATROBAN

Novartis Pharmaceuticals Corporation

INJECTION, SOLUTION

Strength 100 mg/mL

Storage and handling for ARGATROBAN

ARGATROBAN Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]

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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 Novartis Pharmaceuticals Corporation. It is available in strength of 100 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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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.

About GNH

No data

Argatroban is a direct thrombin inhibitor indicated:

Argatroban Injection must be diluted 100-fold by mixing with 0.9% Sodium Chloride Injection, 5% Dextrose Injection or Lactated Ringer's Injection to a final concentration of 1 mg/mL. ()
Heparin-Induced Thrombocytopenia
The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. ()
Percutaneous Coronary Interventions
The dose for patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary interventions is 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. ()

250 mg of argatroban in 2.5 mL of sterile solution for injection in a single-dose vial.
250 mg/2.5 mL single-dose vial ()

Argatroban is contraindicated in

No data

The following adverse reaction is also discussed in other sections of 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 greater than or equal to 2 g/dL, that led to a transfusion of greater than or equal to 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.
n Table 4 gives an overview of the most frequently observed hemorrhagic events, presented separately by major and minor bleeding, sorted by decreasing occurrence among argatroban-treated patients with HIT(with or without thrombosis).
n Table 5 gives an overview of the most frequently observed non-hemorrhagic events sorted by decreasing frequency of occurrence (greater than or equal to 2%) among argatroban-treated HIT/HITTS patients.
Adverse Events in Patients with or at Risk for HIT 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. Adverse events are separated into hemorrhagic (Table 6) and non-hemorrhagic (Table 7) events.
Major bleeding was defined as bleeding that was overt and associated with a hemoglobin decrease greater than or equal to 5 g/dL, that led to a transfusion of greater than or equal to 2 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%.
n Table 7 gives an overview of the most frequently observed non-hemorrhagic events (greater than 2%), sorted by decreasing frequency of occurrence among argatroban-treated PCI patients.
There were 22 serious adverse events in 17 PCI patients (19.6% in 112 interventions). Table 8 lists the serious adverse events occurring in 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 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). Intracranial bleeding was not observed in 317 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. Intracranial bleeding was also observed in a prospective, placebo-controlled study of argatroban in patients who had onset of acute stroke within 12 hours of study entry. Symptomatic intracranial hemorrhage was reported in 5 of 117 patients (4.3%) who received argatroban at 1 to 3 mcg/kg/min and in none of the 54 patients who received placebo. Asymptomatic 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 Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or .

No data

7.4n- 7.5

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]u2011 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 configuration (stereoisomer Type I) and an configuration (stereoisomer Type II). Argatroban consists of a mixture of and stereoisomers at a ratio of approximately 65:35.
The molecular formula of argatroban is CHNOSu2219HO. Its molecular weight is 526.66 g/mol. The structural formula is:
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, and ether.
Argatroban Injection is a sterile clear, colorless to pale yellow, slightly viscous solution in a single-use amber vial containing 250 mg/2.5 mL of argatroban. Each mL of sterile, nonpyrogenic solution contains 100 mg argatroban, 300 mg D-sorbitol, and 400 mg dehydrated alcohol in water for injection.

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 27 mg/kg/day (0.3 times 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 supplied in 2.5 mL solution in single-use vials at the concentration of 100 mg/mL. Each vial contains 250 mg of argatroban.
NDC 0078-0930-61u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 (Package of 1)
Storage
Store the vials in original cartons at room temperature [25u00baC (77u00b0F), with excursions permitted to 15u00baC to 30u00baC (59u00baF - 86u00b0F)]. Do not freeze. 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. Specifically, inform patients to report:

Distributed by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
T2018-13

NDC 0078-0930-61
R only
Arrayn- ARGATROBAN
Arrayn- INJECTION
Arrayn- 250 mg/2.5 mL
Arrayn- Each mL contains 100 mg Argatroban
Arrayn- Single-Use Vial
Arrayn- For I.V. Infusion Only
Arrayn- Dilute Prior to Use
Novartis

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