“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

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]

Disclaimer

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

Delivery Process

Submit a Request

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.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

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.

Submit a Request

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.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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.

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.

Read more

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.

Read more
  • 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

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

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

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

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Dossiers and Stability Studies

Dossiers and Stability Studies

STABILITY STUDIES STABILITY, BA / BE STUDIES Due to our active

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64022 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71252 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51047 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13298 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Office / Warehouse Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2023 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.