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HANGZHOU HOLYPHARM BIOTECH CO.,LTD

Country:China (Mainland)

Year Established: 2009Business type: Other

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1. Brief Description of Argatroban

Argatroban (CAS No. 74863-84-6) is a synthetic direct thrombin inhibitor derived from L-arginine. It 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. With its molecular formula C23H36N6O5SA·H2O, the molecular weight of Argatroban is 526.66. In general, Argatroban is available in 250-mg (in 2.5-mL) single-use amber vials, with gray flip-top caps.

2. Argatroban Package insert

Hangzhou Holypharm biotech Co.,Ltd. is a professional supplier of active pharmaceutical ingredients and intermediates. One of the products is the argatroban, and the company gave the Package insert of Argatroban:

Argatroban is indicated as an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia and an anticoagulant in patients with or at risk for heparin-induced thrombocytopenia undergoing percutaneous coronary intervention (PCI).

Each 2.5-mL vial contains 250 mg of Argatroban; and, as supplied, is a concentrated drug (100 mg/mL), which must be diluted 100-fold prior to infusion. Argatroban should not be mixed with other drugs prior to dilution in a suitable intravenous fluid.

1) The recommended argatroban dosing in patients with HIT/HITTS

Before administering Argatroban, discontinue heparin therapy and obtain a baseline aPTT. [1] The recommended initial dose of Argatroban for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion. See below for standard infusion rates, a dosing checklist, and a summary of recommended dosing.

2) Percutaneous Coronary Interventions (PCI) in HIT/HITTS Patients

An infusion of Argatroban should be started at 25 mcg/kg/min and a bolus of 350 mcg/kg administered via a large bore intravenous (IV) line over 3 to 5 minutes (see Table 9). Activated clotting time (ACT) should be checked 5 to 10 minutes after the bolus dose is completed. The procedure may proceed if the ACT is greater than 300 seconds.

3) Dosing in Special Populations: Hepatic Impairment

For patients with heparin-induced thrombocytopenia with hepatic impairment, the initial dose of Argatroban should be reduced. For patients with moderate hepatic impairment, an initial dose of 0.5 mcg/kg/min is recommended, based on the approximate 4-fold decrease in Argatroban clearance relative to those with normal hepatic function. The aPTT should be monitored closely, and the dosage should be adjusted as clinically indicated

3. The effects on International Normalized Ratio of Argatroban (argatroban inr )

Because Argatroban is a direct thrombin inhibitor, co-administration of Argatroban and warfarin produces a combined effect on the laboratory measurement of the INR. However, concurrent therapy, compared to warfarin monotherapy, exerts no additional effect on vitamin K–dependent factor Xa activity. The relationship between the INR on co-therapy and warfarin alone is dependent on both the Argatroban dosing and the thromboplastin reagent used.

INR Relationship of Argatroban (argatroban inr ) Plus Warfarin vs Warfarin Alone (For 2 mcg/kg/min Dose of Argatroban)

INR Relationship of Argatroban (argatroban inr ) Plus Warfarin vs Warfarin Alone (For 2 mcg/kg/min Dose of Argatroban)

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argatroban dose

Argatroban (CAS No. 74863-84-6) is an anticoagulant that is a small molecule direct thrombin inhibitor and the argatroban dose in different diseases is not the same.

argatroban

basic information of Argatroban and its usage

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