Molecule
Argatroban is an anti-coagulant indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT), among other approved uses. It is available as injection for intravenous use. MedsAcross supplies Argatroban for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
1 Argatroban in 0.9% Sodium Chloride Injection is a direct thrombin inhibitor indicated: For prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT). As an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI)
Source: US FDA prescribing information
Argatroban is a direct thrombin inhibitor that reversibly binds to the thrombin active site. Argatroban does not require the co-factor antithrombin III for antithrombotic activity. Argatroban exerts its anticoagulant effects by inhibiting thrombin-catalyzed or -induced reactions, including fibrin formation, activation of coagulation factors V, VIII, and XIII, activation of protein C, and platelet aggregation. Argatroban inhibits thrombin with an inhibition constant (Ki) of 0.04 μM. At therapeutic concentrations, argatroban has little or no effect on related serine proteases (trypsin, factor Xa, plasmin, and kallikrein). Argatroban is capable of inhibiting the action of both free and clot-associated thrombin.
Source: US FDA prescribing information
1 Argatroban 125 mg in 125 mL aqueous sodium chloride solution (1 mg/mL) is intended for administration to adult patients. Discontinue all parenteral anticoagulants before administering Argatroban Injection. Adjust dosing in patients with HIT who have moderate or severe hepatic impairment. Heparin-Induced Thrombocytopenia. The dose for heparin-induced thrombocytopenia without hepatic impairment is 2 mcg/kg/min administered as a continuous infusion. Discontinue heparin therapy and obtain a baseline aPTT before administering Argatroban. After the initial dose of Argatroban, the dose can be adjusted as clinically indicated. Percutaneous Coronary Intervention.
Source: US FDA prescribing information
Argatroban is contraindicated in: Patients with major bleeding, Patients with a history of hypersensitivity to argatroban. Airway, skin, and generalized hypersensitivity reactions have been reported. Major bleeding. History of hypersensitivity to this product
Source: US FDA prescribing information
Hemorrhage can occur. Unexplained fall in hematocrit or blood pressure or other unexplained symptom may indicate hemorrhage. Use with caution in patients at risk, including those receiving antiplatelet agents, thrombolytics, or other anticoagulants. Hepatic impairment: Adjust starting dose and titrate carefully in patients with HIT who have moderate or severe hepatic impairment. Avoid use in PCI in patients with clinically significant hepatic impairment
Source: US FDA prescribing information
The following adverse reaction is also discussed in other sections of the labeling: Risk of Hemorrhage. HIT patients: The most common (>5%) adverse reactions were dyspnea, hypotension, fever, diarrhea, sepsis, and cardiac arrest. PCI patients: The most common (>5%) adverse reactions were chest pain, hypotension, back pain, nausea, vomiting and headache
Source: US FDA prescribing information
Heparin: Allow sufficient time for heparin’s effect on aPTT to decrease before initiating Argatroban in 0.9% Sodium Chloride Injection therapy. 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 been established
Source: US FDA prescribing information
Storage Store the vials in original cartons at 20º to 25ºC (68º to 77°F). Do not freeze. Retain in the original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Argatroban, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Argatroban 50 mg/50 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Argatroban 250 mg/2.5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
| Argatroban 125 mg/125 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 30 June 2000 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 3 presentations of Argatroban and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Argatroban on 30 June 2000, according to Drugs@FDA.
No listed presentation of Argatroban is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.