Argatroban SOLUTION

Get an overview of ARGATROBAN (solution), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Argatroban can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Argatroban.

Drug Basics

Brand Name: Argatroban

Generic Name: ARGATROBAN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: INTRAVENOUS

Dosage Form: SOLUTION

Data Current As Of: 2018-12-17

indications & usage

heparin-induced thrombocytopenia

Argatroban Injection is indicated for prophylaxis or treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT).

percutaneous coronary intervention

Argatroban Injection is indicated as an anticoagulant in adult patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI).

drug interactions

heparin

If argatroban is to be initiated after cessation of heparin therapy, allow sufficient time for heparin’s effect on the aPTT to decrease prior to initiation of argatroban therapy.

oral anticoagulant agents

Pharmacokinetic drug-drug interactions between argatroban and warfarin (7.5 mg single oral dose) have not been demonstrated. However, the concomitant use of argatroban and warfarin (5 to 7.5 mg initial oral dose, followed by 2.5 to 6 mg/day orally for 6 to 10 days) results in prolongation of the prothrombin time (PT) and International Normalized Ratio (INR) [see Dosage and Administration (2.5) and Clinical Pharmacology (12.2)].

aspirin / acetaminophen

No drug-drug interactions have been demonstrated between argatroban and concomitantly administered aspirin or acetaminophen [see Clinical Pharmacology (12.3)].

thrombolytic agents

The safety and effectiveness of argatroban with thrombolytic agents have not been established [see Adverse Reactions (6.3)].

glycoprotein iib / iiia antagonists

The safety and effectiveness of argatroban with glycoprotein IIb/IIIa antagonists have not been established.

patient counseling information

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:

  • the use of any other products known to affect bleeding.
  • any medical history that may increase the risk for bleeding, including a history of severe hypertension; recent lumbar puncture or spinal anesthesia; major surgery, especially involving the brain, spinal cord, or eye; hematologic conditions associated with increased bleeding tendencies such as congenital or acquired bleeding disorders and gastrointestinal lesions such as ulcerations.
  • any bleeding signs or symptoms.
  • the occurrence of any signs or symptoms of allergic reactions (e.g., airway reactions, skin reactions and vasodilation reactions).

05-2016M

46183444

Manufactured in Canada by Sandoz Canada Inc.,

145 Jules-Léger Street, Boucherville Canada, QC J4B 7K8 for

Sandoz Inc., Princeton, NJ 08540

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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