Argatroban

Dosing and Administration, Dosing in Patients Undergoing Percutaneous Coronary Interventions (2.2) 5/2016

  Argatroban is a direct thrombin inhibitor indicated:

• For prophylaxis or treatment of thrombosis in adult  patients with heparin-induced thrombocytopenia (HIT) (1.1)
• As an anticoagulant in adults patients with or at risk for HIT undergoing percutaneous coronary intervention (PCI) (1.2)

Each 125 mL glass vial contains 125 mg of argatroban (1mg/mL); and, as supplied, is ready for intravenous infusion. Dilution is not required.

Argatroban Injection is a clear, colorless to pale yellow solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Do not use if the solution is cloudy, contains precipitates, or if the flip-off seal is not intact.

Argatroban Injection is supplied in a single use vial containing 125 mg argatroban in 125 mL aqueous sodium chloride solution (1 mg/mL). The solution is ready for intravenous infusion.

• Nursing Mothers: Discontinue nursing or drug, taking into account the importance of the drug to the mother (8.3)
• Pediatric use: Safety and effectiveness have not been established; if used initial infusion doses are lower than in adult patients (2.4, 8.4, 12.3)