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Ceprotin Generic Name & Formulations
Legal Class
Rx
General Description
Protein C concentrate (human) 500 IU, 1000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; contains albumin; preservative-free.
Pharmacological Class
Anticoagulant protein.
How Supplied
Single-use vial—1 (w. diluent, supplies)
Manufacturer
Ceprotin Indications
Indications
Prevention and treatment of venous thrombosis and purpura fulminans in severe congenital Protein C deficiency.
Ceprotin Dosage and Administration
Adults and Children
Give by IV infusion only. <10kg: max rate 0.2mL/kg/min; ≥10kg: max rate 2mL/min. Individualize. Acute episodes/short term prophylaxis: initially 100–120 IU/kg, then 60–80 IU/kg every 6hrs for 3 doses (adjust dose to maintain target peak protein C activity of 100%); maintenance: 45–60 IU/kg every 6 or every 12hrs (maintain trough protein C level above 25% for duration of therapy); continue until desired anticoagulation achieved. Long-term prophylaxis: 45–60 IU/kg every 12hrs (maintain trough protein C level above 25%). Switching to oral anticoagulants: start with low dose; continue protein C replacement until stable anticoagulation obtained.
Ceprotin Contraindications
Not Applicable
Ceprotin Boxed Warnings
Not Applicable
Ceprotin Warnings/Precautions
Warnings/Precautions
Measure protein C activity before and during treatment; if acute thrombotic event occurs, obtain protein C activity measurement before the next injection until patient is stable. Contains human albumin; monitor for possible viral disease and Creutzfeldt-Jakob disease transmission. Mouse protein allergy. Contains heparin; if heparin-induced thrombocytopenia suspected, check platelet counts immediately, consider discontinuing. Renal impairment and/or sodium-restricted (max daily dose contains sodium >200mg). Labor & delivery. Pregnancy. Nursing mothers.
Ceprotin Pharmacokinetics
See Literature
Ceprotin Interactions
Interactions
Increased risk of bleeding with concurrent anticoagulants, tissue plasminogen activator.
Ceprotin Adverse Reactions
Adverse Reactions
Rash, itching, lightheadedness; hypersensitivity reactions (discontinue if occurs).
Ceprotin Clinical Trials
See Literature
Ceprotin Note
Notes
Report all infections suspected to be transmitted by Ceprotin to (866) 888-2472.
Ceprotin Patient Counseling
See Literature
