Natrecor

Natrecor Manufacturers

• Scios Llc
  

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  Natrecor | Scios Llc

  

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  NATRECOR® (nesiritide) is for intravenous (IV) use only. There is limited experience with administering NATRECOR® for longer than 96 hours. Monitor blood pressure closely during NATRECOR® administration.

  2.1 Recommended Dosage

  The recommended dose of NATRECOR® is an IV bolus of 2 mcg/kg followed by a continuous infusion of 0.01 mcg/kg/min. Do not initiate NATRECOR® at a dose that is above the recommended dose.

  The loading dose may not be appropriate for those with low systolic blood pressure (SBP) <110 mm Hg or for patients recently treated with afterload reducers.

  The administration of the recommended dose of NATRECOR® is a two step process:

  Step 1. Administration of the IV Bolus

  After preparation of the infusion bag [see Dosage and Administration (2.3)], withdraw the bolus volume (see Table 1) from the NATRECOR® infusion bag, and administer it over approximately 60 seconds through an IV port in the tubing.

  Bolus Volume (mL) = Patient Weight (kg) / 3

  Table 1: NATRECOR® Weight-Adjusted Bolus Volume Administered Over 60 Seconds (Final Concentration = 6 mcg/mL) Patient Weight (kg) Volume of Bolus (mL=kg/3) 60 20.0 70 23.3 80 26.7 90 30.0 100 33.3 110 36.7

  Step 2. Administration of the Continuous Infusion

  Immediately following the administration of the bolus, infuse NATRECOR® at a flow rate of 0.1 mL/kg/hr. This will deliver a NATRECOR® infusion dose of 0.01 mcg/kg/min.

  To calculate the infusion flow rate to deliver a 0.01 mcg/kg/min dose, use the following formula (see Table 2):

  Infusion Flow Rate (mL/hr) = Patient Weight (kg) × 0.1

  Table 2: NATRECOR® Weight-Adjusted Infusion Flow Rate for a 0.01 mcg/kg/min Dose Following Bolus (Final Concentration = 6 mcg/mL) Patient Weight (kg) Infusion Flow Rate (mL/hr) 60 6 70 7 80 8 90 9 100 10 110 11 2.2 Dose Adjustments

  The dose-limiting side effect of NATRECOR® is hypotension. If hypotension occurs during the administration of NATRECOR®, reduce the dose of or discontinue NATRECOR® and initiate other measures to support blood pressure (IV fluids, changes in body position). When symptomatic hypotension occurs, discontinue NATRECOR®. Because hypotension caused by NATRECOR® may be prolonged (up to hours), a period of observation may be necessary before restarting the drug. NATRECOR® may be subsequently restarted at a dose that is reduced by 30% (with no bolus administration) once the patient has stabilized.

  Do not up-titrate NATRECOR® more frequently than every 3 hours. Use central hemodynamic monitoring and do not exceed 0.03 mcg/kg/min.

  2.3 Preparation and Administration Instructions

  The NATRECOR® bolus must be drawn from the prepared infusion bag. Prime the IV tubing with 5 mL of the solution for infusion prior to connecting to the patient's vascular access port and prior to administering the bolus or starting the infusion.

  Reconstitute one 1.5 mg vial of NATRECOR® by adding 5 mL of diluent removed from a pre-filled 250 mL plastic IV bag containing the diluent of choice. After reconstitution of the vial, each mL contains 0.32 mg of nesiritide. The following preservative-free diluents are recommended for reconstitution: 5% Dextrose Injection (D5W), USP; 0.9% Sodium Chloride Injection, USP; 5% Dextrose and 0.45% Sodium Chloride Injection, USP, or 5% Dextrose and 0.2% Sodium Chloride Injection, USP. Do not shake the vial. Rock the vial gently so that all surfaces, including the stopper, are in contact with the diluent to ensure complete reconstitution. Use only a clear, essentially colorless solution. Withdraw the entire contents of the reconstituted NATRECOR® vial and add to the 250 mL plastic IV bag. This will yield a solution with a concentration of NATRECOR® of approximately 6 mcg/mL. Invert the IV bag several times to ensure complete mixing of the solution. Use the reconstituted solution within 24 hours, as NATRECOR® contains no antimicrobial preservative. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstituted vials of NATRECOR® may be stored at 2 to 25°C (36 to 77°F) for up to 24 hours. 2.4 Chemical/Physical Interactions

  NATRECOR® is physically and/or chemically incompatible with injectable formulations of heparin, insulin, ethacrynate sodium, bumetanide, enalaprilat, hydralazine, and furosemide. Do not co-administer these drugs with NATRECOR® through the same IV catheter. The preservative sodium metabisulfite is incompatible with NATRECOR®. Do not administer injectable drugs that contain sodium metabisulfite in the same infusion line as NATRECOR®. Flush the catheter between administration of NATRECOR® and incompatible drugs.

  NATRECOR® binds to heparin and therefore could bind to the heparin lining of a heparin-coated catheter, decreasing the amount of NATRECOR® delivered to the patient for some period of time. Therefore, do not administer NATRECOR® through a central heparin-coated catheter. Concomitant administration of a heparin infusion through a separate catheter is acceptable.

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