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ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Nesiritide (Natrecor®) Major Indications IV treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity. Mechanism of Action Nesiritide is a human recombinant form of B-type natriuretic peptide (BNP) that is identical to, and mimics the actions of, endogenous BNP. Human BNP binds to (stimulates) the guanylate cyclase receptor of vascular smooth muscle and endothelial cells, leading to increased intracellular concentrations of guanosine 3', 5'-cyclic monophosphate (cGMP) and smooth muscle cell relaxation. Cyclic GMP serves as a second messenger to dilate both veins and arteries. Nesiritide has natriuretic, diuretic, vasodilatory, and smooth muscle relaxant activity. The drug has no pro-arrhythmic effects. Monitoring · · Blood pressure & heart rate should be monitored at 15 min., 30 min., 1 hr., 2 hrs., 3 hrs., 6 hrs., then every 4 hours while on nesiritide In patients with right heart catheters, hemodynamic measurements should be done and documented as clinically indicated. Pharmacokinetics Onset of Action: Peak effect: Duration of Action: Serum Half-life: Nesiritide/page 1 11.2001 revised 9/2003 15 mins Peak clinical effects are reached in approximately 3 hours; 60% of peak effect is reached in 15 min and 95% is reached in 1 hour after starting the infusion 2 hrs. Note: the effects of nesiritide do not dissipate rapidly as most other vasoactive drugs, thus hypotension may persist for > 2 hrs. after stopping the infusion. 18 minutes Dosing, Adjustments, and Administration (see also incompatibility information under Comments) Note: Nesiritide must be ordered via Physician Orders for Nesiritide Intravenous Infusion form Initial Dose: IV bolus of 2 micrograms/kg over 60 seconds followed by a continuous infusion at a dose of 0.01 micrograms/kg/min. Note: the bolus dose (see dosing chart) is never given from the reconstituted vial directly. Pharmacy will draw the bolus dose up from the first infusion bag and provide it in a separate syringe. Adjustments: For symptomatic hypotension, the dose should be held or reduced as other measure to increase blood pressure are initiated (fluids, Trendelenberg). When SBP stabilizes above 90 mmHg and/or symptoms resolve, the drug may be resumed (without a bolus) at 30% less than the initial dose. There is limited experience with doses above the standard recommended doses above, however, for inadequate response, the dose may be increased at intervals no less than every 3 hours. To increase, a 1 mcg/kg bolus may be given over 60 seconds followed by an increase of 0.005 mcg/kg/min. over the previous rate. If a re-bolus is needed, please notify the pharmacy to have the bolus prepared for you. The maximum rate of administration is 0.03 mcg/kg/min. Always infuse nesiritide via an infusion pump device. Never start nesiritide therapy at doses in excess of those recommended above. Adverse Effects Most common Hypotension (11%)* Headache (8%) Back pain (4%) Nausea (4%) Elevated Creatinine > 0.5 over baseline (28%)** Less common Ventricular tachycardia (3%) Ventricular extrasystoles (3%) Dizziness (3%) Anxiety (3%) Insomnia (2%) Angina (2%) Bradycardia (1%) Abdominal pain (1%) Vomiting (1%) * Hypotension may last for 2 hours ** Risk for creatinine elevation is dose-related Contraindications 1. 2. Nesiritide is contraindicated in patients with know hypersensitivity to the drug. According to the manufacturer, nesiritide should not be used in patients in cardiogenic shock, patients with SBP <90 mmHg, or in patients with know, or suspected, low filling pressures. Nesiritide has been used successfully in chronically hypotensive patients with SBP <90 mmHg with careful selection of the bolus and initial infusion doses by the physician. Nesiritide/page 2 11.2001 revised 9/2003 Comments 1. 2. 3. Hypotension may be prolonged as long as 2 hours after stopping the infusion. Risk of symptomatic hypotension is increased in patients using ACE inhibitor medications. Incompatabilities: a. Nesiritide is incompatible with heparin and heparin-containing solutions AND catheters. Do not mix or infuse nesiritide with heparin. Do not infuse nesiritide into heparin impregnated IV catheters. Heparin may be co-administered as long as it is via a separate catheter. b. Nesiritide is incompatible with metabisulfite preservatives. IV medications should be checked for this preservative prior to mixing or co-administering with nesiritide. c. Nesiritide is known to be incompatible with the following medications: Heparin (as above) Insulin Ethacrynate (Edecrin) Bumetanide (Bumex) Enalaprilat (Vasotec) Furosemide (Lasix) Hydralazine 4. Nesiritide may be administered via a peripheral IV or a centrally placed non-heparin coated catheter. Nesiritide/page 3 11.2001 revised 9/2003 ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Pharmacy Department / Clinical Services IV Additive Service DRUG NAME (GENERIC Nesiritide Intravenous Infusion STORAGE REQUIREMENTS Room temperature or refrigereated 1. 2. 3. PREPARATION Remove the 23 ml of overfill from the 250 ml bag of D5W. Add 5 ml of diluent (D5W or NSS), drawn from a 250 ml piggyback bag, to a 1.5 mg vial of nesiritide. 2. Allow the nesiritide to dissolve while rocking the vial gently to ensure that all surfaces, including the stopper, come in contact with the diluent RESULTING CONCENTRATION 6 mcg/ml STABILITY 24 hours (DO NOT SHAKE) 4. Add the dissolved nesiritide into the 250 ml piggyback bag. Invert the bag several times to ensure mixing of the drug. Synonyms (Trade Names): Natrecor (manufactured by SCIOS, Inc.) Notes: The diluted solution is used by the pharmacy to draw up the bolus dose for nursing. Never administer nesiritide directly from the vial. Nesiritide/page 4 11.2001 revised 9/2003 ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Nesiritide (6 mcg / ml) Dosing Chart The following chart allows quick determination of the amount and rate for bolus and maintenance doses, respectively, of nesiritide 6 mcg/ml infusion concentration. Never administer nesiritide directly from the vial. Doses, in ml., for this concentration may also easily be calculated by: Bolus Volume (in ml of 6 mcg/ml concenmtration) = 0.33 X Patient Weight (in KG) Maintenance Rate (in ml/hr of the 6 mcg/ml concentration) = 0.1 X Patient Weight (in KG) To Use Chart: 1. Find the weight (in kg) closest to the patients weight in the far left column 2. Read over to the next column to determine the amount of bolus, in mcg, to achieve a 2 mcg/kg dose. 3. Read over to the third column to determine the amount, in ml., of 6 mcg/ml solution to administer over 60 seconds to achieve a 2 mcg/kg dose 4. Read over, from the patients weight, to the far right column to find the rate to set an infusion pump (in ml/hr) to deliver a 0.01 mcg/kg/min maintenance dose Patient Weight (in KG) Amount of Bolus Dose in mcg (for 2 mcg/kg) Volume of Bolus (in ml of 6 mcg / ml concentration) Rate of Maintenance Infusion (in ml/hr of 6 mcg / ml concentration) 50 100 16.7 5 55 110 18.3 5.5 60 120 20 6 65 130 21.7 6.5 70 140 23.3 7 75 150 25 7.5 80 160 26.7 8 85 170 28.3 8.5 90 180 30 9 95 190 31.7 9.5 100 200 33.3 10 105 210 35 10.5 110 220 36.7 11 115 230 38.3 11.5 120 240 40 12 125 250 41.7 12.5 130 260 43.3 13.0 Nesiritide/page 5 11.2001 revised 9/2003 Anne Arundel Medical Center Annapolis, MD 21401 Physicians Orders I hereby authorize the pharmacy to dispense a generic equivalent unless the particular drug is circled. Physician Orders for Nesiritide (Natrecor) Intravenous Infusion Check boxes as appropriate Date Time Time Ord. Ord. Noted 1. Indication:_____________________________________ 2. Patient’s weight: __________ kg. (required) 3. Labs prior to initiation: ¨ Baseline BNP ¨ Baseline and daily Basic Metabolic Panel 4. Bolus IV Dose (check one): q 2 mcg/kg over 60 seconds q other: _________ mcg/kg over 60 seconds q none 5. Maintenance IV Infusion for ___________ hrs. q 0.01 mcg/kg/min. q other: _________ mcg/kg/min. 6. Monitoring: ¨ Blood pressure and heart rate as per Nesiritide Critical Care Medication Manual Guidelines At 15 min., 30 min., 1 hr., 2 hrs., 3 hrs., 6 hrs., then every 4 hours while on nesiritide. ¨ Baseline and daily weights. ¨ Strict In's and Out's. 7. Notify physician on call for (check one): q SBP < 90 mmHg q SBP < ____ mmHg . Signature of Prescriber Nesiritide/page 6 11.2001 revised 9/2003