A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Natrecor Indications, Dosage, Storage, Stability - Nesiritide
Natrecor Indications, Dosage, Storage, Stability - Nesiritide
INDICATIONS AND USAGE
Natrecor (nesiritide) is indicated for the intravenous treatment
of patients with acutely decompensated congestive heart failure who have dyspnea
at rest or with minimal activity. In this population, the use of Natrecor reduced
pulmonary capillary wedge pressure and improved dyspnea.
DOSAGE AND ADMINISTRATION
The Natrecor bolus must be drawn from the prepared infusion bag.
Natrecor (nesiritide) is for intravenous use only. There is
limited experience with administering Natrecor for longer than 48 hours. Blood
pressure should be monitored closely during Natrecor administration.
If hypotension occurs during the administration of
Natrecor , the dose should be reduced or discontinued and other measures
to support blood pressure should be started (IV fluids, changes in body
position). In the VMAC trial, when symptomatic hypotension occurred,
Natrecor was discontinued and subsequently could be restarted at a
dose that was reduced by 30% (with no bolus administration) once the
patient was stabilized. Because hypotension caused by Natrecor
may be prolonged (up to hours), a period of observation may be necessary
before restarting the drug.
The recommended dose of
Natrecor is an IV bolus of 2 µg/kg followed by a continuous infusion
of 0.01 µg/kg/min. Natrecor should not be initiated at a dose
that is above the recommended dose.
Prime the IV tubing with an
infusion of 25 mL prior to connecting to the patient's vascular access
port and prior to administering the bolus or starting the infusion.
Bolus followed by infusion: After preparation of the infusion bag,
as described previously, withdraw the bolus volume (see table below) from
the Natrecor infusion bag, and administer it over approximately 60 seconds
through an IV port in the tubing. 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 µg/kg/min.
To calculate the appropriate bolus volume and infusion flow
rate to deliver a 0.01-µg/kg/min dose, use the following formulas (or refer
to the following dosing table):
Bolus Volume (mL) = 0.33 x Patient Weight (kg) Infusion Flow
Rate (mL/hr) = 0.1 x Patient Weight (kg)
Natrecor Weight-Adjusted Bolus Volume and Infusion Flow Rate
(2-µg/kg Bolus Followed by a 0.01-µg/kg/min Dose)
|
Patient Weight (kg)
|
Volume of Bolus (mL)
|
Rate of Infusion (mL/h)
|
|
60
|
20.0
|
6
|
|
70
|
23.3
|
7
|
|
80
|
26.7
|
8
|
|
90
|
30.0
|
9
|
|
100
|
33.3
|
10
|
|
110
|
36.7
|
11
|
Dose Adjustments: The dose-limiting side effect
of Natrecor is hypotension. Do not initiate Natrecor at a dose that is
higher than the recommended dose of a 2 µg/kg bolus followed by an infusion
of 0.01 µg/kg/min. In the VMAC trial there was limited experience with
increasing the dose of Natrecor above the recommended dose (23 patients,
all of whom had central hemodynamic monitoring). In those patients, the
infusion dose of Natrecor was increased by 0.005 µg/kg/min (preceded by
a bolus of 1 µg/kg), no more frequently than every 3 hours up to a maximum
dose of 0.03 µg/kg/min. Natrecor should not be titrated at frequent intervals
as is done with other IV agents that have a shorter half-life (see Clinical
Trials).
Chemical/Physical Interactions
Natrecor is physically and/or chemically incompatible with
injectable formulations of heparin, insulin, ethacrynate sodium, bumetamide,
enalaprilat, hydralazine, and furosemide. These drugs should not be co-administered
as infusions with Natrecor through the same IV catheter. The preservative sodium
metabisulfite is incompatible with Natrecor. Injectable drugs that contain sodium
metabisulfite should not be administered in the same infusion line as Natrecor.
The catheter must be flushed 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, Natrecor must not be administered
through a central heparin-coated catheter. Concomitant administration of a heparin
infusion through a separate catheter is acceptable.
Storage
Store Natrecor at controlled room temperature (20–25°C;
68–77°F); excursions permitted to 15–30°C
(59–86°F; see USP Controlled Room Temperature), or
refrigerated (2–8°C; 36–46°F).
Keep in carton until time of use.
HOW SUPPLIED
Natrecor (nesiritide) is provided as a sterile lyophilized
powder in 1.5-mg, single-use vials. Each carton contains one vial and is available
in the following package:
1 vial/carton (NDC 65847-205-25)
US patent No. 5,114,923 and 5,674,710. Distributed
by Scios Inc.
820 West Maude Ave Sunnyvale, CA 94085 Copyright.
2001 Scios Inc. NA1030
August 2001
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