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
Primacor IV Indications, Dosage, Storage, Stability - Milrinone
Primacor IV Indications, Dosage, Storage, Stability - Milrinone
INDICATIONS
PRIMACOR is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving PRIMACOR should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous PRIMACOR has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of PRIMACOR for periods exceeding 48 hours.
DOSAGE AND ADMINISTRATION
PRIMACOR should be administered with a loading
dose followed by a continuous
infusion (maintenance dose) according to the following guidelines:
LOADING DOSE
50 mcg/kg: Administer slowly over 10 minutes
The table below shows
the loading dose
in milliliters (mL) of PRIMACOR (1 mg/mL) by patient
body weight
(kg).
Loading Dose (mL) Using 1 mg/mL Concentration
|
Patient Body Weight (kg)
|
|
kg
|
30
|
40
|
50
|
60
|
70
|
80
|
90
|
100
|
110
|
120
|
|
mL
|
1.5
|
2.0
|
2.5
|
3.0
|
3.5
|
4.0
|
4.5
|
5.0
|
5.5
|
6.0
|
The loading dose
may be given undiluted, but diluting to a rounded total volume of
10 or 20 mL (see Maintenance Dose for diluents) may simplify the
visualization
of the injection rate.
MAINTENANCE DOSE
|
|
Infusion Rate
|
Total Daily Dose
(24 Hours)
|
|
|
Minimum
|
0. 375 mcg/kg/min
|
0.59 mg/kg
|
Administer as a
continuous
intravenous
infusion.
|
|
Standard
|
0.50 mcg/kg/min
|
0.77 mg/kg
|
|
Maximum
|
0.75 mcg/kg/min
|
1.13 mg/kg
|
PRIMACOR drawn from vials should be diluted prior to maintenance
dose administration. The diluents that may be used are 0.45% Sodium
Chloride Injection USP, 0.9% Sodium Chloride Injection USP, or 5%
Dextrose Injection USP. The table
below shows the volume
of diluent in milliliters
(mL) that must be used to achieve 200 mcg/mL concentration
for infusion, and the
resultant total volumes.
|
Desired Infusion Concentration
|
PRIMACOR 1mg/mL
|
Diluent
|
Total Volume
|
|
mcg/mL
|
(mL)
|
(mL)
|
(mL)
|
|
200
|
10
|
40
|
50
|
|
200
|
20
|
80
|
100
|
The infusion rate
should be adjusted according to hemodynamic and clinical response.
Patients should be closely monitored. In
controlled clinical studies, most patients showed an improvement
in hemodynamic status
as evidenced by increases in cardiac
output and reductions
in pulmonary capillary
wedge pressure.
Note: See Dosage Adjustment in Renally Impaired Patients
below.
Dosage may be titrated to the maximum
hemodynamic effect and
should not exceed 1.13 mg/kg/day. Duration of therapy
should depend upon patient responsiveness. The maintenance dose
in mL/hr by patient
body weight
(kg) may be determined by reference to the following table.
Note: PRIMACOR supplied in 100 mL and 200 mL Flexible Containers
(200 mcg/mL in 5% Dextrose Injection) need
not be diluted prior to use.
PRIMACOR Infusion Rate (mL/hr) Using 200 mcg/mL Concentration
|
Maintenance Dose (mcg/kg/min)
|
Patient Body Weight (kg)
|
|
30
|
40
|
50
|
60
|
70
|
80
|
90
|
100
|
110
|
120
|
|
0.375
|
3.4
|
4.5
|
5.6
|
6.8
|
7.9
|
9.0
|
10.1
|
11.3
|
12.4
|
13.5
|
|
0.400
|
3.6
|
4.8
|
6.0
|
7.2
|
8.4
|
9.6
|
10.8
|
12.0
|
13.2
|
14.4
|
|
0.500
|
4.5
|
6.0
|
7.5
|
9.0
|
10.5
|
12.0
|
13.5
|
15.0
|
16.5
|
18.0
|
|
0.600
|
5.4
|
7.2
|
9.0
|
10.8
|
12.6
|
14.4
|
16.2
|
18.0
|
19.8
|
21.6
|
|
0.700
|
6.3
|
8.4
|
10.5
|
12.6
|
14.7
|
16.8
|
18.9
|
21.0
|
23.1
|
25.2
|
|
0.750
|
6.8
|
9.0
|
11.3
|
13.5
|
15.8
|
18.0
|
20.3
|
22.5
|
24.8
|
27.0
|
When administering PRIMACOR (milrinone lactate) by continuous infusion,
it is advisable to use a calibrated electronic
infusion device.
The Flexible Container has a concentration
of milrinone equivalent
to 200 mcg/mL in 5% Dextrose Injection and is more convenient to
use than dilutions prepared from the vials. To use the Flexible
Container, tear the overwrap at the notch
and remove the Pre-Mix solution
container. Squeeze the container
firmly to check for leaks.
Discard the container
if leaks are found since the sterility
of the product could
be affected. Do not add supplementary medication. To prepare the
container for administration
of PRIMACOR intravenously, use aseptic techniques.
- The flow control
clamp of the administration
set is closed.
- The cover of the outlet
proof at the bottom of
the container is
removed.
- Noting the full directions on the administration
set carton, the piercing
pin of the set is inserted
into the proof with a
twisting motion until
it is firmly seated.
- The container
is suspended on
the hanger.
- The drip chamber
is squeezed and released to establish the fill level.
- The flow control
clamp is opened to expel
air from the set, and
then closed.
- The set is attached
to the venipuncture
device, primed, and if not indwelling, the venipuncture
is performed.
- The rate of administration
is controlled with the flow
control clamp. WARNING:
DO NOT USE IN SERIES CONNECTIONS. Caution: Do not use plastic
containers in series
connections. Such use could result in air
embolism due to residual
air being drawn from the
primary container
before administration of the fluid
from the secondary
container is complete.
Intravenous drug products
should be inspected visually and should not be used if particulate
matter or discoloration
is present.
Dosage Adjustment in Renally Impaired Patients
Data obtained from patients with severe renal
impairment (creatinine
clearance = 0 to 30 mL/min) but without congestive heart
failure have demonstrated
that the presence of renal
impairment significantly
increases the terminal elimination half-life
of PRIMACOR. Reductions in infusion
rate may be necessary in
patients with renal impairment.
For patients with clinical
evidence of renal impairment,
the recommended infusion
rate can be obtained from
the following table:
|
Creatinine Clearance
( mL/min/1.73 m²)
|
Infusion Rate
(mcg/kg/min)
|
|
5
|
0.20
|
|
10
|
0.23
|
|
20
|
0.28
|
|
30
|
0.33
|
|
40
|
0.38
|
|
50
|
0.43
|
HOW SUPPLIED
PRIMACOR is supplied as 10 mL (1 mg/mL) NDC 0024-1200-10, box of
10 and 20 mL (1 mg/mL) NDC 0024-1200-20, box of 10 single-dose vials
and 50 mL (1 mg/mL) NDC 0024-1200-50, box of 1 single-dose vial
containing a sterile, clear, colorless to pale yellow
solution. Each mL contains milrinone lactate equivalent to 1 mg
milrinone.
PRIMACOR is also supplied as Carpuject® sterile
cartridge unit with InterLink®
System Cannula, 5 mL (1 mg/mL) NDC 0024-1200-06 in 5 mL cartridges,
box of 10. Each mL contains milrinone lactate
equivalent to 1 mg
milrinone.
PRIMACOR is also supplied as CARPUJECT sterile
cartridge unit (22-gauge,
1 1/4 Inch Needle) 5 mL (1 mg/mL) NDC 0024-1200-05 in 5 mL cartridges,
box of 10. Each mL contains milrinone lactate
equivalent to 1 mg
milrinone.
Store at controlled room
temperature 15°
C to 30° C (59° F to 86° F). Avoid freezing.
The following PRIMACOR Flexible Containers are also supplied:
- 100 mL (200 mcg/mL) NDC 0024-1203-01 in 5% Dextrose Injection
- 200 mL (200 mcg/mL) NDC 0024-1203-02 in 5% Dextrose Injection
Exposure of pharmaceutical
products to heat should
be minimized. Avoid excessive heat. Protect from freezing. It is
recommended that the Flexible Containers be stored at room
temperature, 25° C (77° F), however, brief exposure
up to 40° C (104° F) does not adversely affect
the product.
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