EXP:
1 DAY (RT) Label: Refrigerate/
concentration= 1 mg/ ml.
Dosing (A-fib/flutter) initially 0.25
mg/kg over 2 min. If inadequate give 0.35 mg/kg
over 2 min-15 min after 1st dose. Subsequent doses
should be individualized. Continuous infusion:
started immediately following an effective bolus
dose. Initial rate= 10 mg/hr (some may respond to
5 mg/hr). If needed, may increase up to 15 mg/hr.
Contraindicated: AMI, hypotension (sys<90), 2nd
& 3rd degree AV block.
DOSAGE AND ADMINISTRATION
Direct Intravenous Single Injections (Bolus)
The initial dose of Diltiazem Hydrochloride
Injection should be 0.25 mg/kg actual body weight
as a bolus administered over 2 minutes (20 mg is a
reasonable dose for the average patient). If
response is inadequate, a second dose may be
administered after 15 minutes. The second bolus
dose of diltiazem hydrochloride injection should
be 0.35 mg/kg actual body weight administered over
2 minutes (25 mg is a reasonable dose for the
average patient). Subsequent intravenous bolus
doses should be individualized for each patient.
Patients with low body weights should be dosed on
a mg/kg basis. Some patients may respond to an
initial dose of 0.15 mg/kg, although duration of
action may be shorter. Experience with this dose
is limited.
Continuous Intravenous Infusion
For continued reduction of the heart rate (up to
24 hours) in patients with atrial fibrillation or
atrial flutter, an intravenous infusion of
diltiazem hydrochloride may be administered.
Immediately following bolus administration of 20
mg (0.25 mg/kg) or 25 mg (0.35 mg/kg) diltiazem
hydrochloride injection and reduction of heart
rate, begin an intravenous infusion of diltiazem
hydrochloride. The recommended initial infusion
rate of diltiazem hydrochloride is 10 mg/h. Some
patients may maintain response to an initial rate
of 5 mg/h. The infusion rate may be increased in 5
mg/h increments up to 15 mg/h as needed, if
further reduction in heart rate is required. The
infusion may be maintained for up to 24 hours.
Diltiazem shows dose-dependent, non-linear
pharmacokinetics. Duration of infusion longer than
24 hours and infusion rates greater than 15 mg/h
have not been studied. Therefore, infusion
duration exceeding 24 hours and infusion rates
exceeding 15 mg/h are not recommended.
Dilution: To prepare diltiazem hydrochloride
injection for continuous intravenous infusion
aseptically transfer the appropriate quantity (see
chart) of diltiazem hydrochloride injection to the
desired volume of either Normal Saline, D5W, or
D5W/0.45% NaCl. Mix thoroughly. Use within 24
hours. Keep refrigerated until use.
| Diluent
Volume |
Quantity
of Diltiazem HCl Injection
to Add |
Final
Concentration |
Administration
Dose* |
Infusion
Rate |
| 100
mL |
125
mg (25 mL)
Final Volume
125 mL
|
1
mg/mL |
10
mg/h
15 mg/h
|
10
mL/h
15 mL/h
|
| 250
mL |
250
mg (50 mL)
Final Volume
300 mL
|
0.83
mg/mL |
10
mg/h
15 mg/h
|
12
mL/h
18 mL/h
|
| 500
mL |
250
mg (50 mL) |
0.45
mg/mL |
10
mg/h |
22
mL/h |
| Final
Volume 550 mL |
|
15
mg/h |
33
mL/h |
*5 mg/h may be
appropriate for some patients.
Compatibility:
Diltiazem hydrochloride injection was tested for
compatibility with three commonly used intravenous
fluids at a maximal concentration of 1 mg
diltiazem hydrochloride per milliliter. Diltiazem
hydrochloride injection was found to be physically
compatible and chemically stable in the following
parenteral solutions for at least 24 hours when
stored in glass or polyvinylchloride (PVC) bags at
controlled room temperature 20 to 25°C (68 to 77°F)
[see USP] or under refrigeration 2 to 8°C (36 to
46°F).
• dextrose (5%) injection USP
• sodium chloride (0.9%) injection USP
• dextrose (5%) and sodium chloride (0.45%)
injection USP
Physical Incompatibilities:
Because of potential physical incompatibilities,
it is recommended that diltiazem hydrochloride not
be mixed with any other drugs in the same
container. If possible, it is recommended that
diltiazem hydrochloride not be coinfused in the
same intravenous line. Parenteral drug products
should be inspected visually for particulate
matter and discoloration prior to administration
whenever solution and container permit.
Diltiazem Hydrochloride.Physical incompatibilities
(precipitate formation or cloudiness) were
observed when diltiazem hydrochloride was infused
in the same intravenous line with the following
drugs: acetazolamide, acyclovir, aminophylline,
ampicillin, ampicillin sodium/sulbactam sodium,
cefamandole, cefoperazone, diazepam, furosemide,
hydrocortisone sodium succinate, insulin,
(regular: 100 units/mL), methylprednisolone sodium
succinate, mezlocillin, nafcillin, phenytoin,
rifampin, and sodium bicarbonate.
Transition to Further
Antiarrhythmic Therapy
Transition to other antiarrhythmic agents
following administration of diltiazem
hydrochloride injection is generally safe.
However, reference should be made to the
respective agent manufacturer’s package insert
for information relative to dosage and
administration.
In controlled clinical trials, therapy with
antiarrhythmic agents to maintain reduced heart
rate in atrial fibrillation or atrial flutter or
for prophylaxis of PSVT was generally started
within 3 hours after bolus administration of
diltiazem. These antiarrhythmic agents were
intravenous or oral digoxin, Class 1
antiarrhythmics (e.g., quinidine, procainamide),
calcium channel blockers, and oral beta-blockers.
Experience in the use of antiarrhythmic agents
following maintenance infusion of diltiazem
hydrochloride injection is limited. Patients
should be dosed on an individual basis and
reference should be made to the respective
manufacturer's package insert for information
relative to dosage and administration.
HOW SUPPLIED
Diltiazem Hydrochloride Injection is supplied in
single-dose containers as follows:
10 Fliptop Vials/Carton - 10 mL
10 Fliptop Vials/Carton - 5 mL
DISCARD UNUSED PORTION.
STORE PRODUCT UNDER REFRIGERATION 2 TO 8°C (36 TO
46°F). DO NOT FREEZE.
MAY BE STORED AT ROOM TEMPERATURE FOR UP TO 1
MONTH. DESTROY AFTER 1 MONTH AT ROOM TEMPERATURE.
Revised: June, 2006
©Hospira 2006 EN-1220 Printed in USA
HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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