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
Angiomax Indications, Dosage, Storage, Stability - Bivalirudin
Angiomax Indications, Dosage, Storage, Stability - Bivalirudin
INDICATIONS AND USAGE
Angiomax is indicated for use as an anticoagulant in patients
with unstable angina undergoing percutaneous trans-luminal coronary angioplasty
(PTCA). Angiomax is intended for use with aspirin and has been studied only
in patients receiving concomitant aspirin (see Clinical Trials and DOSAGE
AND ADMINISTRATION).
The safety and effectiveness of Angiomax have not been established
when used in conjunction with platelet inhibitors other than aspirin, such as
glycoprotein IIb/IIIa inhibitors (see PRECAUTIONS,
Drug Interactions).
The safety and effectiveness of Angiomax have not been established
in patients with unstable angina who are not undergoing PTCA or in patients
with other acute coronary syndromes.
DOSAGE AND ADMINISTRATION
The recommended dosage of Angiomax is an intravenous (IV) bolus
dose of 1.0 mg/kg followed by a 4-hour IV infusion at a rate of 2.5 mg/kg/h.
After completion of the initial 4-hour infusion, an additional IV infusion of
Angiomax may be initiated at a rate of 0.2 mg/kg/h for up to 20 hours, if needed.
Angiomax is intended for use with aspirin (300-325 mg daily) and has been studied
only in patients receiving concomitant aspirin. Treatment with Angiomax should
be initiated just prior to PTCA. The dose of Angiomax may need to be reduced,
and anticoagulation status monitored, in patients with renal impairment (see
CLINICAL PHARMACOLOGY, Pharmacokinetics).
Instructions for Administration
Angiomax® (bivalirudin) is intended for intravenous
injection and infusion. To each 250 mg vial add 5 mL of Sterile Water for Injection,
USP. Gently swirl until all material is dissolved. Each reconstituted vial should
be further diluted in 50 mL of 5% Dextrose in Water or 0.9% Sodium Chloride
for Injection to yield a final concentration of 5 mg/mL (e.g., 1 vial in 50
mL; 2 vials in 100 mL; 5 vials in 250 mL). The dose to be administered is adjusted
according to the patient’s weight, see Table 5.
If the low-rate infusion is used after the initial infusion,
a lower concentration bag should be prepared. In order to prepare this bag,
reconstitute the 250 mg vial with 5 mL of Sterile Water for Injection, USP.
Gently swirl until all material is dissolved. Each reconstituted vial should
be further diluted in 500 mL of 5% Dextrose in Water or 0.9% Sodium Chloride
for Injection to yield a final concentration of 0.5 mg/mL. The infusion rate
to be administered should be selected from the right-hand column in Table 5.
|
Table 5. Dosing Table
|
|
|
Using 5 mg/Ml Concentration
|
Using 0.5 mg/mL Concentration
|
|
Weight (kg)
|
Bolus (1mg/kg) (mL)
|
Initial 4-hour Infusion (2.5 mg/kg/h) (mL/h)
|
Subsequent Low-rate Infusion (0.2 mg/kg/h) (mL/h)
|
|
43-47
|
9
|
22.5
|
18
|
|
48-52
|
10
|
25
|
20
|
|
53-57
|
11
|
27.5
|
22
|
|
58-62
|
12
|
30
|
24
|
|
63-67
|
13
|
32.5
|
26
|
|
68-72
|
14
|
35
|
28
|
|
73-77
|
15
|
37.5
|
30
|
|
78-82
|
16
|
40
|
32
|
|
83-87
|
17
|
42.5
|
34
|
|
88-92
|
18
|
45
|
36
|
|
93-97
|
19
|
47.5
|
38
|
|
98-102
|
20
|
50
|
40
|
|
103-107
|
21
|
52.5
|
42
|
|
108-112
|
22
|
55
|
44
|
|
113-117
|
23
|
57.5
|
46
|
|
118-122
|
24
|
60
|
48
|
|
123-127
|
25
|
62.5
|
50
|
|
128-132
|
26
|
65
|
52
|
|
133-137
|
27
|
67.5
|
54
|
|
138-142
|
28
|
70
|
56
|
|
143-147
|
29
|
72.5
|
58
|
|
148-152
|
30
|
75
|
60
|
Angiomax should be administered via an intravenous line. No
incompatibilities have been observed with glass bottles or polyvinyl chloride
bags and administration sets. The following nine drugs should not be administered
in the same intravenous line with Angiomax, since they resulted in haze formation,
microparticulate formation, or gross precipitation when mixed with Angiomax:
alteplase, amiodarone HCl, amphotericin B, chlorpromazine HCl, diazepam, prochlorperazine
edisylate, reteplase, streptokinase, and vancomycin HCl.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration. Preparations of Angiomax containing
particulate matter should not be used. Reconstituted material will be a clear
to slightly opalescent, colorless to slightly yellow solution.
Storage after Reconstitution
Do not freeze reconstituted or diluted Angiomax. Reconstituted
material may be stored at 2-8°C for up to 24 hours. Diluted Angiomax with a
concentration of between 0.5 mg/mL and 5 mg/mL is stable at room temperature
for up to 24 hours. Discard any unused portion of reconstituted solution remaining
in the vial.
HOW SUPPLIED
Angiomax® (bivalirudin) is supplied as a sterile,
lyophilized product in single-use, glass vials. After reconstitution, each vial
delivers 250 mg of Angiomax.
Store Angiomax dosage units at 20-25°C (68-77°F). Excursions
to 15-30°C permitted. [See USP Controlled Room Temperature.]
NDC 65293-001-01
Manufactured by: Ben Venue Laboratories Bedford,
OH, Distributed by: ICS, Louisville, KY. Marketed by: Parsippany, NJ 07054,
For information call: (800) 264-4662 U.S. Patent 5,196,404 Rx only, Hemochron®
is a registered trademark of International Technidyne Corporation, Edison,
NJ., TMC PN 1002-6 (February 10, 2004)
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