Rx Item-Adenosine 3Mg/ml Vial 20ml By Akorn Pharma

Clinical Information
Gen. Code and Des.
31430 adenosine INTRAVEN VIAL 3 MG/ML
GCN and Des.
35352 adenosine INTRAVEN VIAL 3 MG/ML
Strength
3MG/ML
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24040424 CLASS IV ANTIARRHYTHMICS
Active Ingredients
3603 adenosine 58617




Item info.
These highlights do not include all the info. needed to use
ADENOSCAN
safely and effectively. See full prescribing info. for
ADENOSCAN.
ADENOSCAN
?
(adenosine) injection,
for intravenous use
Initial U.S.
App
roval:
1995
--
RECENT MAJOR CHANGES
--
Warnings and Precautions
: Cardiac Arrest, Ventricular Arrhythmias,
and Myocardial Infarction

10/2013
Warnings and Precautions: Cerebrovascular Accidents
8/2014
Warnings and Precautions
: Seizures
(5.
6)
8/2014
Warnings and Precautions:
Hypersensitivity

8/2014
--INDICATIONS AND USAGE
-
Adenoscan
, pharmacologic stress agent,
is indicated as an adjunct to
thallium
-201 myocardial perfusion scintigraphy in
patients unable to exercise
adequately
--
DOSAGE AND ADMINISTRATION
Recommended dose is
0.14
mg/kg/min infused over
six minutes as
continuous peripheral in
travenous infusion (total dose of 0.84 mg/kg)
--
DOSAGE FORMS AND STRENGTHS
-
For
Injection
: mg/mL in s
ingle
-dose vials
-CONTRAINDI
CATIONS
--
--
?
Second
- or
third
-degree AV block (except in patients with functi
oning
artificial pacemaker)
?
Sinus node disease, such as sick sinus syndrome or symptomatic
bradycardia (except in patients with functioning artificial pacemaker)

?
Known or suspected broncho
constrictive or bronchospastic lung disease
(e.g., asthma)

?
Known hypersensitivity to Adenoscan
--
WARNINGS AND PRECAUTIONS

?
Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction
. Fatal
car
diac events
have occurred
. Avoid use in patients with symptoms or signs
of acute myocardial ischemia. Appropriate
resuscitative mea
sures should
be available
?
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block
. First
-, second
- or
third
-degree AV bl
ock, or sinus bradycardia
can occur
. Discontinue
Adenoscan if
patient develops persistent or symptomatic high
-grade
AV
block
?
Bronchoconstriction
. Can
induce dyspnea, bronchoconstriction, and
respiratory compromise, especially in patients with obstruc
tive pulmonary
disease. Discontinue Adenoscan if patient develops severe respiratory
difficulties (5.
3)
?
Hypotension
. Significant hypotension
can occur
. Discontinue
Adenoscan if
patient develops persistent or symptomatic hypotension (5.
4)
?
Cerebrovascular Ac
cident
s. Hemorrhagic and ischemic
cerebrovascular
accidents have occurred (5.
5)
?
Seizures
. New onset or recurrence of convulsive seizures ha
ve occurred.
Use of methylxanthines (e.g., caffeine, aminophylline and theophylline)
is
not recommended
in patients w
ho experience
seizures
in association with
Adenoscan
(5.
6)
?
Hypersensitivity
. Dyspnea, throat tightness, flushing, erythema, rash, and
chest discomfort have occurred
. Have
personnel and resuscitative
equipment immediately available

?
Atrial Fibrillation
. Reported in patients with
or without history of atrial
fibrillation (5.
8)
?
Hypertension
. Clinically significant increases in systolic and diastolic
pressure have been observed (5.
9) ADVERSE REACTIONS

Most common adverse reactions
(incid
ence 10%)
are
: flushing
; chest
discomfort
; shortness of breath
; headache;
throat, neck or jaw discomfort
;
gastrointestinal discomfort
; and dizziness

To report SUSPECTED ADVERSE REACTIONS, contact Astellas
Pharma US, Inc.
at
1-800
-727
-7003
or FDA at
1-800
-FDA-
1088 or
www.fda.gov/medwatch
.
DRUG INTERACTIONS
--

?
Methylxanthines
interfere with the activity of
Adenoscan
(7.1, 10)
?
Nucleoside transport inhibitors such as d
ipyridamole
can
increase the
activity of Adenoscan

See
17 for PATIENT COUNSELING info.
Revised:
8/2014

Rx Item-Adenosine 3Mg/ml Vial 20ml By Ak
Item No.:RX364310 364310 Item No. RX364310, 364310, NDC No.: 17478-0544-20, 17478-544-20, 1747854420, 17478054420, 0544-20, 054420 UPC No. 3-17478-54420-3, 317478-544203, 317478544203

AmericanPharmaWholesale.com
Item No.:RX364310 364310 Item No. RX364310, 364310, NDC No.: 17478-0544-20, 17478-544-20, 1747854420, 17478054420, 0544-20, 054420 UPC No. 3-17478-54420-3, 317478-544203, 317478544203

ADENOSINE AL 3
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