ADENOSINE  - adenosine injection, solution 
General Injectables & Vaccines, Inc

Adenosine 3mg/2mL 2mL single dose vial

ADENOSINE - adenosine injection, solution
Akorn, Inc.
Rx only
Adenosine is an endogenous nucleoside occurring in all cells of the body. It is chemically 6-amino-9-b-D-ribofuranosyl-9-H-purine
and has the following structural formula:


Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming
and lowering the pH. Adenosine is not chemically related to other antiarrhythmic drugs. Adenosine injection is a sterile, nonpyrogenic
solution for rapid bolus intravenous injection. Each mL contains 3 mg adenosine, and 9 mg sodium chloride, in Water for Injection.
The pH of the solution is between 4.5 and 7.5.


Mechanism of Action
Adenosine injection slows conduction time through the A-V node, can interrupt the reentry pathways through the A-V node, and can
restore normal sinus rhythm in patients with paroxysmal supraventricular tachycardia (PSVT), including PSVT associated with Wolff-
Parkinson-White Syndrome.
Adenosine is antagonized competitively by methylxanthines such as caffeine and theophylline, and potentiated by blockers of
nucleoside transport such as dipyridamole. Adenosine is not blocked by atropine.
The intravenous bolus dose of 6 or 12 mg adenosine injection usually has no systemic hemodynamic effects. When larger doses are
given by infusion, adenosine decreases blood pressure by decreasing peripheral resistance.
Intravenously administered adenosine is rapidly cleared from the circulation via cellular uptake, primarily by erythrocytes
and vascular endothelial cells. This process involves a specific transmembrane nucleoside carrier system that is reversible,
nonconcentrative, and bidirectionally symmetrical. Intracellular adenosine is rapidly metabolized either via phosphorylation to
adenosine monophosphate by adenosine kinase, or via deamination to inosine by adenosine deaminase in the cytosol. Since adenosine
kinase has a lower Km and Vmax than adenosine deaminase, deamination plays a significant role only when cytosolic adenosine
saturates the phosphorylation pathway. Inosine formed by deamination of adenosine can leave the cell intact or can be degraded to
hypoxanthine, xanthine, and ultimately uric acid. Adenosine monophosphate formed by phosphorylation of adenosine is incorporated
into the high-energy phosphate pool. While extracellular adenosine is primarily cleared by cellular uptake with a half-life of less than
10 seconds in whole blood. excessive amounts may be deaminated by an ecto-form of adenosine deaminase. As adenosine requires no
hepatic or renal function for its activation or inactivation, hepatic and renal failure would not be expected to alter its effectiveness or
Clinical Trial Results
In controlled studies in the United States, bolus doses of 3, 6, 9, and 12 mg were studied. A cumulative 60% of patients with
paroxysmal supraventricular tachycardia had converted to normal sinus rhythm within one minute after an intravenous bolus dose of 6
mg adenosine (some converted on 3 mg and failures were given 6 mg), and a cumulative 92% converted after a bolus dose of 12 mg.
Seven to sixteen percent of patients converted after 1-4 placebo bolus injections. Similar responses were seen in a variety of patient
subsets, including those using or not using digoxin, those with Wolff-Parkinson-White Syndrome, males, females, blacks, Caucasians:
and Hispanics.
Adenosine is not effective in converting rhythms other than PSVT such as atrial flutter, atrial fibrillation, or ventricular tachycardia, to
normal sinus rhythm. To date, such patients have not had adverse consequences following administration of adenosine.


Adenosine injection is indicated for the following.

Conversion to sinus rhythm of paroxysmal supraventricular tachycardia (PSVT), including that associated with accessory bypass tracts
(Wolff-Parkinson-White Syndrome). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver): should be
attempted prior to adenosine administration.
It is important to be sure the adenosine solution actually reaches the systemic circulation (see DOSAGE AND
Adenosine does not convert atrial flutter, atrial fibrillation, or ventricular tachycardia to normal sinus rhythm. In the presence of
atrial flutter or atrial fibrillation, a transient modest slowing of ventricular response may occur immediately following adenosine


Adenosine injection is contraindicated in:
1. Second- or third-degree A-V block (except in patients with a functioning artificial pacemaker).
2. Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial
3. Known hypersensitivity to adenosine.


Intravenous adenosine has been effectively administered in the presence of other cardioactive drugs, such as quinidine, betaadrenergic
blocking agents, calcium channel blocking agents, and angiotensin converting enzyme inhibitors, without any change
in the adverse reaction profile. Digoxin and verapamil use may be rarely associated with ventricular fibrillation when combined
with adenosine (see WARNINGS). Because of the potential for additive or synergistic depressant effects on the SA and AV nodes,
however, adenosine should be used with caution in the presence of these agents. The use of adenosine in patients receiving digitalis
may be rarely associated with ventricular fibrillation (see WARNINGS).
The effects of adenosine are antagonized by methylxanthines such as caffeine and theophylline. In the presence of these
methylxanthines, larger doses of adenosine may be required or adenosine may not be effective. Adenosine effects are potentiated by
dipyridamole. Thus, smaller doses of adenosine may be effective in the presence of dipyridamole. Carbamazepine has been reported to

increase the degree of heart block produced by other agents. As the primary effect of adenosine is to decrease conduction through the
A-V node: higher degrees of heart block may be produced in the presence of carbamazepine.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies in animals have not been performed to evaluate the carcinogenic potential of adenosine. Adenosine was negative for genotoxic
potential in the Salmonella (Ames Test) and mammalian Microsome Assay.
Adenosine, however, like other nucleosides at millimolar concentrations present for several doubling times of cells in culture, is
known to produce a variety of chromosomal alterations. Fertility studies in animals have not been conducted with adeno
Pregnancy Category C
Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women. As
adenosine is a naturally occurring material, widely dispersed throughout the body, no fetal effects would be anticipated. However,
since it is not known whether adenosine can cause fetal harm when administered to pregnant women, adenosine should be used during
pregnancy only if clearly needed.
Pediatric Use
No controlled studies have been conducted in pediatric patients to establish the safety and efficacy of adenosine injection for the
conversion of paroxysmal supraventricular tachycardia (PSVT). However, intravenous adenosine has been used for the treatment of
PSVT in neonates, infants, children and adolescents (see DOSAGE AND ADMINISTRATION).1
Geriatric Use
Clinical studies of injected adenosine did not include sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between
elderly and younger patients. In general, adenosine in geriatric patients should be used with caution since this population may have
a diminished cardiac function, nodal dysfunction, concomitant diseases or drug therapy that may alter hemodynamic function and
produce severe bradycardia or AV block.


The following reactions were reported with intravenous adenosine used in controlled U.S. clinical trials. The placebo group had less
than 1 % rate of all of these reactions.
Cardiovascular Facial flushing (18%), headache (2%), sweating, palpitations, chest pain, hypotension (less than 1 %).
Respiratory Shortness of breath/dyspnea (12%), chest pressure (7%), hyperventilation, head pressure (less than 1%).
Central Nervous System Lightheadedness (2%), dizziness, tingling in arms, numbness (1%), apprehension, blurred vision, burning
sensation, heaviness in arms, neck and back pain (less than 1 %).
Gastrointestinal Nausea (3%), metallic taste, tightness in throat, pressure in groin (less than 1%).
Post Marketing Experience (see WARNINGS)
The following adverse events have been reported from marketing experience with adenosine. Because these events are reported
voluntarily from a population of uncertain size, are associated with concomitant diseases and multiple drug therapies and surgical
procedures, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions
to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2)
frequency of the reporting, (3) strength of causal connection to the drug, or a combination of these factors.
Prolonged asystole, ventricular tachycardia, ventricular fibrillation, transient increase in blood pressure, bradycardia, atrial fibrillation,
and Torsade de Pointes
Central Nervous System
Seizure activity, including tonic clonic (grand mal) seizures, and loss of consciousness.


The half-life of adenosine injection is less than 10 seconds. Thus, adverse effects are generally rapidly self-limiting. Treatment of any
prolonged adverse effects should be individualized and be directed toward the specific effect. Methylxanthines, such as caffeine and
theophylline, are competitive antagonists of adenosine.


For rapid bolus intravenous use only.
Adenosine injection should be given as a rapid bolus by the peripheral intravenous route. To be certain the solution reaches
the systemic circulation, it should be administered either directly into a vein or, if given into an IV line, it should be given as
close to the patient as possible and followed by a rapid saline flush.

Adult Patients
The dose recommendation is based on clinical studies with peripheral venous bolus dosing. Central venous (CVP or other)
administration of adenosine injection has not been systematically studied.
The recommended intravenous doses for adults are as follows:
Initial dose: 6 mg given as a rapid intravenous bolus (administered over a 1-2 second period).
Repeat administration: If the first dose does not result in elimination of the supraventricular tachycardia within 1-2 minutes, 12 mg
should be given as a rapid intravenous bolus. This 12 mg dose may be repeated a second time if required.
Pediatric Patients
The dosages used in neonates, infants, children and adolescents were equivalent to those administered to adults on a weight basis.
Pediatric Patients with a Body Weight less than 50 kg:
Initial dose: Give 0.05 to 0.1 mg/kg as a rapid IV bolus given either centrally or peripherally. A saline flush should follow.
Repeat administration: If conversion of PSVT does not occur within 1-2 minutes, additional bolus injections of adenosine can be
administered at incrementally higher doses, increasing the amount given by 0.05 to 0.1 mg/kg. Follow each bolus with a saline flush.
This process should continue until sinus rhythm is established or a maximum single dose of 0.3 mg/kg is used.
Pediatric Patients with a Body Weight greater than 50 kg: Administer the adult dose.
Doses greater than 12 mg are not recommended for adult and pediatric patients.
NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.


Adenosine injection is supplied as a sterile non-pyrogenic solution in normal saline as follows:
NDC 17478-542-02, 6 mg/2 mL vial in a carton of ten (not shrink wrapped).
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
DO NOT REFRIGERATE as crystallization may occur. If crystallization has occurred, dissolve crystals by warming to room
temperature. The solution must be clear at the time of use.
Contains no preservatives.
Discard unused portion.
May require needle or blunt. To prevent needle-stick injuries, needles should not be recapped, purposely bent or broken by hand.
1. Paul T, Pfammatter. J-P Adenosine: an effective and safe antiarrhythmic drug in pediatrics. Pediatrics Cardiology 1997;
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
Rev. 11/08



adenosine  injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-026 (17478-542)
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Adenosine (Adenosine) Adenosine 3 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
# NDC Package Description Multilevel Packaging
1 52584-026-02 1 VIAL In 1 BAG contains a VIAL
1 2 mL In 1 VIAL This package is contained within the BAG (52584-026-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078076 10/05/2023

Labeler - General Injectables & Vaccines, Inc (108250663)
Revised: 10/2011General Injectables & Vaccines, Inc