Adenosine
60 mg/20mL · Injection, Solution
- Prescription only
- Adenosine Receptor Agonist
- Active substance
- Adenosine
- Made by
- Eugia US LLC
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2023-09-05
Adenosine Receptor Agonist
- Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
The recommended adenosine injection, USP dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).
Full directions ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
- Adenosine injection USP, a pharmacologic stress agent, is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately ( 1 )
From the official label · 2023-09-05 · DailyMed
How it works
From this product’s own US prescribing label.
Adenosine causes cardiac vasodilation which increases cardiac blood flow.
Adenosine is thought to exert its pharmacological effects through activation of purine receptors (cell-surface A 1 and A 2 adenosine receptors).
Intracellular adenosine is metabolized either via phosphorylation to adenosine monophosphate by adenosine kinase, or via deamination to inosine by adenosine deaminase in the cytosol.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2023-09-05
Do not take it if
- Adenosine injection is contraindicated in patients with:
- Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2) ] Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) [see Warnings and Precautions (5.2) ] Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) [see Warnings and Precautions (5.3) ] Known hypersensitivity to adenosine injection [see Warnings and Precautions (5.7) ] Second- or third-degree AV block (except in patients with a functioning artificial pacemaker) ( 4 ) Sinus node disease, such as sick sinus syndrome or symptomatic bradycardia (except in patients with a functioning artificial pacemaker) ( 4 ) Known or suspected bronchoconstrictive or bronchospastic lung disease (e.g., asthma) ( 4 ) Known hypersensitivity to adenosine injection ( 4 )
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- The recommended adenosine injection, USP dose is 0.14 mg/kg/min infused over six minutes (total dose of 0.84 mg/kg) (Table 1).
- Administer adenosine injection, USP only as a continuous peripheral intravenous infusion Inject Thallium-201 at the midpoint of the adenosine infusion (i.e., after the first three minutes of adenosine injection, USP) Thallium-201 is physically compatible with adenosine injection, USP and may be injected directly into the adenosine infusion set Inject Thallium-201 as close to the venous access as possible to prevent an inadvertent increase in the dose of adenosine injection, USP (the contents of the intravenous tubing) being administered Visually inspect adenosine injection, USP for particulate matter and discoloration prior to administration.
- Do not administer adenosine injection, USP if it contains particulate matter or is discolored.
- There are no data on the safety or efficacy of alternative adenosine infusion protocols.
- The safety and efficacy of adenosine injection, USP administered by the intracoronary route have not been established.
- Table 1 Dosage Chart for Adenosine Injection, USP Patient Weight (kilograms) Infusion Rate (mL per minute over 6 minutes for total dose of 0.84 mg/kg) 45 2.1 50 2.3 55 2.6 60 2.8 65 3 70 3.3 75 3.5 80 3.8 85 4 90
- 4.2 The nomogram displayed in Table 1 was derived from the following general formula:
- Recommended dose is 0.14 mg/kg/min infused over six minutes as a continuous peripheral intravenous infusion (total dose of 0.84 mg/kg) ( 2 ) General Formula
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Fatal cardiac events have occurred.
- Avoid use in patients with symptoms or signs of acute myocardial ischemia.
- Appropriate resuscitative measures should be available ( 5.1 ) Sinoatrial (SA) and Atrioventricular (AV) Nodal Block .
- First-, second- or third-degree AV block, or sinus bradycardia can occur.
- Discontinue adenosine injection if patient develops persistent or symptomatic high-grade AV block ( 5.2 ) Bronchoconstriction .
- Can induce dyspnea, bronchoconstriction, and respiratory compromise, especially in patients with obstructive pulmonary disease.
- Discontinue adenosine injection if patient develops severe respiratory difficulties ( 5.3 ) Hypotension .
- Significant hypotension can occur.
- Discontinue adenosine injection if patient develops persistent or symptomatic hypotension ( 5.4 ) Cerebrovascular Accidents .
- Hemorrhagic and ischemic cerebrovascular accidents have occurred ( 5.5 ) Seizures .
- New onset or recurrence of convulsive seizures have occurred.
- Use of methylxanthines (e.g., caffeine, aminophylline and theophylline) is not recommended in patients who experience a seizures in association with adenosine injection ( 5.6 ) Hypersensitivity .
- Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred.
- Have personnel and resuscitative equipment immediately available ( 5.7 ) Atrial Fibrillation .
- Reported in patients with or without a history of atrial fibrillation ( 5.8 ) Hypertension .
- Clinically significant increases in systolic and diastolic pressure have been observed ( 5.9 )
- 5.1 Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction Fatal and nonfatal cardiac arrest, sustained ventricular tachycardia (requiring resuscitation), and myocardial infarction have occurred following adenosine infusion.
- Avoid use in patients with symptoms or signs of acute myocardial ischemia, for example, unstable angina or cardiovascular instability; these patients may be at greater risk of serious cardiovascular reactions to adenosine injection.
- Appropriate resuscitative measures should be available [see Overdosage (10) ] .
- 5.2 Sinoatrial and Atrioventricular Nodal Block Adenosine injection exerts a direct depressant effect on the SA and AV nodes and may cause first-, second- or third-degree AV block, or sinus bradycardia.
- In clinical trials, approximately 6% of patients developed AV block following adenosine injection administration (first-degree heart block developed in 3%, second-degree in 3%, and third-degree in 0.8% of patients) [see Clinical Trials Experience (6.1) ] .
- Use adenosine injection with caution in patients with pre-existing first-degree AV block or bundle branch block.
- Do not use in patients with high-grade AV block or sinus node dysfunction (except in patients with a functioning artificial pacemaker).
- Discontinue adenosine injection in any patient who develops persistent or symptomatic high-grade AV block.
- 5.3 Bronchoconstriction Adenosine injection administration can cause dyspnea, bronchoconstriction, and respiratory compromise.
- Adenosine injection should be used with caution in patients with obstructive lung disease not associated with bronchoconstriction (e.g., emphysema, bronchitis).
- Do not use in patients with bronchoconstriction or bronchospasm (e.g., asthma).
- Discontinue adenosine injection in any patient who develops severe respiratory difficulties.
- Resuscitative measures should be available prior to adenosine injection administration [see Clinical Trials Experience (6.1) , Overdosage (10) , and Clinical Pharmacology (12.2) ].
- 5.4 Hypotension Adenosine injection is a potent peripheral vasodilator and can induce significant hypotension.
- The risk of serious hypotension may be higher in patients with autonomic dysfunction, hypovolemia, stenotic valvular heart disease, pericarditis or pericardial effusions, or stenotic carotid artery disease with cerebrovascular insufficiency.
- Discontinue adenosine injection in any patient who develops persistent or symptomatic hypotension.
- 5.5 Cerebrovascular Accident Hemorrhagic and ischemic cerebrovascular accidents have occurred.
- Hemodynamic effects of adenosine injection including hypotension or hypertension can be associated with these adverse reactions [see Warnings and Precautions (5.4) and (5.9) ] .
- 5.6 Seizures New-onset or recurrence of convulsive seizures has occurred following adenosine injection.
- Some seizures are prolonged and require emergent anticonvulsive management.
- Aminophylline may increase the risk of seizures associated with adenosine injection.
- Methylxanthine use is not recommended in patients who experience seizures in association with adenosine injection administration [see Overdosage (10) ].
- 5.7 Hypersensitivity Dyspnea, throat tightness, flushing, erythema, rash, and chest discomfort have occurred.
- Symptomatic treatment may be required.
- Have personnel and appropriate treatment available.
- Resuscitative measures may be necessary
- if symptoms progress [see Post-Marketing Experience (6.2) ].
- 5.8 Atrial Fibrillation Adenosine injection can cause atrial fibrillation in patients with or without a history of atrial fibrillation.
- Atrial fibrillation typically began 1.5 to 3 minutes after initiation of adenosine injection, lasted for 15 seconds to 6 hours, and spontaneously converted to normal sinus rhythm [see Post-Marketing Experience (6.2) ] .
- 5.9 Hypertension Adenosine injection can induce clinically significant increases in systolic and diastolic blood pressure.
- Most increases resolved spontaneously within several minutes, but in some cases, hypertension lasted for several hours [see Clinical Trials Experience (6.1) ] .
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Pregnancy Category C .
- Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women.
- Because it is not known whether adenosine injection can cause fetal harm when administered to pregnant women, adenosine injection should be used during pregnancy only if clearly needed.
- It is not known whether adenosine injection is excreted in human milk.
- Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from adenosine injection in nursing infants, the decision to interrupt nursing after administration of adenosine injection or not to administer adenosine injection, should take into account the importance of the drug to the mother.
- IN SPECIFIC POPULATIONS
- 8.1 Pregnancy Pregnancy Category C .
- Animal reproduction studies have not been conducted with adenosine; nor have studies been performed in pregnant women.
- Because it is not known whether adenosine injection can cause fetal harm when administered to pregnant women, adenosine injection should be used during pregnancy only if clearly needed.
- 8.3 Nursing Mothers It is not known whether adenosine injection is excreted in human milk.
- Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from adenosine injection in nursing infants, the decision to interrupt nursing after administration of adenosine injection or not to administer adenosine injection, should take into account the importance of the drug to the mother.
- 8.4 Pediatric Use The safety and effectiveness of adenosine injection in patients less than 18 years of age have not been established.
- 8.5 Geriatric Use Clinical studies with adenosine injection did not include sufficient numbers of subjects aged younger than 65 years to determine whether they respond differently.
- Other reported experience has not revealed clinically relevant differences of the response of elderly in comparison to younger patients.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Methylxanthines interfere with the activity of adenosine injection ( 7.1 , 10 ) Nucleoside transport inhibitors such as dipyridamole can increase the activity of adenosine injection ( 7.1 )
- 7.1 Effects of Other Drugs on Adenosine Injection The vasoactive effects of adenosine are inhibited by adenosine receptor antagonists, (such as methylxanthines (e.g., caffeine, aminophylline, and theophylline).
- The safety and efficacy of adenosine injection in the presence of these agents has not been systematically evaluated [see Overdosage (10) ] .
- The vasoactive effects of adenosine injection are potentiated by nucleoside transport inhibitors such as dipyridamole.
- The safety and efficacy of adenosine in the presence of dipyridamole has not been systematically evaluated.
- Whenever possible, drugs that might inhibit or augment the effects of adenosine should be withheld for at least five half-lives prior to the use of adenosine injection.
- 7.2 Effects of Adenosine Injection on Other Drugs Adenosine injection has been given with other cardioactive drugs (such as beta adrenergic blocking agents, cardiac glycosides, and calcium channel blockers) without apparent adverse interactions, but its effectiveness with these agents has not been systematically evaluated.
- Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, adenosine injection should be used with caution in the presence of these agents [see Warnings and Precautions (5.2) ] .
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- The half-life of adenosine is less than 10 seconds and adverse reactions of adenosine injection usually resolve quickly when the infusion is discontinued, although delayed or persistent reactions have been observed.
- Methylxanthines, such as caffeine, aminophylline, and theophylline, are competitive adenosine receptor antagonists and theophylline has been used to terminate persistent adverse reactions.
- In clinical trials, theophylline (50 mg to 125 mg slow intravenous injection) was used to attenuate adenosine injection adverse reactions in approximately 2% of patients.
- Methylxanthine use is not recommended in patients who experience seizures in association with adenosine injection [see Drug Interactions (7.1) ] .
Quoted from the official label, section “Overdosage”.
Use in children
The safety and effectiveness of adenosine injection in patients less than 18 years of age have not been established.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Clinical studies with adenosine injection did not include sufficient numbers of subjects aged younger than 65 years to determine whether they respond differently.
- Other reported experience has not revealed clinically relevant differences of the response of elderly in comparison to younger patients.
Quoted from the official label, section “Geriatric Use”.
Side effects
- The following adverse reactions are discussed in more detail in other sections of the prescribing information:
- Fatal Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction [see Warnings and Precautions (5.1)] Sinoatrial and Atrioventricular Nodal Block [see Warnings and Precautions (5.2)] Bronchoconstriction [see Warnings and Precautions (5.3) ] Hypotension [see Warnings and Precautions (5.4) ] Cerebrovascular Accident [see Warnings and Precautions (5.5) ] Seizures [see Warnings and Precautions (5.6) ] Hypersensitivity [see Warnings and Precautions (5.7) ] Atrial fibrillation [see Warnings and Precautions (5.8) ] Hypertension [see Warnings and Precautions (5.9) ] Most common adverse reactions (incidence ≥ 10%) are:
- flushing; chest discomfort; shortness of breath; headache; throat, neck or jaw discomfort; gastrointestinal discomfort; and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
- The following adverse reactions, with an incidence of at least 1%, were reported with adenosine injection among 1,421 patients in clinical trials. 11% of the adverse reactions occurred several hours after adenosine injection administration. 8% of the adverse reactions began with adenosine infusion and persisted for up to 24 hours.
- The most common (incidence ≥ 10%) adverse reactions to adenosine injection are flushing, chest discomfort, shortness of breath, headache, throat, neck or jaw discomfort, gastrointestinal discomfort, and dizziness (Table 2).
- Table 2 Adverse Reactions in Clinical Trials (Frequency ≥ 1%) Adverse Reactions Adenosine Injection N = 1,421 Flushing 44% Chest discomfort 40% Dyspnea 28% Headache 18% Throat, neck or jaw discomfort 15% Gastrointestinal discomfort 13% Lightheadedness/dizziness 12% Upper extremity discomfort 4% ST segment depression 3% First-degree AV block 3% Second-degree AV block 3% Paresthesia 2% Hypotension 2% Nervousness 2% Arrhythmias 1% Adverse reactions to adenosine injection of any severity reported in less than 1% of patients include:
- Body as a Whole :
- back discomfort, lower extremity discomfort, weakness Cardiovascular System :
- myocardial infarction, ventricular arrhythmia, third-degree AV block, bradycardia, palpitation, sinus exit block, sinus pause, T-wave changes, hypertension (systolic blood pressure > 200 mm Hg) Respiratory System :
- cough Central nervous System :
- drowsiness, emotional instability, tremors Genital/Urinary System :
- Vaginal pressure, urgency Special Senses :
- blurred vision, dry mouth, ear discomfort, metallic taste, nasal congestion, scotomas, tongue discomfort
- 6.2 Post-Marketing Experience The following adverse reactions have been reported from marketing experience with adenosine injection.
- Because these reactions 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.
- Cardiac Disorders:
- cardiac arrest, atrial fibrillation, cardiac failure, myocardial infarction, tachycardia, ventricular arrhythmia Gastrointestinal Disorders:
- nausea and vomiting General Disorders and Administration Site Conditions:
- chest pain, injection site reaction, infusion site pain Immune System Disorders:
- hypersensitivity Nervous System Disorders:
- cerebrovascular accident including intracranial hemorrhage, seizure activity including tonic-clonic (grand mal) seizures, loss of consciousness Respiratory, Thoracic and Mediastinal Disorders:
- bronchospasm, respiratory arrest, throat tightness
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- Advise patients that they may be at increased risk of fatal and nonfatal heart attacks, abnormal heart rhythms, cardiac arrest, heart block, significant increase or decrease in blood pressure, bronchoconstriction, hypersensitivity reactions, seizures, or cerebrovascular accidents with the use of adenosine injection [see Warnings and Precautions (5.1 to 5.9) ].
- Advise patients with COPD or asthma to discuss their respiratory history with their clinician before scheduling a myocardial perfusion imaging study with adenosine injection [see Warnings and Precautions (5.3) ] .
- Methylxanthines have the potential to impact the effects of adenosine injection.
- Instruct patients to
- avoid consumption of any products containing methylxanthines, including caffeinated coffee, tea or other caffeinated beverages, caffeine-containing drug products, aminophylline, and theophylline prior to the myocardial perfusion imaging study.
- Question patients about a history of seizures [see Warnings and Precautions (5.6) , Drug Interactions (7.1) , and Overdosage (10) ] .
- Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd.
- E.
- Windsor, NJ 08520 Manufactured by:
- Eugia Pharma Specialities Limited Hyderabad - 500032 India
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
- FORMS AND STRENGTHS Adenosine injection, USP is supplied as 20 mL and 30 mL single-dose vials containing a sterile, nonpyrogenic, clear colorless solution of adenosine USP 3 mg/mL. For Injection:
- 3 mg/mL in single-dose vials ( 3 )
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- How Supplied Adenosine injection, USP is supplied as 20 mL and 30 mL vials of sterile, nonpyrogenic, preservative-free, clear colorless solution in normal saline:
- 60 mg per 20 mL (3 mg/mL):
- 20 mL Single-Dose Vials in a Carton of 1 NDC 55150-192-01 20 mL Single-Dose Vials in a Carton of 10 NDC 55150-192-20 90 mg per 30 mL (3 mg/mL):
- 30 mL Single-Dose Vials in a Carton of 1 NDC 55150-193-01 30 mL Single-Dose Vials in a Carton of 10 NDC 55150-193-30 Storage and Handling
- 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 Discard unused portion The vial stopper is not made with natural rubber latex.
Quoted from the official label, section “How Supplied”.
What is in it
- Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine.
- Adenosine has the following structural formula:
- The molecular formula for adenosine is C 10 H 13 N 5 O 4 and its molecular weight is 267.24.
- Adenosine USP is a white or almost white crystalline powder.
- It is soluble in water and practically insoluble in alcohol.
- Solubility increases by warming and lowering the pH of the solution.
- Each adenosine injection, USP vial contains a sterile, non-pyrogenic, clear colorless solution of adenosine USP 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5.
- Adenosine Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
Details
| Made by | Eugia US LLC |
|---|---|
| Active substance | Adenosine |
| Strength | 60 mg/20mL |
| Form | Injection, Solution |
| Route | Intravenous |
| Packs | 1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE · 10 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE |
| NDC | 55150-192 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
17 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution9 products
- 60 mg/20mL
- 90 mg/30mL
- Injection7 products
- Solution1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.