HomeNDC LookupIngredientsAdenosine › 55150-0192-01
Adenosine 60 mg/20mL Injection, Solution — NDC 55150-0192-01 package photo

Adenosine 60 mg/20mL Injection, Solution

by Eugia US LLC · 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-01) / 20 mL in 1 VIAL, SINGLE-DOSE
NDC 55150-0192-01
🏷️ FDA NDC (as labeled) 55150-192-01 billing pads the product segment with a zero
This package
Contains20 mL in 1 vial, single-dose Medicaid pays$3.44 / unit · 12 mo Per package$68.75 / 20 ml · Medicaid Pack sizes2 compare ↓
Also comes in: 10 vials 55150-0192-20
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 55150-192-01
Product NDC 55150-192
11-digit billing NDC 55150019201
NCPDP billing unit ML — per mL (volume)
RxCUI 1654035, 1654040
UNII K72T3FS567
UPC 0355150193011, 0355150192014
Application # ANDA205331
SPL Set ID 61d9b8f6-f93f-46ee-bec2-db8d46999792
Established class (EPC) Adenosine Receptor Agonist
Mechanism of action Adenosine Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-11-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ADENOSINE
GPI-14 94200005002010
GPI class Adenosine (Diagnostic)
GCN Seq No 031430
GCN 35352
HICL code 003734
Ingredient (HICL) Adenosine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A6
Therapeutic class — intermediate (HIC2) Cardiovascular Diagnostic Agents
HIC3 code A6V
Therapeutic class — specific (HIC3) Cardiovascular Diagnostics,Non-Radiopaque Agents
AHFS code 24:04.04.24
AHFS class Class Iv Antiarrhythmics
FDB label name ADENOSINE 60 MG/20 ML VIAL
FDB brand name Adenosine
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 55150-192-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 55150-0192-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Adenosine Receptor Agonist class.

Pharmacologic class Adenosine Receptor Agonist
Drug family (ATC) Other cardiac preparations
How it works Adenosine Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerEugia US LLC
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA205331 (ANDA)
Labeler code55150
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio241 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name ADENOSINE 60 MG/20 ML VIAL Ingredient Adenosine
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $3.44 $68.75 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J0153 $0.394 / J0153 unit
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🧾 Billing & reimbursement

FDA NDC (as labeled)55150-192-01
11-digit billing NDC55150-0192-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ0153
DescriptorINJECTION, ADENOSINE, 1 MG (NOT TO BE USED TO REPORT ANY ADENOSINE PHOSPHATE COMPOUNDS)
Billing units / pkg3 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Adenosine 3 mg/mL 16714-0556-01 NorthStar 1 vial AP FDA listed
Adenosine 3 mg/mL 23155-0258-31 Heritage 1 vial AP FDA listed
Adenosine 60 mg/20mLthis 55150-0192-01 Eugia 1 vial AP FDA listed
Adenosine 3 mg/mL 63323-0651-89 Fresenius 10 syringes AP FDA listed
Adenosine 3 mg/mL 67457-0856-20 Mylan 1 vial AP FDA listed
Adenosine 3 mg/mL 71288-0207-21 Meitheal 10 vials AP FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 55150-0192-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
91
Units reimbursed last 4 qtrs
988
Gross reimbursed last 4 qtrs
$3.4K
Avg / prescription
$37.32
Avg / unit
$3.4371
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care
100% MCO
Fee-for-service · 0 Rx Managed care · 91 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 323 units · 1.4 per 100k residents FL
Units reimbursed · per 100k residents
1.41.4
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Florida 1.4 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
10 vials55150-0192-20 No Medicaid data
Drug total (last 4 qtrs): 91 Rx · 988 units · $3,396 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Adenosine — the ingredient across all brands.

Top reported reactions

Supraventricular Tachycardia98
Hypotension89
Cardiac Arrest79
Dyspnoea74
Pain70
Atrial Fibrillation68
Bradycardia63

Age at onset

Neonate46
Infant13
Child4
Adolescent8
Adult162
Elderly63

Reporter sex

1,627 reports
Male · 52%
Female · 48%
Unknown · 1%

Serious outcomes

Hospitalization770
Life-threatening322
Disabling40
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 139 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
55150-0192-01 You're viewing this 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-01) / 20 mL in 1 VIAL, SINGLE-DOSE 2017-11-02 Active
55150-0192-20 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-192-20) / 20 mL in 1 VIAL, SINGLE-DOSE 2017-11-02 Active

Pack size FAQ

What quantity is in NDC 55150-0192-01?
NDC 55150-0192-01 is listed by the FDA — 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose.
What NDC number is used to bill for this package of Adenosine 60 mg/20mL Injection, Solution?
Bill NDC 55150-0192-01 — the 11-digit billing format is 55150019201. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 55150-192-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 55150-0192-01, written without dashes as 55150019201. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 55150-0192-01, the first segment (55150) is the labeler code FDA assigned to Eugia US LLC; the middle segment (0192) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Eugia US LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 10 vials (55150-0192-20). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Eugia US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J0153 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 49 words

1 INDICATIONS AND USAGE 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 )

⏱️ Dosage and Administration ~1 min read

2 DOSAGE AND ADMINISTRATION 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

4.2The 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

💊 Dosage Forms and Strengths 40 words

3 DOSAGE 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 )

Contraindications 139 words

4 CONTRAINDICATIONS 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 )

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Cardiac Arrest, Ventricular Arrhythmias, and Myocardial Infarction . 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 )

5.1Cardiac 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) ] .

5.2Sinoatrial 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.

5.3Bronchoconstriction 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) ].

5.4Hypotension 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. Di…

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS 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.

6.1Clinical 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

6.2Post-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 tightne…

🔄 Drug Interactions ~1 min read

7 DRUG INTERACTIONS 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 )

7.1Effects 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.

7.2Effects 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) ] .

👥 Use in Specific Populations 189 words

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy 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.

8.3Nursing 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.

8.4Pediatric Use The safety and effectiveness of adenosine injection in patients less than 18 years of age have not been established.

8.5Geriatric 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.

🤰 Pregnancy 51 words

8.1Pregnancy 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.

🧒 Pediatric Use 22 words

8.4Pediatric Use The safety and effectiveness of adenosine injection in patients less than 18 years of age have not been established.

🧓 Geriatric Use 45 words

8.5Geriatric 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.

🆘 Overdosage 101 words

10 OVERDOSAGE 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) ] .

🧬 Clinical Pharmacology ~2 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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). Although the exact mechanism by which adenosine receptor activation relaxes vascular smooth muscle is not known, there is evidence to support both inhibition of the slow inward calcium current reducing calcium uptake, and activation of adenylate cyclase through A 2 receptors in smooth muscle cells.

Adenosine may also lessen vascular tone by modulating sympathetic neurotransmission. The intracellular uptake of adenosine is mediated by a specific transmembrane nucleoside transport system. Once inside the cell, adenosine is rapidly phosphorylated by adenosine kinase to adenosine monophosphate, or deaminated by adenosine deaminase to inosine.

These intracellular metabolites of adenosine are not vasoactive. Myocardial uptake of thallium-201 is directly proportional to coronary blood flow. Since adenosine injection significantly increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, adenosine injection causes relatively less thallium-201 uptake in vascular territories supplied by stenotic coronary arteries i.e., a greater difference is seen after adenosine injection between areas served by normal and areas served by stenotic vessels than is seen prior to adenosine injection.

12.2Pharmacodynamics Hemodynamic Effects Adenosine produces a direct negative chronotropic, dromotropic and inotropic effect on the heart, presumably due to A 1 -receptor agonism, and produces peripheral vasodilation, presumably due to A 2 -receptor agonism. The net effect of adenosine injection in humans is typically a mild to moderate reduction in systolic, diastolic and mean arterial blood pressure associated with a reflex increase in heart rate. Rarely, significant hypotension and tachycardia have been observed [see Warnings and Precautions (5.4) ] .

12.3Pharmacokinetics Distribution Intravenously administered adenosine distributes 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. Metabolism Intracellular adenosine is 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 K m and V max 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.

Elimination While extracellular adenosine is primarily cleared from plasma 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. Specific Populations Renal Impairment As adenosine does not require renal function for its activation or inactivation, renal impairment would not be expected to alter its effectiveness or tolerability. Hepatic Impairment As adenosine does not require hepatic function for its activation or inactivation, hepatic impairment would not be expected to alter its effectiveness or tolerability.

🧬 Mechanism of Action 204 words

12.1Mechanism of Action 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). Although the exact mechanism by which adenosine receptor activation relaxes vascular smooth muscle is not known, there is evidence to support both inhibition of the slow inward calcium current reducing calcium uptake, and activation of adenylate cyclase through A 2 receptors in smooth muscle cells.

Adenosine may also lessen vascular tone by modulating sympathetic neurotransmission. The intracellular uptake of adenosine is mediated by a specific transmembrane nucleoside transport system. Once inside the cell, adenosine is rapidly phosphorylated by adenosine kinase to adenosine monophosphate, or deaminated by adenosine deaminase to inosine.

These intracellular metabolites of adenosine are not vasoactive. Myocardial uptake of thallium-201 is directly proportional to coronary blood flow. Since adenosine injection significantly increases blood flow in normal coronary arteries with little or no increase in stenotic arteries, adenosine injection causes relatively less thallium-201 uptake in vascular territories supplied by stenotic coronary arteries i.e., a greater difference is seen after adenosine injection between areas served by normal and areas served by stenotic vessels than is seen prior to adenosine injection.

📦 How Supplied / Storage and Handling 144 words

16 HOW SUPPLIED/STORAGE AND HANDLING 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.

📋 Description 105 words

11 DESCRIPTION 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

💬 Information for Patients 171 words

17 PATIENT COUNSELING INFORMATION 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) ] .

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Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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