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Esmolol Hydrochloride 100 mg/10mL Injection, Solution — NDC 55150-0194-10 package photo
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Esmolol Hydrochloride 100 mg/10mL Injection, Solution — NDC 55150-194-10 (Billing 55150-0194-10)

by Eugia US LLC · 25 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

This is a package of Esmolol Hydrochloride 100 mg/10mL Injection, Solution from Eugia US LLC, marketed since Jul 2015 and currently FDA-listed. It is this product's only package size.

NDC 55150-0194-10
🏷️ FDA NDC (as labeled) 55150-194-10 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55150-194-10
Product NDC 55150-194
11-digit billing NDC 55150019410
NCPDP billing unit ML — per mL (volume)
RxCUI 979432, 1736541, 1736546
UNII V05260LC8D
UPC 0355750420012, 0355150421015
Application # ANDA205520
SPL Set ID ac22475d-2d78-469f-9435-b403ac4ee380
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-07-23
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance ESMOLOL HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 33200025102015
GPI class Esmolol HCl
GCN Seq No 005148
GCN 39380
HICL code 002108
Ingredient (HICL) Esmolol Hcl
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J7
Therapeutic class — intermediate (HIC2) Antiadrenergics
HIC3 code J7C
Therapeutic class — specific (HIC3) Beta-Adrenergic Blocking Agents
AHFS code 12:16.08.08
AHFS class Selective Beta-Adrenergic Blocking Agent
FDB label name ESMOLOL HCL 100 MG/10 ML VIAL
FDB brand name Esmolol Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005148
  • GCN: 39380
  • GPI-14 (Medi-Span): 33200025102015
  • HICL (First Databank): 002108
  • AHFS class code: 12:16.08.08
  • RxCUI (RxNorm): 979432
Why two NDCs? The FDA registers this code as 55150-194-10 — 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 → 55150-0194-10. 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 beta-Adrenergic Blocker class.

Pharmacologic class beta-Adrenergic Blocker
Drug family (ATC) Beta blocking agents, selective
How it works Adrenergic beta-Antagonists
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.

Clinical

Label name ESMOLOL HCL 100 MG/10 ML VIAL Ingredient Esmolol Hcl
📗 Our plain-language guide HelloPharmacist
  • It slows a racing heart for a short time. Doctors use it for atrial fibrillation, atrial flutter and other fast heart rhythms. They also use it for fast heart rate and high blood p...
  • You will get it through an IV from a healthcare professional, usually as a steady infusion. The team adjusts the speed based on your heart rate or blood pressure.
  • The most common are low blood pressure, sweating, dizziness, nausea, sleepiness and irritation where the IV goes in. Tell your nurse right away if you feel faint, have trouble brea...
  • Quickly. Its half-life is about 9 minutes, and its effects largely fade within 10 to 20 minutes after the infusion stops. Low blood pressure usually improves within about 30 minute...
📖 Read our full Esmolol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Esmolol may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Esmolol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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.

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 $14.56 $3,639.40 / 250 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1805 $0.230 / J1805 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)55150-194-10
11-digit billing NDC55150-0194-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1805
DescriptorINJECTION, ESMOLOL HYDROCHLORIDE, 10 MG
Billing units / pkg1 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 10 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$44 · 23 claims · $1.93 per claim (all NDCs under J1805)
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55150-0194-10 You're viewing this Main listing 25 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE 2015-07-23 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Esmolol Hydrochloride 10 mg/mL 00404-9785-10 Henry 1 vial — AP FDA listed —
Brevibloc 10 mg/mL 00404-9825-10 Henry 1 vial — AP FDA listed —
Esmolol Hydrochloride 100 mg/10mL 00404-9858-10 Henry 1 vial — AP FDA listed —
Brevibloc 10 mg/mL 10019-0115-01 Baxter 25 vials — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 10019-0120-01 Baxter 25 vials — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 51662-1322-01 HF 10 ml — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 51662-1371-01 HF 10 ml — — FDA listed —
Esmolol Hydrochloride 100 mg/10mL 51662-1444-01 HF 10 ml — AP FDA listed —
Esmolol Hydrochloride 100 mg/10mLthis 55150-0194-10 Eugia 25 vials — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 63323-0652-10 Fresenius 25 vials — — FDA listed —
Esmolol Hydrochloride 10 mg/mL 63323-0661-14 Fresenius 25 vials — — FDA listed —
Esmolol Hydrochloride 10 mg/mL 67457-0182-10 Mylan 10 vials — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 68083-0211-25 Gland 25 vials — AP FDA listed —
Esmolol Hydrochloride 100 mg/10mL 70518-4410-00 REMEDYREPACK 25 vials — AP FDA listed —
Esmolol Hydrochloride 100 mg/10mL 71872-7049-01 Medical 1 vial — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 71872-7136-01 Medical 1 vial — AP FDA listed —
Esmolol Hydrochloride 100 mg/10mL 84549-0194-10 ProPharma 10 ml — 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

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerEugia US LLC
Application holderEUGIA PHARMA SPECIALITIES LTD
FDA applicationANDA205520 (ANDA)
Labeler code55150
First marketedJul 2015
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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 186 words ▾

1 INDICATIONS AND USAGE Esmolol hydrochloride injection is a beta adrenergic blocker indicated for the short-term treatment of: Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia (1.1) Control of perioperative tachycardia and hypertension (1.2)

1.1Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia Esmolol hydrochloride injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention.

Esmolol hydrochloride injection is intended for short-term use.

1.2Intraoperative and Postoperative Tachycardia and/or Hypertension Esmolol hydrochloride injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated. Use of esmolol hydrochloride injection to prevent such events is not recommended.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Administer intravenously (2.1, 2.2) Titrate using ventricular rate or blood pressure at ≥4-minute intervals. (2.1, 2.2) Supraventricular tachycardia (SVT) or noncompensatory sinus tachycardia (2.1) Optional loading dose: 500 mcg per kg infused over one minute Then 50 mcg per kg per minute for the next 4 minutes Adjust dose as needed to a maximum of 200 mcg per kg per minute. Additional loading doses may be administered Perioperative tachycardia and hypertension (2.2) Loading dose: 500 mcg per kg over 1 minute for gradual control (1 mg per kg over 30 seconds for immediate control) Then 50 mcg per kg per min for gradual control (150 mcg per kg per minute for immediate control) adjusted to a maximum of 200 (tachycardia) or 300 (hypertension) mcg per kg per min (2.2)

2.1Dosing for the Treatment of Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia Esmolol hydrochloride injection is administered by continuous intravenous infusion with or without a loading dose. Additional loading doses and/or titration of the maintenance infusion (step-wise dosing) may be necessary based on desired ventricular response. Table 1 Step-Wise Dosing Step Action 1 Optional loading dose (500 mcg per kg over 1 minute), then 50 mcg per kg per min for 4 min 2 Optional loading dose if necessary, then 100 mcg per kg per min for 4 min 3 Optional loading dose if necessary, then 150 mcg per kg per min for 4 min 4 If necessary, increase dose to 200 mcg per kg per min In the absence of loading doses, continuous infusion of a single concentration of esmolol reaches pharmacokinetic and pharmacodynamic steady-state in about 30 minutes.

The effective maintenance dose for continuous and step-wise dosing is 50 to 200 mcg per kg per minute, although doses as low as 25 mcg per kg per minute have been adequate. Dosages greater than 200 mcg per kg per minute provide little added heart rate lowering effect, and the rate of adverse reactions increases. Maintenance infusions may be continued for up to 48 hours.

2.2Intraoperative and Postoperative Tachycardia and Hypertension In this setting it is not always advisable to slowly titrate to a therapeutic effect. Therefore two dosing options are presented: immediate control and gradual control. Immediate Control Administer 1 mg per kg as a bolus dose over 30 seconds followed by an infusion of 150 mcg per kg per min if necessary.

Adjust the infusion rate as required to maintain desired heart rate and blood pressure. Refer to Maximum Recommended Doses below. Gradual Control Administer 500 mcg per kg as a bolus dose over 1 minute followed by a maintenance infusion of 50 mcg per kg per min for 4 minutes.

Depending on the response obtained, continue dosing as outlined for supraventricular tachycardia. Refer to Maximum Recommended Doses below. Maximum Recommended Doses For the treatment of tachycardia, maintenance infusion dosages greater than 200 mcg per kg per min are not recommended; dosages greater than 200 mcg per kg per min provide little additional heart rate-lowering effect, and the rate of adverse reactions increases.

For the treatment of hypertension, higher maintenance infusion dosages (250 to 300 mcg per kg per min) may be required. The safety of doses above 300 mcg per kg per minute has not been studied.

2.3Transition from Esmolol Hydrochloride Injection Therapy to Alternative Drugs After patients achieve adequate control of the heart rate and a stable clinical status, transition to alternative antiarrhythmic drugs may be accomplished. When transitioning from esmolol hydrochloride injection to alternative drugs, the physician should carefully consider the labeling instructions of the alternative drug selected and reduce the dosage of esmolol hydrochloride injection as follows: 1. Thirty minutes following the first dose of the alternative drug, reduce the esmolol hydrochloride infusion rate by one-half (50%).

2. After administration of the second dose of the alternative drug, moni… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 120 words ▾

3 DOSAGE FORMS AND STRENGTHS All esmolol hydrochloride injection dosage forms are iso-osmotic solutions of esmolol hydrochloride in sodium chloride. Table 2 Esmolol Hydrochloride Injection Presentations Product Name Esmolol Hydrochloride in Sodium Chloride Injection Esmolol Hydrochloride in Sodium Chloride Injection Double Strength Esmolol Hydrochloride Injection Total Dose 2,500 mg/250 mL 2,000 mg/100 mL 100 mg/10 mL Esmolol Hydrochloride Concentration 10 mg/mL 20 mg/mL 10 mg/mL Packaging 250 mL Bag 100 mL Bag 10 mL Vial Injection: 100 mg/10 mL (10 mg/mL) in 10 mL vial ( 3 ) Injection: 2,500 mg/250 mL (10 mg/mL) in 250 mL premixed injection bag ( 3 ) Injection: 2,000 mg/100 mL (20 mg/mL) in 100 mL double strength premixed injection bag ( 3 )

⛔ Contraindications 210 words ▾

4 CONTRAINDICATIONS Esmolol hydrochloride injection is contraindicated in patients with: Severe sinus bradycardia: May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2)]. Heart block greater than first degree: Second- or third-degree atrioventricular block may precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2) ] . Sick sinus syndrome: May precipitate or worsen bradycardia resulting in cardiogenic shock and cardiac arrest [see Warnings and Precautions (5.2) ].

Decompensated heart failure: May worsen heart failure. Cardiogenic shock: May precipitate further cardiovascular collapse and cause cardiac arrest. IV administration of cardiodepressant calcium-channel antagonists (e.g., verapamil) and esmolol hydrochloride in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving esmolol hydrochloride and intravenous verapamil.

Pulmonary hypertension: May precipitate cardiorespiratory compromise. Hypersensitivity reactions, including anaphylaxis, to esmolol or any of the inactive ingredients of the product (cross-sensitivity between beta blockers is possible). Severe sinus bradycardia (4) Heart block greater than first degree (4) Sick sinus syndrome (4) Decompensated heart failure (4) Cardiogenic shock (4) Coadministration of IV cardiodepressant calcium-channel antagonists (e.g. verapamil) in close proximity to esmolol hydrochloride injection (4, 7) Pulmonary hypertension (4) Known hypersensitivity to esmolol (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Risk of hypotension, bradycardia, and cardiac failure: Monitor for signs and symptoms of cardiovascular adverse effects. Reduce or discontinue use (5.1, 5.2, 5.3, 5.10) Risk of exacerbating reactive airway disease (5.5) Diabetes: May mask symptoms of hypoglycemia and alter glucose levels; monitor (5.6) Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma (5.9) Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease (5.12, 5.15)

5.1Hypotension Hypotension can occur at any dose but is dose-related. Patients with hemodynamic compromise or on interacting medications are at particular risk. Severe reactions may include loss of consciousness, cardiac arrest, and death.

For control of ventricular heart rate, maintenance doses greater than 200 mcg per kg per min are not recommended. Monitor patients closely, especially if pretreatment blood pressure is low. In case of an unacceptable drop in blood pressure, reduce or stop esmolol hydrochloride.

Decrease of dose or termination of infusion reverses hypotension, usually within 30 minutes.

5.2Bradycardia Bradycardia, including sinus pause, heart block, severe bradycardia, and cardiac arrest have occurred with the use of esmolol hydrochloride. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk. Monitor heart rate and rhythm in patients receiving esmolol hydrochloride [see Contraindications (4) ]. If severe bradycardia develops, reduce or stop esmolol hydrochloride.

5.3Cardiac Failure Beta blockers, like esmolol hydrochloride, can cause depression of myocardial contractility and may precipitate heart failure and cardiogenic shock. At the first sign or symptom of impending cardiac failure, stop esmolol hydrochloride and start supportive therapy [see Overdosage (10) ].

5.4Intraoperative and Postoperative Tachycardia and/or Hypertension Monitor vital signs closely and titrate esmolol hydrochloride slowly in the treatment of patients whose blood pressure is primarily driven by vasoconstriction associated with hypothermia.

5.5Reactive Airways Disease Patients with reactive airways disease should, in general, not receive beta blockers. Because of its relative beta 1 selectivity and titratability, titrate esmolol hydrochloride to the lowest possible effective dose. In the event of bronchospasm, stop the infusion immediately; a beta 2 stimulating agent may be administered with appropriate monitoring of ventricular rates.

5.6Hypoglycemia Beta-blockers may prevent early warning signs of hypoglycemia, such as tachycardia, and increase the risk for severe or prolonged hypoglycemia at any time during treatment, especially in patients with diabetes mellitus or children and patients who are fasting (i.e., surgery, not eating regularly, or are vomiting). If severe hypoglycemia occurs, patients should be instructed to seek emergency treatment.

5.7Infusion Site Reactions Infusion site reactions have occurred with the use of esmolol hydrochloride. They include irritation, inflammation, and severe reactions (thrombophlebitis, necrosis, and blistering), in particular when associated with extravasation [see Adverse Reactions (6) ]. Avoid infusions into small veins or through a butterfly catheter. If a local infusion site reaction develops, use an alternative infusion site and avoid extravasation.

5.8Use in Patients with Prinzmetal’s Angina Beta blockers may exacerbate anginal attacks in patients with Prinzmetal’s angina because of unopposed alpha receptor–mediated coronary artery vasoconstriction. Do not use nonselective beta blockers.

5.9Use in Patients with Pheochromocytoma If esmolol hydrochloride is used in the setting of pheochromocytoma, give it in combination with an alpha-blocker, and only after the alpha-blocker has been initiated. Administration of beta-blockers alone in the setting of pheochromocytoma has been associated w… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most common adverse reactions (incidence >10%) are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension (6) 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 clinical practice. The following adverse reaction rates are based on use of esmolol hydrochloride in clinical trials involving 369 patients with supraventricular tachycardia and over 600 intraoperative and postoperative patients enrolled in clinical trials.

Most adverse effects observed in controlled clinical trial settings have been mild and transient. The most important and common adverse effect has been hypotension [see Warnings and Precautions (5.1) ]. Deaths have been reported in post-marketing experience occurring during complex clinical states where esmolol hydrochloride was presumably being used simply to control ventricular rate [see Warnings and Precautions (5.5) ].

Table 3 Clinical Trial Adverse Reactions (Frequency ≥3%) System Organ Class (SOC) Preferred MedDRA Term Frequency VASCULAR DISORDERS Hypotension* Asymptomatic hypotension Symptomatic hypotension (hyperhidrosis, dizziness) 25% 12% GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Infusion site reactions (inflammation and induration) 8% GASTROINTESTINAL DISORDERS Nausea 7% NERVOUS SYSTEM DISORDERS Dizziness Somnolence 3% 3% * Hypotension resolved during esmolol hydrochloride infusion in 63% of patients. In 80% of the remaining patients, hypotension resolved within 30 minutes following discontinuation of infusion.

Clinical Trial Adverse Reactions (Frequency <3%) Psychiatric Disorders Confusional state and agitation (~2%) Anxiety, depression and abnormal thinking (<1%) Nervous System Disorders Headache (~ 2%) Paresthesia, syncope, speech disorder, and lightheadedness (<1%) Convulsions (<1%), with one death Vascular Disorders Peripheral ischemia (~1%) Pallor and flushing (<1%) Gastrointestinal Disorders Vomiting (~1%) Dyspepsia, constipation, dry mouth, and abdominal discomfort (<1%) Renal and Urinary Disorders Urinary retention (<1%)

6.2Post-Marketing Experience In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been reported in the post-marketing experience. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or to establish a causal relationship to drug exposure. Cardiac Disorders Cardiac arrest, Coronary arteriospasm Skin and Subcutaneous Tissue Disorders Angioedema, Urticaria, Psoriasis

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Concomitant use of esmolol hydrochloride with other drugs that can lower blood pressure, reduce myocardial contractility, or interfere with sinus node function or electrical impulse propagation in the myocardium can exaggerate esmolol hydrochloride’s effects on blood pressure, contractility, and impulse propagation. Severe interactions with such drugs can result in, for example, severe hypotension, cardiac failure, severe bradycardia, sinus pause, sinoatrial block, atrioventricular block, and/or cardiac arrest.

In addition, with some drugs, beta blockade may precipitate increased withdrawal effects. (See clonidine, guanfacine, and moxonidine below.) Esmolol hydrochloride should therefore be used only after careful individual assessment of the risks and expected benefits in patients receiving drugs that can cause these types of pharmacodynamic interactions, including but not limited to: Digitalis glycosides: Concomitant administration of digoxin and esmolol hydrochloride leads to an approximate 10% to 20% increase of digoxin blood levels at some time points.

Digoxin does not affect esmolol hydrochloride pharmacokinetics. Both digoxin and beta blockers slow atrioventricular conduction and decrease heart rate. Concomitant use increases the risk of bradycardia.

Anticholinesterases: Esmolol hydrochloride prolonged the duration of succinylcholine-induced neuromuscular blockade and moderately prolonged clinical duration and recovery index of mivacurium. Antihypertensive agents clonidine, guanfacine, or moxonidine: Beta blockers also increase the risk of clonidine-, guanfacine-, or moxonidine-withdrawal rebound hypertension. If, during concomitant use of a beta blocker, antihypertensive therapy needs to be interrupted or discontinued, discontinue the beta blocker first, and the discontinuation should be gradual.

Calcium channel antagonists: In patients with depressed myocardial function, use of esmolol hydrochloride with cardiodepressant calcium channel antagonists (e.g., verapamil) can lead to fatal cardiac arrests. Sympathomimetic drugs: Sympathomimetic drugs having beta-adrenergic agonist activity will counteract effects of esmolol hydrochloride. Vasoconstrictive and positive inotropic agents: Because of the risk of reducing cardiac contractility in presence of high systemic vascular resistance, do not use esmolol hydrochloride to control tachycardia in patients receiving drugs that are vasoconstrictive and have positive inotropic effects, such as epinephrine, norepinephrine, and dopamine.

Digitalis glycosides: Risk of bradycardia (7) Anticholinesterases: Prolongs neuromuscular blockade (7) Antihypertensive agents: Risk of rebound hypertension (7) Sympathomimetic drugs: Dose adjustment needed (7) Vasoconstrictive and positive inotropic effect substances: Avoid concomitant use (7)

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Esmolol hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose (300 mcg/kg/min). There are no adequate and well-controlled studies in pregnant women. Esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Teratogenicity studies in rats at intravenous dosages of esmolol hydrochloride up to 3,000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. In rabbits, intravenous dosages up to 1,000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2,500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions.

8.2Labor and Delivery Although there are no adequate and well-controlled studies in pregnant women, use of esmolol in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of drug infusion. Esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from esmolol hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use The safety and effectiveness of esmolol hydrochloride in pediatric patients have not been established.

8.5Geriatric Use Clinical studies of esmolol hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy.

8.6Hepatic Impairment No special precautions are necessary in patients with hepatic impairment because esmolol hydrochloride is metabolized by red-blood cell esterases [see Clinical Pharmacology (12) ].

8.7Renal Impairment No dosage adjustment is required for esmolol in patients with renal impairment receiving a maintenance infusion of esmolol 150 mcg/kg for 4 hours. There is no information on the tolerability of maintenance infusions of esmolol using rates in excess of 150 mcg/kg or maintained longer than 4 hours [see Clinical Pharmacology (12) ].

🤰 Pregnancy 138 words ▾

8.1Pregnancy Esmolol hydrochloride has been shown to produce increased fetal resorptions with minimal maternal toxicity in rabbits when given in doses approximately 8 times the maximum human maintenance dose (300 mcg/kg/min). There are no adequate and well-controlled studies in pregnant women. Esmolol hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Teratogenicity studies in rats at intravenous dosages of esmolol hydrochloride up to 3,000 mcg/kg/min (10 times the maximum human maintenance dosage) for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while a dosage of 10,000 mcg/kg/min produced maternal toxicity and lethality. In rabbits, intravenous dosages up to 1,000 mcg/kg/min for 30 minutes daily produced no evidence of maternal toxicity, embryotoxicity or teratogenicity, while 2,500 mcg/kg/min produced minimal maternal toxicity and increased fetal resorptions.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and effectiveness of esmolol hydrochloride in pediatric patients have not been established.

🧓 Geriatric Use 80 words ▾

8.5Geriatric Use Clinical studies of esmolol hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should usually start at the low end of the dosing range, reflecting greater frequency of decreased renal or cardiac function and of concomitant disease or other drug therapy.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Signs and Symptoms of Overdose Overdoses of esmolol hydrochloride can cause cardiac and central nervous system effects. These effects may precipitate severe signs, symptoms, sequelae, and complications (for example, severe cardiac and respiratory failure, including shock and coma), and may be fatal. Continuous monitoring of the patient is required.

Cardiac effects include bradycardia, atrioventricular block (1 st -, 2 nd -, 3 rd degree), junctional rhythms, intraventricular conduction delays, decreased cardiac contractility, hypotension, cardiac failure (including cardiogenic shock), cardiac arrest/asystole, and pulseless electrical activity. Central nervous system effects include respiratory depression, seizures, sleep and mood disturbances, fatigue, lethargy, and coma. In addition, bronchospasm, mesenteric ischemia, peripheral cyanosis, hyperkalemia, and hypoglycemia (especially in children) may occur.

10.2Treatment Recommendations Because of its approximately 9-minute elimination half-life, the first step in the management of toxicity should be to discontinue the esmolol hydrochloride infusion. Then, based on the observed clinical effects, consider the following general measures . Bradycardia Consider intravenous administration of atropine or another anticholinergic drug or cardiac pacing.

Cardiac Failure Consider intravenous administration of a diuretic or digitalis glycoside. In shock resulting from inadequate cardiac contractility, consider intravenous administration of dopamine, dobutamine, isoproterenol, or inamrinone. Glucagon has been reported to be useful.

Symptomatic hypotension Consider intravenous administration of fluids or vasopressor agents such as dopamine or norepinephrine. Bronchospasm Consider intravenous administration of a beta 2 stimulating agent or a theophylline derivative.

10.3Dilution Errors Massive accidental overdoses of esmolol hydrochloride have resulted from dilution errors. Use of esmolol hydrochloride sodium chloride injection and esmolol hydrochloride sodium chloride injection double strength may reduce the potential for dilution errors. Some of these overdoses have been fatal while others resulted in permanent disability.

Bolus doses in the range of 625 mg to 2.5 g (12.5 to 50 mg/kg) have been fatal. Patients have recovered completely from overdoses as high as 1.75 g given over one minute or doses of 7.5 g given over one hour for cardiovascular surgery. The patients who survived appear to be those whose circulation could be supported until the effects of esmolol hydrochloride resolved.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Esmolol hydrochloride is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent with rapid onset, a very short duration of action, and no significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic dosages. Its elimination half-life after intravenous infusion is approximately 9 minutes. Esmolol hydrochloride inhibits the beta 1 receptors located chiefly in cardiac muscle, but this preferential effect is not absolute and at higher doses it begins to inhibit beta 2 receptors located chiefly in the bronchial and vascular musculature.

12.2Pharmacodynamics Clinical pharmacology studies in normal volunteers have confirmed the beta blocking activity of esmolol hydrochloride, showing reduction in heart rate at rest and during exercise, and attenuation of isoproterenol-induced increases in heart rate. Blood levels of esmolol hydrochloride have been shown to correlate with extent of beta blockade. After termination of infusion, substantial recovery from beta blockade is observed in 10 to 20 minutes.

The acid metabolite of esmolol exhibits negligible pharmacological activity. In human electrophysiology studies, esmolol hydrochloride produced effects typical of a beta blocker: a decrease in the heart rate, increase in sinus cycle length, prolongation of the sinus node recovery time, prolongation of the AH interval during normal sinus rhythm and during atrial pacing, and an increase in antegrade Wenckebach cycle length. In patients undergoing radionuclide angiography, esmolol hydrochloride, at dosages of 200 mcg/kg/min, produced reductions in heart rate, systolic blood pressure, rate pressure product, left and right ventricular ejection fraction and cardiac index at rest, which were similar in magnitude to those produced by intravenous propranolol (4 mg).

During exercise, esmolol hydrochloride produced reductions in heart rate, rate pressure product and cardiac index which were also similar to those produced by propranolol, but esmolol hydrochloride produced a significantly larger fall in systolic blood pressure. In patients undergoing cardiac catheterization, the maximum therapeutic dose of 300 mcg/kg/min of esmolol hydrochloride produced similar effects and, in addition, there were small, clinically insignificant increases in the left ventricular end diastolic pressure and pulmonary capillary wedge pressure.

At 30 minutes after the discontinuation of esmolol hydrochloride infusion, all of the hemodynamic parameters had returned to pretreatment levels. The relative cardioselectivity of esmolol hydrochloride was demonstrated in 10 mildly asthmatic patients. Infusions of esmolol hydrochloride 100, 200 and 300 mcg/kg/min produced no significant increases in specific airway resistance compared to placebo.

At 300 mcg/kg/min, esmolol hydrochloride produced slightly enhanced bronchomotor sensitivity to dry air stimulus. These effects were not clinically significant, and esmolol hydrochloride was well tolerated by all patients. Six of the patients also received intravenous propranolol, and at a dosage of 1 mg, two experienced significant, symptomatic bronchospasm requiring bronchodilator treatment.

One other propranolol-treated patient also experienced dry air-induced bronchospasm. No adverse pulmonary effects were observed in patients with COPD who received therapeutic dosages of esmolol hydrochloride for treatment of supraventricular tachycardia (51 patients) or in perioperative settings (32 patients).

12.3Pharmacokinetics Esmolol is rapidly metabolized by hydrolysis of the ester linkage, chiefly by the esterases in the cytosol of red blood cells and not by plasma cholinesterases or red cell membrane acetylcholinesterase. Total body clearance in man was found to be about 20 L/kg/hr, which is greater than cardiac output; thus the metabolism of esmolol is not limited by the rate of blood flow to metabolizing tissues such as the liver or affected by hep… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 85 words ▾

12.1Mechanism of Action Esmolol hydrochloride is a beta 1 -selective (cardioselective) adrenergic receptor blocking agent with rapid onset, a very short duration of action, and no significant intrinsic sympathomimetic or membrane stabilizing activity at therapeutic dosages. Its elimination half-life after intravenous infusion is approximately 9 minutes. Esmolol hydrochloride inhibits the beta 1 receptors located chiefly in cardiac muscle, but this preferential effect is not absolute and at higher doses it begins to inhibit beta 2 receptors located chiefly in the bronchial and vascular musculature.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Esmolol Hydrochloride Injection Esmolol hydrochloride injection is a clear, colorless to light yellow, sterile, nonpyrogenic solution of esmolol hydrochloride and is supplied as follows: 100 mg per 10 mL (10 mg/mL) 10 mL Single-Dose Vials in a Carton of 25 NDC 55150-194-10 Esmolol Hydrochloride in Sodium Chloride Injection Esmolol hydrochloride in sodium chloride injection is a clear, colorless to light yellow, sterile, non pyrogenic, iso-osmotic solution of esmolol hydrochloride and is supplied as follows: 2,500 mg per 250 mL (10 mg/mL) 250 mL Single-Dose Flexible Container packaged in a Carton of 10 NDC 55150-420-10 2,000 mg per 100 mL (20 mg/mL) 100 mL Single-Dose Flexible Container packaged in a Carton of 10 NDC 55150-421-10

16.2Storage Esmolol Hydrochloride Injection Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat.

The vial stopper is not made with natural rubber latex. Esmolol Hydrochloride in Sodium Chloride Injection Store at 25°C (77°F); excursions permitted to 15˚ to 30˚C (59˚ to 86˚F) [see USP Controlled Room Temperature]. Protect from freezing.

Avoid excessive heat. Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded.

Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Do not use plastic containers in series connections.

Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged.

The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag.

Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact.

Preparation for intravenous administration: Use aseptic technique. Suspend premixed bag from eyelet support. Remove plastic protector from delivery port at bottom of bag.

Attach administration set. Refer to complete directions accompanying set.

📋 Description ~2 min read ▾

11 DESCRIPTION Esmolol hydrochloride injection is a beta adrenergic receptor blocker with a very short duration of action (elimination half-life is approximately 9 minutes). Esmolol hydrochloride is: (±)-Methyl p-[2-hydroxy-3-(isopropylamino) propoxy] hydrocinnamate hydrochloride and has the following structure: Esmolol hydrochloride, USP has the molecular formula C 16 H 26 NO 4 Cl and a molecular weight of 331.8. It has one asymmetric center and exists as an enantiomeric pair.

Esmolol hydrochloride, USP is a white to off-white crystalline powder. It is a relatively hydrophilic compound which is very soluble in water and freely soluble in alcohol. Its partition coefficient (octanol/water) at pH 7.0 is 0.42 compared to 17 for propranolol.

11.1Esmolol Hydrochloride Injection Dosage Forms All Esmolol hydrochloride injection presentations are a clear, colorless to light yellow, sterile, nonpyrogenic solution of esmolol hydrochloride. The formulation for esmolol hydrochloride in sodium chloride injection and esmolol hydrochloride injection is described in the table below: Table 4 Esmolol Hydrochloride Injection Formulations Esmolol Hydrochloride in Sodium Chloride Injection Esmolol Hydrochloride in Sodium Chloride Injection Double Strength Esmolol Hydrochloride Injection Esmolol Hydrochloride, USP 10 mg/mL 20 mg/mL 10 mg/mL Sodium Chloride, USP 5.9 mg/mL 4.1 mg/mL 5.9 mg/mL Water for Injection, USP Q.S. to volume of 250 mL Q.S. to volume of 100 mL Q.S. to volume of 10 mL Sodium Acetate Trihydrate, USP 2.8 mg/mL 2.8 mg/mL 2.8 mg/mL Glacial Acetic Acid, USP 0.546 mg/mL 0.546 mg/mL 0.546 mg/mL Sodium Hydroxide Q.S. to adjust pH to 4.5 to

5.5Hydrochloric Acid Q.S. to adjust pH to 4.5 to

5.5Q.S. = Quantity sufficient The calculated osmolarity of esmolol hydrochloride in sodium chloride injection and esmolol hydrochloride in sodium chloride injection double strength is 312 mOsmol/L. The 250 mL and 100 mL bags are non-latex, non-PVC flexible containers with dual polypropylene ports. The flexible containers are manufactured from a specially designed multilayer polypropylene.

Solutions in contact with the plastic container leach out certain chemical compounds from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Esmolol Chemical Structure

💬 Information for Patients 85 words ▾

17 PATIENT COUNSELING INFORMATION Physicians should inform patients of the risks associated with esmolol hydrochloride: The most common adverse reactions are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension. Inform patients or caregivers that there is a risk of hypoglycemia when esmolol is given to patients who are fasting or who are vomiting. Monitor for symptoms of hypoglycemia. [See Warnings and Precautions (5.6) ].

Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India

🍼 Nursing Mothers 63 words ▾

8.3Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from esmolol hydrochloride, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Esmolol is rapidly metabolized by hydrolysis of the ester linkage, chiefly by the esterases in the cytosol of red blood cells and not by plasma cholinesterases or red cell membrane acetylcholinesterase. Total body clearance in man was found to be about 20 L/kg/hr, which is greater than cardiac output; thus the metabolism of esmolol is not limited by the rate of blood flow to metabolizing tissues such as the liver or affected by hepatic or renal blood flow. Esmolol has a rapid distribution half-life of about 2 minutes and an elimination half-life of about 9 minutes.

Using an appropriate loading dose, steady-state blood levels of esmolol hydrochloride for dosages from 50 to 300 mcg/kg/min are obtained within five minutes. Steady-state is reached in about 30 minutes without the loading dose. Steady-state blood levels of esmolol increase linearly over this dosage range and elimination kinetics are dose-independent over this range.

Steady-state blood levels are maintained during infusion but decrease rapidly after termination of the infusion. Because of its short half-life, blood levels of esmolol can be rapidly altered by increasing or decreasing the infusion rate and rapidly eliminated by discontinuing the infusion. Consistent with the high rate of blood-based metabolism of esmolol, less than 2% of the drug is excreted unchanged in the urine.

Within 24 hours of the end of infusion, the acid metabolite of esmolol in urine accounts for approximately 73 to 88% of the dosage. Metabolism of esmolol results in the formation of the corresponding free acid and methanol. The acid metabolite has been shown in animals to have negligible activity and in normal volunteers its blood levels do not correspond to the level of beta blockade.

The acid metabolite has an elimination half-life of about 3.7 hours and is excreted in the urine with a clearance approximately equivalent to the glomerular filtration rate. After a 4 hour maintenance infusion of 150 mcg/kg, the plasma concentrations of esmolol are similar in subjects with normal renal function and in patients with ESRD on dialysis. The half-life of the acid metabolite of esmolol hydrochloride, which is primarily excreted unchanged by the kidney, is increased about 12-fold to 48 hours in patients with ESRD.

The peak concentrations of the acid metabolite are doubled in ESRD. Methanol blood levels, monitored in subjects receiving esmolol hydrochloride for up to 6 hours at 300 mcg/kg/min and 24 hours at 150 mcg/kg/min, approximated endogenous levels and were less than 2% of levels usually associated with methanol toxicity. Esmolol hydrochloride has been shown to be 55% bound to human plasma protein, while the acid metabolite is only 10% bound.

🧬 Pharmacodynamics ~2 min read ▾

12.2Pharmacodynamics Clinical pharmacology studies in normal volunteers have confirmed the beta blocking activity of esmolol hydrochloride, showing reduction in heart rate at rest and during exercise, and attenuation of isoproterenol-induced increases in heart rate. Blood levels of esmolol hydrochloride have been shown to correlate with extent of beta blockade. After termination of infusion, substantial recovery from beta blockade is observed in 10 to 20 minutes.

The acid metabolite of esmolol exhibits negligible pharmacological activity. In human electrophysiology studies, esmolol hydrochloride produced effects typical of a beta blocker: a decrease in the heart rate, increase in sinus cycle length, prolongation of the sinus node recovery time, prolongation of the AH interval during normal sinus rhythm and during atrial pacing, and an increase in antegrade Wenckebach cycle length. In patients undergoing radionuclide angiography, esmolol hydrochloride, at dosages of 200 mcg/kg/min, produced reductions in heart rate, systolic blood pressure, rate pressure product, left and right ventricular ejection fraction and cardiac index at rest, which were similar in magnitude to those produced by intravenous propranolol (4 mg).

During exercise, esmolol hydrochloride produced reductions in heart rate, rate pressure product and cardiac index which were also similar to those produced by propranolol, but esmolol hydrochloride produced a significantly larger fall in systolic blood pressure. In patients undergoing cardiac catheterization, the maximum therapeutic dose of 300 mcg/kg/min of esmolol hydrochloride produced similar effects and, in addition, there were small, clinically insignificant increases in the left ventricular end diastolic pressure and pulmonary capillary wedge pressure.

At 30 minutes after the discontinuation of esmolol hydrochloride infusion, all of the hemodynamic parameters had returned to pretreatment levels. The relative cardioselectivity of esmolol hydrochloride was demonstrated in 10 mildly asthmatic patients. Infusions of esmolol hydrochloride 100, 200 and 300 mcg/kg/min produced no significant increases in specific airway resistance compared to placebo.

At 300 mcg/kg/min, esmolol hydrochloride produced slightly enhanced bronchomotor sensitivity to dry air stimulus. These effects were not clinically significant, and esmolol hydrochloride was well tolerated by all patients. Six of the patients also received intravenous propranolol, and at a dosage of 1 mg, two experienced significant, symptomatic bronchospasm requiring bronchodilator treatment.

One other propranolol-treated patient also experienced dry air-induced bronchospasm. No adverse pulmonary effects were observed in patients with COPD who received therapeutic dosages of esmolol hydrochloride for treatment of supraventricular tachycardia (51 patients) or in perioperative settings (32 patients).

🔬 Clinical Studies ~1 min read ▾

14 CLINICAL STUDIES Supraventricular Tachycardia In two multicenter, randomized, double-blind, controlled comparisons of esmolol hydrochloride with placebo and propranolol, maintenance doses of 50 to 300 mcg/kg/min of esmolol hydrochloride were found to be more effective than placebo and about as effective as propranolol, 3 to 6 mg given by bolus injections, in the treatment of supraventricular tachycardia, principally atrial fibrillation and atrial flutter. The majority of these patients developed their arrhythmias postoperatively.

About 60 to 70% of the patients treated with esmolol hydrochloride developed either a 20% reduction in heart rate, a decrease in heart rate to less than 100 bpm, or, rarely, conversion to normal sinus rhythm and about 95% of these patients did so at a dosage of 200 mcg/kg/min or less. The average effective dosage of esmolol hydrochloride was approximately 100 mcg/kg/min in the two studies. Other multicenter baseline-controlled studies gave similar results.

In the comparison with propranolol, about 50% of patients in both the esmolol hydrochloride and propranolol groups were on concomitant digoxin. Response rates were slightly higher with both beta blockers in the digoxin-treated patients. In all studies significant decreases of blood pressure occurred in 20 to 50% of patients, identified either as adverse reaction reports by investigators, or by observation of systolic pressure less than 90 mmHg or diastolic pressure less than 50 mmHg.

The hypotension was symptomatic (mainly hyperhidrosis or dizziness) in about 12% of patients, and therapy was discontinued in about 11% of patients, about half of whom were symptomatic. Hypotension was more common with esmolol hydrochloride (53%) than with propranolol (17%). The hypotension was rapidly reversible with decreased infusion rate or after discontinuation of therapy with esmolol hydrochloride.

For both esmolol hydrochloride and propranolol, hypotension was reported less frequently in patients receiving concomitant digoxin.

🧪 Nonclinical Toxicology 21 words ▾

13 NONCLINICAL TOXICOLOGY Because of its short term usage no carcinogenicity, mutagenicity, or reproductive performance studies have been conducted with esmolol.

📄 Recent Major Changes 8 words ▾

Warnings and Precautions, Hypoglycemia ( 5.6 ) 06/2023

📄 Package Label / Principal Display Panel ~3 min read ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg per 10 mL (10 mg/mL) Container Label Rx only NDC 55150-194-10 Esmolol Hydrochloride Injection 100 mg per 10 mL (10 mg/mL) For Intravenous Use 10 mL Single-Dose Vial PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg per 10 mL (10 mg/mL) Container Label

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg per 10 mL (10 mg/mL) Container-Carton (25 Vials) Rx only NDC 55150-194-10 Esmolol Hydrochloride Injection 100 mg per 10 mL (10 mg/mL) For Intravenous Use Contains no preservatives - discard unused portion. eugia 25 x 10 mL Single-Dose Vials PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 100 mg per 10 mL (10 mg/mL) Container-Carton (25 Vials)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 2,500 mg per 250 mL (10 mg/mL) - Infusion Bag Label 250 mL Single-Dose Containers NDC 55150-420-01 Rx only Esmolol HCl in Sodium Chloride Injection 2,500 mg per 250 mL (10 mg/mL) Single Intravenous Use Only Iso-Osmotic No Preservative Added Each mL contains 10 mg esmolol hydrochloride USP, 5.9 mg sodium chloride USP in water for injection USP. Buffered with 2.8 mg sodium acetate trihydrate USP and 0.546 mg glacial acetic acid USP. pH adjusted with sodium hydroxide and/or hydrochloric acid. pH 5.0 (4.5 to 5.5).

Sterile, nonpyrogenic. Usual Dosage: See package insert. Cautions: Check for leaks by squeezing container firmly.

If leaks are found discard as sterility may be impaired. Use only if solution is clear colorless to light yellow. Discard unused portion.

DO NOT INTRODUCE ADDITIVES. Must not be used in series connections. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

PROTECT FROM FREEZING. Avoid excessive heat. Mfd. in India for: Code: TS/DRUGS/01/2013/LVP Eugia US LLC E.

Windsor, NJ 08520 P1431890 PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 2,500 mg per 250 mL (10 mg/mL) - Infusion Bag Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 2,500 mg per 250 mL (10 mg/mL) - Pouch Label TO OPEN - TEAR AT NOTCH 250 mL Single-Dose Container NDC 55150-420-01 Rx only Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier.

The inner bag maintains the sterility of the product. Esmolol HCl in Sodium Chloride Injection 2,500 mg per 250 mL (10 mg/mL) Single Intravenous Use Only Iso-Osmotic No Preservative Added Each mL contains 10 mg esmolol hydrochloride USP, 5.9 mg sodium chloride USP in water for injection USP. Buffered with 2.8 mg sodium acetate trihydrate USP and 0.546 mg glacial acetic acid USP. pH adjusted with sodium hydroxide and/or hydrochloric acid. pH 5.0 (4.5 to 5.5).

Sterile, nonpyrogenic. Usual Dosage: See package insert. Cautions: After removing the overwrap, check for leaks by squeezing container firmly.

If leaks are found, discard as sterility may be impaired. Use only if solution is clear colorless to light yellow. Discard unused portion.

DO NOT INTRODUCE ADDITIVES. Must not be used in series connections. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

PROTECT FROM FREEZING. Avoid excessive heat. Mfd. in India for: Code: TS/DRUGS/01/2013/LVP Eugia US LLC P4000382 E.

Windsor, NJ 08520 eugia PACKAGE LABEL PRINCIPAL DISPLAY PANEL - 2,500 mg per 250 mL (10 mg/mL) - Infusion Bag Label

PACKAGE LABEL PRINCIPAL DISPLAY PANEL 2,500 mg per 250 mL (10 mg/mL) - Carton Label 10 x 250 mL Single-Dose NDC 55150-420-10 Container Rx only Esmolol HCl in Sodium Chloride Injection 2,500 mg per 250 mL (10 mg/mL) Single Intravenous Use Only Iso-Osmotic No Preservative Added Each mL contains 10 mg esmolol hydrochloride USP, 5.9 mg sodium chloride USP in water for injection USP. Buffered with 2.8 mg sodium acetate trihydrate USP and 0.546 mg glacial acetic acid USP. pH adjusted with sodium hydroxide and/or hydrochloric acid. pH 5.0 (4.5 to 5.5).

Sterile, nonpyrogenic. Usual Dosage: See package insert. Cautions: After removing t… [Excerpted — this section continues on DailyMed.]

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

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 this package alone, 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
5K
Units reimbursed last 4 qtrs
31.2K
Gross reimbursed last 4 qtrs
$453.8K
Avg / prescription
$90.46
Avg / unit
$14.5574
Latest quarter Q4 2025
918Rx
Fee-for-service vs managed care ⓘ
20% FFS 80% MCO
Fee-for-service · 989 Rx Managed care · 4,027 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: 2,444 units · 124 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 248 units · 4.3 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 1,057 units · 5.4 per 100k residents NY Vermont: 445 units · 68.8 per 100k residents VT New Hampshire: 1,228 units · 87.6 per 100k residents NH Oregon: 363 units · 8.6 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 538 units · 16.8 per 100k residents IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 1,614 units · 13.7 per 100k residents OH Pennsylvania: 601 units · 4.6 per 100k residents PA New Jersey: 365 units · 3.9 per 100k residents NJ Massachusetts: 625 units · 8.9 per 100k residents MA California: 4,898 units · 12.6 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 685 units · 34.6 per 100k residents NE Missouri: 1,234 units · 19.9 per 100k residents MO Kentucky: 2,826 units · 62.4 per 100k residents KY West Virginia: no data reported WV Virginia: 641 units · 7.4 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 410 units · 19.4 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 1,178 units · 16.5 per 100k residents TN North Carolina: 1,895 units · 17.5 per 100k residents NC South Carolina: no data reported SC Delaware: 1,249 units · 121 per 100k residents DE Oklahoma: 3,879 units · 95.7 per 100k residents OK Louisiana: no data reported LA Mississippi: 243 units · 8.3 per 100k residents MS Alabama: no data reported AL Georgia: 115 units · 1.0 per 100k residents GA D.C.: 290 units · 42.7 per 100k residents DC Hawaii: no data reported HI Texas: 210 units · 0.7 per 100k residents TX Florida: 1,890 units · 8.4 per 100k residents FL
Units reimbursed · per 100k residents
0.7124
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 Idaho 124 /100k
2 Delaware 121 /100k
3 Oklahoma 95.7 /100k
4 New Hampshire 87.6 /100k
5 Vermont 68.8 /100k
6 Kentucky 62.4 /100k
7 D.C. 42.7 /100k
8 Nebraska 34.6 /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.

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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
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 J1805 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.
← 55150-0193-01 · Eugia 55150-0195-20 · Eugia →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.