Home › NDC Lookup › Ingredients › Esmolol Hydrochloride › 44567-0811-10
Esmolol Hydrochloride in Water 10 mg/mL Injection — NDC 44567-0811-10 package photo

Esmolol Hydrochloride in Water 10 mg/mL Injection

by WG Critical Care, LLC · 10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG
NDC 44567-0811-10
🏷️ FDA NDC (as labeled) 44567-811-10 billing pads the product segment with a zero
Rx only Brand 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 44567-811-10
Product NDC 44567-811
11-digit billing NDC 44567081110
NCPDP billing unit ML — per mL (volume)
RxCUI 979432, 1736541
UNII V05260LC8D
Application # NDA205703
SPL Set ID 60b10020-f802-4fef-a487-0f11eca246c5
Established class (EPC) beta-Adrenergic Blocker
Mechanism of action Adrenergic beta-Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-12-04
Route INTRAVENOUS
Dosage form INJECTION
Substance ESMOLOL HYDROCHLORIDE
GPI-14 33200025102030
GPI class Esmolol HCl
GCN Seq No 075966
GCN 41175
HICL code 043347
Ingredient (HICL) Esmolol Hcl In Sterile Water
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-WATER 2,500 MG/250 ML
FDB brand name Esmolol Hcl-Water
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 44567-811-10 — 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 → 44567-0811-10. 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.

🏭 Manufacturer & labeler

LabelerWG Critical Care, LLC
Application holderHQ SPECIALTY PHARMA CORP
FDA applicationNDA205703 (NDA)
Labeler code44567
First marketedDec 2017
Product typeHuman Prescription Drug
Portfolio85 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 ESMOLOL-WATER 2,500 MG/250 ML Ingredient Esmolol Hcl In Sterile Water
📗 Our plain-language guide HelloPharmacist
  • Esmolol is an IV medication specifically designed for situations where your heart rate or blood pressure needs to be brought under control very quickly — like during or after surge...
  • Why am I getting esmolol instead of a pill for my heart rate?
  • Esmolol is intended for short-term use only. Your care team will run the infusion only as long as needed to control your heart rate or blood pressure in the current situation. Once...
  • Some people feel a drop in blood pressure, which can cause dizziness or sweating. Nausea or drowsiness can also occur. The most common issue is low blood pressure — your care team...
📖 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.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $0.8969 $8.97 / 10 bags
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J1806 $0.196 / J1806 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)44567-811-10
11-digit billing NDC44567-0811-10
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ1806
DescriptorINJECTION, ESMOLOL HYDROCHLORIDE (WG CRITICAL CARE) NOT THERAPEUTICALLY EQUIVALENT TO J1805, 10 MG
Billing units / pkg1 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
Brevibloc 10 mg/mL 10019-0055-61 Baxter 250 ml — AP FDA listed —
Brevibloc 10 mg/mL 10019-0670-10 Baxter 250 ml — AP FDA listed —
Brevibloc 10 mg/mL 10019-0672-10 Baxter 250 ml — AP FDA listed —
esmolol hydrochloride 10 mg/mL 25021-0308-84 Sagent 250 ml — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 44567-0450-10 WG 250 ml — AP FDA listed —
Esmolol Hydrochloride in Water 10 mg/mLthis 44567-0811-10 WG 250 ml — — FDA listed —
Esmolol Hydrochloride 10 mg/mL 51662-1427-01 HF 250 ml — AP FDA listed —
esmolol hydrochloride 10 mg/mL 55150-0420-10 Eugia 10 pouches — AP FDA listed —
esmolol hydrochloride in sodium chloride 10 mg/mL 67457-0657-25 Mylan 1 pouch — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 70121-1716-07 Amneal 10 pouches — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 51662-1371-01 HF 10 ml — — FDA listed —
Esmolol Hydrochloride 10 mg/mL 68083-0211-25 Gland 25 vials — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 71872-7136-01 Medical 1 vial — 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 00404-9785-10 Henry 1 vial — AP FDA listed —
Brevibloc 10 mg/mL 00404-9825-10 Henry 1 vial — AP FDA listed —
Esmolol Hydrochloride 10 mg/mL 51662-1322-01 HF 10 ml — 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 67457-0182-10 Mylan 10 vials — AP FDA listed —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2016
First FDA approval
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Apr 7, 2016 RLD RS ⏳ ~6.5 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8829054 — drug product
US 8835505 — drug product
US 8835505 — drug product
US 8829054 — drug product
2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (4)
PatentTypeUse codeExpires
US 8829054 ↗ Drug product — Mar 15, 2033
US 8835505 ↗ Drug product — Mar 15, 2033
US 8835505 ↗ Drug product — Mar 15, 2033
US 8829054 ↗ Drug product — Mar 15, 2033
Common questions
Is there a generic version of ESMOLOL-WATER 2,500 MG/250 ML?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for ESMOLOL-WATER 2,500 MG/250 ML. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 44567-0811-10, 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
54
Units reimbursed last 4 qtrs
377
Gross reimbursed last 4 qtrs
$338.13
Avg / prescription
$6.26
Avg / unit
$0.8969
Latest quarter Q4 2025
0Rx
Fee-for-service vs managed care ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 54 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: 377 units · 8.3 per 100k residents 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: no data reported FL
Units reimbursed · per 100k residents
8.38.3
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 Kentucky 8.3 /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.

🔬 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 Esmolol Hydrochloride in Water (this brand).

Top reported reactions

Cardiac Arrest7
Condition Aggravated6
Drug Ineffective For Unapproved Indication6
Hepatotoxicity6
Hyperbilirubinaemia6
Hypotension6
Renal Failure6

Age at onset

Neonate4
Infant8
Adult5
Elderly6

Reporter sex

113 reports
Male · 55%
Female · 45%

Serious outcomes

Hospitalization41
Life-threatening18
Death18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 13 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
44567-0811-10 You're viewing this 10 BAG in 1 CARTON (44567-811-10) / 250 mL in 1 BAG 2017-12-04 Active

🧭 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 FDA registers it as 44567-811-10, 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: 44567-0811-10, written without dashes as 44567081110. 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 44567-0811-10, the first segment (44567) is the labeler code FDA assigned to WG Critical Care, LLC; the middle segment (0811) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) 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 WG Critical Care, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WG Critical Care, 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 J1806 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 ⏱️ 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 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 181 words ▾

1 INDICATIONS AND USAGE Esmolol Hydrochloride 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 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 is desirable. Esmolol hydrochloride is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride is intended for short-term use.

1.2Intraoperative and Postoperative Tachycardia and Hypertension Esmolol hydrochloride 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 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/kg infused over one minute Then 50 mcg/kg/min for the next 4 minutes Titrate as needed to a maximum of 200 mcg/kg/min Additional loading doses may be administered • Perioperative tachycardia and hypertension ( 2.2 ) Loading dose: 500 mcg/kg over 1 minute for gradual control (1 mg/kg over 30 seconds for immediate control) Then 50 mcg/kg/min for gradual control (150 mcg/kg/min for immediate control) adjusted to a maximum of 200 (tachycardia) or 300 (hypertension) mcg/kg/min

2.1Dosing for the Treatment of Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia Esmolol hydrochloride is administered by continuous intravenous infusion with or without a loading dose. Additional loading doses and/or titration of the maintenance infusion (stepwise dosing) may be necessary based on desired ventricular response. Table 1.

Step-Wise Dosing Step Action 1 Optional loading dose (500 mcg/kg over 1 minute), then 50 mcg/kg/min for 4 min 2 Optional loading dose if necessary, then 100 mcg/kg/min for 4 min 3 Optional loading dose if necessary, then 150 mcg/kg/min for 4 min 4 If necessary increase dose to 200 mcg/kg/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/kg/min, although doses as low as 25 mcg/kg/min have been adequate.

Dosages greater than 200 mcg/kg/min 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/kg as a bolus dose over 30 seconds followed by an infusion of 150 mcg/kg/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/kg as a bolus dose over 1 minute followed by a maintenance infusion of 50 mcg/kg/min for 4 minutes. • Depending on the response obtained, continue dosing as outlined for supraventricular tachycardia (refer to Figure 1). Refer to Maximum Recommended Doses below.

Maximum Recommended Doses • For the treatment of tachycardia, maintenance infusion dosages greater than 200 mcg/kg/min are not recommended; dosages greater than 200 mcg/kg/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/kg/min) may be required. The safety of doses above 300 mcg/kg/min 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 to alternative drugs, consider the labeling instructions of the alternative drug selected and reduce the dosage of esmolol hydrochloride 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, monitor the patient's response, and, if satisfactory control is maintained for the first hour, discontinue the esmolol hydrochloride infusion.

2.4 Directions for Use Avoid infusions into small veins or through butte…

💊 Dosage Forms and Strengths 79 words ▾

3 DOSAGE FORMS AND STRENGTHS Table 2. Esmolol Hydrochloride in Water for Injection Presentations Presentations Product Name Esmolol Hydrochloride Esmolol Hydrochloride DOUBLE STRENGTH Total Dose 2500 mg/250 mL 2000 mg/100 mL Esmolol Hydrochloride Concentration 10 mg/mL 20 mg/mL Packaging 250 mL Bag 100 mL Bag • Injection: 2500 mg/250 mL (10 mg/mL) in 250 mL Premixed Injection bag ( 3 ) • Injection: 2000 mg/100 mL (20 mg/mL) in 100 mL DOUBLE STRENGTH Premixed Injection bag ( 3 )

⛔ Contraindications 159 words ▾

4 CONTRAINDICATIONS Esmolol hydrochloride is contraindicated in patients with: • Severe sinus bradycardia, heart block greater than first degree, 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 and cause cardiogenic shock • Concomitant use of IV cardiodepressant calcium-channel antagonists (e.g., verapamil): May cause cardiovascular collapse. • 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 ( 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 dose or discontinue use ( 5.1 , 5.2 , 5.3 , 5.8 ) • Risk of exacerbating reactive airway disease ( 5.4 ) • Diabetes mellitus: May mask symptoms of hypoglycemia and alter glucose levels; monitor ( 5.5 ) • Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma ( 5.7 ) • Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease ( 5.10 , 5.11 )

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/kg/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.

Reduction 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. If the patient develops signs or symptoms of cardiac failure, stop esmolol hydrochloride and start supportive therapy.

5.4Reactive 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 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 rate.

5.5Hypoglycemia 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.

5.6Use 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.

5.7Use 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 with a paradoxical increase in blood pressure from the attenuation of beta-mediated vasodilation in skeletal muscle.

5.8Use in Hypovolemic Patients In hypovolemic patients, esmolol hydrochloride can attenuate reflex tachycardia and increase the risk of hypotension.

5.9Use in Patients with Peripheral Circulatory Disorders In patients with peripheral circulatory disorders (including Raynaud’s disease or syndrome, and peripheral occlusive vascular disease), esmolol hydrochloride may aggravate peripheral circulatory disorders.

5.10Abrupt Discontinuation of Esmolol Hydrochloride Severe exacerbations of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery…

🤒 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 WG Critical Care, LLC at 1-866-562-4708 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 ( 5.3 )] . 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%) (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 3% Somnolence 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 have (<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 ~1 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. • 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 or guanfacine: Beta-blockers also increase the risk of clonidine-, or guanfacine-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 ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Available data from published case reports, case series and clinical studies over decades of use with Esmolol during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. Esmolol use in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of the drug infusion (see Clinical Considerations) . In animal reproductive studies, administration of esmolol hydrochloride to pregnant rats during the period of organogenesis did not demonstrate embryotoxicity or teratogenicity at doses up to approximately 1.6 times the maximum human maintenance dose (300 mcg/kg/min).

In rabbits, intravenous administration of esmolol hydrochloride at approximately 2.7 times the maximum human maintenance dose (300 mcg/kg/min) during organogenesis produced minimal maternal toxicity and increased fetal resorptions (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Esmolol use in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of the drug infusion. Because of hypotension to the mother, monitor the pregnant woman for decreased uterine blood flow and resulting fetal hypoxia. Data Animal Data In animal reproduction studies, administration of esmolol during organogenesis, in the rat study did not demonstrate embryotoxicity or teratogenicity in doses up to 3,000 mcg (3 mg)/kg/min for 30 min.

Based on body surface area, this dose is approximately 1.6 times the maximum human maintenance dose (300 mcg/kg/min). In rabbits, intravenous dosage of 2,500 mcg (2.5 mg)/kg/min during organogenesis, produced minimal maternal toxicity and increased fetal resorptions, which is approximately 2.7 times the maximum human maintenance dose (300 mcg/kg/min).

8.2Lactation Risk Summary There are no data on the presence of esmolol or its metabolite in either human or animal milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for esmolol and any potential adverse effects on the breastfed infant from esmolol hydrochloride or from the underlying maternal condition.

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 ( 12.3 )] .

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 ( 12.3 )] .

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Available data from published case reports, case series and clinical studies over decades of use with Esmolol during pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes. Esmolol use in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of the drug infusion (see Clinical Considerations) . In animal reproductive studies, administration of esmolol hydrochloride to pregnant rats during the period of organogenesis did not demonstrate embryotoxicity or teratogenicity at doses up to approximately 1.6 times the maximum human maintenance dose (300 mcg/kg/min).

In rabbits, intravenous administration of esmolol hydrochloride at approximately 2.7 times the maximum human maintenance dose (300 mcg/kg/min) during organogenesis produced minimal maternal toxicity and increased fetal resorptions (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Esmolol use in the last trimester of pregnancy or during labor or delivery has been reported to cause fetal bradycardia, which continued after termination of the drug infusion. Because of hypotension to the mother, monitor the pregnant woman for decreased uterine blood flow and resulting fetal hypoxia. Data Animal Data In animal reproduction studies, administration of esmolol during organogenesis, in the rat study did not demonstrate embryotoxicity or teratogenicity in doses up to 3,000 mcg (3 mg)/kg/min for 30 min.

Based on body surface area, this dose is approximately 1.6 times the maximum human maintenance dose (300 mcg/kg/min). In rabbits, intravenous dosage of 2,500 mcg (2.5 mg)/kg/min during organogenesis, produced minimal maternal toxicity and increased fetal resorptions, which is approximately 2.7 times the maximum human maintenance dose (300 mcg/kg/min).

🧒 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 ~1 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.

🧬 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 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 that 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 hepatic o…

📦 How Supplied / Storage and Handling 198 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Esmolol Hydrochloride is a clear, colorless to light yellow, sterile, non-pyrogenic solution that is available in a single-dose 250 mL dual port bag with an aluminum overwrap. The container closure is not made with natural rubber latex. It is available in the following presentation: Strength Package NDC Number 2500 mg (10 mg/mL) 10 bags per carton 44567-811-10 Esmolol Hydrochloride DOUBLE STRENGTH is a clear, colorless to light yellow, sterile, non-pyrogenic solution that is available in a single-dose 100 mL dual port bag with an aluminum overwrap.

The container closure is not made with natural rubber latex. It is available in the following presentation: Strength Package NDC Number 2000 mg (20 mg/mL) 10 bags per carton 44567-812-10

16.2Storage Store at 20° to 25°C (68° to 77°F); excursions are permitted from 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PROTECT FROM FREEZING. Avoid excessive heat. 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.

📋 Description ~1 min read ▾

11 DESCRIPTION Esmolol Hydrochloride 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 has the empirical 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 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 17.0 for propranolol. Esmolol Hydrochloride is a clear, colorless to light yellow, sterile, non-pyrogenic solution of esmolol hydrochloride.

The formulations for Esmolol Hydrochloride are described in the table below: Table 4. Esmolol Hydrochloride Formulations Esmolol Hydrochloride Esmolol Hydrochloride DOUBLE STRENGTH Esmolol Hydrochloride 10 mg/mL 20 mg/mL Ethanol 1% v/v 1% v/v Propylene Glycol 10 mg/mL 10 mg/mL Water for Injection, USP Q.S. to volume of 250 mL Q.S. to volume of 100 mL Sodium Acetate Trihydrate , USP 0.68 mg/mL 0.68 mg/mL Glacial Acetic Acid, USP 0.27 mg/mL 0.27 mg/mL Osmolarity 320 to 450 mOsmol/L 440 to 500 mOsmol/L Sodium Hydroxide Q.S. to adjust pH to 5.0 (4.5 to 6.5) Q.S. = Quantity sufficient The 250 mL and 100 mL dual port bags have an aluminum overwrap and the container closure is not made with natural rubber latex.

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. structural formula

💬 Information for Patients 92 words ▾

17 PATIENT COUNSELING INFORMATION 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 hydrochloride is given to patients who are fasting or who are vomiting. Instruct patients or caregivers how to monitor for signs of hypoglycemia [see Warnings and Precautions ( 5.5 )] . Rx only Manufactured for: WG Critical Care, LLC Paramus, NJ 07652 Made in Switzerland U.S.

Patent Numbers 8,829,054 and 8,835,505

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 44567-0804-01 · WG 44567-0812-10 · WG →
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.