Esmolol Hydrochloride in Water 20 mg/mL
Esmolol Hydrochloride · INJECTION · WG Critical Care, LLC
Esmolol Hydrochloride in Water is a injection containing esmolol hydrochloride at 20 mg/mL, taken intravenous. Manufactured by WG Critical Care, LLC.
Key Facts
- Brand Name
- Esmolol Hydrochloride in Water
- Generic Name
- Esmolol Hydrochloride
- NDC Code (Product)
44567-812- Manufacturer
- WG Critical Care, LLC
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA205703
- Marketing Start
- 12/04/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 ) 1.1 Supraventricular 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. 1.2 Intraoperative 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 perio…
Dosage & Administration
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 2.1 Dosing 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/…
Contraindications
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 )
Drug Interactions
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…
Adverse Reactions
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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in 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…
Frequently Asked Questions
What is Esmolol Hydrochloride in Water used for?
Esmolol Hydrochloride in Water contains Esmolol Hydrochloride. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Esmolol Hydrochloride in Water a controlled substance?
Esmolol Hydrochloride in Water is not classified as a controlled substance by the DEA.
What is the generic name for Esmolol Hydrochloride in Water?
The generic name for Esmolol Hydrochloride in Water is Esmolol Hydrochloride. There are 11 other brand versions of Esmolol Hydrochloride.
What is the NDC code for Esmolol Hydrochloride in Water 20 mg/mL?
The NDC (National Drug Code) for Esmolol Hydrochloride in Water 20 mg/mL is 44567-812, listed by WG Critical Care, LLC.
Other Esmolol Brands
See all →- Brevibloc10 mg/mL10019-055
- BREVIBLOC10 mg/mL10019-670
- BREVIBLOC10 mg/mL10019-672
- esmolol hydrochloride10 mg/mL25021-308
- Esmolol Hydrochloride20 mg/mL44567-451
- ESMOLOL HYDROCHLORIDE10 mg/mL51662-1322
- esmolol hydrochloride in sodium chloride10 mg/mL67457-657
- Esmolol Hydrochloride100 mg/10mL70518-4410
- ESMOLOL HYDROCHLORIDE100 mg/10mL0404-9858
- Brevibloc10 mg/mL10019-115
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)