Brevibloc 10 mg/mL
Esmolol Hydrochloride · INJECTION · Baxter Healthcare Company
Brevibloc is a injection containing esmolol hydrochloride at 10 mg/mL, taken intravenous. Manufactured by Baxter Healthcare Company.
Key Facts
- Brand Name
- Brevibloc
- Generic Name
- Esmolol Hydrochloride
- NDC Code (Product)
10019-055- Manufacturer
- Baxter Healthcare Company
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA019386
- Marketing Start
- 12/31/1986
Recall History
Baxter Healthcare Corp.
Discoloration: presence of atypical yellow discoloration of the solution .
Baxter Healthcare Corp.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BREVIBLOC 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 ) 1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC (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. BREVIBLOC injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. BREVIBLOC injection is intended for short-term use. 1.2 Intraoperative and Postoperative Tachycardia and/or Hypertension BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during s…
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 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 ) 2.1 Dosing for the Treatment of Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia BREVIBLOC 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 Do…
Contraindications
4 CONTRAINDICATIONS BREVIBLOC (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 BREVIBLOC injection in close proximity (i.e., while cardiac effects from the other are still present); fatal cardiac arrests have occurred in patients receiving BREVIBLOC injection and intravenous verapamil. • Pulmonary hypertension: May precipitate cardiorespiratory compromise. • Hypersensitivity reactions, including anaphylaxis, to e…
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of BREVIBLOC injection 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 BREVIBLOC injection’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.) BREVIBLOC injection 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 BREVIBLOC injection leads to an approximate 10% to 20% increase of digoxin blood levels at some time points. Digoxin does not affect BREVIBLOC injection pharmacokinetics. Both digoxin and beta blockers slow atrioventricul…
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 Baxter Healthcare Corporation at 1-866-888-2472 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 BREVIBLOC (Esmolol Hydrochloride) injection 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 BREVIBLOC injection was pres…
Frequently Asked Questions
What is Brevibloc used for?
Brevibloc contains Esmolol Hydrochloride. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Brevibloc a controlled substance?
Brevibloc is not classified as a controlled substance by the DEA.
What is the generic name for Brevibloc?
The generic name for Brevibloc is Esmolol Hydrochloride. There are 10 other brand versions of Esmolol Hydrochloride.
What is the NDC code for Brevibloc 10 mg/mL?
The NDC (National Drug Code) for Brevibloc 10 mg/mL is 10019-055, listed by Baxter Healthcare Company.
Other Brevibloc Dosages
Other Esmolol Brands
See all →- BREVIBLOC10 mg/mL10019-670
- BREVIBLOC10 mg/mL10019-672
- esmolol hydrochloride10 mg/mL25021-308
- Esmolol Hydrochloride20 mg/mL44567-451
- Esmolol Hydrochloride in Water20 mg/mL44567-812
- ESMOLOL HYDROCHLORIDE10 mg/mL51662-1322
- esmolol hydrochloride in sodium chloride10 mg/mL67457-657
- Esmolol Hydrochloride100 mg/10mL70518-4410
- ESMOLOL HYDROCHLORIDE100 mg/10mL0404-9858
- ESMOLOL HYDROCHLORIDE10 mg/mL51662-1427
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)