"The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product appr"...
(esmolol hydrochloride) Injection
BREVIBLOC (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 C16H26NO4Cl 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.
BREVIBLOC Dosage Forms
All BREVIBLOC presentations are clear, colorless to light yellow, sterile, nonpyrogenic, iso-osmotic solutions of esmolol hydrochloride in sodium chloride. The formulations for BREVIBLOC PREMIXED INJECTION, BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION, and BREVIBLOC INJECTION are described in the table below:
Table 3 : BREVIBLOC Formulations
|BREVIBLOC PREMIXED INJECTION (Esmolol Hydrochloride)||BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION (Esmolol Hydrochloride)||BREVIBLOC INJECTION (Esmolol Hydrochloride)|
|Esmolol Hydrochloride||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 4.5-5.5|
|Hydrochloric Acid||Q.S. to adjust pH to 4.5-5.5|
|Q.S. = Quantity sufficient|
The calculated osmolarity of BREVIBLOC PREMIXED INJECTION and BREVIBLOC DOUBLE STRENGTH PREMIXED INJECTION is 312 mOsmol/L. The 250 mL and 100 mL bags are non-latex, non-PVC IntraVia bags with dual PVC ports. The IntraVia bags are manufactured from a specially designed multilayer plastic (PL 2408). 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.
What are the possible side effects of esmolol (Brevibloc)?
Esmolol use has been associated with low blood pressure and other serious side effects.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...
Last reviewed on RxList: 12/27/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Brevibloc Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.