ESMOLOL HYDROCHLORIDE- esmolol hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESMOLOL HYDROCHLORIDE (UNII: V05260LC8D) (ESMOLOL - UNII:MDY902UXSR)

Available from:

General Injectables and Vaccines, Inc.

INN (International Name):

ESMOLOL HYDROCHLORIDE

Composition:

ESMOLOL HYDROCHLORIDE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Supraventricular Tachycardia Esmolol hydrochloride is indicated for the rapid control of ventriculare 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 is also indicated in noncompensatory sinus tachycardia where, in the physician's judgment, the rapid heart rate requires specific intervention. Esmolol is not intended for use in chronic settings where transfer to another agent is anticipated. Intraoperative and Postoperative Tachycardia and/or Hypertension Esmolol hydrochloride is indicated for the treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on eemergence from anesthesia, and in the postoperative period, when in the physician's judgment such specific intervention is considered indicated. Esmolol hydrochloride is contraindicated in patients with sinus bradycardia, heart block gre

Product summary:

Esmolol Hydrochloride Injection, 100 mg/10 mL (10mg/mL) 67457-182-10 Carton containing 10, 10 mL Ready-to-use Vials Store at 20o to 25o C (68o to 77o F). [See USP Controlled Room Temperature.[ Protect from freezing. Avoid excessive heat. Mylan Manufactured for: Mylan International LLC Rockford, IL 61103 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland 0643L102 REVISED JANUARY 2013 MI:ESMOIJ:R2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESMOLOL HYDROCHLORIDE- ESMOLOL HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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ESMOLOL HYDROCHLORIDE
DESCRIPTION
Ready-to-use Vials
10 mL Vials
FOR INTRAVENOUS USE
CAN BE USED FOR DIRECT INTRAVENOUS USE.
Esmolol Hydrochloride Concentration = 10 milligrams/mL (10,000
micrograms/mL)
SINGLE PATIENT USE ONLY
NO PRESERVATIVES ADDED
Esmolol hydrochloride is a beta
-selective (cardioselective) adrenergic receptor blocking agent
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 molecular formula C
H
NO
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 INJECTION, 10 MG/ML
Esmolol hydrochloride injection, 10 mg/mL is a clear, colorless to
light yellow, sterile, nonpyrogenic
solution.
100 MG, 10 ML SINGLE DOSE VIAL - Each mL contains 10 mg Esmolol
Hydrochloride and Water for
Injection buffered with 1.688 mg Sodium Acetate Anhydrous (equivalent
to 2.8 mg Sodium Acetate
Trihydrate) and 0.546 mg Glacial Acetic Acid. Sodium Hydroxide and/or
Hydrochloric Acid added as
necessary, to adjust pH to 4.5 to 5.5.
CLINICAL PHARMACOLOGY
Esmolol hydrochloride is a beta
-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 inhibits the beta
receptors located chiefly in cardiac muscle, but
this preferential effect is not ab