ESMOLOL HYDROCHLORIDE - esmolol hydrochloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Esmolol Hydrochloride (UNII: V05260LC8D) (Esmolol - UNII:MDY902UXSR)

Available from:

General Injectables & 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 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. 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 emergence from anesthesia, and in the postoperative period, when in the physician's judgment such specific intervention is considered indicated. Use of esmolol to prevent such events is not recommended. Esmolol hydrochloride is cont

Product summary:

Esmolol Hydrochloride Injection is supplied as: NDC 55390-062-10 , 100 mg/10 mL (10 mg/mL) - 10 mL Ready-to-use Vials, carton of 10. Store at 20° to25°C (68° to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING. Avoid excessive heat. Manufactured for:                                     Manufactured by: Bedford Laboratories™                             Ben Venue Laboratories, Inc. Bedford, OH 44146                                   Bedford, OH 44146 August 2008                                            Div-ESM-P03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESMOLOL HYDROCHLORIDE - ESMOLOL HYDROCHLORIDE INJECTION
GENERAL INJECTABLES & VACCINES, INC
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ESMOLOL HCL INJECTION 10 MG/ML INJECTION, USP 10 ML SINGLE DOSE VIAL
DES CRIPTION
RX ONLY
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 beta1-selective (cardioselective)
adrenergic receptor blocking agent with a
very short duration of action (elimination half-life is approximately
9 minutes). The chemical name for
esmolol hydrochloride is (±)-Methyl p-[2-hydroxy-3-
(isopropylamino)propoxy]hydrocinnamate
hydrochloride and it has the following structure:
Esmolol hydrochloride has the molecular formula C16H26NO4CI 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 HCl Injection 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 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 beta1-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 halflife
after intravenous infusion is
approximately 9 minutes. Esmolol inhibits the beta1 receptors located
chiefly in cardiac muscle, but this
preferential effect is not absolute and at higher doses it begi