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:

West Ward Pharmaceutical Corporation

INN (International Name):

ESMOLOL HYDROCHLORIDE

Composition:

ESMOLOL HYDROCHLORIDE 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hydrochloride is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride is not intended for use in chronic settings where transfer to another agent is anticipated. 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 hydrochloride to prevent such events is not recommended. Esmolol hydrochloride is contraindicated in patients with sinus bradycardia, heart block

Product summary:

Esmolol Hydrochloride Injection NDC 0641-2965-45, 100 mg - 10 mL Ready-to-use Vials, Package of 25 Store at 25˚C (77˚F). Excursions permitted to 15˚-30˚C (59˚-86˚F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING. Avoid excessive heat. Manufactured for Baxter Healthcare Corporation Deerfield, IL 60015 USA Baxter is a registered trademark of Baxter International Inc. U.S. Patent Nos. 6,310,094 and 6,528,540. For Product Inquiry 1 800 ANA DRUG (1-800-262-3784) MLT-01608/4.0

Authorization status:

New Drug Application

Summary of Product characteristics

ESMOLOL HYDROCHLORIDE- ESMOLOL HYDROCHLORIDE INJECTION
WEST WARD PHARMACEUTICAL CORPORATION
----------
ESMOLOL HYDROCHLORIDE INJECTION
Ready-to-use Vials
10 mL Vials
Iso-Osmotic Solution of Esmolol Hydrochloride in Sodium Chloride
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
RX ONLY
DESCRIPTION
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 empirical 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
Esmolol Hydrochloride Injection is a clear, colorless to light yellow,
sterile, nonpyrogenic, iso-
osmotic solution of esmolol hydrochloride in sodium chloride.
100 MG, 10 ML SINGLE DOSE VIAL– Each mL contains 10 mg Esmolol
Hydrochloride, 5.9 mg Sodium
Chloride, USP and Water for Injection, USP; buffered with 2.8 mg
Sodium Acetate Trihydrate, USP and
0.546 mg Glacial Acetic Acid, USP. Sodium Hydroxide and/or
Hydrochloric Acid added, as necessary
to adjust pH to 5.0 (4.5-5.5).
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
1
16
26
4
1
stabilizing activity at therapeutic dosages. Its elimination half-life
after intravenous infusion is
approximatel