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:

Baxter Healthcare 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 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. Esmolol hydrochloride injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol hydrochloride injection is intended for short-term use. Esmolol hydrochloride injection is indicated for the short-term 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 injection to prevent such events is not recommended. Esmolol hydrochloride injection is contraindicated in patients with: Esmolol hydrochlori

Product summary:

Esmolol Hydrochloride Injection 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.

Authorization status:

New Drug Application

Summary of Product characteristics

ESMOLOL HYDROCHLORIDE- ESMOLOL HYDROCHLORIDE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESMOLOL HYDROCHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ESMOLOL HYDROCHLORIDE
INJECTION.
ESMOLOL HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Esmolol hydrochloride injection is a beta adrenergic blocker indicated
for the short-term treatment of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warnings and Precautions, Hypoglycemia (5.6) 06/2023
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)
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)
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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)
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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)
Injection: 100 mg/10 mL (10 mg/mL) in 10 mL vial (3)
Severe sinus bradycardia (4)
Heart block greater than first degree (4)
Sick sinus syndrome (4)
Decompensated heart failure (4)
Cardiogenic shock (4)
Coadministration of IV cardiodepr