ESMOLOL HYDROCHLORIDE- esmolol hydrochloride in sodium chloride injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

WG Critical Care, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Esmolol Hydrochloride in Sodium Chloride 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 in Sodium Chloride Injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. Esmolol Hydrochloride in Sodium Chloride Injection is intended for short-term use. Esmolol Hydrochloride in Sodium Chloride 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 in Sodium Chloride Injection to prevent such events is not recomm

Product summary:

Esmolol Hydrochloride in Sodium Chloride Injection 2500 mg/250 mL (10 mg/mL) (single-dose plastic bag): NDC 44567-450-01 Single-Dose Plastic Bag NDC 44567-450-10 Carton of 10 Esmolol Hydrochloride in Sodium Chloride Injection 2000 mg/100 mL (20 mg/mL) (single-dose plastic bag) DOUBLE STRENGTH: NDC 44567-451-01 Single-Dose Plastic Bag NDC 44567-451-10 Carton of 10 Store at 25°C (77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Protect from freezing. Avoid excessive heat. Each bag contains no preservative. Once drug has been withdrawn from the ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded. Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Product should be used within 28 days of removal from aluminum overwrap. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact. Discard unused portion. Preparation for intravenous administration:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESMOLOL HYDROCHLORIDE- ESMOLOL HYDROCHLORIDE IN SODIUM
CHLORIDE INJECTION
WG CRITICAL CARE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESMOLOL
HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE
INJECTION.
ESMOLOL HYDROCHLORIDE IN SODIUM CHLORIDE INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
Warnings and Precautions, Hypoglycemia (5.6) 06/2023
INDICATIONS AND USAGE
Esmolol Hydrochloride in Sodium Chloride Injection is a
beta-adrenergic blocker indicated for the short-
term treatment of: (1)
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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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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)
o
o
o
o
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)
o
o
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 minute 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
minute (2.2).
Injection: 2500 mg/250 mL (10 mg/mL) in 250 mL Premixed Injection bag
(3)
Injection: 2000 mg/100 mL (20 mg/mL) in 100 mL Double Strength
Premixed Injecti