ESMOLOL HYDROCHLORIDE

ESMOLOL HYDROCHLORIDE- esmolol hydrochloride injection, solution
HF Acquisition Co LLC, DBA HealthFirst

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

INDICATIONS AND USAGE

Esmolol hydrochloride injection is a beta adrenergic blocker indicated for the short-term treatment of:


Control of ventricular rate in supraventricular tachycardia including atrial fibrillation and atrial flutter and control of heart rate in noncompensatory sinus tachycardia ( 1-1.1)

Control of perioperative tachycardia and hypertension ( 1- 1.2)

DOSAGE AND ADMINISTRATION


Administer intravenously ( 2-2.1, 2-2.2)

Titrate using ventricular rate or blood pressure at ≥ 4-minute intervals ( 2-2.1, 2-2.2)

Supraventricular tachycardia (SVT) or noncompensatory sinus tachycardia ( 2-2.1)

o
Optional loading dose: 500 mcg per kg infused over one minute
o
Then 50 mcg per kg per minute for the next 4 minutes
o
Adjust dose as needed to a maximum of 200 mcg per kg per minute
o
Additional loading doses may be administered


Perioperative tachycardia and hypertension ( 2-2.2)
o
Loading dose: 500 mcg per kg over 1 minute for gradual control (1 mg per kg over 30 seconds for immediate control)
o
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 ( 2-2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 100 mg/10 mL (10 mg/mL) in 10 mL vial ( 3)

CONTRAINDICATIONS


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 cardiodepressant calcium-channel antagonists (e.g. verapamil) in close proximity to esmolol hydrochloride injection ( 4, 7)

Pulmonary hypertension ( 4)

Known hypersensitivity to esmolol ( 4)

WARNINGS AND PRECAUTIONS


Risk of hypotension, bradycardia, and cardiac failure: Reduce or discontinue use ( 5-5.1, 5-5.2, 5-5.3, 5-5.10)

Risk of exacerbating reactive airway disease ( 5-5.5)

Diabetes mellitus: Increases the effect of hypoglycemic agents and masks hypoglycemic tachycardia ( 5-5.6)

Risk of unopposed alpha-agonism and severe hypertension in untreated pheochromocytoma ( 5-5.9)

Risk of myocardial ischemia when abruptly discontinued in patients with coronary artery disease ( 5-5.12, 5-5.15)

ADVERSE REACTIONS

Most common adverse reactions (incidence > 10%) are symptomatic hypotension (hyperhidrosis, dizziness) and asymptomatic hypotension ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS


Digitalis glycosides: Risk of bradycardia ( 7)

Anticholinesterases: Prolongs neuromuscular blockade ( 7)

Antihypertensive agents: Risk of rebound hypertension ( 7)

Sympathomimetic drugs: Dose adjustment needed ( 7)

Vasoconstrictive and positive inotropic effect substances: Avoid concomitant use ( 7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2017

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE
1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
1.2 Intraoperative and Postoperative Tachycardia and Hypertension
2 DOSAGE AND ADMINISTRATION
2.1 Dosing for the Treatment of Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia
2.2 Intraoperative and Postoperative Tachycardia and Hypertension
2.3 Transition from Esmolol Hydrochloride Injection Therapy to Alternative Drugs
2.4 Directions for Use
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Hypotension
5.2 Bradycardia
5.3 Cardiac Failure
5.4 Intraoperative and Postoperative Tachycardia and Hypertension
5.5 Reactive Airways Disease
5.6 Use in Patients with Diabetes Mellitus and Hypoglycemia
5.7 Infusion Site Reactions
5.8 Use in Patients with Prinzmetal’s Angina
5.9 Use in Patients with Pheochromocytoma
5.10 Use in Hypovolemic Patients
5.11 Use in Patients with Peripheral Circulatory Disorders
5.12 Abrupt Discontinuation of Esmolol Hydrochloride Injection
5.13 Hyperkalemia
5.14 Use in Patients with Metabolic Acidosis
5.15 Use in Patients with Hyperthyroidism
5.16 Use in Patients at Risk of Severe Acute Hypersensitivity Reactions
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
10 OVERDOSAGE
10.1 Signs and Symptoms of Overdose
10.2 Treatment Recommendations
10.3 Dilution Errors
11 DESCRIPTION
11.1 Esmolol Hydrochloride Injection Dosage Forms
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
14 CLINICAL STUDIES
1616 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
17 PATIENT COUNSELING INFORMATION

* Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS & USAGE

1.1 Supraventricular Tachycardia or Noncompensatory Sinus Tachycardia

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.

1.2 Intraoperative and Postoperative Tachycardia and Hypertension

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.

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