Alcohol

Prescription

Brand names: DEHYDRATED ALCOHOL

Dosage Form

Other

Route

PERCUTANEOUS

Manufacturer

Accord Healthcare Inc.

About This Medication

11 DESCRIPTION Dehydrated alcohol injection, USP is a sterile, preservative free solution of ≥ 99% by volume ethyl alcohol and no excipients. Dehydrated alcohol injection, USP is for cardiac septal branch intra-arterial use. It has a molecular formula of C 2 H 6 O and a molecular weight of 46.07. Dehydrated alcohol injection, USP is a potent tissue toxin. Ethanol is a clear, colorless, volatile, and flammable liquid miscible with water. It has the following structural formula: Structure

Active Ingredients

Ingredient	Strength
Alcohol	-

Indications & Usage

1 INDICATIONS & USAGE Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. Dehydrated alcohol injection is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. (1)

How It Works

12.1 Mechanism of Action Dehydrated alcohol is a tissue toxin that produces a myocardial infarction when injected through an intra-arterial catheter into a target septal vessel, which causes the hypertrophied septum to thin.

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, using the minimal dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. (2.1) • In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose that should be used in a single procedure is 5 mL. (2.1) 2.1 Recommended Dosing Use the minimum dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, guided by assessment of the gradient. In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose of dehydrated alcohol injection that should be used in a single procedure is 5 mL. 2.2 Administration Dehydrated alcohol injection should only be administered under the supervision of a qualified interventional cardiologist experienced in the percutaneous transluminal septal myocardial ablation procedure. Inspect visually for particulate matter and discoloration prior to administration. Dehydrated alcohol injection should appear as a clear, colorless solution. Discard unused portion.

Side Effects Overview

6 ADVERSE REACTIONS Heart block [ see Warnings and precautions (5.1) ] The following other adverse reactions associated with percutaneous transluminal septal myocardial ablation with the use of dehydrated alcohol, such as dehydrated alcohol injection, were identified in the literature: Ventricular tachycardia and ventricular fibrillation. Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation. (6) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings & Precautions

5 WARNINGS AND PRECAUTIONS • Transient heart block: Transient heart block is common at the time of injection. A temporary pacing wire is routinely inserted to mitigate transient heart block. (5.1) • Persistent heart block: Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker. (5.1) • Remove the temporary pacemaker lead if no episode of high-degree atrioventricular block occurs. (5.1) • Monitor the patient for heart failure, chest pain, and arrhythmias several days after the procedure. (5.1, 5.2, 5.3) 5.1 Heart Block Transient Heart Block Transient heart block is common at the time of dehydrated alcohol, such as dehydrated alcohol injection, injection into a septal artery. Prior to the injection, a temporary pacing wire is routinely inserted into the apex of the right ventricle, usually via the femoral vein, to treat transient heart block. The pacing lead can be removed if no episode of high-degree atrioventricular block occurs, usually after several hours of observation following percutaneous transluminal septal myocardial ablation. Persistent Heart Block Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker following percutaneous transluminal septal myocardial ablation. Risk factors for permanent pacemaker dependency after septal ablation include a baseline PQ interval >160 ms, baseline minimum heart rate < 50 bpm, baseline left ventricular outflow gradient >70 mmHg, maximum QRS during the first 48 hours > 155 ms, 3rd degree atrio-ventricular block occurring during the procedure, and no clinical recovery between 12 to 48 hours after the procedure. 5.2 Myocardial Infarction Injection of dehydrated alcohol is intended to create a controlled myocardial infarction for therapeutic purposes. However, excessive myocardial necrosis and subsequent heart failure have been reported. Factors increasing the risk of excessive tissue necrosis include higher volume of alcohol used and a higher number of septal branches injected to reduce the left ventricular outflow tract gradient. 5.3 Ventricular Arrhythmia Ventricular tachycardia and ventricular fibrillation requiring electrocardioversion occurred at a frequency of approximately 1%. Perform continuous electrocardiographic monitoring for 48 hours after the procedure.

Contraindications

4 CONTRAINDICATIONS None. None (4)

Pharmacokinetics

12.3 Pharmacokinetics Because injection of dehydrated alcohol during septal ablation is not expected to increase the systemic concentrations of endogenous alcohol significantly, the pharmacokinetics of dehydrated alcohol are not expected to be clinically significant.

Frequently Asked Questions

1 INDICATIONS & USAGE Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. Dehydrated alcohol injection is an ablative agent indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy. (1)

2 DOSAGE AND ADMINISTRATION • Inject small volumes over 1 to 2 minutes percutaneously into septal arterial branches, using the minimal dose necessary to achieve the desired reduction in peak left ventricular outflow tract pressure gradient. (2.1) • In most situations, a dose of 1 mL to 2 mL is sufficient. The maximum dose that should be used in a single procedure is 5 mL. (2.1) 2.1 Recommended Dosing Use the minimum dose necessary to achieve the desired reduction in …

5 WARNINGS AND PRECAUTIONS • Transient heart block: Transient heart block is common at the time of injection. A temporary pacing wire is routinely inserted to mitigate transient heart block. (5.1) • Persistent heart block: Approximately 10% of complete heart block events become permanent and require placement of a permanent pacemaker. (5.1) • Remove the temporary pacemaker lead if no episode of high-degree atrioventricular block occurs. (5.1) • Monitor the patient for heart failure, chest pain, and arrhythmias several days …

4 CONTRAINDICATIONS None. None (4)

Alcohol is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Alcohol drug label (National Library of Medicine)
• openFDA — Alcohol label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 2048982 (NLM Normalized Drug Names)
• NDC Directory — Alcohol (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS