Medication reference
Ethanol
PERCUTANEOUS
Ethanol. INDICATIONS AND USAGE Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in adults
Brand names
DEHYDRATED ALCOHOLDehydrated Alcohol
Active ingredients
ALCOHOLDEHYDRATED ALCOHOL
Indications
INDICATIONS AND 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 )
Dosage
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.
Warnings
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 12-48 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
CONTRAINDICATIONS None. None. ( 4 )
Adverse reactions
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 dehyrated 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 XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Mechanism of action
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.
Available forms (80)
1 ML ethanol 0.98 ML/ML Injection1 ML ethanol 0.99 ML/ML Injection5 ML ethanol 0.98 ML/ML Injection5 ML ethanol 0.99 ML/ML Injectionethanol 0.31 ML/ML Medicated Padethanol 0.3 ML/ML Medicated Liquid Soapethanol 0.48 ML/ML Topical Solutionethanol 0.5 ML/ML Topical Solutionethanol 0.61 ML/ML Topical Gelethanol 0.61 ML/ML Topical Lotionethanol 0.625 ML/ML Topical Foamethanol 0.625 ML/ML Topical Gelethanol 0.625 ML/ML Topical Solutionethanol 0.62 ML/ML Medicated Padethanol 0.62 ML/ML Topical Foamethanol 0.62 ML/ML Topical Gelethanol 0.62 ML/ML Topical Lotionethanol 0.62 ML/ML Topical Solutionethanol 0.62 ML/ML Topical Sprayethanol 0.635 ML/ML Topical Gelethanol 0.63 ML/ML Topical Foamethanol 0.63 ML/ML Topical Gelethanol 0.63 ML/ML Topical Solutionethanol 0.63 ML/ML Topical Sprayethanol 0.643 ML/ML Topical Solutionethanol 0.645 ML/ML Topical Gelethanol 0.645 ML/ML Topical Solutionethanol 0.648 ML/ML Topical Gelethanol 0.64 ML/ML Medicated Padethanol 0.64 ML/ML Topical Gelethanol 0.656 ML/ML Topical Gelethanol 0.659 ML/ML Medicated Padethanol 0.65 ML/ML Medicated Padethanol 0.65 ML/ML Topical Foamethanol 0.65 ML/ML Topical Gelethanol 0.65 ML/ML Topical Solutionethanol 0.65 ML/ML Topical Sprayethanol 0.665 ML/ML Medicated Padethanol 0.665 ML/ML Topical Gelethanol 0.665 ML/ML Topical Solutionethanol 0.66 ML/ML Topical Gelethanol 0.67 ML/ML Medicated Padethanol 0.67 ML/ML Topical Gelethanol 0.68 ML/ML Topical Gelethanol 0.68 ML/ML Topical Sprayethanol 0.695 ML/ML Medicated Padethanol 0.69 ML/ML Topical Gelethanol 0.6 ML/ML Topical Gelethanol 0.6 ML/ML Topical Solutionethanol 0.6 ML/ML Topical Sprayethanol 0.71 ML/ML Medicated Padethanol 0.71 ML/ML Topical Gelethanol 0.71 ML/ML Topical Solutionethanol 0.71 ML/ML Topical Sprayethanol 0.72 ML/ML Topical Gelethanol 0.72 ML/ML Topical Sprayethanol 0.738 ML/ML Topical Foamethanol 0.743 ML/ML Topical Foamethanol 0.74 ML/ML Topical Foamethanol 0.74 ML/ML Topical Sprayethanol 0.75 ML/ML Medicated Padethanol 0.75 ML/ML Topical Foamethanol 0.75 ML/ML Topical Gelethanol 0.75 ML/ML Topical Solutionethanol 0.75 ML/ML Topical Sprayethanol 0.76 ML/ML Medicated Padethanol 0.76 ML/ML Topical Foamethanol 0.76 ML/ML Topical Gelethanol 0.76 ML/ML Topical Solutionethanol 0.77 ML/ML Topical Gelethanol 0.77 ML/ML Topical Solutionethanol 0.7 ML/ML Medicated Padethanol 0.7 ML/ML Topical Foamethanol 0.7 ML/ML Topical Gelethanol 0.7 ML/ML Topical Lotionethanol 0.7 ML/ML Topical Solutionethanol 0.7 ML/ML Topical Sprayethanol 0.83 ML/ML Topical Sprayethanol 0.85 ML/ML Topical Foamethanol 0.85 ML/ML Topical Gel
NDC examples
16729-71054288-10554288-14439822-930055579-30682983-42683634-30650090-764350742-539
Indicated ICD-10 codes
Treats these conditions
Source: openFDA + RxNorm · 2026
Look up another medication