Mediclarum
Medicine guide

Dehydrated Alcohol

5 mL/5mL · Injection, Solution

  • Prescription only
Active substance
Dehydrated Alcohol
Made by
Ingenus Pharmaceuticals, LLC

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-07-11

Used for
  • Dehydrated alcohol injection is indicated to induce controlled cardiac septal infarction to improve exercise capacity in
The label’s usual adult dose

( 2.1 ) In most situations, a dose of 1 mL to 2 mL is sufficient.

Full directions ↓
Do not take it if

None. None ( 4 )

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • 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 )

From the official label · 2025-07-11 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-07-11

Do not take it if

None. None ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 liquid.
  • Discard unused portion.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • 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 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, 3 rd 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but dehydrated alcohol injection, is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation.
  • Maternal use is not expected to result in fetal exposure to the drug.
  • Clinical Considerations Dehydrated alcohol injection for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy.
  • When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period.
  • Data Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in human.
  • The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women.
  • IN SPECIFIC POPULATIONS Dehydrated alcohol injection is not recommended during pregnancy.
  • Maternal use is not expected to result in fetal exposure to the drug.
  • ( 8.1 ) The rate of heart blocks and dysrhythmia increased with age.
  • ( 8.5 ) See 17 for PATIENT COUNSELING INFORMATION
  • 8.1 Pregnancy Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but dehydrated alcohol injection, is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation.
  • Maternal use is not expected to result in fetal exposure to the drug.
  • Clinical Considerations Dehydrated alcohol injection for percutaneous transluminal septal myocardial ablation has not been evaluated in pregnant women and is not recommended during pregnancy.
  • When possible, the percutaneous transluminal septal myocardial ablation procedure should be postponed in women until the postpartum period.
  • Data Animal reproduction studies have shown an adverse effect on the fetus and chronic fetal alcohol exposure is known to cause developmental defects in human.
  • The developmental effects of acute ethanol exposure, such as from percutaneous transluminal septal myocardial ablation, have not been studied in pregnant or lactating women.
  • 8.2 Lactation Dehydrated alcohol injection is not expected to increase significantly the systemic concentrations of endogenous alcohol following administration into a septal artery during percutaneous transluminal septal myocardial ablation and breastfeeding is not expected to result in exposure of the child to the drug.
  • 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
  • 8.5 Geriatric Use A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients < 60 years old and in patients ≥60 years old showed similar improvement in exercise capacity after ablation.
  • The rate of heart blocks and dysrhythmia increased with age.
  • Permanent pacemaker dependency increased to 34% in patients > 60 years old.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • There is a direct correlation between the volume of alcohol and size of iatrogenic myocardial infarction.
  • Stop the procedure if there is failure to reduce the left ventricular outflow tract pressure gradient to less than 10 mmHg when reaching a total dose of 5 mL.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • A comparison of the outcomes in patients with hypertrophic obstructive cardiomyopathy in patients < 60 years old and in patients ≥60 years old showed similar improvement in exercise capacity after ablation.
  • The rate of heart blocks and dysrhythmia increased with age.
  • Permanent pacemaker dependency increased to 34% in patients > 60 years old.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • 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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

  • FORMS AND STRENGTHS Injection:
  • 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass vial. Injection:
  • 5 mL of ethyl alcohol ≥ 99% by volume as a clear, colorless liquid in a single-dose glass vial. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Dehydrated alcohol injection, USP is a clear, colorless liquid supplied in clear, glass, single-dose vials.
  • Each mL contains ≥ 99% by volume ethyl alcohol.
  • Volume NDC Single vial Carton of 10 vial 5 mL 50742-539-01 50742-539-10
  • Store at room temperature, between 20°C and 25°C (68°F and 77°F).
  • Do not refrigerate or freeze.
  • Highly flammable, store away from any heat source.
  • Manufactured for:
  • Ingenus Pharmaceuticals, LLC Orlando, FL 32811-7193 Made in Germany Rx Only Image

Quoted from the official label, section “How Supplied”.

What is in it

  • 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 and with practically all organic solvents.
  • It has the following structural formula: Image

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Details

Made byIngenus Pharmaceuticals, LLC
Active substanceDehydrated Alcohol
Strength5 mL/5mL
FormInjection, Solution
RoutePercutaneous
Packs10 VIAL, GLASS in 1 CARTON / 5 mL in 1 VIAL, GLASS
NDC50742-539

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

9 products are sold under this name. Grouped by form; a number on a strength means several companies make it.