Dehydrated Alcohol 1 mL/mL
alcohol · INJECTION, SOLUTION · Avenacy, LLC
Dehydrated Alcohol is a injection, solution containing alcohol at 1 mL/mL, taken percutaneous. Manufactured by Avenacy, LLC.
Key Facts
- Brand Name
- Dehydrated Alcohol
- Generic Name
- alcohol
- NDC Code (Product)
83634-306- Manufacturer
- Avenacy, LLC
- Strength
- 1 mL/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- PERCUTANEOUS
- Marketing Status
- Application #
- ANDA219569
- Marketing Start
- 07/17/2025
Recall History
Walgreens Infusion Services
Lack of sterility assurance.
Ranier's Compounding Laboratory
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Full Prescribing Information
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)
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 u…
Contraindications
4 CONTRAINDICATIONS None. None (4)
Adverse Reactions
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.
Frequently Asked Questions
What is Dehydrated Alcohol used for?
Dehydrated Alcohol contains alcohol. It is a injection, solution taken percutaneous. Consult your doctor for specific uses.
Is Dehydrated Alcohol a controlled substance?
Dehydrated Alcohol is not classified as a controlled substance by the DEA.
What is the generic name for Dehydrated Alcohol?
The generic name for Dehydrated Alcohol is alcohol. There are 12 other brand versions of alcohol.
What is the NDC code for Dehydrated Alcohol 1 mL/mL?
The NDC (National Drug Code) for Dehydrated Alcohol 1 mL/mL is 83634-306, listed by Avenacy, LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)