Dehydrated Alcohol

Dehydrated Alcohol is an FDA-registered drug product whose active ingredient is ALCOHOL. It is labelled by Breckenridge Pharmaceutical Inc taken by intra-arterial and marketed as a human prescription drug product. Identifiers on file: NDC 51991-999, application ANDA219444, label effective 20260827. It is one of 582 FDA drug label records sharing the active ingredient ALCOHOL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ALCOHOL are most often described in connection with: dehydrated alcohol, indicated induce, controlled cardiac, septal infarction, improve exercise, capacity adults, symptomatic hypertrophic, obstructive cardiomyopathy. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 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 )

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.

4 CONTRAINDICATIONS None. None ( 4 )

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 Breckenridge Pharmaceutical, Inc at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 582 drug label records with ALCOHOL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

2 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Dehydrated Alcohol used for?
1 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 …

Who makes Dehydrated Alcohol?
Breckenridge Pharmaceutical Inc is the labeler of record for Dehydrated Alcohol. 582 FDA label records share the active ingredient ALCOHOL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Dehydrated Alcohol come in?
administered by intra-arterial. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Dehydrated Alcohol prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ALCOHOL?
Yes. 582 FDA drug label records list ALCOHOL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Dehydrated Alcohol been recalled?
2 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.