Dehydrated Alcohol
Generic: ALCOHOL
Basic Information
Manufacturer
Solupharm Pharmazeutische Erzeugnisse GmbH
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
PERCUTANEOUS
FDA Set ID
372d3eb5-78ee-414c-a146-4a19e2266184
Indications & Usage
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 )
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 )
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 Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse reactions include arrhythmias, including ventricular tachycardia and/or ventricular fibrillation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Avenacy at 1-855-283-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.