DEHYDRATED ALCOHOL- alcohol injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Verfügbar ab:

Belcher Pharmaceuticals, LLC

Verabreichungsweg:

PERCUTANEOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

ABLYSINOL ® 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. None. Risk Summary The concentrations of alcohol in blood after PTSMA were not measured, but ABLYSINOL 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 ABLYSINOL 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 ex

Produktbesonderheiten:

 ABLYSINOL (dehydrated alcohol) injection is a clear, colorless liquid supplied in clear, glass, single-dose ampules. Each mL contains ≥ 99% by volume ethyl alcohol. 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.

Berechtigungsstatus:

New Drug Application

Fachinformation

DEHYDRATED ALCOHOL- ALCOHOL INJECTION, SOLUTION
BELCHER PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ABLYSINOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ABLYSINOL.
ABLYSINOL (DEHYDRATED ALCOHOL) INJECTION, FOR CARDIAC SEPTAL BRANCH
INTRA-ARTERIAL USE
INITIAL U.S. APPROVAL: 1946
INDICATIONS AND USAGE
ABLYSINOL 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 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)
DOSAGE FORMS AND STRENGTHS
Injection: 1 mL or 5 mL of ethyl alcohol ≥ 99% by volume as a clear,
colorless liquid in a single-dose
glass ampule. ( 3)
CONTRAINDICATIONS
None ( 4)
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)
ADVERSE REACTIONS
Adverse reactions include arrhythmias, including ventricular
tachycardia and/or ventricular fibrillation. ( 6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BELCHER PHARMACEUTICALS
AT (727) 471-
0850 OR FDA AT 1-800-FDA-1088 OR _www.fda.gov/medwatch_.
USE IN SPECIFIC