SOTALOL HYDROCHLORIDE injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)

זמין מ:

ALTATHERA Pharmaceuticals, LLC

INN (שם בינלאומי):

SOTALOL HYDROCHLORIDE

הרכב:

SOTALOL HYDROCHLORIDE 15 mg in 1 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Sotalol is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Sotalol is indicated for the treatment of life-threatening ventricular tachycardia. Antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias. Sotalol hydrochloride is contraindicated in patients with: - Sinus bradycardia (<50 bpm), sick sinus syndrome or second or third degree AV block without a pacemaker - Congenital or acquired long QT syndromes, QT interval >450 ms - Cardiogenic shock, decompensated heart failure - Serum potassium <4 mEq/L - Bronchial asthma or related bronchospastic conditions - Known hypersensitivity to sotalol Risk Summary Both the untreated underlying condition in pregnancy and the use of sotalol in pregnancy cause adverse outcomes to the mother and fetus/neonate (see Clinical Considerations). In animal reproduction studies in r

leaflet_short:

Sotalol injection is supplied in 10 mL single-dose vials, each containing 150 mg of sotalol hydrochloride as a clear solution (15 mg/mL). NDC 69724-112-10 carton containing one 10 mL vial Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from freezing and light.

מצב אישור:

New Drug Application

מאפייני מוצר

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE INJECTION
ALTATHERA PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTALOL
HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SOTALOL HYDROCHLORIDE.
SOTALOL HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOTALOL CAN CAUSE LIFE THREATENING VENTRICULAR TACHYCARDIA ASSOCIATED
WITH QT INTERVAL
PROLONGATION. ( 5.1)
INITIATE OR REINITIATE IN A FACILITY THAT CAN PROVIDE CARDIAC
RESUSCITATION AND
CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING. ( 2.3)
DO NOT INITIATE INTRAVENOUS SOTALOL THERAPY IF THE BASELINE QTC IS
LONGER THAN 450 MS.
IF THE QTC PROLONGS TO 500 MS OR GREATER, REDUCE THE DOSE OR
DISCONTINUE. ( 2.3)
RECENT MAJOR CHANGES
Warnings and Precautions, Hypoglycemia ( 5.7) 05/2023
INDICATIONS AND USAGE
Sotalol is an antiarrhythmic indicated for:
the maintenance of normal sinus rhythm [delay in time to recurrence of
atrial fibrillation/atrial flutter in
patients with symptomatic AFIB/AFL] who are currently in sinus rhythm.
( 1.1)
the treatment of life-threatening ventricular tachycardia. ( 1.2)
DOSAGE AND ADMINISTRATION
(2)
Intravenous sotalol can substitute for oral sotalol using a regimen
that mimics oral exposure ( 2.2)
Under close medical monitoring, intravenous sotalol can be used to
achieve near steady-state
exposure to sotalol prior to initiating or increasing oral dosing. (
2.3)
Recommended dosage depends on target oral dose and creatinine
clearance. Refer to full prescribing
information. ( 2.2, 2.3, 2.4)
(2)
DOSAGE FORMS AND STRENGTHS
Injection: 10-mL vial containing sotalol hydrochloride 150 mg ( 3)
CONTRAINDICATIONS
Bradyarrhythmia, sick sinus syndrome or 2
or 3
degree AV block without a pacemaker ( 4)
Congenital or acquired long QT syndrome ( 4)
Cardiogenic shock or decompensated heart failure ( 4)
Serum potassium