SOTALOL HYDROCHLORIDE tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Aphena Pharma Solutions - Tennessee, LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use: Because sotalol hydrochloride/sotalol hydrochloride AF tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride AF tablets. Sotalol hydrochloride/Sotalol hydrochloride (AF) is cont

Product samenvatting:

Sotalol hydrochloride tablets, USP are available as follows: 80 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SO” bisect “80” on the other side. Bottles of 100 NDC 60429-748-01 Bottles of 500 NDC 60429-748-05 120 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “120” on the other side. Bottles of 100 NDC 60429-749-01 160 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “160” on the other side. Bottles of 100 NDC 60429-750-01 240 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “240” on the other side. Bottles of 100 NDC 60429-751-01 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS. THESE
HIGHLIGHTS DO NOT
INCLUDE ALL THE INFORMATION NEEDED TO USE SOTALOL
HYDROCHLORIDE/SOTALOL
HYDROCHLORIDE AF TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SOTALOL HYDROCHLORIDE/SOTALOL HYDROCHLORIDE AF TABLETS
SOTALOL HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
SOTALOL HYDROCHLORIDE AF TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOTALOL HYDROCHLORIDE/ SOTALOL HYDROCHLORIDE AF CAN CAUSE
LIFE-THREATENING VENTRICULAR
TACHYCARDIA ASSOCIATED WITH QT INTERVAL PROLONGATION.
IF THE QT INTERVAL PROLONGS TO 500 MSEC OR GREATER, REDUCE THE DOSE,
LENGTHEN THE
DOSING INTERVAL, OR DISCONTINUE THE DRUG.
INITIATE OR REINITIATE IN A FACILITY THAT CAN PROVIDE CARDIAC
RESUSCITATION AND
CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING.
ADJUST THE DOSING INTERVAL BASED ON CREATININE CLEARANCE.
INDICATIONS AND USAGE
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an
antiarrhythmic indicated for:
the treatment of life-threatening ventricular arrhythmias ( 1.1)
the maintenance of normal sinus rhythm in patients with atrial
fibrillation or flutter (AFIB/AFL) ( 1.2)
Limitations of Use
Sotalol
hydrochloride has not been shown to enhance survival in patients with
life threatening ventricular arrhythmias
(1.1)
Avoid use in patients with minimally symptomatic or easily reversible
AFIB/AFL ( 1.2)
DOSAGE AND ADMINISTRATION
Sotalol hydrochloride/Sotalol hydrochloride AF tablets: Initial dosage
in adults is 80 mg twice daily.
Increase the dose as needed in increments of 80 mg/day, every 3 days
to a maximum 320 mg total
daily dose ( 2.2)
Pediatrics: Dosage depends on age ( 2.4)
DOSAGE FORMS AND STRENGTHS
80 mg, 120 mg and 160 mg and 240 mg tablets ( 3)
CONTRAINDICATIONS
For the treatment of AFIB