SOTALOL- sotalol hydrochloride tablet

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Bryant Ranch Prepack

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Sotalol Hydrochloride Tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol Hydrochloride Tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of Sotalol Hydrochloride Tablets, including a 1.5 to 2% rate of Torsade de Pointes (TdP) or new ventricular tachycardia/fibrillation (VT/VF) in patients with either non-sustained ventricular tachycardia (NSVT) or supraventricular arrhythmias (SVT), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Avoid treatment of patients with asymptomatic ventricular premature contractions [ see Warnings and Precautions (5.2) .] Sotalol Hydrochloride Tablets are contraindicated in patients with: - Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker i

Povzetek izdelek:

NDC: 71335-1189-1: 60 Tablets in a BOTTLE NDC: 71335-1189-2: 30 Tablets in a BOTTLE NDC: 71335-1189-3: 100 Tablets in a BOTTLE

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SOTALOL- SOTALOL HYDROCHLORIDE TABLET
BRYANT RANCH PREPACK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTALOL
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
SOTALOL HYDROCHLORIDE TABLETS.SOTALOL HYDROCHLORIDE TABLETS, FOR ORAL
USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOTALOL HYDROCHLORIDE TABLETS 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 Tablets are an antiarrhythmic indicated for:
the treatment of life threatening ventricular arrhythmias (1.1)
LIMITATIONS OF USE
Avoid use in patients with asymptomatic ventricular premature
contraction (1.1)
DOSAGE AND ADMINISTRATION
Sotalol Hydrochloride 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 tablets (3)
CONTRAINDICATIONS
For the treatment of ventricular arrythmias
Sinus bradycardia, 2nd or 3rd degree AV block, sick sinus syndrome (4)
Congenital or acquired long QT syndrome, (4)
Serum potassium <4 mEq/L(4)
Cardiogenic shock, decompensated heart failure (4)
Bronchial asthma or related bronchospastic conditions (4)
Hypersensitivity to sotalol (4)
WARNINGS AND PRECAUTIONS
QT prolongation, bradycardia, AV block, hypotension, worsening heart
failure: Reduce dose or
discontinue (5.1)
Acute exacerbation of coronary artery disease upon cessation of
therapy: Do not abruptly discon