SOTALOL- sotalol hydrochloride tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Aphena Pharma Solutions - Tennessee, LLC

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 is present - Congenital or acquired

Ürün özeti:

Sotalol Hydrochloride Tablets, USP; capsule-shaped light-blue scored tablets, imprinted with the strength and “B104”, “B105”, and “B106” are available as follows: 80 mg strength, bottles of 100 (NDC 10135-0661-01) 120 mg strength, bottles of 100 (NDC 10135-0662-01) 160 mg strength, bottles of 100 (NDC 10135-0663-01) Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SOTALOL- SOTALOL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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) Hype
rsensitivity 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: