SOTALOL HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Aurobindo Pharma Limited

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Sotalol hydrochloride tablets (AF) are indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use:   Sotalol hydrochloride tablets (AF) has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. Sotalol hydrochloride tablets (AF) 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 tablets (AF) 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 tablets AF. Sotalol hydrochloride tablets (AF) are contraindicated in patients with: - Sinus bradycardia, sick sinus syndrome, second and third degree AV block,

Ürün özeti:

Sotalol Hydrochloride Tablets, USP (AF) are available containing 80 mg, 120 mg or 160 mg of sotalol hydrochloride, USP. The 80 mg tablets are a light orange, approximately 7.938 mm round biconvex tablets debossed with S and 80 one side and score on other side of the tablet. They are available as follows: Bottles of 100 tablets                               NDC 59651-775-01 The 120 mg tablets are a light orange, approximately 8.731 mm round biconvex tablets debossed with S and 120 one side and score on other side of the tablet. They are available as follows: Bottles of 100 tablets                              NDC 59651-776-01 The 160 mg tablets are a light orange, approximately 9.525 mm round biconvex tablets debossed with S and 160 one side and score on other side of the tablet. They are available as follows: Bottles of 100 tablets                             NDC 59651-777-01 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE TABLET
AUROBINDO PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTALOL
HYDROCHLORIDE TABLETS (AF) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
SOTALOL HYDROCHLORIDE TABLETS (AF).
SOTALOL HYDROCHLORIDE TABLETS (AF), FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE-THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SOTALOL HYDROCHLORIDE TABLETS (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 tablets (AF) 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 tablets (AF) 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 tablets (AF): 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 AFIB/AFL or ventricular arrhythmias
Sinus bradycardia, 2
or 3
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 ast