SOTALOL HYDROCHLORIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Proficient Rx LP

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Us

제품 요약:

Sotalol hydrochloride tablets USP, 80 mg are available as light blue, oval-shaped tablets that are scored on one side and debossed with the numbers “93” and “61” on each side of the score, and plain on the other side. They are available in bottles of 30 (NDC 71205-046-30), 60 (NDC 71205-046-60) and 90 (NDC 71205-046-90). 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, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
PROFICIENT RX LP
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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._
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INDICATIONS AND USAGE
Sotalol hydrochloride tablets are an antiarrhythmic indicated for:
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LIMITATIONS OF USE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
80 mg, 120 mg, 160 mg, and 240 mg tablets (3)
CONTRAINDICATIONS
For the treatment of AFIB/AFL or ventricular arrhythmias
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For the treatment of AFIB/AFL also contraindicated for:
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WARNINGS AND PRECAUTIONS
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SOTALOL 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.
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)
Avoid use in patients with asymptomatic ventricular premature
contraction (1.1)
Avoid use in patients with minimally symptomatic or easily reversible
AFIB/AFL (1.2)
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)
Sinus bradycardia, 2
or 3 degree AV block, sick sinus syndrome (4)
nd
rd
Congenital or acquired long QT syndrome, (4)
Serum potassium <4 mEq/L (4)
Cardiogenic