SOTALOL HYDROCHLORIDE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

Sotalol Hydrochloride (UNII: HEC37C70XX) (Sotalol - UNII:A6D97U294I)

Mevcut itibaren:

Major Pharmaceuticals

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

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. Cartons of 100 tablets (10 blister packs x 10), NDC 0904-7143-61 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].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
MAJOR PHARMACEUTICALS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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._
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INDICATIONS AND USAGE
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an
antiarrhythmic indicated for:
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Limitations of Use
3.
4.
DOSAGE AND ADMINISTRATION
3.
4.
DOSAGE FORMS AND STRENGTHS
80 mg, 120 mg and 160 mg and 240 mg tablets (3)
CONTRAINDICATIONS
For the treatment of AFIB/AFL or ventricular arrythmias
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For the treatment of AFIB/AFL also contraindicated for:
2.
WARNINGS AND PRECAUTIONS
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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.
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)
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)
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