SOTALOL HYDROCHLORIDE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

AvPAK

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride/Sotalol hydrochloride AF tablets may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of sotalol hydrochloride/ sotalol hydrochloride AF 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/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhyt

Ringkasan produk:

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. NDC 50268-724-15 (10 tablets per card, 5 cards per carton). 120 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “120” on the other side. NDC 50268-725-15 (10 tablets per card, 5 cards per carton). 160 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “160” on the other side. 240 mg tablets: White to off-white capsule shaped, scored tablets, imprinted “APO” on one side and “SOT” bisect “240” on the other side. Sotalol hydrochloride AF tablets, USP are available as follows: 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].

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
AVPAK
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
SOTALOL HYDROCHLORIDE TABLETS, USP
RX ONLY
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
INITIAL U.S. APPROVAL: 1992
WARNING: LIFE THREATENING PROARRHYTHMIA
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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.
INDICATIONS AND USAGE
Sotalol hydrochloride/Sotalol hydrochloride AF tablets 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
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)
DOSAGE AND ADMINISTRATION
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 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 and 240 mg tablets ( 3)
CONTRAINDICATIONS
For the treatment of AFIB/AFL or ventricular arrythmias
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