SOTALOL HYDROCHLORIDE tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Cardinal Health 107, LLC

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 rhythm (delay in time to r

Produktu pārskats:

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. Overbagged with 10 tablets per bag, NDC 55154-8179-0 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
CARDINAL HEALTH 107, LLC
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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
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DOSAGE AND ADMINISTRATION
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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:
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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)
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/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