SOTALOL HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sotalol is indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol may not enhance survival in patients with ventricular arrhythmias. Because of the proarrhythmic effects of sotalol, 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 is 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 Use: Because sotalol can cause life-threatening ventricular arrhythmias, reserve its use fo

Product summary:

Sotalol hydrochloride tablets, USP; capsule-shaped bisected light-blue scored tablets, are available as follows: 80 mg strength debossed “841” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-841-10           Bottles of 500: NDC 69584-841-50 120 mg strength debossed “842” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-842-10           Bottles of 300: NDC 69584-842-30 160 mg strength debossed “843” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-843-10 240 mg strength debossed “844” on left side of score on one side and debossed “O” on the reverse side available in the following configurations:           Bottles of 100: NDC 69584-844-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SOTALOL HYDROCHLORE 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._
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.
INDICATIONS AND USAGE
SOTALOL HYDROCHLORIDE is 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 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,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 failure ( 4)
Bronchial asthma or related bronchospastic conditions ( 4)
Hypersensitivity to sotalol ( 4)
For the tre