Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Cardinal Health 107, LLC
ORAL
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET CARDINAL HEALTH 107, LLC ---------- 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._ • • • • INDICATIONS AND USAGE Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for: • • LIMITATIONS OF USE • • DOSAGE AND ADMINISTRATION • • 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 • • • • • • For the treatment of AFIB/AFL also contraindicated for: • • 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 Přečtěte si celý dokument