Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Par Pharmaceutical
SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE 80 mg
ORAL
PRESCRIPTION DRUG
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 for
Sotalol hydrochloride tablets, USP; capsule-shaped bisected light-blue scored tablets, are available as follows: 80 mg strength imprinted “58/75” on one side and “V” on the reverse side available in the following configurations: • Bottles of 100: NDC 0603-5769-21 • Bottles of 500: NDC 0603-5769-28 120 mg strength imprinted “58/76” on one side and “V” on the reverse side available in the following configurations: • Bottles of 100: NDC 0603-5770-21 • Bottles of 300: NDC 0603-5770-25 160 mg strength imprinted “58/77” on one side and “V” on the reverse side available in the following configurations: • Bottles of 100: NDC 0603-5771-21 240 mg strength imprinted “58/78” on one side and “V” on the reverse side available in the following configurations: • Bottles of 100: NDC 0603-5772-21 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET PAR PHARMACEUTICAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SOTALOL HYDROCHLORIDE 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 arrhythmias 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 treatment of AFIB/AFL also cont Đọc toàn bộ tài liệu