国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Marlex Pharmaceuticals Inc
ORAL
PRESCRIPTION DRUG
Sotalol AF are indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Sotalol AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB whose AFIB/AFL that is easily reversed (by Valsalva maneuver, for example) should usually not be given Sotalol AF (see WARNINGS ). In general, antiarrhythmic therapy for AFIB/AFL aims to prolong the time in normal sinus rhythm. Recurrence is expected in some patients (see Clinical Studies ). Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name Betapace® (sotalol hydrochloride) . Sotalol hydrochloride tablets, however, must not be substituted for sotalol hydrochloride tablets (AF) because of significan
Sotalol Hydrochloride Tablets, USP (AF) are presented as follows: For 80 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B107' on one side and scored on the other side. For 120 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B108' on one side and scored on the other side. For 160 mg strength: White to off-white colored, capsule shaped, scored tablets debossed 'B109' on one side and scored on the other side. Sotalol Hydrochloride Tablets, USP (AF) are available as follows: 80 mg strength, NDC 10135-0715-01 in bottle of 100 120 mg strength, NDC 10135-0716-01 in bottle of 100 160 mg strength, NDC 10135-0717-01 in bottle of 100 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 10/20 BS
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE AF- SOTALOL HYDROCHLORIDE TABLET MARLEX PHARMACEUTICALS INC ---------- SOTALOL HYDROCHLORIDE TABLETS - AF SOTALOL HYDROCHLORIDE AF- SOTALOL HYDROCHLORIDE TABLES AF TABLET MARLEX PHARMACEUTICALS, INC. ---------- SOTALOL HYDROCHLORIDE TABLETS, USP (AF) 80 MG, 120 MG, AND 160 MG TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR RE-INITIATED ON SOTALOL HYDROCHLORIDE TABLETS (AF) SHOULD BE PLACED FOR A MINIMUM OF THREE DAYS (ON THEIR MAINTENANCE DOSE) IN A FACILITY THAT CAN PROVIDE CARDIAC RESUSCITATION, CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING AND CALCULATIONS OF CREATININE CLEARANCE. FOR DETAILED INSTRUCTIONS REGARDING DOSE SELECTION, AND SPECIAL CAUTIONS FOR PEOPLE WITH RENAL IMPAIRMENT, SEE DOSAGE AND ADMINISTRATION. Sotalol is also indicated for the treatment of documented life threatening ventricular arrhythmias and is marketed under the brand name Betapace (sotalol hydrochloride tablets). Sotalol hydrochloride tablets, however, should not be substituted for sotalol hydrochloride tablets (AF) because of significant differences in labeling (i.e., patient package insert, dosing administration and safety information). Rx only DESCRIPTION Sotalol Hydrochloride Tablets, USP (AF) is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l- _N_-[4-[1-hydroxy-2-[(1- methylethyl)amino]ethyl]phenyl]methanesulfonamide monohydrochloride. The molecular formula is C H N O S•HCl and is represented by the following structural formula: Sotalol Hydrochloride Tablets, USP (AF) contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, stearic 完全なドキュメントを読む