Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
SOTALOL HYDROCHLORIDE (UNII: HEC37C70XX) (SOTALOL - UNII:A6D97U294I)
Eon Labs, Inc.
SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE 80 mg
ORAL
PRESCRIPTION DRUG
Sotalol hydrochloride tablets USP are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that in the judgment of the physician are life-threatening. Because of the proarrhythmic effects of sotalol hydrochloride tablets (see WARNINGS ), including a 1.5% to 2% rate of Torsade de Pointes or new VT/VF in patients with either NSVT or supraventricular arrhythmias, their use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided. Initiation of sotalol hydrochloride tablet USP treatment or increasing doses, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. The response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) prior to continuing the patient on chronic therapy. Various approaches have been used to
Sotalol Hydrochloride Tablets USP, for oral administration, are available as follows: 80 mg: Blue, capsule shaped tablets, debossed “E 171” on one side and bisected on the reverse side and supplied as: NDC 0185-0171-09 bottles of 90 NDC 0185-0171-01 bottles of 100 NDC 0185-0171-05 bottles of 500 120 mg: Blue, capsule shaped tablets, debossed “E 170” on one side and bisected on the reverse side and supplied as: NDC 0185-0170-09 bottles of 90 NDC 0185-0170-01 bottles of 100 NDC 0185-0170-05 bottles of 500 160 mg: Blue, capsule shaped tablets, debossed “E 177” on one side and bisected on the reverse side and supplied as: NDC 0185-0177-09 bottles of 90 NDC 0185-0177-01 bottles of 100 NDC 0185-0177-05 bottles of 500 240 mg: Blue, capsule shaped tablets, debossed “E 174” on one side and bisected on the reverse side and supplied as: NDC 0185-0174-09 bottles of 90 NDC 0185-0174-01 bottles of 100 NDC 0185-0174-05 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store in a dry place. Keep tightly closed. Avoid excessive heat. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. BETAPACE AFTM is a trademark of Bayer Healthcare. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Sandoz Inc. Princeton, NJ 08540 OS7554 REV. 05/12 MF0171REV05/12 MG #18481
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET EON LABS, INC. ---------- SOTALOL HYDROCHLORIDE TABLETS USP TO MINIMIZE THE RISK OF INDUCED ARRHYTHMIA, PATIENTS INITIATED OR REINITIATED ON SOTALOL HYDROCHLORIDE SHOULD BE PLACED FOR A MINIMUM OF THREE DAYS (ON THEIR MAINTENANCE DOSE) IN A FACILITY THAT CAN PROVIDE CARDIAC RESUSCITATION AND CONTINUOUS ELECTROCARDIOGRAPHIC MONITORING. CREATININE CLEARANCE SHOULD BE CALCULATED PRIOR TO DOSING. FOR DETAILED INSTRUCTIONS REGARDING DOSE SELECTION AND SPECIAL CAUTIONS FOR PEOPLE WITH RENAL IMPAIRMENT, SEE DOSAGE AND ADMINISTRATION. SOTALOL IS ALSO 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 AND IS MARKETED UNDER THE BRAND NAME BETAPACE AF . SOTALOL HYDROCHLORIDE IS NOT APPROVED FOR THE AFIB/AFL INDICATION AND SHOULD NOT BE SUBSTITUTED FOR BETAPACE AF BECAUSE ONLY BETAPACE AF IS DISTRIBUTED WITH A PATIENT PACKAGE INSERT THAT IS APPROPRIATE FOR PATIENTS WITH AFIB/AFL. DESCRIPTION Sotalol hydrochloride USP is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a light-blue, capsule-shaped tablet for oral administration. Sotalol hydrochloride USP 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 USP is d,l-_N_-[4-[1-hydroxy- 2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C H N O S•HCl and is represented by the following structural formula: Each sotalol hydrochloride tablet USP, for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, FD&C blue No. 1 aluminum lake, hydroxypr Lue koko asiakirja