Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
sotalol hydrochloride (UNII: HEC37C70XX) (sotalol - UNII:A6D97U294I)
MUTUAL PHARMACEUTICAL CO., INC.
sotalol hydrochloride
TABLET
80 mg
ORAL
PRESCRIPTION DRUG
Sotalol is 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 (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, its 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 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 determine the response to antiarrhythmic therapy, including sotalol. In the
SOTALOL HYDROCHLORIDE TABLETS are available as follows: Sotalol hydrochloride tablets, 80 mg, light blue, capsule shaped, scored, debossed MP 514 Bottles of 50 NDC 53489-288-02 Bottles of 100 NDC 53489-288-01 Bottles of 250 NDC 53489-288-03 Bottles of 500 NDC 53489-288-05 Bottles of 1000 NDC 53489-288-10 Sotalol hydrochloride tablets, 120 mg, light blue, capsule shaped, scored, debossed MP 515 Bottles of 50 NDC 53489-289-02 Bottles of 100 NDC 53489-289-01 Bottles of 250 NDC 53489-289-03 Bottles of 500 NDC 53489-289-05 Bottles of 1000 NDC 53489-289-10 Sotalol hydrochloride tablets, 160 mg, light blue, capsule shaped, scored, debossed MP 516 Bottles of 50 NDC 53489-290-02 Bottles of 100 NDC 53489-290-01 Bottles of 250 NDC 53489-290-03 Bottles of 500 NDC 53489-290-05 Bottles of 1000 NDC 53489-290-10 Sotalol hydrochloride tablets, 240 mg, light blue, capsule shaped, scored, debossed MP 517 Bottles of 50 NDC 53489-291-02 Bottles of 100 NDC 53489-291-01 Bottles of 250 NDC 53489-291-03 Bottles of 500 NDC 53489-291-05 Bottles of 1000 NDC 53489-291-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET MUTUAL PHARMACEUTICAL CO., INC. ---------- SOTALOL HYDROCHLORIDE TABLETS RX ONLY To minimize the risk of induced arrhythmia, patients initiated or re-initiated on sotalol should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation, 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 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 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 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 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-[l-hydroxy-2-[(l- methylethyl)amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C H N 0 S•HCl and is represented by the following structural formula: Each tablet for oral administration contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch gl Belgenin tamamını okuyun