Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Sotalol Hydrochloride (UNII: HEC37C70XX) (Sotalol - UNII:A6D97U294I)
Major Pharmaceuticals
ORAL
PRESCRIPTION DRUG
Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the treatment of documented, life-threatening, ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol hydrochloride/Sotalol hydrochloride AF has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. Sotalol hydrochloride/Sotalol hydrochloride AF tablets are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of AFIB/AFL) in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm. Limitation of Use: Because sotalol hydrochloride/sotalol hydrochloride AF tablets can cause life-threatening ventricular arrhythmias, reserve its use for patients in whom AFIB/AFL is highly symptomatic. Patients with paroxysmal AFIB that is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol hydrochloride/sotalol hydrochloride AF tablets. Sotalol hydrochloride/Sotalol hydrochloride (AF) is cont
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. Cartons of 100 tablets (10 blister packs x 10), NDC 0904-7143-61 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]. Dispense in tight, light-resistant container [see USP].
Abbreviated New Drug Application
SOTALOL HYDROCHLORIDE- SOTALOL HYDROCHLORIDE TABLET MAJOR PHARMACEUTICALS ---------- 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._ 5. 6. 7. 8. INDICATIONS AND USAGE Sotalol hydrochloride/Sotalol hydrochloride AF tablets are an antiarrhythmic indicated for: 3. 4. Limitations of Use 3. 4. DOSAGE AND ADMINISTRATION 3. 4. 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 7. 8. 9. 10. 11. 12. For the treatment of AFIB/AFL also contraindicated for: 2. WARNINGS AND PRECAUTIONS 5. 6. 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) Sotalol hydrochloride has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (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 Přečtěte si celý dokument