Sotalol Hydrochloride AF 160 mg/1
Sotalol Hydrochloride Tablets AF · TABLET · UNICHEM PHARMACEUTICALS (USA), INC.
Sotalol Hydrochloride AF is a tablet containing sotalol hydrochloride tablets af at 160 mg/1, taken oral. Manufactured by UNICHEM PHARMACEUTICALS (USA), INC..
Key Facts
- Brand Name
- Sotalol Hydrochloride AF
- Generic Name
- Sotalol Hydrochloride Tablets AF
- NDC Code (Product)
76385-127- Manufacturer
- UNICHEM PHARMACEUTICALS (USA), INC.
- Strength
- 160 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA207429
- Marketing Start
- 02/21/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE Sotalol/Sotalol AF 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 • Sotalol 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) 1.1 Life-Threatening Ventricular Arrhythmias Sotalol/Sotalol AF is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia (VT). Limitation of Use: Sotalol/Sotalol AF has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias. 1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL) Sotalol/Sotalol AF is 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/Sotalol AF can cause life-threatening ventricular arrhythmias, reserve its use for patie…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Sotalol/Sotalol AF: 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) 2.1 General Safety Measures for Initiation of Oral Sotalol Therapy Withdraw other antiarrhythmic therapy before starting Sotalol/Sotalol AF and monitor for a minimum of 2 to 3 plasma half-lives prior to initiating Sotalol/Sotalol AF therapy if the patient's clinical condition permits [see Drug Interactions (7) ]. Hospitalize patients being initiated or re-initiated on sotalol for at least 3 days or until steady-state drug levels are achieved, in a facility that can provide cardiac resuscitation and continuous electrocardiographic monitoring. Initiate oral sotalol therapy in the presence of personnel trained in the management of serious arrhythmias. Perform a baseline ECG to determine the QT interval and measure and normalize serum potassium and magnesium levels before initiating therapy. Measure serum creatinine and calculate an estimated creatinine clearance in order to establish the appropriate dosing interval. Monitor QTc 2 to 4 hours a…
Contraindications
4 CONTRAINDICATIONS Sotalol/Sotalol AF is contraindicated in patients with: Sinus bradycardia, sick sinus syndrome, second and third degree AV block, unless a functioning pacemaker is present Congenital or acquired long QT syndromes Cardiogenic shock or decompensated heart failure Serum potassium <4 mEq/L Bronchial asthma or related bronchospastic conditions Hypersensitivity to sotalol For the treatment of AFIB/AFL, Sotalol/Sotalol AF is also contraindicated in patients with: Baseline QT interval >450 msec For the treatment of AFIB/AFL or ventricular arrhythmias Sinus bradycardia, 2nd or 3rd 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 contraindicated for: QT interval >450 msec (4)
Drug Interactions
7 DRUG INTERACTIONS Class I or III Antiarrhythmics or other drugs that prolong the QT interval: Avoid concomitant use ( 7.1 ) Digoxin, calcium channel blocker: increased risk of bradycardia, hypotension, heart failure ( 7.2 ) Dosage of insulin or antidiabetic drugs may need adjustment ( 7.5 ) Aluminum or magnesium-based antacids reduce sotalol exposure ( 7.7 ) 7.1 Antiarrhythmics and other QT Prolonging Drugs Discontinue Class I or Class III antiarrhythmic agents for at least three half-lives prior to dosing with sotalol. Class Ia antiarrhythmic drugs, such as disopyramide, quinidine, and procainamide, and other Class III drugs (for example, amiodarone) are not recommended as concomitant therapy with Sotalol/Sotalol AF, because of their potential to prolong refractoriness [ see Warnings and Precautions (5.2 )]. 7.2 Negative Chronotropes Digitalis glycosides, diltiazem, verapamil, and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use with negative chronotropes can increase the risk of bradycardia or hypotension. 7.3 Catecholamine-Depleting Agents Concomitant use of catecholamine-depleting drugs, such as reserpine and guanethidine, with a beta-bl…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (≥2%) for Sotalol Hydrochloride Tablets are: fatigue 4%, bradycardia (less than 50 bpm) 3%, dyspnea 3%, proarrhythmia 3%, asthenia 2%, and dizziness 2%. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Beximco Pharmaceuticals USA Inc. at 877-372-6093 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions that are clearly related to sotalol are those which are typical of its Class II (beta-blocking) and Class III (cardiac action potential duration prolongation) effects and are dose related. Ventricular Arrhythmias Serious Adverse Reactions Sotalol/Sotalol AF can cause serious and potentially fatal ventricular arrhythmias such as sustained VT/VF, primarily Torsade de Pointes (TdP) [see Warnings and Precautions (5.1)]. The effect on QT and the risk of Torsade de Pointes are both dose related. Pediatric Patients In an unblinde…
Frequently Asked Questions
What is Sotalol Hydrochloride AF used for?
Sotalol Hydrochloride AF contains Sotalol Hydrochloride Tablets AF. It is a tablet taken oral. Consult your doctor for specific uses.
Is Sotalol Hydrochloride AF a controlled substance?
Sotalol Hydrochloride AF is not classified as a controlled substance by the DEA.
What is the generic name for Sotalol Hydrochloride AF?
The generic name for Sotalol Hydrochloride AF is Sotalol Hydrochloride Tablets AF. There are no other listed brand versions of Sotalol Hydrochloride Tablets AF.
What is the NDC code for Sotalol Hydrochloride AF 160 mg/1?
The NDC (National Drug Code) for Sotalol Hydrochloride AF 160 mg/1 is 76385-127, listed by UNICHEM PHARMACEUTICALS (USA), INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)