Sotalol Hydrochloride Injection while Breastfeeding

Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Sotalol Hydrochloride Injection ? Know what is Sotalol Hydrochloride Injection and how it can affect your breast milk and whether Sotalol Hydrochloride Injection is safe for your kid or not.

Sotalol hydrochloride for intravenous use is an antiarrhythmic agent indicated for: Substitution for oral sotalol in patients who are unable to take sotalol orally (1.1) Oral sotalol is indicated for: Maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter (1.2) Treatment of documented life -threatening ventricular arrhythmias (1.3) 1.1 Substitution for Oral Sotalol Therapy Intravenous sotalol can substitute for oral sotalol in patients who are unable to take sotalol orally. 1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter Sotalol is 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 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 is easily reversed (by Valsalva maneuver, for example) should usually not be given sotalol. 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 ( 14.2 )]. Patients with atrial fibrillation should be anticoagulated according to usual medical practice. 1.3 Documented Life-Threatening Ventricular Arrhythmia Sotalol is indicated for the treatment of documented life-threatening ventricular arrhythmias. Because of the proarrhythmic effects of sotalol [see Warnings and Precautions ( 5.1 )] 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. In life-threatening ventricular arrhythmias, the response to treatment should then be evaluated by a suitable method (e.g., PES or Holter monitoring) at steady state blood levels of drug prior to continuing the patient on chronic therapy. Antiarrhythmic drugs may not enhance survival in patients with ventricular arrhythmias.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Sotalol is secreted in human milk in high levels. In five mothers whose mean sotalol dose was 433 mg/day, sotalol concentrations in milk ranged from 4.8 to 20.2 mg/L (mean=10.5 mg/L), with a milk: plasma ratio of 5.5:1 (range 2.2-8.8). The calculated infant dose was 0.8-3.4 mg/kg, which is similar to recommended therapeutic doses in neonates. Two other case reports showed similar findings. Because of the potential for adverse reactions in nursing infants from sotalol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.