Sotylize

SOTYLIZE is an antiarrhythmic indicated for:

• The treatment of life-threatening ventricular arrhythmias (
  1.1 Life-Threatening Ventricular Arrhythmia

  SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.

  Limitation of Use

  SOTYLIZE has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.
  )
• The maintenance of normal sinus rhythm in patients with highly symptomatic atrial fibrillation/flutter (AFIB/AFL) (
  1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)

  SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.

  Limitation of Use

  Because sotalol 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 SOTYLIZE

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  )

Limitations of Use

• SOTYLIZE has not been shown to enhance survival in patients with life threatening ventricular arrhythmias (
  1.1 Life-Threatening Ventricular Arrhythmia

  SOTYLIZE is indicated for the treatment of documented, life-threatening ventricular arrhythmias, such as sustained ventricular tachycardia.

  Limitation of Use

  SOTYLIZE has not been shown to enhance survival in patients with life-threatening ventricular arrhythmias.
  )
• Avoid use in patients with minimally symptomatic or easily reversible AFIB/AFL (
  1.2 Delay in Recurrence of Atrial Fibrillation/Atrial Flutter (AFIB/AFL)

  SOTYLIZE is indicated for the maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL)] in patients with highly symptomatic AFIB/AFL who are currently in sinus rhythm.

  Limitation of Use

  Because sotalol 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 SOTYLIZE

  .
  )

• Initiate therapy at 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 Adult Dose for Ventricular Arrhythmia

  The recommended initial dose is 80 mg twice daily. This dose may be increased in increments of 80 mg per day every 3 days provided the QTc <500 msec

  [see Warning and Precautions (5.1)]

  . Continually monitor patients until steady state blood levels are achieved. In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in two or three divided doses. Oral doses as high as 480 to 640 mg once or twice a day have been utilized in patients with refractory life-threatening arrhythmias.
  )
• If creatinine clearance is between 60 and 40 mL/min, administer once daily, if less than 40 mL/min, sotalol is not recommended (
  2.1 General Safety Measures of Oral Sotalol Therapy

  Withdraw other antiarrhythmic therapy before starting SOTYLIZE and monitor for a minimum of 2 to 3 plasma half-lives prior to initiating SOTYLIZE 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 after each uptitration in dose.

  Discharge patients on sotalol therapy from an in-patient setting with an adequate supply of sotalol to allow uninterrupted therapy until the patient can fill a sotalol prescription.

  Advise patients who miss a dose to take the next dose at the usual time. Do not double the dose or shorten the dosing interval.
  )
• Pediatrics: Dosage depends on age (
  2.4 Pediatric Dose for Ventricular Arrhythmias or AFIB/AFL

  Use the same precautionary measures for children as you would use for adults when initiating and re-initiating sotalol treatment.

  For Children Aged About 2 Years and Older

  For children aged about 2 years and older with normal renal function, doses normalized for body surface area are appropriate for both initial and incremental dosing. Since the Class III potency in children is not very different from that in adults, reaching plasma concentrations that occur within the adult dose range is an appropriate guide

  [see Clinical Pharmacology (12.1, 12.3)].

  For initiation of treatment, 1.2 mg/kg three times a day (3.6 mg/kg total daily dose) is approximately equivalent to the initial 160 mg total daily dose for adults. Subsequent titration to a maximum of 2.4 mg/kg three times a day (approximately equivalent to the 360 mg total daily dose for adults) can then occur. Titration should be guided by clinical response, heart rate, and QTc, with increased dosing being preferably conducted in-hospital. Allow at least 36 hours between dose increments to attain steady-state plasma concentrations of sotalol in patients with age-adjusted normal renal function.

  For Children Aged About 2 Years or Younger

  For children aged 2 years or younger, the pediatric dosage should be reduced by a factor that depends upon age, as shown in the following graph (age plotted on a logarithmic scale in months):

  For a child aged 1 month, multiply the starting dose by 0.7; the initial starting dose would be (1.2 mg/kg × 0.7)=0.8 mg/kg, administered three times daily. For a child aged about 1 week, multiply the initial starting dose by 0.3; the starting dose would be (1.2 mg/kg × 0.3)=0.4 mg/kg. Use similar calculations for dose titration.

  

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Oral solution: 5 mg/mL, in 250 mL or 480 mL bottles.

• Lactation: Do not breastfeed (
  8.2 Lactation

  Risk Summary

  Limited available data from published literature report that sotalol is present in human milk. The estimated daily infant dose of sotalol received from breastmilk is 0.8-3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of SOTYLIZE (

  see Data

  ). The amount of drug in breast milk is similar to the neonatal therapeutic dosage. Therefore, there is potential for bradycardia and other symptoms from beta-blockers such as dry mouth, skin or eyes, diarrhea or constipation in the breastfed infant. There is no information regarding the effects of sotalol on milk production. Because of the potential serious adverse reactions to the breastfed child and high level of sotalol in breast milk, advise women not to breastfeed while on treatment with SOTYLIZE.

  Data

  Sotalol is present in human milk in high levels. A prospective study evaluated 20 paired samples of breast milk and maternal blood from 5 mothers who elected to breastfeed. Breast milk samples had a mean sotalol concentration of 10.5 g µg/mL (± 1.1 µg/mL; range: 4.8 to 20.2 µg/mL compared to a simultaneous mean maternal plasma concentration of 2.3 µg/mL (± 0.3 µg/mL; range: 0.8 to 5.0 µg/mL). The mean milk plasma ratio was 5:4:1 (range: 2.2 to 8.8.). The estimated daily infant dose was 0.8 -3.4 mg/kg, estimated at 22 to 25.5% of the maternal weight-adjusted dosage of sotalol. This is similar to recommended therapeutic dose in neonates. None of the mothers reported any adverse reactions in the breastfed infant.
  )