Determining the Dose of Sotalol in a Pediatric Patient to Control Atrial Fibrillation or Flutter

 

General steps in determining the dose in the adult:

(1) The patient should be admitted to a health care facility where the ECG can be monitored.

(2) The creatinine clearance is estimated based on age, body weight and serum creatinine levels.

(3) If contraindications are present then the drug is not given.

(4) The initial dosing interval is selected based on the creatinine clearance.

(5) The dose can be increased gradually based on arrhythmia control and effect on the QT interval.

(6) Monitor the QT for 2-4 hours after each dose. Discontinue an infusion if QT > 500 msec during initial dosing.

(7) The person should be monitored for at least 3 days after dosing changes (up to 6 days on QD schedule).

 

Contraindications to therapy with sotalol:

(1) creatinine clearance < 40 mL per minute

(2) QT > 450 msec before initiation.

 

where:

• The creatinine clearance is not specified to be adjusted for body surface area. However, the decision points for renal function are based on the adult, so adjusting to 1.73 square meters BSA seems reasonable. The method of Dechaux et al (see Chapter 14) is used in the implementation. If the creatinine clearance is not adjusted for BSA, then the decision points need to be adjusted down.

• The PDR uses QT interval and not QTc.

• The PDR says to use QT > 500 msec as the point for caution when starting in children and > 550 msec to curtail the drug during therapy.

 

Dosing for pediatric patients:

(1) The use of sotalol in children with renal impairment has not been investigated. If used in a child with renal impairment, a lower dose and/or increased dosing interval may be needed.

(2) For a child >= 2 years of age with normal renal function, the initial dose is 30 mg per square meter BSA tid.

(3) For a child < 2 years with normal renal function, the initial dose = ((age factor) * 30) mg per square meter BSA tid.

(4) The maximum dose is 60 mg per square meter BSA tid for a child > 2 years.

(5) It takes 36 hours for steady state to be achieved after a dose adjustment

Age	Age Factor
< 0.1 months	do not give
0.1 months (3 days)	0.18
0.2 months	0.29
0.3 months	0.38
0.4 months	0.47
0.5 months	0.52
0.6 months	0.57
0.7 months	0.59
0.8 months	0.62
0.9 months	0.65
1.0 months	0.68
1.5 months	0.74
2.0 months	0.78
3.0 months	0.85
4.0 months	0.89
5.0 months	0.91
6.0 months	0.92
7.0 months	0.93
8 to 10 months	0.94
11 to 15 months	0.95
16 to 19 months	0.96
20 to 23 months	0.97
>= 24 months	1.00

estimated from graph page 939