Sotylize (sotalol HCl)

Dosage of sotalol hydrochloride must be adjusted carefully according to individual requirements and response, patient tolerance, renal function, and QT interval.

Appropriate dosage adjustments should be made for patients with impaired renal function to minimize the risk of drug accumulation and arrhythmogenic events. (See Dosage and Administration: Dosage in Renal and Hepatic Impairment.) If a dose is missed, patients should be advised to take the next dose at the regularly scheduled time and to not take a double dose or increase the dosing frequency to compensate for the missed dose.

In patients with renal impairment, the dose or dosing frequency of sotalol hydrochloride should be reduced to minimize the risk of proarrhythmia; as in patients with normal renal function, QT interval and heart rate should be closely monitored. (See Cautions: Arrhythmogenic Effects.) Dosing interval should be modified according to the patient's estimated creatinine clearance. In general, the initial oral adult sotalol hydrochloride dose of 80 mg and subsequent doses should be administered twice daily in patients with a creatinine clearance greater than 60 mL/minute and once daily in patients with a creatinine clearance of 40-60 mL/minute. The drug is generally contraindicated in patients with creatinine clearance less than 40 mL/minute. In patients with ventricular arrhythmias, some manufacturers recommend a dosing interval of 36-48 hours in adults with creatinine clearance of 10-29 mL/minute and individualized dosing in those with creatinine clearance less than 10 mL/minute. Since terminal elimination half-life of the drug is prolonged in patients with renal impairment, dosage increases generally should be made after administration of at least 5 doses at appropriate intervals. Sotalol is partially removed by dialysis; however, the manufacturers make no dosing recommendations for patients undergoing dialysis. Dosage of sotalol hydrochloride in children with renal impairment has not been established; however, reduced doses and increased dosing intervals are recommended in patients of all age groups with renal impairment.

The manufacturer states that clearance of sotalol is not altered by impaired hepatic function.

Sotalol hydrochloride is administered orally or by IV infusion when oral administration is not feasible.

Because of the arrhythmogenic potential of sotalol, initiation or reinitiation of therapy, or conversion from IV to oral therapy should be performed in a facility capable of providing cardiac resuscitation, continuous electrocardiogram (ECG) monitoring, and calculation of creatinine clearance; treatment should be initiated in the presence of personnel trained in the management of serious arrhythmias. Patients should be closely monitored for at least 3 days (or until steady-state plasma concentrations are achieved) whenever treatment is initiated or dosage is increased. Prior to initiating therapy, the patient's baseline QT interval and creatinine clearance should be determined; therapy should not be initiated if the QT interval corrected for rate (QTc) exceeds 450 msec or creatinine clearance is less than 40 mL/minute. Because the potential for arrhythmogenic events increases with increasing dosage, patients should be monitored closely during the dose titration phase until steady-state concentrations are reached. When titrating dosage, QT interval should be determined 2-4 hours after each dose increase (if the drug is given orally) or after completion of each IV infusion; dose should be reduced, dosing interval increased, or therapy discontinued if prolongation of the QT interval to 500 msec or greater occurs.

Patients should be advised not to discontinue or interrupt sotalol therapy without consulting their clinician. Patients should be given an adequate supply of the drug upon hospital discharge to allow uninterrupted therapy until their outpatient prescription can be filled.

Patients with atrial fibrillation should be anticoagulated according to usual medical practice. (See Uses: Embolism Associated with Atrial Fibrillation in Warfarin 20:12.04.08.)

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rats and rabbits during organogenesis did not reveal any teratogenic potential at sotalol hydrochloride doses that were 100 and 22 times the maximum recommended human oral dose on a mg/kg basis (9 and 7 times the maximum recommended human oral dose on a mg/m2 basis), respectively. However, higher sotalol hydrochloride dosages of 160 mg/kg daily (16 times the maximum recommended human oral dosage on a mg/kg basis or 6 times the maximum recommended human oral dosage on a mg/m2 basis) in rabbits were associated with a slight increase in fetal death likely resulting from maternal toxicity. A sotalol hydrochloride dosage of 80 mg/kg daily (8 times the maximum recommended human oral dosage on a mg/kg basis or 3 times the maximum recommended human oral dosage on a mg/m2 basis) did not produce this effect. An increase in the number of early resorptions was associated with a sotalol hydrochloride dosage of 1000 mg/kg daily in rats (100 times the maximum recommended human oral dosage on a mg/kg basis or 18 times the maximum recommended human oral dosage on a mg/m2 basis), while no increase was observed at 14 times the maximum recommended human oral dosage on mg/kg basis (2.5 times the maximum recommended human oral dosage on a mg/m2 basis). Animal data are not always indicative of human response. There are no adequate and well-controlled studies using sotalol in pregnant women, but the drug has been shown to cross the placenta and is found in amniotic fluid.

Sotalol is distributed into milk, apparently in concentrations approximately 2.5-5.5 times concurrent maternal serum concentrations. Because of the potential for adverse reactions to sotalol in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.