logo image

Sotalol information from DrugsUpdate  

See Available Brands of Sotalol in India

P - Caution when used during pregnancy
L - Caution when used during lactation
FI - Food *

Sotalol (trade names Betapace and Betapace AF, Berlex Laboratories, Sotalex and Sotacor, Bristol-Myers Squibb) is a drug used in individuals with rhythm disturbances (cardiac arrhythmias) of the heart, and to treat hypertension in some individuals.

Sotalol is a non-selective beta blocker. It is also a potassium channel blocker and is therefore a class III anti-arrhythmic agent. Because of this dual-action, Sotalol prolongs both the PR interval and the QT interval.

Pharmacodynamics

Pharmacokinetics

Sotalol is a non-cardioselective β-blocker. It increases sinus cycle length, slows heart rate, decreases AV nodal conduction and increases AV nodal refractoriness. It also prolongs AV monophasic action potentials. However, it lacks intrinsic sympathomimetic and membrane-stabilising properties. It is used in the treatment of ventricular arrhythmias.

Absorption

Almost completely absorbed from the GI tract (oral); peak plasma concentrations after 2-4 hours.

Distribution

Crosses the placenta and enters breast milk; crosses the blood-brain barrier and enters CSF (small amounts). Protein-binding: Low.

Metabolism
Minimal metabolism.

Excretion
Via urine (as unchanged). Elimination half-life: 10-20 hours.

Sotalol Indications / Sotalol Uses

Information Not Available

Sotalol Adverse Reactions / Sotalol Side Effects

Nausea, sleep disorders, lassitude, diarrhoea, palpitations, bradycardia, weakness, dyspnoea, decreased sexual activity, impotence, extremity pain, back pain, asthma, visual disturbances, cardiac arrhythmias. Rebound angina, arrhythmias and MI if withdrawn abruptly.

Potentially Fatal: Polymorphic ventricular tachycardia (very rare). Rebound hypertension.

Precautions

Renal Impairment
Sotalol hydrochloride is eliminated principally via the kidneys through glomerular filtration and to a small degree by tubular secretion. There is a direct relationship between renal function, as measured by serum creatinine or creatinine clearance, and the elimination rate of Sotalol hydrochloride.

Overdosage
Rarely results in death.

Special Precautions

Pregnancy and lactation. Renal insufficiency; preexisting sick sinus syndrome; compensated heart failure; gradual withdrawal is recommended. DM, 1st degree AV block. May mask the symptoms of hyperthyroidism and of hypoglycaemia. May unmask myasthenia gravis. May worsen psoriasis.

Other Drug Interactions

Decreased effect with antacids, calcium salts, NSAIDs, ampicillin, rifampicin. May reduce response to insulin and oral hypoglycaemics. May lead to enhanced hypotension when used with aldesleukin and general anaesthetics. Increased risk of bradycardia and heart block when used with calcium channel blockers and other cardiac depressants. May develop elevated BP when used with adrenaline. Reduced absorption when used with aluminium salts and bile-acid binding resins. Decreased metabolism when used with cimetidine, hydralazine, erythromycin and fluvoxamine.

Potentially Fatal: Rebound hypertension with clonidine and abrupt withdrawal of either drug. Polymorphic ventricular tachycardia with antidepressants and quinidine.

Other Interactions

Food Interaction
Absorption may be reduced by food especially by milk.

Dosage

Oral
Supraventricular and Ventricular Arrhythmias
Adult: Initially, 80 mg daily as a single or in 2 divided doses, increased gradually every 2-3 days. Usual dose: 160-320 mg daily in 2 divided doses. Max: 640 mg daily.
Child: Neonates: Initially, 1 mg/kg bid, increased every 3-4 days, if necessary. Max: 4 mg/kg bid. 1 months-12 years: Initially, 1 mg/kg bid, increased as necessary every 2-3 days. Max: 4 mg/kg bid, not exceeding 80 mg bid. For refractory supraventricular tachycardia, sotalol may be given with flecainide; <1 year: 100-250 mg/m2 daily of sotalol and 40-150 mg/m2 daily of flecainide.

CrCl (ml/min)    Dosage Recommendation
30-60               Halve the usual dose.
10-30               Quarter the usual dose.
<10                  Not recommended.

Oral
Life-threatening Ventricular Arrhythmias
Adult: 480-640 mg daily.


CrCl (ml/min)    Dosage Recommendation
30-60               Halve the usual dose.
10-30               Quarter the usual dose.
<10                  Not recommended.

Intravenous
Acute arrhythmias
Adult: 20-120 mg (0.5-1.5 mg/kg) given by injection over 10 minutes, may repeat every 6 hours if needed. To substitute for oral treatment, 0.2-0.5 mg/kg/hour infusion may be used.

CrCl (ml/min)    Dosage Recommendation
30-60               Halve the usual dose.
10-30               Quarter the usual dose.
<10                  Not recommended.

Intravenous
Programmed electrical stimulation (to test antiarrhythmic efficacy)
Adult: Initially, 1.5 mg/kg injection over 10-20 minutes, followed by of 0.2-0.5 mg/kg/hours infusion.

CrCl (ml/min)    Dosage Recommendation
30-60               Halve the usual dose.
10-30               Quarter the usual dose.
<10                  Not recommended.

Food(before/after)

Should be taken on an empty stomach. (Take 1-2 hours before meals.)

List of Contraindications

Sotalol and Pregnancy

Caution when used during pregnancy

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

In 2nd & 3rd trimesters.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Sotalol and Lactation

Caution when used during lactation

Sotalol and Children

The safety and effectiveness of Sotalol in pediatric patients have not been established. However, the Class III electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (QTc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old.

Sotalol and Geriatic

Information Not Available

Sotalol and Other Contraindications

Bronchospasm, asthma, history of obstructive airways disease, sinus bradycardia, cardiogenic shock. 2nd and 3rd degree AV block, uncontrolled cardiac failure, metabolic acidosis, hypotension, severe peripheral arterial disease.

Storage

Intravenous
Store at 20-25°C.

Oral
Store at 20-25°C.

Lab interference

Intravenous
Store at 20-25°C.

Oral
Store at 20-25°C.

Sotalol brands in India:

Solet Sotagard Sotalar

© 2011-2018 DrugsUpdate.com. Disclaimer | Site Map

Feedback