Drugs List

Therapeutic Indications

Uses

Maintenance of sinus rhythm after conversion of atrial flutter/fibrillation
Supraventricular arrhythmias - prophylaxis and treatment
Ventricular arrhythmias - treatment (except torsade de pointes)

Treatment of life threatening ventricular tachyarrhythmias (except Torsade de Pointes) and symptomatic non-sustained ventricular tachyarrhythmias.

Maintenance of sinus rhythm after conversion of atrial flutter/fibrillation.

Prophylaxis of supraventricular arrhythmias:
Paroxysmal atrial tachycardia.
Paroxysmal atrial fibrillation.
Paroxysmal A-V nodal re-entrant tachycardia.
Paroxysmal A-V re-entrant tachycardia using accessory pathways.
Paroxysmal supraventricular tachycardia after cardiac surgery.

Contraindications

Anaesthesia producing myocardial depression
Breastfeeding
Cardiogenic shock
Diabetic ketoacidosis
Galactosaemia
History of asthma
History of bronchospasm
History of obstructive pulmonary disease
Hypotension - unless secondary to arrhythmia
Long QT syndrome
Metabolic acidosis
Non-paced second degree atrioventricular block
Non-paced sinus node dysfunction
Non-paced third degree atrioventricular block
Prinzmetal's angina
Raynaud's syndrome
Renal impairment - creatinine clearance below 10ml/minute
Severe bradycardia
Severe peripheral circulatory disorder
Torsade de pointes
Uncontrolled cardiac failure
Uncontrolled phaeochromocytoma

Precautions and Warnings

Children under 18 years
During surgery
Family history of long QT syndrome
Left ventricular ejection fraction value of 40% or less
Upper respiratory tract infection
Alcoholism
Bradycardia
Cardiac failure
Cardiomegaly
Diabetes mellitus
Electrolyte imbalance
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
History of psoriasis
History of torsade de pointes
Hypocalcaemia
Hypoglycaemia
Hypokalaemia
Hypomagnesaemia
Ischaemic heart disease
Lactose intolerance
Myasthenia gravis
Portal hypertension
Pregnancy
Psoriasis
QTc interval greater than or equal to 500 msec
Recent myocardial infarction
Renal impairment - creatinine clearance 10-60ml/minute
Severe diarrhoea

Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Correct electrolyte disorders before treatment
May mask symptoms of hyperthyroidism
Reduce dose in patients with creatinine clearance of 10-60ml/min
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
If QTc >550msec during therapy, consider alternative regimen
Monitor acid-base balance
Monitor antidiabetic drug treatment
Monitor ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of cardiac failure
Monitor renal function
Monitor serum electrolytes
Monitor serum potassium regularly
Beta blockers may reduce the response to adrenaline in anaphylaxis
May aggravate/provoke arrhythmias
May exacerbate psoriasis
May increase sensitivity to allergens
Discontinue 4 days prior to surgery unless risk of angina/arrhythmia
Do not withdraw this drug suddenly
Possibly withdraw treatment if dry eyes and/or skin rash occur
Not licensed for use in children under 18 years

Do not discontinue suddenly, especially in patients with ischaemic heart disease, suspected thyrotoxicosis or hypertension. Decrease dose gradually over 1 to 2 weeks. Abrupt withdrawal may precipitate latent coronary insufficiency. Initiation of replacement therapy may be required.

Pro-arrhythmic events may occur on initiation of therapy and with every dose increase.

Avoid in patients with left ventricular ejection fractions less than or equal to 40% without serious ventricular arrhythmias.

Sotalol should be stopped four days prior to surgery. However, where withdrawal may cause severe angina or arrhythmias, the following precautions can be taken to allow anaesthesia to proceed:
i) Vagal dominance is counteracted by premedication with intravenously administered atropine sulfate.
ii) Anaesthetic agents such as ether, chloroform, cyclopropane, trichloroethylene, methoxyflurane and enflurane are not used.

Pregnancy and Lactation

Pregnancy

Use sotalol with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus and that the neonate should be monitored for 48 to 72 hours after delivery if the maternal therapy with this medication could not be interrupted two to three days before the birth date.

The is limited data on the use of sotalol in pregnancy, especially in the first trimester, but there appears to be low risk.

Foetal growth restriction has not been reported. Typically, for beta blockers without intrinsic sympathomimetic activity (ISA), such as sotalol, continuous treatment beginning early in the second trimester results in the greatest weight reductions, whereas treatment restricted to the third trimester primarily affects only placental weight (Briggs, 2015).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Sotalol is contraindicated in breastfeeding.

Sotalol is secreted into milk in high levels.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anxiety
Asthenia
AV conduction disorders
Bradycardia
Bronchospasm
Cardiac failure
Chest pain
Cold extremities
Conjunctivitis
Cramp
Cyanosis of extremities
Depression
Diarrhoea
Dizziness
Dry eyes
Dyspepsia
Dyspnoea
ECG changes
Exacerbation of psoriasis
Fatigue
Fever
Flatulence
Headache
Hearing disturbances
Hyperglycaemia
Hypoglycaemia
Hypotension
Increase in antinuclear antibodies (ANA)
Intermittent claudication
Lacrimation disorder
Light-headedness
Mood changes
Nausea
Oedema
Palpitations
Paraesthesia
Pro-arrhythmic effects
Rash
Raynaud's phenomenon
Sexual dysfunction
Sleep disturbances
Syncope
Taste disturbances
Torsades de pointes
Visual disturbances
Vomiting

Presentation

Oral formulations of sotalol.

Drugs List

Therapeutic Indications

Uses

Maintenance of sinus rhythm after conversion of atrial flutter/fibrillation
Supraventricular arrhythmias - prophylaxis and treatment
Ventricular arrhythmias - treatment (except torsade de pointes)

Treatment of life threatening ventricular tachyarrhythmias (except Torsade de Pointes) and symptomatic non-sustained ventricular tachyarrhythmias.

Maintenance of sinus rhythm after conversion of atrial flutter/fibrillation.

Prophylaxis of supraventricular arrhythmias:
Paroxysmal atrial tachycardia.
Paroxysmal atrial fibrillation.
Paroxysmal A-V nodal re-entrant tachycardia.
Paroxysmal A-V re-entrant tachycardia using accessory pathways.
Paroxysmal supraventricular tachycardia after cardiac surgery.

Dosage

Adults

Children

Neonates

Patients with Renal Impairment

Contraindications

Anaesthesia producing myocardial depression
Breastfeeding
Cardiogenic shock
Diabetic ketoacidosis
Galactosaemia
History of asthma
History of bronchospasm
History of obstructive pulmonary disease
Hypotension - unless secondary to arrhythmia
Long QT syndrome
Metabolic acidosis
Non-paced second degree atrioventricular block
Non-paced sinus node dysfunction
Non-paced third degree atrioventricular block
Prinzmetal's angina
Raynaud's syndrome
Renal impairment - creatinine clearance below 10ml/minute
Severe bradycardia
Severe peripheral circulatory disorder
Torsade de pointes
Uncontrolled cardiac failure
Uncontrolled phaeochromocytoma

Precautions and Warnings

Children under 18 years
During surgery
Family history of long QT syndrome
Left ventricular ejection fraction value of 40% or less
Upper respiratory tract infection
Alcoholism
Bradycardia
Cardiac failure
Cardiomegaly
Diabetes mellitus
Electrolyte imbalance
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
History of psoriasis
History of torsade de pointes
Hypocalcaemia
Hypoglycaemia
Hypokalaemia
Hypomagnesaemia
Ischaemic heart disease
Lactose intolerance
Myasthenia gravis
Portal hypertension
Pregnancy
Psoriasis
QTc interval greater than or equal to 500 msec
Recent myocardial infarction
Renal impairment - creatinine clearance 10-60ml/minute
Severe diarrhoea

Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Correct electrolyte disorders before treatment
May mask symptoms of hyperthyroidism
Reduce dose in patients with creatinine clearance of 10-60ml/min
Advise ability to drive/operate machinery may be affected by side effects
Contains lactose
If QTc >550msec during therapy, consider alternative regimen
Monitor acid-base balance
Monitor antidiabetic drug treatment
Monitor ECG in patients at risk of QT prolongation
Monitor patients for signs and symptoms of cardiac failure
Monitor renal function
Monitor serum electrolytes
Monitor serum potassium regularly
Beta blockers may reduce the response to adrenaline in anaphylaxis
May aggravate/provoke arrhythmias
May exacerbate psoriasis
May increase sensitivity to allergens
Discontinue 4 days prior to surgery unless risk of angina/arrhythmia
Do not withdraw this drug suddenly
Possibly withdraw treatment if dry eyes and/or skin rash occur
Not licensed for use in children under 18 years

Do not discontinue suddenly, especially in patients with ischaemic heart disease, suspected thyrotoxicosis or hypertension. Decrease dose gradually over 1 to 2 weeks. Abrupt withdrawal may precipitate latent coronary insufficiency. Initiation of replacement therapy may be required.

Pro-arrhythmic events may occur on initiation of therapy and with every dose increase.

Avoid in patients with left ventricular ejection fractions less than or equal to 40% without serious ventricular arrhythmias.

Sotalol should be stopped four days prior to surgery. However, where withdrawal may cause severe angina or arrhythmias, the following precautions can be taken to allow anaesthesia to proceed:
i) Vagal dominance is counteracted by premedication with intravenously administered atropine sulfate.
ii) Anaesthetic agents such as ether, chloroform, cyclopropane, trichloroethylene, methoxyflurane and enflurane are not used.

Pregnancy and Lactation

Pregnancy

Use sotalol with caution in pregnancy.

The manufacturer notes that this medication should only be considered if the expected benefit to the mother is greater than any risk to the foetus and that the neonate should be monitored for 48 to 72 hours after delivery if the maternal therapy with this medication could not be interrupted two to three days before the birth date.

The is limited data on the use of sotalol in pregnancy, especially in the first trimester, but there appears to be low risk.

Foetal growth restriction has not been reported. Typically, for beta blockers without intrinsic sympathomimetic activity (ISA), such as sotalol, continuous treatment beginning early in the second trimester results in the greatest weight reductions, whereas treatment restricted to the third trimester primarily affects only placental weight (Briggs, 2015).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Sotalol is contraindicated in breastfeeding.

Sotalol is secreted into milk in high levels.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anxiety
Asthenia
AV conduction disorders
Bradycardia
Bronchospasm
Cardiac failure
Chest pain
Cold extremities
Conjunctivitis
Cramp
Cyanosis of extremities
Depression
Diarrhoea
Dizziness
Dry eyes
Dyspepsia
Dyspnoea
ECG changes
Exacerbation of psoriasis
Fatigue
Fever
Flatulence
Headache
Hearing disturbances
Hyperglycaemia
Hypoglycaemia
Hypotension
Increase in antinuclear antibodies (ANA)
Intermittent claudication
Lacrimation disorder
Light-headedness
Mood changes
Nausea
Oedema
Palpitations
Paraesthesia
Pro-arrhythmic effects
Rash
Raynaud's phenomenon
Sexual dysfunction
Sleep disturbances
Syncope
Taste disturbances
Torsades de pointes
Visual disturbances
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2018

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

Summary of Product Characteristics: Beta-Cardone Tablets 200mg. Focus Pharmaceuticals Ltd. Revised August 2010.

Summary of Product Characteristics: Sotacor tablets. Cheplapharm Arzneimittel GmbH. Revised August 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 September 2018