Drugs List

Therapeutic Indications

Uses

Adjunctive therapy in thyrotoxicosis (short term)
Angina
Anxiety state
Hypertension
Management of essential tremor
Migraine (prophylaxis)
Prophylaxis of upper GI bleeding in patients with oesophageal varices
Prophylaxis of upper GI bleeding in patients with portal hypertension

Contraindications

Children under 12 years
Predisposition to hypoglycaemia
Prolonged fasting
Bradycardia
Cardiogenic shock
Hereditary fructose intolerance
History of asthma
History of bronchospasm
Hypotension
Metabolic acidosis
Non-paced sinus node dysfunction
Prinzmetal's angina
Reversible obstructive pulmonary disease
Second degree atrioventricular block
Severe peripheral circulatory disorder
Third degree atrioventricular block
Uncontrolled cardiac failure
Uncontrolled phaeochromocytoma

Precautions and Warnings

Children aged 12 to 18 years
Elderly
History of allergies including anaphylaxis
Breastfeeding
Chronic hepatic disorder
Decompensated liver disease
Diabetes mellitus
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
Haemodialysis
Hepatic impairment
History of obstructive pulmonary disease
Myasthenia gravis
Peripheral vascular disease
Phaeochromocytoma
Poor cardiac reserve
Portal hypertension
Pregnancy
Psoriasis
Renal impairment

Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Anaesthetist should be made aware patient is taking this medication
Give in conjunction with alpha blocker in patients with phaeochromocytoma
May cause hepatic encephalopathy in patients with hepatic disease
May mask symptoms of thyrotoxicosis
May unmask the symptoms of myasthenia gravis
Advise patient dizziness may affect ability to drive or operate machinery
Some formulations contain sucrose
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients during drug withdrawal esp. in ischaemic heart disease
Reduce dose if bradycardia develops
Beta blockers may reduce the response to adrenaline in anaphylaxis
May increase sensitivity to allergens
May affect results of some laboratory tests
Withdraw drug gradually, especially in patients with cardiac ischaemia
Discontinue if persistent or symptomatic hypotension occurs
Consider reducing initial dose in the elderly
Hypotensive effects may be potentiated by alcohol

Concurrent calcium channel blockers with negative inotropic effects: Avoid concurrent use, particularly in patients with impaired ventricular function or conduction abnormalities due to risk of severe hypotension, bradycardia and cardiac failure.

Propranolol has occasionally caused hypoglycaemia in non-diabetic patients, e.g. children, elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose. Therefore, propranolol must be used with extreme caution and careful monitoring in patients susceptible to hypoglycaemia. An inadequate response to hypoglycaemia is likely to occur in patients with malnutrition, prolonged fasting, starvation, chronic liver disease or diabetes.

Treatment with beta-blockers should not be stopped abruptly. The dosage should be withdrawn gradually over a period of 7 to 14 days. An equivalent dosage of another beta-blocker may be substituted during the withdrawal period to facilitate a reduction in dosage below propranolol modified release 80mg. Patients should be followed during withdrawal especially those with ischaemic heart disease. Patients should be advised not to stop taking propranolol modified release capsules except on medical advice.

When a patient is scheduled for surgery and a decision is made to discontinue beta-blocker therapy, this should be done at least 24 hours prior to the procedure. The risk/benefit of stopping beta blockade should be made for each patient.

Pregnancy and Lactation

Pregnancy

Use propranolol with caution in pregnancy.

Propranolol should be used with caution in pregnancy. Beta blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. Intrauterine growth retardation (IUGR), and reduced placental weight may be caused by propranolol. The greatest weight reductions are seen when treatment begins in the second trimester (Briggs, 2011). Schaefer (2007) states that beta-receptor blockers such as propranolol, which have been in long term use, are among the first-line drugs of choice for treating hypertension in pregnancy. It is important to be aware of pharmacological effects such as decreased heart rate, hypoglycaemia, and respiratory problems, particularly in premature neonates, when treatment with beta blockers continues until birth.

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

Use propranolol with caution in breastfeeding.

Most beta-blockers, particularly lipophilic compounds, will pass into breast milk therefore breastfeeding is not recommended. The peak concentrations is 2 to 3 hours after a dose (Briggs, 2011). Briggs and Hale (2014) consider the quantities excreted in breast milk, insufficient to cause adverse effects. Hale concludes not to be used in breastfeeding mothers of infants with reactive airways disease. Breastfed infants should be monitored for symptoms of beta blockade, e.g. respiratory depression, bradycardia and hypoglycaemia.

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

Aggravation of cardiac failure
Alopecia
Bradycardia
Bronchospasm
Cardiac failure
Cold extremities
Conduction disturbances
Confusion
Diarrhoea
Dizziness
Dry eyes
Dyspnoea
Exacerbation of intermittent claudication
Exacerbation of myasthenia gravis
Exacerbation of psoriasis
Exacerbation of Raynaud's disease
Fatigue
Gastro-intestinal disturbances
Hallucinations
Headache
Hepatic encephalopathy
Hypoglycaemia
Hypotension
Increase in antinuclear antibodies (ANA)
Lassitude
Memory loss
Mood changes
Myasthenia gravis-like syndrome
Nausea
Nightmares
Paraesthesia
Peripheral vasoconstriction
Possible alteration of laboratory tests
Postural hypotension
Precipitation of heart block
Psoriasiform rash
Psychosis
Purpura
Rash
Sexual dysfunction
Sleep disturbances
Syncope
Thrombocytopenia
Vertigo
Visual disturbances
Vomiting

Presentation

Modified release formulations of propranolol

Drugs List

Therapeutic Indications

Uses

Adjunctive therapy in thyrotoxicosis (short term)
Angina
Anxiety state
Hypertension
Management of essential tremor
Migraine (prophylaxis)
Prophylaxis of upper GI bleeding in patients with oesophageal varices
Prophylaxis of upper GI bleeding in patients with portal hypertension

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Children under 12 years
Predisposition to hypoglycaemia
Prolonged fasting
Bradycardia
Cardiogenic shock
Hereditary fructose intolerance
History of asthma
History of bronchospasm
Hypotension
Metabolic acidosis
Non-paced sinus node dysfunction
Prinzmetal's angina
Reversible obstructive pulmonary disease
Second degree atrioventricular block
Severe peripheral circulatory disorder
Third degree atrioventricular block
Uncontrolled cardiac failure
Uncontrolled phaeochromocytoma

Precautions and Warnings

Children aged 12 to 18 years
Elderly
History of allergies including anaphylaxis
Breastfeeding
Chronic hepatic disorder
Decompensated liver disease
Diabetes mellitus
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
Haemodialysis
Hepatic impairment
History of obstructive pulmonary disease
Myasthenia gravis
Peripheral vascular disease
Phaeochromocytoma
Poor cardiac reserve
Portal hypertension
Pregnancy
Psoriasis
Renal impairment

Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Anaesthetist should be made aware patient is taking this medication
Give in conjunction with alpha blocker in patients with phaeochromocytoma
May cause hepatic encephalopathy in patients with hepatic disease
May mask symptoms of thyrotoxicosis
May unmask the symptoms of myasthenia gravis
Advise patient dizziness may affect ability to drive or operate machinery
Some formulations contain sucrose
Monitor blood glucose closely in patients with diabetes mellitus
Monitor patients during drug withdrawal esp. in ischaemic heart disease
Reduce dose if bradycardia develops
Beta blockers may reduce the response to adrenaline in anaphylaxis
May increase sensitivity to allergens
May affect results of some laboratory tests
Withdraw drug gradually, especially in patients with cardiac ischaemia
Discontinue if persistent or symptomatic hypotension occurs
Consider reducing initial dose in the elderly
Hypotensive effects may be potentiated by alcohol

Concurrent calcium channel blockers with negative inotropic effects: Avoid concurrent use, particularly in patients with impaired ventricular function or conduction abnormalities due to risk of severe hypotension, bradycardia and cardiac failure.

Propranolol has occasionally caused hypoglycaemia in non-diabetic patients, e.g. children, elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose. Therefore, propranolol must be used with extreme caution and careful monitoring in patients susceptible to hypoglycaemia. An inadequate response to hypoglycaemia is likely to occur in patients with malnutrition, prolonged fasting, starvation, chronic liver disease or diabetes.

Treatment with beta-blockers should not be stopped abruptly. The dosage should be withdrawn gradually over a period of 7 to 14 days. An equivalent dosage of another beta-blocker may be substituted during the withdrawal period to facilitate a reduction in dosage below propranolol modified release 80mg. Patients should be followed during withdrawal especially those with ischaemic heart disease. Patients should be advised not to stop taking propranolol modified release capsules except on medical advice.

When a patient is scheduled for surgery and a decision is made to discontinue beta-blocker therapy, this should be done at least 24 hours prior to the procedure. The risk/benefit of stopping beta blockade should be made for each patient.

Pregnancy and Lactation

Pregnancy

Use propranolol with caution in pregnancy.

Propranolol should be used with caution in pregnancy. Beta blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. Intrauterine growth retardation (IUGR), and reduced placental weight may be caused by propranolol. The greatest weight reductions are seen when treatment begins in the second trimester (Briggs, 2011). Schaefer (2007) states that beta-receptor blockers such as propranolol, which have been in long term use, are among the first-line drugs of choice for treating hypertension in pregnancy. It is important to be aware of pharmacological effects such as decreased heart rate, hypoglycaemia, and respiratory problems, particularly in premature neonates, when treatment with beta blockers continues until birth.

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

Use propranolol with caution in breastfeeding.

Most beta-blockers, particularly lipophilic compounds, will pass into breast milk therefore breastfeeding is not recommended. The peak concentrations is 2 to 3 hours after a dose (Briggs, 2011). Briggs and Hale (2014) consider the quantities excreted in breast milk, insufficient to cause adverse effects. Hale concludes not to be used in breastfeeding mothers of infants with reactive airways disease. Breastfed infants should be monitored for symptoms of beta blockade, e.g. respiratory depression, bradycardia and hypoglycaemia.

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

Aggravation of cardiac failure
Alopecia
Bradycardia
Bronchospasm
Cardiac failure
Cold extremities
Conduction disturbances
Confusion
Diarrhoea
Dizziness
Dry eyes
Dyspnoea
Exacerbation of intermittent claudication
Exacerbation of myasthenia gravis
Exacerbation of psoriasis
Exacerbation of Raynaud's disease
Fatigue
Gastro-intestinal disturbances
Hallucinations
Headache
Hepatic encephalopathy
Hypoglycaemia
Hypotension
Increase in antinuclear antibodies (ANA)
Lassitude
Memory loss
Mood changes
Myasthenia gravis-like syndrome
Nausea
Nightmares
Paraesthesia
Peripheral vasoconstriction
Possible alteration of laboratory tests
Postural hypotension
Precipitation of heart block
Psoriasiform rash
Psychosis
Purpura
Rash
Sexual dysfunction
Sleep disturbances
Syncope
Thrombocytopenia
Vertigo
Visual disturbances
Vomiting

Effects on Laboratory Tests

Propranolol has been reported to interfere with the estimation of serum bilirubin by the diazo method and with the determination of catecholamines by methods using fluorescence.

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: March 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

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

Summary of Product Characteristics Bedranol 80mg SR Capsules. Sandoz Ltd. March 2016.
Summary of Product Characteristics Bedranol 160mg SR Capsules. Sandoz Ltd. December 2015.

Summary of Product Characteristics Half Beta-Prograne SR Capsules 80mg. Tillomed Laboratories. December 2011.
Summary of Product Characteristics Beta-Prograne SR Capsules 160mg. Tillomed Laboratories. December 2011.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 13 September 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Propranolol Last revised: 7 September, 2013
Last accessed: 22 March, 2016