Propranolol oral standard release
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of standard release propranolol hydrochloride.
Drugs List
Therapeutic Indications
Uses
Angina pectoris
Cardiac arrhythmias especially supraventricular tachycardia
Dysrhythmias associated with tetralogy of Fallot
Generalised anxiety - somatic symptoms
Hypertension
Hypertrophic obstructive cardiomyopathy
Management of essential tremor
Management of phaeochromocytoma peri-operatively (with an alpha blocker)
Migraine (prophylaxis)
Myocardial infarction (prevention of secondary attack)
Phaeochromocytoma in patients unsuitable for surgery
Prophylaxis of upper GI bleeding in patients with oesophageal varices
Prophylaxis of upper GI bleeding in patients with portal hypertension
Relief of right ventricular outflow shut-down in tetralogy of Fallot
Situational anxiety
Thyrotoxic crisis
Thyrotoxicosis
Dosage
Adults
Hypertension
Initial dose: 80mg twice daily. Increase at weekly intervals according to response.
Maintenance dose: 160mg to 320mg daily.
Angina; Migraine; Essential tremor
Initial dose: 40mg two or three times daily. Increase at weekly intervals according to response.
Maintenance dose in migraine: 80mg to 160mg daily in divided doses. Some sources suggest an unlicensed maximum dose of 240mg daily in divided doses.
Maintenance dose in essential tremor: 80mg to 160mg daily.
Maintenance dose in angina: 120mg to 240mg daily. Some sources suggest up to 480mg daily may be used.
Anxiety
Short term, situational anxiety: 40mg daily.
Longer term, generalised anxiety: 40mg twice daily. In certain cases, the dose may be increased to 40mg three times daily if necessary. Treatment should be continued according to response and reviewed after six to twelve months.
Arrhythmias, anxiety tachycardia, hypertrophic obstructive cardiomyopathy and thyrotoxicosis (adjunct)
Maintenance dose: 10mg to 40mg three or four times daily.
Post myocardial infarction
Initial dose: 40mg four times a day for 2 or 3 days beginning 5 to 21 days after myocardial infarction.
Maintenance dose: 80mg twice a day thereafter.
Portal hypertension and oesophageal varices
Initial dose: 40mg twice daily. Increased to 80mg twice daily depending on heart rate response.
Maximum dose: 160mg twice daily.
Dose titration should be gradual to achieve approximately 25% reduction in resting heart rate.
Phaeochromocytoma
Use only with an alpha-receptor blocking drug (propranolol inhibits the beta-2 vasodilatory effects).
Pre-operative: 60mg daily for three days before surgery.
OR
Non-operable malignant cases: 30mg daily in patients unsuitable for surgery.
Children
Arrhythmias; Phaeochromocytoma; Thyrotoxicosis
Dosage should be individually determined.
250micrograms/kg to 500micrograms/kg three or four times daily.
For thyrotoxicosis, some sources suggest up to 1mg/kg every 8 hours (Maximum 40mg every 8 hours).
For arrhythmias, some sources suggest a maximum dose of 160mg daily, or 1mg/kg four times a day.
Migraine
Children aged 12 to 18 years: (See Dosage; Adult).
Children aged under 12 years: 20mg two or three times a day.
Fallot's tetralogy
Dosage should be individually determined.
250micrograms/kg to 1mg/kg three or four times a day.
Hypertension
Children aged 12 to 18 years
(See Dosage; Adult)
Children aged 1 month to 12 years (unlicensed)
Initial dose: 250micrograms/kg to 1mg/kg three times a day. Increase, if necessary, at weekly intervals.
Maximum dose: 5mg/kg daily in divided doses.
Neonates
Hyperthyroidism with autonomic symptoms; Thyrotoxicosis (adjunct); Thyrotoxic crisis
Initial dose: 250micrograms/kg to 500micrograms/kg every 6 to 8 hours. Adjust according to response.
Hypertension (unlicensed)
Initial dose: 250micrograms/kg three times a day. Increase, if necessary to a maximum of 2mg/kg three times daily.
Arrhythmias
250micrograms/kg to 500micrograms/kg three times a day. Adjust according to response.
Fallot's tetralogy
250micrograms/kg to 1mg/kg two or three times a day.
Maximum dose: 2mg/kg three times a day.
Contraindications
Prolonged fasting
Asthma
Cardiogenic shock
Galactosaemia
History of asthma
History of bronchospasm
History of obstructive pulmonary disease
Hypoglycaemia
Hypotension
Metabolic acidosis
Non-paced sinus node dysfunction
Obstructive pulmonary disease
Prinzmetal's angina
Second degree atrioventricular block
Severe bradycardia
Severe peripheral arterial disease
Third degree atrioventricular block
Uncontrolled cardiac failure
Uncontrolled phaeochromocytoma
Precautions and Warnings
Allergic disposition
Elderly
Bradycardia
Breastfeeding
Decompensated liver disease
Diabetes mellitus
First degree atrioventricular block
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
Intermittent claudication
Ischaemic heart disease
Lactose intolerance
Myasthenia gravis
Peripheral vascular disease
Poor cardiac reserve
Portal hypertension
Pregnancy
Psoriasis
Raynaud's syndrome
Renal impairment - glomerular filtration rate below 20ml/minute
Thyrotoxicosis
Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Anaesthetist should be made aware patient is taking this medication
May mask symptoms of thyrotoxicosis
Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Oral solution with maltitol unsuitable in hereditary fructose intolerance
Some brands contain Sunset Yellow (E110) - can trigger allergic reactions
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Advise patient to report symptoms of allergic type hypersensitivity
Beta blockers may reduce the response to adrenaline in anaphylaxis
May aggravate symptoms of peripheral arterial circulatory disorders
Reduce dose or discontinue if symptoms of severe bradycardia occur
May affect results of some laboratory tests
Discontinue treatment 24 hours prior to surgery
Withdraw drug gradually, especially in patients with cardiac ischaemia
Discontinue if persistent or symptomatic hypotension occurs
Not licensed for all indications in all age groups
Hypotensive effects may be potentiated by alcohol
Beta-blockers, including those considered to be cardioselective, should not be given to patients with a history of asthma or bronchospasm. However, in rare situations where there is no alternative, a cardioselective beta-blocker is given to these patients with extreme caution and under specialist supervision.
Propranolol occasionally causes hypoglycaemia, even in non-diabetic patients. Severe hypoglycaemia associated with propranolol has rarely presented with seizures and or coma in isolated patients. Caution must be exercised in the concurrent use of propranolol and hypoglycaemia therapy in diabetic patients. Propranolol may prolong the hypoglycaemic response to insulin.
In patients with portal hypertension, liver function may deteriorate and hepatic encephalopathy may develop. There have been reports suggesting that treatment with propranolol may increase the risk of developing hepatic encephalopathy.
Pregnancy and Lactation
Pregnancy
Use propranolol with caution in pregnancy.
At the time of writing there is no evidence of teratogenicity with propranolol. However, beta adrenoceptor blocking agents reduce placenta perfusion, which may result in intra-uterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia in the neonate and bradycardia in the foetus) may occur. There is an increased risk of cardiac and pulmonary complications in the neonate in the post-natal period. The greatest weight reductions are seen when treatment begins in the second trimester (Briggs, 2015).
Lactation
Use propranolol with caution in breastfeeding.
Propranolol passes into breast milk. The manufacturers recommend not breastfeeding whilst using propranolol.
LactMed states that only low levels are seen in breast milk and the amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. Therefore no special precautions are required. Propranolol has been used successfully in cases of persistent pain of the breast during breastfeeding.
Side Effects
Agranulocytosis
Alopecia
Angina pectoris
Arthralgia
Blood dyscrasias
Bradycardia
Bronchospasm
Cardiac conduction disturbances
Cardiac failure
Change in lipid metabolism
Cold extremities
Confusion
Conjunctivitis
Constipation
Depression
Diarrhoea
Dizziness
Dry eyes
Dry mouth
Dyspnoea
Exacerbation of intermittent claudication
Exacerbation of myasthenia gravis
Exacerbation of psoriasis
Fatigue
Gastro-intestinal disturbances
Hallucinations
Headache
Hepatic encephalopathy (in patients with hepatic disease)
Hypoglycaemia
Hypotension
Increase in antinuclear antibodies (ANA)
Insomnia
Lassitude
Memory loss
Mood changes
Muscular fatigue
Myasthenia gravis-like syndrome
Nausea
Nightmares
Paraesthesia
Peripheral vasoconstriction
Postural hypotension
Precipitation of heart block
Psoriasiform rash
Psychoses
Purpura
Rash
Raynaud's phenomenon
Reduced renal blood flow
Seizures
Sexual dysfunction
Sleep disturbances
Syncope
Thrombocytopenia
Vertigo
Visual disturbances
Vomiting
Weight gain
Worsening heart failure
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: November 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.
Summary of Product Characteristics: Angilol 10mg film coated tablets. Chelonia Healthcare Ltd. Revised April 2019.
Summary of Product Characteristics: Angilol 40mg film coated tablets. Chelonia Healthcare Ltd. Revised April 2019.
Summary of Product Characteristics: Angilol 80mg film coated tablets. Chelonia Healthcare Ltd. Revised April 2019.
Summary of Product Characteristics: Bedranol 10mg tablets. Ennogen UK Ltd. Ennogen UK Ltd. Revised August 2017.
Summary of Product Characteristics: Bedranol 40mg tablets. Ennogen UK Ltd. Ennogen UK Ltd. Revised August 2017.
Summary of Product Characteristics: Bedranol 80mg tablets. Ennogen UK Ltd. Ennogen UK Ltd. Revised August 2017.
Summary of Product Characteristics: Bedranol 160mg tablets. Ennogen UK Ltd. Ennogen UK Ltd. Revised August 2017.
Summary of Product Characteristics: Propranolol tablets BP 10mg. Actavis UK Ltd. Revised June 2018.
Summary of Product Characteristics: Propranolol tablets BP 40mg. Actavis UK Ltd. Revised June 2018.
Summary of Product Characteristics: Propranolol tablets BP 80mg. Actavis UK Ltd. Revised June 2018.
Summary of Product Characteristics: Propranolol tablets BP 160mg. Actavis UK Ltd. Revised June 2018.
Summary of Product Characteristics: Propranolol 5mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised November 2017.
Summary of Product Characteristics: Propranolol 10mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised November 2017.
Summary of Product Characteristics: Propranolol 40mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised November 2017.
Summary of Product Characteristics: Propranolol 50mg/5ml Oral Solution. Rosemont Pharmaceuticals Ltd. Revised November 2017.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 27 November 2018
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: 31 October 2018
Last accessed: 27 November 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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