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PROPRANOLOL is a brand name for Propranolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propranolol is a competitive blocker of adrenergic β-receptor sites. It is indicated in: a) The control of hypertension. b) The management of angina pectoris. c) The prevention of re-infarction after recovery from acute myocardial infarction. d) The control of most forms of cardiac arrhythmias including sinus…
Verbatim from this product's MHRA label. Tap a section to expand.
Dosage requires individual adjustment. The lowest appropriate dose should be given initially to be able to identify cardiac decompensation or bronchial phenomena at an early stage. Subsequent increases in dose should take place slowly on the basis of clinical response.
A heart rate of 55/minute or less is an indication that dosage should be increased no further.
Posology Adults:
Hypertension: A starting dose of 80mg, twice a day, may be increased at weekly intervals according to response. The usual dose range is 160mg to 320mg per day. With concurrent diuretic or other antihypertensive drugs a further reduction of blood pressure is obtained.
Angina, migraine and essential tremor:
A starting dose of 40mg, 2 or 3 times daily may be increased by the same amount at weekly intervals according to patient response. An adequate response in migraine and essential tremor is usually seen in the range 80 to 160 mg/day and in angina in the range 120 to 240 mg/day.
Post myocardial infarction:
Treatment should start between day 5 and 21 after myocardial infarction, with an initial dose of 40mg, 4 times a day for 2 or 3 days. In order to improve compliance the total daily dosage may thereafter be given as 80mg twice a day.
Dysrhythmias, thyrotoxicosis: 10mg to 40mg, 3 or 4 times daily. Phaeochromocytoma: (Used only with an alpha-receptor blocking drug). Pre-operative: 60mg daily for 3 days is recommended. Non-operable malignant cases: 30mg daily.
Elderly people:
Evidence concerning the relationship between blood level and age is conflicting. Propranolol should be used to treat the elderly with caution. It is suggested that treatment should start with the lowest dose. The optimum dose should be individually determined according to clinical response.
Patients with renal and hepatic dysfunction:
The half-life of propranolol may be increased in patients with severe renal or hepatic impairment. Due caution should therefore be exercised when initiating treatment and selecting the dose to be employed. 5mg/kg, 3 or 4 times daily as required.
Propranolol is usually well tolerated. In clinical studies the undesired events reported are usually attributable to the pharmacological actions of propranolol. The following undesired events, listed by body system, have been reported.
The following definitions of frequencies are used:
Very common (≥ 1/10), common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Blood and lymphatic system disorders Rare: thrombocytopenia.
Frequency not known: agranulocytosis.
Endocrine disorders Frequency not known:
Hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis, patients on concomitant antidiabetic therapy, patients with prolonged fasting and patients with chronic liver disease has been reported, changes in lipid metabolism (changes in blood concentrations of triglycerides and cholesterol).
Psychiatric disorders Frequency not known: depression, confusion.
Nervous system disorders Common:
Sleep disturbances, nightmares.
Rare:
Hallucinations, psychoses, mood changes, confusion, memory loss, paraesthesia.
Very rare:
Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported. Frequency not known: headache, seizure linked to hypoglycaemia.
Eye disorders Rare:
Dry eyes, visual disturbances. Frequency not known: conjunctivitis. Cardiovascular disorders Common: bradycardia, cold extremities, Raynaud’s phenomenon Rare: Heart failure deterioration, precipitation of heart block, postural hypotension which may be associated with syncope, exacerbation of intermittent claudication Frequency not known: worsening of attacks of angina pectoris.
3), may be used in patients whose signs of heart failure have been controlled. Caution must be exercised in patients whose cardiac reserve is poor. g. verapamil, diltiazem), as it can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or SA or AV conduction abnormalities.
This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-blocker nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other. 3), may also aggravate less severe peripheral arterial circulatory disturbances.
Therefore, propranolol should be used with great caution in conditions such as Raynaud's disease/syndrome or intermittent claudication. - Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block.
- May block/modify the signs and symptoms of hypoglycaemia (especially tachycardia). g. neonates, infants, children, elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose.
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 hypoglycaemic therapy in diabetic patients. 3). - Heart failure due to thyrotoxicosis often responds to propranolol alone, but if other adverse factors co-exist myocardial contractility must be maintained and signs of failure controlled with digitalis and diuretics.
Propranolol may mask the important signs of thyrotoxicosis and hyperthyroidism. - Should not be used in untreated pheochromocytoma. However, in patients with pheochromocytoma an alpha-blocker may be given concomitantly. - Will reduce heart rate as a result of its pharmacological action.
1. Propranolol must not be used if there is a history of bronchial asthma or bronchospasm. The product label states the following warning: “do not take this medicine if you have a history of wheezing or asthma”. A similar warning appears in the patient information leaflet.
Bronchospasm can usually be reversed by beta2 agonist bronchodilators such as salbutamol. Large doses of the beta2 agonist bronchodilator may be required to overcome the beta blockade produced by propranolol and the dose should be titrated according to the clinical response; both intravenous and inhalational administration should be considered.
The use of intravenous aminophylline and/or the use of ipratropium (given by nebuliser) may also be considered. Glucagon (1 to 2 mg given intravenously) has also been reported to produce a bronchodilator effect in asthmatic patients.
Oxygen or artificial ventilation may be required in severe cases. Propranolol as with other beta-blockers must not be used in patients with any of the following conditions: - Bradycardia - Cardiogenic shock - Hypotension - Metabolic acidosis - After prolonged fasting - Severe peripheral arterial circulatory disturbances - Second- and third-degree heart block - Sick sinus syndrome (including sino-atrial block) - Untreated pheochromocytoma - Uncontrolled heart failure - Prinzmetal’s angina.
, patients after prolonged fasting or patients with restricted counter-regulatory reserves. Patients with restricted counter regulatory reserves may have reduced autonomic and hormonal responses to hypoglycaemia which includes glycogenolysis, gluconeogenesis and /or impaired modulation of insulin secretion.
Patients at risk for an inadequate response to hypoglycaemia includes individuals with malnutrition, prolonged fasting, starvation, chronic liver disease, diabetes and concomitant use of drugs which block the full response to catecholamines.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Migraine:
Oral: Children under the age of 12: 20mg, 2 or 3 times daily.
Over the age of 12:
The adult dose.
Method of administration:
For oral administration.
Respiratory, thoracic and mediastinal disorders Rare:
Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome. Frequency not known: dyspnoea.
Gastrointestinal disorders Uncommon:
Gastrointestinal disturbance such as diarrhoea, nausea, vomiting. Frequency not known: constipation, dry mouth. Skin and subcutaneous tissue disorders Rare: alopecia, purpura, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.
Musculoskeletal system and connective tissue disorders Frequency not known: arthralgia. Renal and urinary disorders Frequency not known: reduced renal blood flow and GFR. Reproductive system and breast disorders Frequency not known: sexual dysfunction.
General disorders and administration site conditions Common: fatigue and/or lassitude (often transient).
Rare:
Dizziness.
Investigations Very rare:
An increase in ANA (antinuclear antibodies) has been observed, however the clinical relevance of this is not clear. Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions.
Cessation of therapy with a beta-blocker should be gradual. In the rare event of intolerance, manifested as bradycardia and hypotension, the drug should be withdrawn and, if necessary, treatment for overdosage instituted. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In the rare instances when a treated patient develops symptoms which may be attributable to a slow heart rate, the dose may be reduced. - May cause a more severe reaction to a variety of allergens when given to patients with a history of anaphylactic reaction to such allergens.
Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. Abrupt withdrawal of beta-blockers is to be avoided. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable.
In the rare event of intolerance, manifested as bradycardia and hypotension, the drug should be withdrawn and, if necessary, treatment for overdosage instituted. The sudden withdrawal of beta-receptor antagonists may result in severe exacerbation of angina pectoris, acute myocardial infarction, sudden death, malignant tachycardia, sweating, palpitation and tremor.
The dosage should be withdrawn gradually over a period of 7 to 14 days. Either the equivalent dose of another beta-blocker may be substituted, or the withdrawal of Propranolol should be gradual. This can be carried out by substituting the equivalent dose in propranolol tablets and then reducing the dose.
Patients should be followed during withdrawal especially those with ischaemic heart disease. 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. Since the half-life may be increased in patients with significant hepatic or renal impairment, caution must be exercised when starting treatment and selecting the initial dose.
2). In patients with portal hypertension, liver function may deteriorate and hepatic encephalopathy may develop. 2).
Interference with 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. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.