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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: • Angina pectoris. • Hypertension. • Long-term prophylaxis against myocardial reinfarction after recovery from acute myocardial infarction Hypertrophic obstructive cardiomyopathy. • Essential tremor. • Supraventricular cardiac arrhythmia. • Ventricular cardiac arrythmias. • Hyperthyroidism and thyrotoxicosis…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
Angina pectoris: The starting dose is 40 mg two to three times daily, increasing by the same amount at weekly intervals according to the response. The dose may be increased to120 - 240 mg daily.
Migraine:
The starting dose is 40 mg two to three times daily. The dose may be increased to 80mg -160 mg daily.
Essential tremor:
The starting dose is 40 mg two to three times daily. For these indications the dosage and the dose intervals should be adapted to individual patient needs.
Hypertension:
Initially 40 mg two or three times daily, which may be increased by 80 mg per day at weekly intervals according to response. The usual dose range is 160-320 mg daily. With concurrent diuretic and/or peripheral vasodilators a further reduction of blood pressure is obtained.
Arrhythmias The starting dose is 10 mg to -40 mg two or three times a day.
Hypertrophic obstructive cardiomyopathy:
Most patients respond within the dosage range of 10-40mg three or four times daily.
Post myocardial infarction:
Treatment should be initiated when myocardial infarction has been stabilized with an initial dose of 40 mg 2-3 times daily for two or three days. In order to improve compliance, the total daily dosage may thereafter be given as 80 mg twice a day.
Thyrotoxicosis:
Most patients respond within the dosage range of 10-40 mg three or four times daily.
Hyperthyroidism:
The dose is adjusted according to clinical response.
Phaeochromocytoma (used only in conjunction with an alpha-receptor blocking drug):
Pre-operatively; 60 mg daily for three days is recommended. In-operable malignant cases, 30 mg daily.
Portal Hypertension:
Summary of the safety profile Propranolol is usually well tolerated. In clinical studies the undesired events reported are usually attributable to the pharmacological actions of propranolol. Side effects are mostly related to the pharmacological effect.
Most common are fatigue, including muscle weakness reported in between 3-5%. Adverse reactions related to propranolol are listed below by system organ class and frequency.
Frequencies are defined as:
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); Frequency not known (cannot be estimated from the available data).
The following undesired events, listed by body system, have been reported:
Blood and lymphatic system disorders Rare: thrombocytopenia, Frequency not known: agranulocytosis Immune system disorders Rare: angioedema. Endocrine disorders Frequency not known: masking signs of thyrotoxicosis. Metabolic and nutritional disorders Very rare : 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). Severe hypoglycemia may rarely lead to seizures or coma.
Psychiatric disorders Common:
Sleep disturbances, nightmares.
Rare:
Hallucinations, psychoses, mood changes Frequency not known: depression Nervous system disorders Rare: confusion, memory loss, dizziness, paraesthesia.
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.
- Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first degree heart block. - Propranolol may block/modify the signs and symptoms of the hypoglycaemia (especially tachycardia).
Propranolol may occasionally cause hypoglycaemia even in non-diabetics patients, such as neonates, infants, children, elderly patients, patients on hemodialysis 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 hypoglycemic therapy in diabetic patients. 3). - Propranolol may mask signs of thyrotoxicosis.
- Should not be used in untreated phaeochromocytoma. However, in patients with phaeochromocytoma, an alpha-blocker may be given concomitantly. ; In the rare instances when a treated patient develops symptoms may be attributable to 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.
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 Propranolol if you have a history of asthma or wheezing”. 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: - Cardiac decompensation which is not adequately treated. - Sick sinus syndrome/SA-block.
- History of bronchospasm or bronchial asthma, chronic obstructive pulmonary disease. - Metabolic acidosis. - Second and third-degree heart block. g. due to prolonged fasting or restricted counter regulatory reserve. - Cardiogenic shock.
- Untreated phaeochromocytoma. , 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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Dosage should be titrated to achieve approximately 25% reduction in heart rate at rest. Dosing should begin with 40 mg twice daily, increasing to 80 mg twice daily depending on heart rate response. If necessary, the dose may be increased incrementally to a maximum of 160 mg twice daily.
Pediatric population:
Arrhythmias: Dosage should be determined according to the cardiac status of the patient and the circumstances necessitating treatment. 5 mg/kg 3-4 times daily, adjusted according to clinical response.
Elderly:
Evidence concerning the relationship between blood level and age is conflicting. Propranolol should be used to treat older people with caution. It is suggested that treatment should start with the lowest dose. The optimum dose should be individually determined according to clinical response.
Hepatic impairment:
The bioavailability of propranolol may be increased in patients with hepatic impairment and dose adjustments may be required. g. cirrhosis) a low initial dose is recommended (not exceeding 20 mg three times a day) with close monitoring of the response to treatment (such as the effect on heart rate).
Renal impairment:
Concentrations of propranolol may increase in patients with significant renal impairment and haemodialysis. Caution should be exercised when starting treatment and selecting the initial dose. As with other beta-adrenoceptor blocking agents, treatment should not be discontinued abruptly.
The dosage should be withdrawn gradually over a period of 7 to 14 days. Either the equivalent dosage of another beta- adrenoceptor blocker may be substituted or the withdrawal of propranolol should be gradual. Patients should be followed during withdrawal especially those with ischaemic heart disease.
The risk/benefit of stopping beta blockade should be made for each patient.
Method of administration:
The tablets should preferably be administered before meals. For oral administration.
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: visual disturbances, dry eyes Frequency not known: conjunctivitis Cardiac disorders Common: bradycardia Rare: Heart failure deterioration, precipitation of heart block, postural hypotension which may be associated with syncope, Frequency not known: worsening of attacks of angina pectoris Vascular disorders Common: cold extremities, Raynaud's syndrome Rare: exacerbation of intermittent claudication, Respiratory thoracic and mediastinal disorders Common: breathlessness 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: 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 Very rare: isolated cases of hyperhidrosis has been reported.
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: impotence 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 with many beta blockers, however the clinical relevance of this is not clear.
Discontinuance of the drug should be considered if, according to clinical judgement, the wellbeing of the patient is adversely affected by any of the above reactions. 4). 9). 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.
Abrupt withdrawal of beta-blockers is to be avoided. The dosage should be withdrawn gradually over a period of 7 to 14 days. 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 48 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). In patients with chronic obstructive pulmonary disease, non-selective beta blockers such as propranolol may aggravate the obstructive condition.
3). Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported in patients administered propranolol.
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.
Important information regarding the ingredients of this medicine Lactose:
This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.