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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: • Control of hypertension • Management of angina • Management of essential tremor • Management of situational anxiety and generalised anxiety symptoms • Adjunctive management of thyrotoxicosis • Prophylaxis of migraine • Prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults Hypertension:
The usual starting dose is one Propranolol 160 mg Sustained-Release Capsule daily, taken either morning or evening. An adequate response is seen in most patients at this dosage. If necessary, it can be increased in 80 mg increments until an adequate response is achieved (up to a maximum of 320 mg daily).
A further reduction in blood pressure can be attained if a diuretic or other antihypertensive agent is given in addition.
Angina, essential tremor, thyrotoxicosis, prophylaxis of migraine:
Adequate control is gained in most patients on one Propranolol 80 mg Capsule per day (either morning or evening). If necessary, further control may be gained by increasing the dose in 80 mg increments (one 80 mg Capsule) to a maximum of 240 mg per day, taken either morning or evening, which may be administered in the most convenient form using either Propranolol 160 mg or 80 mg Capsules.
Situational and generalised anxiety:
An 80 mg Capsule taken daily should be sufficient to provide short-term relief of acute situational anxiety. Generalised anxiety, requiring longer term therapy, usually responds adequately at the same dosage. In individual cases, the dosage may be increased to one Propranolol 160 mg Capsule per day.
Treatment should be continued according to patient’s response. Patients should be reviewed after 6 to 12 months’ treatment.
Portal Hypertension:
Since portal blood pressure cannot normally be monitored directly, dosage should be titrated to achieve approximately 25% reduction in resting heart rate. Dosing should begin with one Propranolol 80 mg Capsule daily, increasing to one 160 mg Capsule daily depending on heart rate response.
Further 80 mg Capsule increments may be added up to a maximum dose of 320 mg once daily. Patients who are already established on equivalent daily doses of Propranolol should be transferred to the equivalent doses of 80 mg or 160 mg Sustained-Release Capsules daily, taken either morning or evening.
Older People Evidence concerning the relation between blood level and age is conflicting. Treatment should start with one Propranolol 80 mg Capsule once daily. The dose may be increased to one 160 mg Capsule daily or higher as appropriate.
Propranolol 160 mg and 80 mg Sustained-Release Capsules are usually well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of propranolol.
Adverse reactions frequency is defined using the following convention:
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). Frequency Organ System Common Uncommon Rare Very rare Not known General Fatigue and/or lassitude (often transient) Dizziness Cardiovascula r Bradycardi a, cold extremities, Raynaud’s phenomeno n Heart failure deterioration, precipitation of heart block, postural hypotension, which may be associated with syncope, exacerbation of intermittent claudication CNS Sleep isturbanc e, nightmares.
Hallucinations, psychoses, mood changes, confusion, memory loss GI Gastrointestin al disturbance, such as nausea, vomiting, diarrhoea Blood Thrombocytopaeni a Skin Purpura, alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.
Neurological Paraesthesia Eyes Dry eyes, visual disturbances Respiratory Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome Endocrine system Hypoglycaemi a 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.
Seizure linked to hypoglycaemi a. Investigations An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear Nervous system Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported Headaches Reproductive System & Breast Disorders Impotence 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.
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. • 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.
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 not the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other. • beta-blockers may increase the number and duration of anginal attacks in patients with Prinzmetal’s angina, due to unopposed alpha-receptor mediated coronary artery vasoconstriction.
3). • in patients with peripheral circulatory disorders (Raynaud’s disease or syndrome, intermittent claudication), beta-blockers should be used with great caution as aggravation of these disorders may occur. 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. • may block/modify the signs and symptoms of the hypoglycaemia (especially tachycardia). , 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 160 mg and 80 mg Sustained-Release Capsules has rarely presented with seizures and/or coma in isolated patients. Caution must be exercised in the concurrent use of Propranolol 160 mg and 80 mg Sustained-Release Capsules and hypoglycaemic therapy in diabetic patients.
e. patients after sustained fasting or patients with restricted counter-regulatory reserves.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Propranolol in United Kingdom.
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Paediatric population Propranolol 160 mg Sustained-Release Capsules and 80 mg Sustained-Release Capsules are not intended for use in children. Method of administration For oral administration.
Cessation of therapy with a beta-adrenoceptor blocking drug 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.
3). • may mask the signs of thyrotoxicosis. • should not be used in untreated phaeochromocytoma. However, in patients with phaeochromocytoma, an alpha-blocker may be given concomitantly. 2). • will reduce heart rate as a result of its pharmacological action.
In the rare instances, if the pulse rate decreases to below 50-55 beats per minute at rest, when a treated patient develops symptoms that 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. 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 80 mg Sustained-Release Capsules.
Patients should be followed during withdrawal especially those with ischaemic heart disease.
Anaesthesia:
As with all beta-adrenoceptor blocking drugs it may be decided to withdraw Propranolol before surgery. In this case 24-48 hours should be allowed to elapse between the last dose and anaesthesia. If treatment is continued care should be taken when using anaesthetic agents which cause myocardial depression such as cyclopropane and trichloroethylene, which are best avoided.
Anaesthetics may cause attenuation of the reflex tachycardia and increase the risk of hypotension. Continuation of beta-blockade reduces the risk of arrhythmia during induction and intubation. The anaesthesiologist should be informed when the patient is receiving a beta-blocking agent.
). 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). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Patients with rare hypersensitivity for sulphur dioxide should not take this medicine; which may cause hypersensitivity reactions and bronchospasm. Patients with a history of wheezing or asthma should not take propranolol unless it is considered essential.
The product label states the following warning: “Do not take Propranolol 160 mg Sustained-Release Capsules if you have a history of asthma or wheezing”. A similar warning appears in the Patient Information Leaflet. Bronchospasm can usually […]