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BEDRANOL (PROPRANOLOL HYDROCHLORIDE) SR is a brand name for Propranolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: a) Control of hypertension. b) Management of angina. c) Prophylaxis of migraine. d) Management of essential tremor. e) Management of anxiety. f) Adjunctive management of thyrotoxicosis. g) Prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults (i) Hypertension The initial dose is usually 160mg daily taken orally in the morning or evening. An adequate response is seen by most patients at this dosage. If necessary it can be increased in 80 mg increments until the desired response is achieved (up to a maximum of 320 mg daily).
A further reduction in blood pressure may be achieved by combining Bedranol* SR with other anti-hypertensive agents or a diuretic. (ii) aAngina, essential tremor, thyrotoxicosis, and the prophylaxis of migraine The usual dose is 80mg daily, taken orally in the morning or evening, may be sufficient to give adequate control to most patients.
The dose may be increased to 160mg, and then if necessary further increased to 240mg per day. (iii) Situational and generalised anxiety A daily dose of one Bedranol* SR 80 mg Capsule 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 some case the dosage may be increased to 160 mg. Patients should be reviewed after 6 – 12 months of treatment. Treatment should be continued in accordance with the patient’s response.
(iv) Portal hypertension Dosage should be aimed to achieve approximately 25% reduction in resting heart rate. Dosing should be initiated at 80 mg increasing to 160 mg depending on heart rate response. Further 80 mg increments may be added up to a maximum dose of 320 mg once daily.
Patients who are already established on 160mg propranolol daily, one capsule of Bedranol* SR Capsules 160mg may be given, taken either in the morning or evening. Older people The evidence concerning the relationship between blood levels and age are conflicting.
It is suggested that older people being started off on propranolol treatment may need smaller initial doses and in these circumstances Bedranol* SR Capsules 80mg or an alternative preparation should be considered. Paediatric population Bedranol* SR is not suitable for use in children.
Method of administration For oral use.
Bedranol* SR 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.
Common may affect up to 1 in 10 people General:
Fatigue and/or lassitude (often transient) Cardiovascular: Bradycardia, cold extremities, Raynaud's phenomenon.
CNS:
Sleep disturbances, nightmares.
Uncommon may affectup to 1 in 100 people GI:
Gastrointestinal disturbance, such as nausea, vomiting, diarrhoea.
Rare may affect 1 in 1,000 people General:
Dizziness.
Blood:
Thrombocytopaenia.
Cardiovascular:
Heart failure deterioration, precipitation of heart block, postural hypotension, which may be associated with syncope, exacerbation of intermittent claudication.
CNS:
Hallucinations, psychoses, mood changes, confusion, memory loss.
Skin:
Purpura, alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes.
Neurological:
Paraesthesia.
Eyes:
Dry eyes, visual disturbances.
Patients with a history of wheezing or asthma should not take propranolol unless it is considered essential. ”. The patient information leaflet will state “Do not take this medicine if you have a history of wheezing or asthma. ”. In patients with ischaemic heart disease treatment must not be discontinued abruptly.
Either the equivalent dose of another beta-blocker may be substituted, or the withdrawal of Bedranol* SR should be gradual. This can be carried out by substituting the equivalent dose in propranolol 40mg tablets and then reducing the dose.
Bedranol* SR may aggravate peripheral arterial circulatory disturbances. 3) Bedranol* SR can be given to patients whose signs of heart failure have been controlled. Caution should be taken in patients with a poor cardiac reserve. As propranolol has a negative effect on conduction time, care must be taken when giving it to patients with first degree heart block.
Bedranol* SR will reduce the heart rate due to its pharmacological action. Rarely a patient taking this medicine may develop symptoms that may be attributed to a slower heart rate then the dose may be reduced. 3). 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 could result in severe hypotension, bradycardia and cardiac failure. Neither the beta blocker nor the calcium channel blocker should be given intravenously within 48 hours of discontinuing the other. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Intolerance to propranolol, shown as bradycardia and hypotension may occur, in which case propranolol should be withdrawn. If necessary, treatment for overdose should be started. Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions, they also may make patients less responsive to doses of adrenaline used to treat the allergic reactions.
1: • hypersensitivity to propranolol or any of the other ingredients • a history of bronchospasm or asthma • bradycardia • second or third degree heart block • sick sinus syndrome • cardiogenic shock • uncontrolled heart failure • hypotension • severe peripheral arterial disease • Prinzmetal’s angina • untreated phaeochromocytoma • prolonged fasting, or prone to hypoglycaemia • metabolic acidosis.
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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Respiratory:
Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome. Very rare may affect up to 1 in 10,000 people 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. Not known ( frequencycannot be estimated from the available data) Endocrine system: 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.
Seizure linked to hypoglycaemia 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. Cases of abnormal weight gain have also been reported. 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).
Bedranol* SR may mask the signs of thyrotoxicosis. Bedranol* SR should not be used in untreated phaeochromocytoma, but in patients with phaeochromocytoma an alpha blocker may be administered concomitantly. 2). Care must be taken in patients with renal or hepatic dysfunction when beginning treatment and choosing the initial dose.
Bedranol* SR should be used with care in patients with decompensated cirrhosis. In patients with portal hypertension, liver function may deteriorate. There have been reports that treatment with propranolol may increase the risk of developing hepatic encephalopathy.
Since the half life may be increased in patients with a significant hepatic or renal impairment, cautions should be taken especially at the start of treatment and the initial dosage. Propranolol, as with other beta-blocking drugs may block the 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. It has rarely caused seizures and/or coma in isolated patients. Caution should be exercised in the concurrent use of propranolol therapy in diabetic patients as it may prolong the hypoglycaemic response to insulin.
Bronchospasms can usually be reversed by beta 2 agonist bronchodilators such as salbutamol. Large doses beta 2 agonist bronchodilators may be needed to overcome the beta blockade produced by propranolol and the dose should be titrated according to the clinical response; both intravenous and inhalation administration should be considered.
The use of intravenous aminophylline and / or ipratropium (given via a nebuliser) should 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 necessary in severe cases.
When a patient is going to have surgery and a decision made to discontinue the 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.
Withdrawal of the drug for any reason should be gradual.
Interference with laboratory tests:
Bedranol* SR has been reported to interfere with the estimation of serum bilirubin using the diazo method and with the determination of catecholamines by methods when using fluorescence.