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PROPRANOLOL ROSEMONT is a brand name for Propranolol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Propranolol is indicated in: - the control of hypertension - the management of angina pectoris - the long term prophylaxis against reinfarction after recovery from acute myocardial infarction - the control of most forms of cardiac arrhythmia - the prophylaxis of migraine - the management of essential tremor - relief…
Verbatim from this product's MHRA label. Tap a section to expand.
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 160 – 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 two or three 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 80-160mg/day and in angina in the range 120-240mg/day.
Situational and generalised anxiety – A dose of 40mg daily may provide short term relief of acute situational anxiety. Generalised anxiety, requiring longer term therapy, usually responds adequately to 40mg twice daily which, in individual cases, may be increased to 40mg three times daily.
Treatment should be continued according to response. Patients should be reviewed after six to twelve months treatment. Arrhythmias, anxiety, tachycardia, hypertrophic obstructive cardiomyopathy and thyrotoxicosis – A dosage range of 10-40mg three or four times a day usually achieves the required response.
Post myocardial infarction - Treatment should start between days 5 and 21 after myocardial infarction with an initial dose of 40mg four times a day for 2 or 3 days. In order to improve compliance the total daily dosage may thereafter be given as 80mg twice daily.
Portal hypertension:
Dosage should be titrated to achieve approximately 25% reduction in resting heart rate. Dosage should begin with 40mg twice daily, increasing to 80mg twice daily depending on heart rate response. If necessary, the dose may be increased incrementally to a maximum of 160mg twice daily.
Phaeochromocytoma (Used only with an alpha-receptor blocking drug)- Pre-operative: 60mg daily for three days is recommended. Non-operable malignant cases: 30mg daily. Elderly Evidence concerning the relation 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 the clinical response. Paediatric population Arrhythmias, phaeochromocytoma, thyrotoxicosis – Dosage should be individually determined and the following is only a guide: 250 – 500 micrograms per kilogram three or four times daily as required.
Propranolol is usually well tolerated, however, listed below are the side effects that may occur: 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). System 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 (frequency cannot be estimated from the available data Blood and lymphatic system disorders: Thrombocytopenia Endocrine disorders 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 Nervous system disorders: Sleep disturbances, nightmares Confusion, mood changes, psychoses, hallucinations memory loss, paraesthesia Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported Depression Eye disorders: Dry eyes, visual disturbances Cardiac disorders: Bradycardia Heart failure deterioration, precipitation of heart block, congestive cardiac failure Vascular disorders: Cold extremities, Raynaud’s phenomenon Exacerbation of intermittent claudication, postural hypotension which may be associated with syncope Respiratory, thoracic and mediastinal disorders: Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome Gastrointestinal disorders: Gastrointestinal disturbance, such as nausea, vomiting, diarrhoea Skin and subcutaneous tissue disorders: Purpura, alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes General disorders and administration site conditions: Fatigue and/or Lassitude (often transient) Dizziness Investigations: An increase in ANA (antinuclear antibodies), although the clinical relevance of this has not been established Weight gain If these effects occur, thought should be given to withdrawing the drug.
3), propranolol may be used where the signs of heart failure have been controlled by the use of appropriate concomitant medication. Propranolol should be used with caution in patients whose cardiac reserve is poor. Treatment should not be discontinued abruptly in patients with ischaemic heart disease.
Either the equivalent dose of another beta-adrenoceptor blocking drug may be substituted or the withdrawal of propranolol should be gradual over a period of 7 to 14 days. Patient should be followed during withdrawal especially those with ischaemic heart disease.
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. Propranolol may block/modify the signs and symptoms of 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 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). 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 Propranolol should not be used in untreated phaeochromocytoma. However, in patients with phaeochromocytoma, an alpha-blocker may be given concomitantly. 3), propranolol may also aggravate less severe peripheral arterial circulatory disturbances.
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 2mg 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-adrenoceptor blocking drugs must not be used in patients with any of the following: hypersensitivity to propranolol hydrochloride or any of the ingredients; the presence of second or third degree heart block; in cardiogenic shock; metabolic acidosis; after prolonged fasting; bradycardia; hypotension; severe peripheral arterial circulatory disturbances; sick sinus syndrome; untreated phaeochromocytoma; uncontrolled heart failure or 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 – Under the age of 12: 20mg two or three times daily Over the age of 12: the adult dose Fallot’s tetralogy – The value of propranolol in this condition is confined mainly to the relief of right-ventricular outflow tract shut-down.
It is also useful for treatment of associated arrhythmias and angina.
Dosage should be individually determined and the following is only a guide:
Up to 1mg/Kg repeated three or four times a day as required.. Method of administration For oral administration only.
However, it should be withdrawn gradually. Bradycardia and hypotension are usually a sign of overdosage but may be rarely linked to intolerance. If this occurs the drug should be withdrawn and overdosage treatment initiated. 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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
One of the pharmacological actions of propranolol is to reduce the heart rate. Therefore the dosage should be reduced in those rare cases where symptoms are attributable to a slow heart rate. Due to propranolol having a negative effect on conduction time, caution must be exercised if it is given to patients with first degree heart block.
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. In patients with portal hypertension, liver function may deteriorate and hepatic encephalopathy may develop.
2). Propranolol 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.
Propranolol may mask the signs of thyrotoxicosis. 2). 2) 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.
liquid maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine - Propylene glycol 20 mg in each ml. - Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.
- While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.
- Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.
9 mg of alcohol (ethanol) in each ml. The amount in 5ml dose of this medicine is equivalent to less than 1 ml beer or 1 ml wine. The small amount of alcohol in this medicine will not have any noticeable effects.