PROPRANOLOL ROSEMONT

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.