Plain-language summary, compiled from the cited regulatory records
Propranolol is a medication belonging to the drug class of non-selective beta-blocking agents [1]. It is approved for the management of hypertension, also known as high blood pressure [1]. Propranolol hydrochloride tablets can be used as a standalone treatment or in combination with other medications for high blood pressure, such as thiazide diuretics [1]. However, it is not indicated for the treatment of hypertensive emergencies [1].
Additionally, propranolol hydrochloride tablets are indicated to reduce the frequency of angina pectoris, a type of chest pain caused by coronary atherosclerosis, and to improve exercise tolerance in affected patients [1].
Propranolol is available under various brand names [1].
This is not medical advice. Consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
• Management of angina pectoris • Control of hypertension • Long-term management against re-infarction after recovery from acute myocardial infarction • Management of hypertrophic obstructive cardiomyopathy • Management of essential tremor • Relief of situational anxiety and generalised anxiety symptoms, particularly those of somatic type • Control of most forms of cardiac disrhythmias • Adjunctive management of thyrotoxicosis and thyrotoxic crisis • Management of phaeochromocytoma peri-operatively (with an alpha-blocker) • Prophylaxis of migraine • Prophylaxis of upper gastrointestinal bleeding in patients with portal hypertension and oesophageal varices
How to take
USUnited States· FDA
14 products
Uses
USOfficial regulatory label· revised April 22, 2026[2]
INDICATIONS AND USAGE
Hypertension Propranolol hydrochloride tablets, USP are indicated in the management of hypertension. They may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride tablets, USP are not indicated in the management of hypertensive emergencies.
Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets, USP are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets, USP are indicated to control ventricular rate in patients with atrial fibrillation and a rapid ventricular response.
Myocardial Infarction Propranolol hydrochloride tablets, USP are indicated to reduce cardiovascular mortality in patients who have survived the acute phase of myocardial infarction and are clinically stable. Migraine Propranolol hydrochloride tablets, USP are indicated for the prophylaxis of common migraine headache.
CACanada· Health Canada
2 products
Uses
CAOfficial regulatory label· revised March 22, 2025[3]
HEMANGIOL (propranolol oral solution) is indicated for:
The treatment of proliferating infantile hemangioma requiring systemic therapy: Life- or function-threatening hemangioma, Ulcerated hemangioma with pain and/or lack of response to simple wound care measures, Hemangioma with a risk of permanent scarring or disfigurement.
Treatment should be initiated in infants aged 5 weeks to 5 months. Age for treatment initiation should be corrected in case of prematurity. HEMANGIOL therapy should be initiated and monitored by healthcare professionals experienced in the use of beta-blockers in infants and in the management of infantile hemangioma.
1 Pediatrics Pediatrics (below 5 weeks of age or below 5 weeks of corrected age for premature babies): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for these pediatric populations.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised February 9, 2023[4]
HEMANGIOL is indicated in the treatment of proliferating infantile haemangioma requiring systemic therapy: • Life- or function-threatening haemangioma, • Ulcerated haemangioma with pain and/or lack of response to simple wound care measures, • Haemangioma with a risk of permanent scars or disfigurement.
2).
How to take
Drug interactions
Known interactions involving Propranolol. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 600. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]FDA DailyMed · 07c3fcab-33fe-4a… · revised April 22, 2026 [PDF]
[3]Health Canada (DPD) · 02457857 · revised March 22, 2025
[4]European Medicines Agency · EMEA/H/C/002621 · revised February 9, 2023
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 29, 2026[1]
Posology Adults and children over 12 years:
Angina, migraine and essential tremor: Initially, 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.
Hypertension:
Initially 80mg twice daily, which may be increased at weekly intervals according to response. The usual dose range is 160-320mg/daily. With concurrent diuretic or other antihypertensive drugs a further reduction of blood pressure is obtained.
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. 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.
Post myocardial infarction:
Treatment should be initiated 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 a day.
Phaeochromocytoma: (Used only with an alpha-receptor blocking drug). Pre-operative: 60mg daily for three days is recommended. Non-operable malignant cases: 30mg 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 dosage may be increased incrementally to a maximum of 160mg twice daily.
Elderly people:
Evidence concerning the relationship 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 clinical response.
5mg/kg three or four times daily as required.
Migraine Oral:
Under the age of 12: 20 mg 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 dysrhythmias and angina.
Dosage should be individually determined and the following is only a guide:
Oral: Up to 1 mg/kg repeated three or four times daily as required. Method of administration For oral use.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 29, 2026[1]
Propranolol 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.
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 Organ class Frequency Undesirable Effect Blood and lymphatic system disorders Rare Thrombocytopaenia Endocrine disorders Not known 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 Common Sleep disturbances, nightmares Rare Hallucinations, psychoses, mood changes, confusion, memory loss, paraesthesia Very Rare Isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported Eye disorders Rare Dry eyes, visual disturbances Cardiovascular Disorders Common Bradycardia, cold extremities, Raynaud’s phenomenon Rare Heart failure deterioration, precipitation of heart block, postural hypotension, which may be associated with syncope, exacerbation of intermittent claudication Respiratory, thoracic and mediastinal disorders Rare Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome Gastrointestinal disorders Uncommon Gastrointestinal disturbance, such as nausea, vomiting, diarrhea Skin and subcutaneous tissue disorders Rare Purpura, alopecia, psoriasis form skin reactions, exacerbation of psoriasis, skin rashes 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, however the clinical relevance of this is not clear 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. 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.
GBOfficial regulatory label· Warnings and precautions· revised May 29, 2026[1]
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. - may block/modify the signs and symptoms of the hypoglycaemia (especially tachycardia). g. 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). - 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. - will reduce heart rate as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which 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. 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 24 hours prior to the procedure.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 29, 2026[1]
1. Propranolol tablet 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 tablet 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 tablet as with other beta-blockers must not be used in patients with any of the following conditions: known hypersensitivity to the substance; bradycardia; cardiogenic shock; hypotension; metabolic acidosis; after prolonged fasting; severe peripheral arterial circulatory disturbances; second or third degree heart block; 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.
This is not medical advice. Consult a qualified healthcare professional.
The efficacy of propranolol in the treatment of a migraine attack that has started has not been established, and propranolol is not indicated for such use. Essential Tremor Propranolol hydrochloride tablets, USP are indicated in the management of familial or hereditary essential tremor.
Familial or essential tremor consists of involuntary, rhythmic, oscillatory movements, usually limited to the upper limbs. It is absent at rest, but occurs when the limb is held in a fixed posture or position against gravity and during active movement.
Propranolol hydrochloride causes a reduction in the tremor amplitude, but not in the tremor frequency. Propranolol hydrochloride tablets, USP are not indicated for the treatment of tremor associated with Parkinsonism. Hypertrophic Subaortic Stenosis Propranolol hydrochloride tablets, USP improves NYHA functional class in symptomatic patients with hypertrophic subaortic stenosis.
Pheochromocytoma Propranolol hydrochloride tablets, USP are indicated as an adjunct to alpha-adrenergic blockade to control blood pressure and reduce symptoms of catecholamine-secreting tumors.
How to take
USOfficial regulatory label· revised April 22, 2026[2]
DOSAGE AND ADMINISTRATION
General Because of the variable bioavailability of propranolol, the dose should be individualized based on response. Hypertension The usual initial dosage is 40 mg propranolol hydrochloride twice daily, whether used alone or added to a diuretic.
Dosage may be increased gradually until adequate blood pressure control is achieved. The usual maintenance dosage is 120 mg to 240 mg per day. In some instances a dosage of 640 mg a day may be required. The time needed for full antihypertensive response to a given dosage is variable and may range from a few days to several weeks.
While twice-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, some patients, especially when lower doses are used, may experience a modest rise in blood pressure toward the end of the 12 hour dosing interval.
This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. If control is not adequate, a larger dose, or 3 times daily therapy may achieve better control.
Angina Pectoris Total daily doses of 80 mg to 320 mg propranolol hydrochloride, when administered orally, twice a day, three times a day, or four times a day, have been shown to increase exercise tolerance and to reduce ischemic changes in the ECG.
If treatment is to be discontinued, reduce dosage gradually over a period of several weeks (see WARNINGS ). Atrial Fibrillation The recommended dose is 10 mg to 30 mg propranolol hydrochloride three or four times daily before meals and at bedtime.
d. as tolerated. The recommended daily dosage is 180 mg to 240 mg propranolol hydrochloride per day in divided doses. d. d. d. d. regimen (see PHARMACODYNAMICS AND CLINICAL EFFECTS ). The effectiveness and safety of daily dosages greater than 240 mg for prevention of cardiac mortality have not been established.
However, higher dosages may be needed to effectively treat coexisting diseases such as angina or hypertension (see above). Migraine The initial dose is 80 mg propranolol hydrochloride daily in divided doses. The usual effective dose range is 160 mg to 240 mg per day.
The dosage may be increased gradually to achieve optimum migraine prophylaxis. If a satisfactory response is not obtained within four to six weeks after reaching the maximum dose, propranolol hydrochloride therapy should be discontinued.
It may be advisable to withdraw the drug gradually over a period of several weeks. Essential Tremor The initial dosage is 40 mg propranolol hydrochloride twice daily. Optimum reduction of essential tremor is usually achieved with a dose of 120 mg per day.
Occasionally, it may be necessary to administer 240 mg to 320 mg per day. Hypertrophic Subaortic Stenosis The usual dosage is 20 mg to 40 mg propranolol hydrochloride three or four times daily before meals and at bedtime. Pheochromocytoma The usual dosage is 60 mg propranolol hydrochloride daily in divided doses for three days prior to surgery as adjunctive therapy to alpha-adrenergic blockade.
For the management of inoperable tumors, the usual dosage is 30 mg daily in divided doses as adjunctive therapy to alpha-adrenergic blockade.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised April 22, 2026[2]
ADVERSE REACTIONS
The following adverse events were observed and have been reported in patients using propranolol. Cardiovascular Bradycardia; congestive heart failure; intensification of AV block; hypotension; paresthesia of hands; thrombocytopenic purpura; arterial insufficiency, usually of the Raynaud type.
Central Nervous System Light-headedness, mental depression manifested by insomnia, lassitude, weakness, fatigue; catatonia; visual disturbances; hallucinations; vivid dreams; an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics.
Oculomucocutaneous syndrome involving the skin, serous membranes and conjunctivae reported for a beta blocker (practolol) have not been associated with propranolol. Genitourinary Male impotence; Peyronie’s disease. To report SUSPECTED ADVERSE REACTIONS, contact Innogenix, LLC.
gov/medwatch.
USOfficial regulatory label· Warnings and precautions· revised April 22, 2026[2]
WARNINGS
Angina Pectoris There have been reports of exacerbation of angina and, in some cases, myocardial infarction, following abrupt discontinuance of propranolol therapy. Therefore, when discontinuance of propranolol is planned, the dosage should be gradually reduced over at least a few weeks and the patient should be cautioned against interruption or cessation of therapy without the physician’s advice.
If propranolol therapy is interrupted and exacerbation of angina occurs, it usually is advisable to reinstitute propranolol therapy and take other measures appropriate for the management of angina pectoris. Since coronary artery disease may be unrecognized, it may be prudent to follow the above advice in patients considered at risk of having occult atherosclerotic heart disease who are given propranolol for other indications.
Hypersensitivity and Skin Reactions Hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, have been associated with the administration of propranolol (see ADVERSE REACTIONS). Cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, and urticaria, have been reported with use of propranolol (see ADVERSE REACTIONS ).
Cardiac Failure Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. Although beta blockers should be avoided in overt congestive heart failure, some have been shown to be highly beneficial when used with close follow-up in patients with a history of failure who are well compensated and are receiving additional therapies, including diuretics as needed.
Beta-adrenergic blocking agents do not abolish the inotropic action of digitalis on heart muscle. In Patients without a History of Heart Failure Continued use of beta blockers can, in some cases, lead to cardiac failure. , Chronic Bronchitis, Emphysema) In general, patients with bronchospastic lung disease should not receive beta blockers.
Propranolol should be administered with caution in this setting since it may provoke a bronchial asthmatic attack by blocking bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta-receptors. Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised April 22, 2026[2]
CONTRAINDICATIONS
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.
This is not medical advice. Consult a qualified healthcare professional.
5 kg at treatment initiation): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for these pediatric populations. 2 Geriatrics Geriatrics: No data are available to Health Canada; therefore, Health Canada has not authorized an indication for geriatric use.
How to take
CAOfficial regulatory label· revised March 22, 2025[3]
2 Drug Interactions Overview 10/2019 4 DOSAGE AND ADMINISTRATION. 3 Administration 10/2019 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed . RECENT MAJOR LABEL CHANGES............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[3]
4 Post-Market Adverse Reactions 10/2019
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[3]
4 Geriatrics 06/2021
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[3]
5 kg Product Monograph HEMANGIOL (propranolol hydrochloride) Page 5 of 48 Breastfed infants, if the mother is treated with medicines contraindicated with propranolol (see section 9 DRUG INTERACTIONS) Asthma or history of bronchospasm Second- or third-degree heart blocks Disease of the sinus node (including sinoatrial block) Bradycardia: the following limits were used in the HEMANGIOL clinical trials: Age 0-3 months 3-6 months 6-12 months Heart rate (beats/min) 100 90 80 Low blood pressure below the following limits: Age 0-3 months 3-6 months 6-12 months Blood pressure (systolic/diastolic, mmHg) 65/45 70/50 80/55 Cardiogenic shock Heart failure not controlled by treatment Prinzmetal’s angina Severe peripheral arterial circulatory disturbances (Raynaud’s phenomenon) Patients prone to hypoglycemia Pheochromocytoma HEMANGIOL is contraindicated in patients who are hypersensitive to propranolol or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
This is not medical advice. Consult a qualified healthcare professional.
Treatment with HEMANGIOL should be initiated by physicians who have expertise in the diagnosis, treatment and management of infantile haemangioma, in a controlled clinical setting where adequate facilities for handling of adverse reactions, including those requiring urgent measures, are available.
Posology The posology is expressed in propranolol base. 5 mg/kg. It is recommended to increase the dose up to the therapeutic dose under medical supervision as follows: 1 mg/kg/day for 1 week, then 2 mg/kg/day for 1 week and then 3 mg/kg/day as a maintenance dose.
5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes. HEMANGIOL is to be given during or right after a feed to avoid the risk of hypoglycaemia. If the child is not eating enough or is vomiting it is recommended to skip the dose.
3 In case the child spits up a dose or does not take all of the medicinal product no other dose should be given before the next scheduled dose. During the titration phase, each dose increase must be managed and monitored by a physician in the same conditions as the administration of the initial dose.
After the titration phase, the dose will be readjusted by the physician according to the changes in the child’s weight. Clinical monitoring of the child condition, and dose readjustment, need to be performed at least monthly.
Duration of treatment:
HEMANGIOL should be administered for a 6-month period. Discontinuation of treatment does not require a progressive decrease in the dose. In the minority of patients showing a relapse of symptoms after treatment discontinuation, treatment may be re-initiated under the same conditions with a satisfactory response.
Paediatric populations In the absence of clinical efficacy and safety data, HEMANGIOL should not be used in infants aged below 5 weeks. There is no clinical efficacy and safety data in the clinical studies carried out with HEMANGIOL to recommend its initiation in infants and children aged above 5 months.
4). Method of administration Oral use. HEMANGIOL should be administered directly into the child's mouth using the graduated oral syringe, calibrated in mg of propranolol base, supplied with the oral solution bottle (see instructions for use in section 3 of the patient information leaflet).
The bottle should not be shaken before use. If necessary, the medicinal product may be diluted in a small quantity of baby-milk or age-adapted apple and/or orange fruit juice. The medicine should not be put in the full filled bottle.
The mixing may be done with one teaspoonful (approximately 5 mL) of milk for children weighing up to 5 kg, or with a tablespoonful (approximately 15 mL) of milk or fruit juice for children weighing more than 5 kg, delivered in a baby’s bottle.
The mixing should be used within 2 hours. HEMANGIOL and the feed must be given by the same person in order to avoid the risk of hypoglycaemia. If different people are involved, good communication is essential in order to ensure the safety of the child.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised February 9, 2023[4]
5%). Globally, the adverse reactions reported in the compassionate use program and in literature concerned hypoglycemia (and related event like hypoglycaemic seizure) and aggravated respiratory tract infections with respiratory distress.
Tabulated list of adverse reactions The following table gives the adverse reactions, reported whatever dose and treatment duration, in three clinical studies, including 435 patients treated by HEMANGIOL at 1 mg/kg/day or 3 mg/kg/day for a maximum treatment duration of 6 months.
Their frequency is defined using the following conventions: 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).
Due to the clinical trial database size rare and very rare categories are not represented. Within each system organ class, adverse reactions are presented in order of decreasing seriousness. Very common Common Uncommon Not known Infections and infestations Bronchitis Bronchiolitis Metabolism and nutrition disorders Decreased appetite Psychiatric disorders Sleep disorder Agitation Nightmares Irritability Nervous system disorders Somnolence Hypoglycemic seizure Cardiac disorders AV block Bradycardia Vascular disorders Peripheral coldness Hypotension Vasoconstriction Raynaud’s phenomenon Respiratory, thoracic and mediastinal disorders Bronchospasm Gastrointestinal disorders Diarrhea Vomiting Constipation Abdominal pain Skin and subcutaneous tissue disorders Erythema Dermatitis diaper Urticaria Alopecia Dermatitis psoriasiform Investigations Decreased blood pressure Decreased blood glucose Decreased heart rate Neutropenia Agranulocytosis Hyperkaliemia 9 Description of selected adverse reactions Concerning the lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with HEMANGIOL due to the bronchoconstrictive effect of propranolol.
4). Sleep disorders corresponded to insomnia, poor quality of sleep and hypersomnia. Other Central Nervous System disorders were principally observed during the early periods of treatment. Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease.
The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day. None of cases was of severe intensity and led to treatment discontinuation. Cardiovascular events reported during clinical studies were asymptomatic. In the context of the 4 hours cardiovascular monitoring during the titration days, it was observed a decrease of heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) following drug administration.
One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation. Isolated cases of symptomatic bradycardia and hypotension have been reported in literature.
Blood sugar decreases observed during clinical studies were asymptomatic. 4). 5). 4). 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 national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised February 9, 2023[4]
Initiation of treatment Prior to initiating propranolol therapy, screening for risks associated with propranolol use must be performed. An analysis of the medical history and a full clinical examination must be performed including heart rate, cardiac and pulmonary auscultation.
In case of suspected cardiac abnormality, a specialist advice must be sought before treatment initiation to determine any subjacent contra-indication. In case of acute broncho-pulmonary abnormality, the initiation of the treatment should be postponed.
Hypoglycaemia Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia. It masks the adrenergic warning signs of hypoglycaemia, particularly tachycardia, shakiness, anxiety and hunger. g. poor oral food intake, infection, vomiting), when glucose demands are increased (cold, stress, infections), or in case of overdose.
Hypoglycaemic episodes associated with the taking of propranolol may present exceptionally in the form of seizures and/or coma. If clinical signs of hypoglycaemia occur, it is necessary to make the child drink a sugary liquid solution and to temporarily stop the treatment.
Appropriate monitoring of the child is required until symptoms disappear. Prescribers should inform carers/parents on the risk of serious hypoglycaemia that remains equally prominent throughout the whole treatment period. 2). Carers should be provided guidance on how to recognise the clinical signs of hypoglycaemia in order to : • immediately treat the hypoglycaemic condition to prevent life-threatening situations, • contact a doctor or to go straight to hospital, • discontinue the treatment.
In children with diabetes, blood glucose monitoring should be more frequent and followed by the endocrinologist. Respiratory disorders In the event of lower respiratory tract infection associated with dyspnoea and wheezing, treatment should be temporarily discontinued.
The administration of beta2 agonists and inhaled corticosteroids is possible. The readministration of propranolol may be considered when the child has fully recovered; in case of reoccurrence, treatment should be permanently discontinued.
In the event of isolated bronchospasm, treatment must be permanently discontinued. 5 Cardiovascular disorders Propranolol, due to its pharmacological action, may cause or worsen bradycardia or blood pressure abnormalities. Bradycardia should be diagnosed if the heart rate declines by more than 30 bpm from baseline.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised February 9, 2023[4]
1 • Asthma or history of bronchospasm • Second- or third-degree atrioventricular blocks • Disease of the sinus node (including sinoatrial block) • Bradycardia below the following limits: Age 0-3 months 3-6 months 6-12 months Heart rate (beats/min) 100 90 80 4 • Low blood pressure below the following limits: Age 0-3 months 3-6 months 6-12 months Blood pressure (mmHg) 65/45 70/50 80/55 • Cardiogenic shock • Heart failure not controlled by treatment • Prinzmetal’s angina • Severe peripheral arterial circulatory disturbances (Raynaud’s phenomenon) • Infants prone to hypoglycaemia • Phaeochromocytoma
This is not medical advice. Consult a qualified healthcare professional.
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).
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. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Diabetes and Hypoglycemia Beta-adrenergic blockade may prevent the appearance of certain premonitory signs and symptoms (pulse rate and pressure changes) of acute hypoglycemia, especially in labile insulin-dependent diabetics. In these patients, it may be more difficult to adjust the dosage of insulin.
Propranolol therapy, particularly when given to infants and children, diabetic or not, has been associated with hypoglycemia, especially during fasting as in preparation for surgery. Hypoglycemia has been reported in patients taking propranolol after prolonged physical exertion and in patients with renal insufficiency.
Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism. Therefore, abrupt withdrawal of propranolol may be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm. Propranolol may change thyroid function tests, increasing T4 and reverse T3 and decreasing T3.
Wolff-Parkinson-White Syndrome Beta-adrenergic blockade in patients with Wolf-Parkinson-White Syndrome and tachycardia has been associated with severe bradycardia requiring treatment with a pacemaker. In one case, this result was reported after an initial dose of 5 mg propranolol.
Pheochromocytoma Blocking only the peripheral dilator (beta) action of epinephrine with propranolol leaves its constrictor (alpha) action unopposed. In the event of hemorrhage or shock, there is a disadvantage in having both beta and alpha blockade since the combination prevents the increase in heart rate and peripheral vasoconstriction needed to maintain blood pressure.
Bradycardia is defined below the following limits:
Age 0-3 months 3-6 months 6-12 months Heart rate (beats/min) 100 90 80 After the first intake and each dose increase, a clinical monitoring including blood pressure and heart rate must be performed at least hourly for at least 2 hours.
In case of symptomatic bradycardia or bradycardia under 80 bpm, immediate specialist advice must be sought. In case of severe and/or symptomatic bradycardia or hypotension occurring at any time during treatment, treatment must be discontinued and a specialist advice should be sought.
Cardiac failure:
Sympathetic stimulation may be a vital component supporting circulatory function in patients with congestive heart failure, and its inhibition by beta blockade may precipitate more severe failure. In children with cardiac failure, the treatment should be managed by the cardiologist.
PHACE syndrome Very limited safety data of propranolol in PHACE syndrome patients are available. Propranolol may increase the risk of stroke in PHACE syndrome patients with severe cerebrovascular anomalies by dropping blood pressure and attenuating flow through occluded, narrow, or stenotic vessels.
Infants with large facial infantile hemangioma should be thoroughly investigated for potential arteriopathy associated with PHACE syndrome, with magnetic resonance angiography of the head and neck and cardiac imaging to include the aortic arch, prior to considering propranolol therapy.
Specialised advice should be sought.
Breast-feeding:
Propranolol passes through breast milk, mothers being treated with propranolol who breastfeed their infant should inform their health care professional. Liver or kidney failure Propranolol is metabolised in the liver and excreted by the kidneys.
2). Hypersensitivity In patients likely to experience severe anaphylactic reaction, regardless of origin, particularly with iodinated contrast agents, beta-blocker treatment may lead to worsening of the reaction and resistance to its treatment with adrenaline at normal doses.
In children who are at risk of anaphylaxis, the benefit risk of the medicinal product should be evaluated. General anaesthesia Beta-blockers will result in an attenuation of reflex tachycardia and an increased risk of hypotension. It is necessary to alert the anaesthetist to the fact that the patient is being treated with beta-blockers.
When a patient is scheduled for surgery, beta-blocker therapy should be discontinued at least 48 hours prior to the procedure. Hyperkaliemia Hyperkaliemia cases have been reported in patients with large ulcerated hemangioma. A monitoring of electrolyte should be performed in these patients.
Psoriasis Worsening of disease has been reported with beta-blockers in patients suffering from psoriasis. Therefore the need for treatment should be carefully weighed up. e. essentially ‘sodium- free’. 08 mg of propylene glycol/kg/day.
Caution should be taken into account in babies less than 4 weeks old, in particular if the baby is given other medicines that contain propylene glycol or alcohol. Co-administration with any […]