severe and/or symptomatic bradycardia or hypotension occurring at any time during
treatment, treatment must be discontinued and a specialist advice should be sought.
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. It can aggravate hypoglycaemia in children, especially in case of fasting, vomiting or overdose.
These 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.
In children with diabetes, blood glucose monitoring should be increased.
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.
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.
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. Specialized 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. In the absence of data in children, propranolol is not recommended in case of renal or hepatic impairment (see section 4.2).
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.
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 t |
