Proliferating infantile haemangioma

Active Ingredient: Propranolol

Indication for Propranolol

Population group: only newborns (0 - 40 days old) , infants (40 days - 1 year old)

Propranolol 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.

It is to be initiated in infants aged 5 weeks to 5 months.

For this indication, competent medicine agencies globally authorize below treatments:

1-3 mg/kg in 2 divided doses daily

Route of admnistration

Oral

Defined daily dose

1 - 3 mg per kg of body weight

Dosage regimen

From 0.5 To 1.5 mg per kg of body weight 2 time(s) per day every day for 180 day(s)

Loading dose

1 mg per kg of body weight

Maintenance dose

3 mg per kg of body weight

Detailed description

The posology is expressed in propranolol base.

The recommended starting dose is 1 mg/kg/day which is divided into two separate doses of 0.5 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.

The therapeutic dose is 3 mg/kg/day, which is to be administered into 2 separate doses of 1.5 mg/kg, one in the morning and one in late afternoon, with a time interval of at least 9 hours between two intakes. Propranolol is to be given during or right after a feed to avoid the risk of hypoglycaemia.

If the child is not eating or is vomiting it is recommended to skip the dose.

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

Propranolol 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.

Active ingredient

Propranolol

Propranolol is a competitive antagonist at both beta, and beta2-adrenoceptor, but has membrane stabilising activity at concentrations exceeding 1-3mg/litre, though such concentrations are rarely achieved during oral therapy. Competitive beta-blockade has been demonstrated in man by a parallel shift to the right in the dose-heart rate response curve to beta-agonists such as isoprenaline.

Read more about Propranolol

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