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PP-043 Propranolol 2 mg/ml as syrup for skin angiomas. Clinical evaluation of an off-label preparation
  1. V Borsi1,
  2. L Scala1,
  3. G Scialino1,
  4. G Renzi2,
  5. I Mercaldo2,
  6. A Greco3,
  7. F Calderoni1,
  8. A Di Renzo1,
  9. L Di Simone1,
  10. AM Calvani1
  1. 1”A. Meyer” University Children’s Hospital, Department of Pharmacy, Florence, Italy
  2. 2University of Florence, School Specialization in Hospital Pharmacy, Florence, Italy
  3. 3”A. Meyer” University Children’s Hospital, Department of Dermatology, Florence, Italy

Abstract

Background Propanolol has shown good antiangiogenic activity, but in our country there is no commercial product for skin angiomas. Thus the laboratory of our pharmacy, in accordance with the dermatology department and by respecting the NBP, produced a preparation in syrup to treat this disease in newborn and paediatric patients.

Purpose To evaluate the effectiveness of a galenic preparation by consulting patient medical records (age between 3 months and 1 year). Parameters that were evaluated were: angioma dimension measurements, deepness of angioma evaluated by MRI, cardiac parameters and serum glucose levels.

Material and methods Consultation of the medical records of patients that were treated in 2013–2014 and had counselling with the clinician after evaluation of clinical parameters to establish the efficacy of therapy. The dosage of propranolol was 2 mg/kg, three times a day, and parameters were measured once a month. Patients treated were 13 in 2014 and 10 in 2013.

Results In the years analysed, resonance parameters and angioma measurements showed complete remission of the disease (80%) for patients with severe disease: cardiac parameters and serum glucose levels, assessed to evaluate cardiac activity of propranolol, were irrelevant. Cases where angioma had not been completely eradicated were due to the relative severity of the disease (20%) or poor compliance.

Conclusion Our work has confirmed the clinical relevance of such galenic preparations and shows once again how clinical pharmacists are able to fill gaps in the pharmaceutical industry that sometimes does not pay much attention to orphan dosages that could be relevant for paediatric diseases.

No conflict of interest.

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