Propranolol hydrochloride (Hemangiol)
Infantile hemangiomas (IHs) are the most common vascular tumours occurring in children. The incidence and prevalence of IH in Canada is uncertain; however, the manufacturer has estimated that the incidence of IH ranges from 4.5% to 10.0%. Hemangiol is an oral solution containing 3.75 mg/mL propranol...
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| Format: | eBook |
| Language: | English |
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Ottawa (ON)
Canadian Agency for Drugs and Technologies in Health
2017, 2017
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| Series: | Common drug review
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | Infantile hemangiomas (IHs) are the most common vascular tumours occurring in children. The incidence and prevalence of IH in Canada is uncertain; however, the manufacturer has estimated that the incidence of IH ranges from 4.5% to 10.0%. Hemangiol is an oral solution containing 3.75 mg/mL propranolol that is indicated for the treatment of proliferating IH requiring systemic therapy in the following circumstances: life- or function-threatening hemangioma; ulcerated hemangioma with pain and/or lack of response to simple wound care measures; or hemangioma with a risk of permanent scarring or disfigurement. The manufacturer has requested that propranolol oral solution receive a recommendation to reimburse in accordance with the Health Canada-approved indication. Propranolol oral solution is the first treatment specifically indicated for the treatment of patients with IH in Canada. The product monograph states that treatment should be initiated in infants aged five weeks to five months and the age for treatment initiation should be corrected in cases of premature birth. The recommended therapeutic dosage of propranolol for the treatment of IH is 3 mg/kg/day (administered as 1.5 mg/kg twice daily). The product monograph recommends that the first dose and each dose escalation should be administered in a clinical setting where there are adequate facilities for handling adverse events, including events that require urgent measures. The CADTH Common Drug Review (CDR) conducted a systematic review to evaluate the beneficial and harmful effects of propranolol oral solution for the treatment of proliferating IH requiring systemic therapy. The CDR review focused on the use of propranolol at the Health Canada-approved dosage regimen of 3 mg/kg/day for six months |
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| Physical Description: | 1 PDF file (ix, 55 pages illustrations |