Propranolol in Use for Treatment of Complex Infant Hemangiomas: Literature Review Regarding Current Guidelines for Preassessment and Standards of Care before Initiation of Therapy

Fette, Andreas

doi:10.1155/2013/850193

Cited by 18 publications

(23 citation statements)

References 70 publications

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“…The use of propranolol, the well‐known antihypertensive medication, has been serendipitously noted to control the growth of hemangiomas by Léauté‐Labrèze and her coworkers in 2008 in a large‐scale placebo‐controlled randomized clinical study while being in use for treatment of (congenital) heart disease in French children . As a consequence, oral propranolol has become the first‐line therapy for the treatment of hemangiomas for its efficacy and safety .…”

Section: Discussionmentioning

confidence: 99%

Successful management of extremely high‐output refractory congenital chylothorax with chemical pleurodesis using 4% povidone–iodine and propranolol: a case report

Borcyk

Kamil

Hagerty

et al. 2018

Clinical Case Reports

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Key Clinical MessageFirst‐line therapy for congenital chylothorax is conservative treatment. However, surgical intervention or chemical pleurodesis is required for refractory cases. With all the concerns regarding its complications, povidone–iodin provided a successful management for a high‐output congenital chylothorax. However, renal and thyroid function must be monitored during treatment.

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Section: Discussionmentioning

confidence: 99%

Successful management of extremely high‐output refractory congenital chylothorax with chemical pleurodesis using 4% povidone–iodine and propranolol: a case report

Borcyk

Kamil

Hagerty

et al. 2018

Clinical Case Reports

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“…The phase 2/3 dose ranging study has demonstrated the efficacy and tolerability of the new pediatric solution of propranolol at the dose of 3 mg kg −1 day −1 given BID. However, the available literature on the treatment of IH largely documented TID dosing regimen . Considering that repeated administration of treatment in infants could not always be a regular dosing regimen (due to possible irregular sleeping periods and meal times), irregular BID dosing regimen and 2 different TID dosing regimens were simulated and compared with the regular BID dosing regimen investigated in the clinical PK study.…”

Section: Discussionmentioning

confidence: 99%

“…However, the available literature on the treatment of IH largely documented TID dosing regimen. 11,13,16,42 Considering that repeated administration of treatment in infants could not always be a regular dosing regimen (due to possible irregular sleeping periods and meal times), irregular BID dosing regimen and 2 different TID dosing regimens were simulated and compared with the regular BID dosing regimen investigated in the clinical PK study. Whatever the dosing regimen, simulations confirmed that infants are exposed to propranolol over a 24 hour-period.…”

Section: Discussionmentioning

confidence: 99%

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Propranolol pharmacokinetics in infants treated for Infantile Hemangiomas requiring systemic therapy: Modeling and dosing regimen recommendations

Frari

Léauté‐Labrèze

Guibaud

et al. 2018

Pharmacology Res & Perspec

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Propranolol has become the first choice therapy for complicated Infantile Hemangiomas (IH). The pharmacokinetics of propranolol were evaluated after repeated oral administration of a new pediatric solution of propranolol at 3 mg kg−1 day−1 given twice daily (BID) in infants (77‐243 days) with IH. A population model was built to describe the pharmacokinetics of propranolol in infants and to simulate different dosing regimens. One hundred and sixty‐seven plasma concentrations from 22 infants were used in the population analysis. Weight effect was tested on apparent clearance and volume of distribution. Monte‐Carlo simulations were performed for 4 dosing regimens: BID dosing with irregular or strict 12‐hour intervals and 2 different 3 time daily dosing (TID) regimens. The best model was a one‐compartment model with first‐order absorption and elimination rates. The weight affected the clearance but not the volume. Typical oral clearance was estimated at 3.06 L hour−1 kg−1 (95% CI: 1.14‐8.61 L hour−1 kg−1), close to adult clearance data. When regular BID dosing was compared to TID or irregular BID regimens, simulated median Cmin and Cmax were <20% different. To conclude, a model using a weight allometric function on clearance was established and confirmed that the dose in mg/kg should be used without adaptation by range of age in treatment of complicated IH. The simulations support the use of a BID dosing preferably to a TID dosing thanks to close Cmin and Cmax at steady state between both regimen and showed the possibility of irregular BID dosing, allowing early administration in the evening when needed.

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“…Recent clinical studies have demonstrated new therapeutic indications with lower concentrations of propranolol, as in the treatment of infantile hemangiomas (19), burned patients (20), and posttraumatic stress disorder (21), although further research is required to confirm these findings.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Quality Attributes of Propranolol Split Tablets: Focus on Dose Variability

Eserian

Lombardo

2017

Infarma

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Tablet splitting is a widespread practice among patients and health professionals aiming the administration of lower doses and the reduction of the cost of prescriptions. Nevertheless, potential concerns such as weight variation, stability and uneven drug content of the halves are related to this practice. The objective of this study was to evaluate the uniformity of half-tablets regarding weight and drug content in three different commercial products containing propranolol. Also, it was assessed drug content for whole tablets. Weight variation and drug content uniformity tests were evaluated for whole and split tablets, as well as the weight loss due to the splitting process. Drug content evaluation for whole tablets showed that all products were satisfactory. All the products were approved in the weight variation and drug content uniformity tests before splitting, with results close to 100%, but the halves of all products failed the tests, presenting a high variability between the portions. In one of the products, halves ranged from 75.5 to 120.4% of the target drug content, indicating that when administered to patients, daily doses may vary around 45%. Splitting propranolol tablets might compromise clinical treatment, affecting blood pressure and consequently producing side effects. Clinical implications due to tablet splitting might not be critical in some cases. Nevertheless, the high variability between doses should be considered by healthcare professionals when prescribing a therapy involving this practice.Keywords: tablet splitting; uniformity of dosage; propranolol RESUMO A divisão de comprimidos é uma prática comum entre pacientes e profissionais da área de saúde visando à administração de doses mais baixas e redução do custo do tratamento. No entanto, problemas potenciais como variação no peso, estabilidade e distribuição desigual de substância ativa nas metades estão relacionados a esta prática. O objetivo deste estudo foi avaliar a uniformidade de comprimidos divididos em relação ao peso e conteúdo de substância ativa em três medicamentos comerciais diferentes contendo propranolol. Também avaliou-se o teor dos comprimidos inteiros. A determinação de peso e uniformidade de conteúdo foram avaliadas tanto nos comprimidos inteiros quanto nas metades, assim como a perda de massa devido ao processo de divisão. O ensaio de teor dos comprimidos inteiros foi satisfatório para todos os medicamentos. Os ensaios de determinação de peso e uniformidade de conteúdo apresentaram resultados satisfatórios para todos os medicamentos antes do processo de divisão, com resultados próximos a 100%, mas suas metades apresentaram resultados insatisfatórios, evidenciados pela alta variabilidade entre as mesmas. Em um dos medicamentos, as metades variaram de 75,5 a 120,4% do conteúdo de substância ativa, indicando que, quando administradas aos pacientes, as doses podem variar cerca de 45%. Dividir comprimidos de propranolol pode comprometer o tratamento clínico, afetando a pressão sanguínea e consequentemente produzind...

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Propranolol in Use for Treatment of Complex Infant Hemangiomas: Literature Review Regarding Current Guidelines for Preassessment and Standards of Care before Initiation of Therapy

Cited by 18 publications

References 70 publications

Successful management of extremely high‐output refractory congenital chylothorax with chemical pleurodesis using 4% povidone–iodine and propranolol: a case report

Successful management of extremely high‐output refractory congenital chylothorax with chemical pleurodesis using 4% povidone–iodine and propranolol: a case report

Propranolol pharmacokinetics in infants treated for Infantile Hemangiomas requiring systemic therapy: Modeling and dosing regimen recommendations

Evaluation of Quality Attributes of Propranolol Split Tablets: Focus on Dose Variability

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