Compounded medications for cardiovascular use in neonatology: an integrative review

Abstract

Objective: To analyze the profile of the compounded cardiovascular medicines prescribed in neonatology in Brazil. Data source: An integrative bibliographic review was carried out, including studies published in the last 20 years. The used descriptors were: Intensive Care Neonatal, Off-Label Use, Pharmaceutical Preparations, in the databases Virtual Health Library (VHL), PubMed, and Scientific Electronic Library Online (SciELO). Review articles and guidelines were excluded. The quality of the evidence was analyzed, and 10 articles were selected to integrate the study. Data synthesis: The profile of routine prescrption in the neonatal unit was evaluated. The main cardiovascular medications prescribed as compounding formulation were: Spironolactone, Captopril, Furosemide, Hydrochlorothiazide, Propranolol, Amiodarone, Nifedipine, Carvedilol, Digoxin, Enalapril, Epinephrine, and Hydralazine. The drugs were obtained from adaptations of dosage forms, through the transformation of capsules or tablets into liquid formulations, as a solution, suspension, or syrup, as well as in the form of solutions prepared from active pharmaceutical ingredients. The compounding of medications made drug therapy possible in neonatology, considering that such medications do not have registration of the oral liquid dosage form in the country, despite being part of the List of Essential Medicines for Children of the Word Health Organization. Conclusions: It was possible to analyze the profile of compounded cardiovascular medicines prescribed in neonatology in Brazil. The results showed the need for the development of medications suitable for the neonatal population, and the standardization of operational procedures for preparing extemporaneous formulations in neonatology to increase drug safety.

Biotecnologia: Fonte De Novas Moléculas Antimicrobianas Para O Tratamento De Infecções Bacterianas Multirresistentes

“…A administração de medicamentos em pacientes pediátricos apresenta desafios únicos devido às diferenças fisiológicas, de desenvolvimento e de aceitação de formulações. O captopril, um fármaco utilizado no tratamento da hipertensão arterial, requer formulações específicas para uso pediátrico (DÍEZ et al, 2019;GREENHALGH et al, 2023). Nesta revisão foram discutidos de forma integrativa os dados encontrados na literatura que abordam o desenvolvimento de formulações de captopril destinadas ao público pediátrico.…”

“…Além disso, estas condições fisiopatológicas e anatômicas variam de acordo com a idade da criança (GOES et al, 2019). Neste sentido, diversas pesquisas científicas mostraram que formulações líquidas, como soluções e suspensões, são amplamente utilizadas devido à escassez de formas farmacêuticas adequadas para uso oral em neonatos e crianças, incluindo para fármacos destinados ao tratamento de doenças cardiovasculares (TAN et al, 2021;GREENHALGH et al, 2023).…”

“…Ainda, é necessário atentar-se aos excipientes selecionados para o preparo destas formulações, visto que muitos excipientes comumente empregados para o público adulto não são recomendados para uso na pediatria (ROUAZ et al, 2021). Outro fato importante a ser considerado é a possibilidade de interações com embalagens ou sondas, fórmulas de substituição do leite, além de potenciais interações medicamentosas (GREENHALGH et al, 2023). Dessa forma, é fundamental que essas formulações sejam preparadas por profissionais de saúde qualificados, seguindo diretrizes e padrões adequados de preparação de medicamentos, com acompanhamento médico regular (DIEZ et al, 2019).…”

Evaluation of the type and frequency of extemporaneous formulations dispensed in hospital and community pharmacies

“…Elevated risk is particularly seen in newborn infants, because they are more likely to be predisposed to adverse drug reactions due to their physiological immaturity. 19 , 20 Liquid dosage forms prepared from commercially available medicines may contain preservatives; these excipients are considered to be largely inert in adults, but can lead to life threatening toxicity in paediatric patients if multiple doses of medications with these preservatives are employed. 21 , 22 Reports have documented on the stability of individual extemporaneous preparations 23 , 24 ; however, there remains a clear need for comprehensive stability studies and more detailed information on extemporaneous medicines as a collective.…”

Quality and Stability Evaluation of Extemporaneously Compounded Losartan Potassium Oral Suspension at the Hospital Pharmacy

“…When formulating extemporaneous preparations, quality must be built in from the early stages to the final product [15]. The extemporaneous compounding of suspensions from tablets or capsules available on the market is a common practice in hospital pharmacies [16,17]. Oral suspension is a dispersion of finely divided particles distributed somewhat uniformly throughout a liquid medium [18].…”