Introduction: According to current understanding of the role of excipient in medicines, they could not be considered as completely pharmacologically inert substances. Although excipients do not have the potential to cause adverse drug reactions (ADRs) in most patients, some of their negative effects have been established. Special caution regarding excipients intake is advised, especially in vulnerable populations such as pediatric one.
Aim: The aim of this paper was to investigate the exposure of children on antibiotic ther-
apy to excipients with known effects (EKE).
Methods: During a one-month period antibiotic prescriptions data were taken from com-
munity pharmacies in Novi Sad, Serbia. Age, diagnosis and prescribed therapy were ob-
served. Data about qualitative content of prescribed medicines were taken from Summaries of Product Characteristics (SmPC) available at the official website of Medicines and medical devices agency of Serbia (ALIMS). Excipients were considered to be potentially
harmful if they were listed in European Medicines Agency (EMA) guidelines.
Results: The most commonly observed diagnosis was a respiratory infection, which af-
fected more than 88% of children prescribed with an antibiotic. Only 5 out of 33 prescribed
antibiotic formulations did not contain at least one EKE. Prescribed medicines mostly con-
tained sodium compounds (77.78%), sucrose (34.07%) and sodium benzoate (31.11%). In
addition, the following EKE were detected: propylene glycol, aspartame, sorbitol, lactose,
potassium, mannitol, benzalkonium chloride, azorubine, parabens, sodium metabisulfite
and sunset yellow. Around 75% of prescribed antibiotic formulations contained inappro-
priately labeled EKE (sodium and potassium compounds, sodium benzoate and propylene
glycol). Additionally, inappropriately labeled information leaflets did not include possible
adverse effects caused by the EKE.
Conclusions: This paper indicates high exposure of patients to EKE, where almost all children treated with antibiotics (96.3%) were simultaneously administered at least one EKE. Introduction: According to current understanding of the role of excipient in medicines,
they could not be considered as completely pharmacologically inert substances. Although
excipients do not have the potential to cause adverse drug reactions (ADRs) in most pa-
tients, some of their negative effects have been established. Special caution regarding
excipients intake is advised, especially in vulnerable populations such as pediatric one.
Aim: The aim of this paper was to investigate the exposure of children on antibiotic ther-
apy to excipients with known effects (EKE).
Methods: During a one-month period antibiotic prescriptions data were taken from com-
munity pharmacies in Novi Sad, Serbia. Age, diagnosis and prescribed therapy were ob-
served. Data about qualitative content of prescribed medicines were taken from Summa-
ries of Product Characteristics (SmPC) available at the official website of Medicines and
medical devices agency of Serbia (ALIMS). Excipients were considered to be potentially
harmful if they were listed in European Medicines Agency (EMA) guidelines.
Results: The most commonly observed diagnosis was a respiratory infection, which af-
fected more than 88% of children prescribed with an antibiotic. Only 5 out of 33 prescribed
antibiotic formulations did not contain at least one EKE. Prescribed medicines mostly con-
tained sodium compounds (77.78%), sucrose (34.07%) and sodium benzoate (31.11%). In
addition, the following EKE were detected: propylene glycol, aspartame, sorbitol, lactose,
potassium, mannitol, benzalkonium chloride, azorubine, parabens, sodium metabisulfite
and sunset yellow. Around 75% of prescribed antibiotic formulations contained inappro-
priately labeled EKE (sodium and potassium compounds, sodium benzoate and propylene
glycol). Additionally, inappropriately labeled information leaflets did not include possible
adverse effects caused by the EKE.
Conclusions: This paper indicates high exposure of patients to EKE, where almost all children treated with antibiotics (96.3%) were simultaneously administered at least one EKE.