Drug sodium intake: Warning in cardiovascular diseases treatment

Abstract

Introduction: Hypertension is a condition which represents one of the main risk factors for the development of cardiovascular diseases. High sodium intake contributes to occurrence of hypertension, increasing the volume of extracellular fluid. Therefore, World Health Organization (WHO) and other associations involved with hypertension research advise to decrease intake of sodium. Effervescent dosage forms usually contain high levels of sodium which could lead to above mentioned health issues. Aim: The aim of this study was to evaluate the levels of sodium in the effervescent dosage forms available in the Serbian drug market. Methods: Data about sodium levels, and excipients was obtained from Summary of Product Characteristics from website of Medicines and Medical Devices Agency of Serbia (ALIMS). Maximum daily doses recommended by the manufacturer and approved by ALIMS were observed. Exposure to sodium through consumption of maximum daily doses was calculated as percentages of the adequate daily intake given by Food and Nutrition Board (Institute of Medicine, National Academies, Washington D.C., USA), and also as percentage of recommended daily intake of sodium given by WHO. Results: There are five formulations with exposure to sodium through consumption of maximum daily doses higher than 100% of the adequate daily intake (2 g), all of which are effervescent tablet formulations. The highest exposure to sodium was found in effervescent tablets containing acetylsalycic acid (500 mg) as active pharmaceutical ingredient: 250.62 % for people aged 51 to 70 years; 271.50 % for people aged 70 and older. Conclusion: In effervescent dosage forms available on Serbian market, level of sodium can be very high, even up to 271.50% of adequate daily intake when maximum daily doses are consumed. Major cause for concern is for vascular patients who use effervescents for chronic therapy. This data should be considered during prescribing and dispensing this category of medicines as well as during analyzing pharmacovigilance.

Exposure of children in Serbia to potentially harmful excipients when treated with approved antibiotics

“…Puača GG et al: Exposure of Children in Serbia to Potentially Harmful Excipients When Treated with Approved Antibiotics mostly focusing on effervescent drug forms which usually contain large concentrations of sodium ion [14,15]. EMA and Serbian regulations are harmonized on this matter, requiring declaration on quantitative sodium content in a medicine.…”

Excipients of inhaled medications with potential to cause adverse reactions

“…This information is taken with caution, because excipients in their original form, in doses and concentrations that are commonly used can cause different problems and they can react in various ways and lead to the same problems in the presence of various environmental factors [1]. In the Serbian market, in effervescent dosage forms the sodium level can be up to 271,50% of the adequate daily intake when the maximum daily dose of drug is ad-ministrated [4]. This leads us to another very important and desirable characteristic that is not always satisfied in all patients.…”