การเปรียบเทียบข้อมูลขนาดยาของผลิตภัณฑ์ยาน้ำพาราเซตามอลกับเอกสารอ้างอิง A Comparison of Dose of Paracetamol Syrup Products With References

Abstract

Objective: To compare information regarding dose and dosage regimen ofparacetamol syrup both single ad combination formulas with well knownreferences. Method: We bought paracetamol syrup products from drugsstores and grocery stores (213 sampled products from a total of 453registered products) from March 2013 to February 2014. We evaluatedaccordance between dose and dosage regimen information on eachproduct and the information in various references with (Drug InformationHandbook 19th edition 2010 – 2011, Pediatric & Neonatal DosageHandbook 19th edition 2012 – 2013, Micromedex® version 2.0, AHFSDrug Information 2012, BNF for Children 2011). With a theoretical caseof 8-month, 2-, 4-, and 8-year old child case, we evaluated theappropriateness of each product’s labeled dose with the recommended 10– 15 mg/kg/dosing whether it was “lower than,” “within,” “higher than,”“lower than and within,” and “within and higher than” the recommendedrange. Results: Of 57 products obtained, the majority was paracetamolonlyproducts (84.21%) and with a strength of 120 mg/5 ml (63.61%). Doseand dosage regimen information of these products were in a very negligibleaccordance with well known references (0 – 12.28%). In theoretical case of8-month old child, 46.61% (of 57 products) offered doses that resulted inthe ones lower than, and 7.02% within the recommended range. For those2 and 4 years old, almost half of the products offered doses that were“lower than and within” recommended range (45.61% and 42.11%,respectively). For those 8 years old, on the other hand, 42.11% and15.53% of products offered doses that were “within” and “within and higherthan” the recommended range. Conclusion: Dose and dosage regimenstated in the paracetamol syrup products were not in accordance with therecommended range from the well known references which couldpotentially inappropriate dosing to children. Such information onparacetamol syrup products should be updated.Keywords: paracetamol syrup, dose, dosage regimen, label, packageinsert, reference