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Analysis of various doses of paracetamol in the indian market: a need to revisit

Ayush Jain, Annwesha Chaudhury, Shikha Dwivedi, Libin Sanjeev L

2023

Abstract

Abstract Introduction One of the most often used OTC antipyretic and analgesic is paracetamol or acetaminophen. Though widely used, the mechanism by which it reduces fever and pain remains unknown. Although paracetamol is available in a variety of formulations, there are no set guidelines for the various formulations of paracetamol alone or in combination. Materials and Methods In Department of Pharmacology at Government Doon Medical College, the study was planned as an observational cross-sectional study. Data regarding different paracetamol dosages and dosages of paracetamol in fixed dose combinations (FDCs) with various ingredients were gathered and evaluated from the editions of Drug Today, Current Index Of Medical Specialties (CIMS), Monthly Index Of Medical Specialties (MIMS), and India 2021/2022. Results Analysing Drug Today, CIMS and MIMS, it was found, 810 formulations of paracetamol tablets are available in the Indian market, of which, 77 formulations contain only paracetamol, rest being fixed dose combinations (FDCs). Among all the available FDCs with paracetamol having 2or 3 drug formulation, among the 2 constituent FDCs group containing paracetamol, 47% drugs have paracetamol in 325 mg or less dose, whereas, 53% drugs are in clear violation of the notice by CDSCO, by containing more than 325 mg paracetamol. Conclusion In spite of widespread use there is ambiguity in paracetamol doses, as well as absence of data for few constituents in the FDCs. Thus, further…

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