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Evaluation of package inserts of Ayurveda drug formulations from Mumbai city

INTRODUCTION: Package insert (PI) is a vital document accompanying a prescribed medication to provide information to the prescriber and end-user at a glance. Studies regarding PIs of Ayurvedic medicines in accordance with standard guidelines are lacking. AIM: Present study was undertaken to evaluate...

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Autores principales: Shirolkar, Sudatta, Tripathi, Raakhi K., Potey, Anirudha V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5041383/
https://www.ncbi.nlm.nih.gov/pubmed/27833363
http://dx.doi.org/10.4103/0974-8520.190694
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author Shirolkar, Sudatta
Tripathi, Raakhi K.
Potey, Anirudha V.
author_facet Shirolkar, Sudatta
Tripathi, Raakhi K.
Potey, Anirudha V.
author_sort Shirolkar, Sudatta
collection PubMed
description INTRODUCTION: Package insert (PI) is a vital document accompanying a prescribed medication to provide information to the prescriber and end-user at a glance. Studies regarding PIs of Ayurvedic medicines in accordance with standard guidelines are lacking. AIM: Present study was undertaken to evaluate PI of Ayurveda drugs. MATERIALS AND METHODS: PIs of Ayurveda drugs were obtained from five randomly selected Ayurveda medical shops located in three main zones of Mumbai. From each medical shop, a range of 15–20 PI was planned to be collected for different formulations. It was decided to collect a minimum fifty PIs/group for equitable distribution of various formulations in period of January–June2013. Checklist was prepared, and content validity was achieved. Final validated checklist contained a total of 13 items, and the presence or absence of information pertaining to these items on the PI was evaluated. Any other additional information present on PI was also noted. Each item was analyzed and expressed as percentages. RESULTS: The information on 258 PIs included: Name of ingredients (67%), quantity of ingredients (47.27%), route of administration (86.8%), dosage form (86.8%), indications (18%), dose (18%), contraindications (18%), side effects (9%), shelf life (5.81%), storage conditions (11%), and manufacturers name with contact details (34%). CONCLUSION: PIs accompanying Ayurveda medicinal products in India are deficient in information required to be furnished by them.
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spelling pubmed-50413832016-11-10 Evaluation of package inserts of Ayurveda drug formulations from Mumbai city Shirolkar, Sudatta Tripathi, Raakhi K. Potey, Anirudha V. Ayu Survey Study INTRODUCTION: Package insert (PI) is a vital document accompanying a prescribed medication to provide information to the prescriber and end-user at a glance. Studies regarding PIs of Ayurvedic medicines in accordance with standard guidelines are lacking. AIM: Present study was undertaken to evaluate PI of Ayurveda drugs. MATERIALS AND METHODS: PIs of Ayurveda drugs were obtained from five randomly selected Ayurveda medical shops located in three main zones of Mumbai. From each medical shop, a range of 15–20 PI was planned to be collected for different formulations. It was decided to collect a minimum fifty PIs/group for equitable distribution of various formulations in period of January–June2013. Checklist was prepared, and content validity was achieved. Final validated checklist contained a total of 13 items, and the presence or absence of information pertaining to these items on the PI was evaluated. Any other additional information present on PI was also noted. Each item was analyzed and expressed as percentages. RESULTS: The information on 258 PIs included: Name of ingredients (67%), quantity of ingredients (47.27%), route of administration (86.8%), dosage form (86.8%), indications (18%), dose (18%), contraindications (18%), side effects (9%), shelf life (5.81%), storage conditions (11%), and manufacturers name with contact details (34%). CONCLUSION: PIs accompanying Ayurveda medicinal products in India are deficient in information required to be furnished by them. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC5041383/ /pubmed/27833363 http://dx.doi.org/10.4103/0974-8520.190694 Text en Copyright: © AYU (An International Quarterly Journal of Research in Ayurveda) http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
spellingShingle Survey Study
Shirolkar, Sudatta
Tripathi, Raakhi K.
Potey, Anirudha V.
Evaluation of package inserts of Ayurveda drug formulations from Mumbai city
title Evaluation of package inserts of Ayurveda drug formulations from Mumbai city
title_full Evaluation of package inserts of Ayurveda drug formulations from Mumbai city
title_fullStr Evaluation of package inserts of Ayurveda drug formulations from Mumbai city
title_full_unstemmed Evaluation of package inserts of Ayurveda drug formulations from Mumbai city
title_short Evaluation of package inserts of Ayurveda drug formulations from Mumbai city
title_sort evaluation of package inserts of ayurveda drug formulations from mumbai city
topic Survey Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5041383/
https://www.ncbi.nlm.nih.gov/pubmed/27833363
http://dx.doi.org/10.4103/0974-8520.190694
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