Cefixime-associated acute generalized exanthematous pustulosis: Rare cases in India (Record no. 8351)

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fixed length control field a
003 - CONTROL NUMBER IDENTIFIER
control field OSt
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20190514115929.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 190227b xxu||||| |||| 00| 0 eng d
040 ## - CATALOGING SOURCE
Original cataloging agency AIKTC-KRRC
Transcribing agency AIKTC-KRRC
100 ## - MAIN ENTRY--PERSONAL NAME
9 (RLIN) 7682
Author Vipin Kumar
245 ## - TITLE STATEMENT
Title Cefixime-associated acute generalized exanthematous pustulosis: Rare cases in India
250 ## - EDITION STATEMENT
Volume, Issue number Vol. 50(4), July-August
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Mumbai
Year 2018
Name of publisher, distributor, etc. Wolter Kluwer
300 ## - PHYSICAL DESCRIPTION
Pagination 204-207
520 ## - SUMMARY, ETC.
Summary, etc. BACKGROUND: Cefixime is a widely used third-generation cephalosporin schedule H1 drug, which is prescribed for the treatment of otitis media, respiratory tract infections, and uncomplicated urinary tract infections and is effective against infections caused by Enterobacteriaceae and Haemophilus influenzae species in India. The National Coordination Centre (NCC)-Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), has received rare individual case safety reports (ICSRs) for acute generalized exanthematous pustulosis (AGEP) associated with the use of cefixime. MATERIALS AND METHODS: IPC, NCC-PvPI also acts as a national collaborating center for pharmacovigilance activities under the aegis of Ministry of Health and Family Welfare, Government of India; moreover, it is a member country in global pharmacovigilance system, World Health Organization-Uppsala Monitoring Centre, Sweden. There are more than 250 government/corporate medical colleges and hospitals acting as regional adverse drug reaction monitoring centers, actively functioning under PvPI. Furthermore, various stakeholders including consumers and pharmaceutical industries also play a significant contribution. NCC-PvPI receives spontaneous ICSRs from various stakeholders. RESULTS: NCC-PvPI, IPC has received a total of four spontaneous ICSRs for cefixime-induced AGEP. After clinical evaluation of reported ICSRs, a strong causal relationship was established between AGEP and cefixime and was supported by published literature and histopathological examination of skin. Based on the statistics with positive information component (IC025 Value: 0.17) and proportionality relative risk (PRR:3.4), PvPI considered cefixime-associated AGEP may be a potential signal. CONCLUSION: Hence, initially, AEGP is considered by PvPI as drug safety alert in July 2016. Therefore, to enhance the safety of population in rational usage of medication, as a result, there is a need for physicians and health-care professionals to sensitize about serious adverse reaction while prescribing the cefixime as signal in India.
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
9 (RLIN) 4774
Topical term or geographic name entry element PHARMACOLOGY
700 ## - ADDED ENTRY--PERSONAL NAME
9 (RLIN) 7683
Co-Author Kalaiselvan, Vivekanandan
700 ## - ADDED ENTRY--PERSONAL NAME
9 (RLIN) 7684
Co-Author Pramod Kumar A.
773 0# - HOST ITEM ENTRY
Place, publisher, and date of publication Andheri - Mumbai Wolters Kluwer India Private Limited
International Standard Serial Number 0253-7613
Title Indian Journal of Pharmacology
856 ## - ELECTRONIC LOCATION AND ACCESS
Link text Click here
URL http://www.ijp-online.com/article.asp?issn=0253-7613;year=2018;volume=50;issue=4;spage=204;epage=207;aulast=Kumar;type=0
942 ## - ADDED ENTRY ELEMENTS (KOHA)
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    Dewey Decimal Classification     School of Pharmacy School of Pharmacy Archieval Section 29/03/2019   2018278 19/06/2019 29/03/2019 Articles Abstract Database
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