Toll Free: 18001210443
HIMACHAL PRADESH STATE PHARMACY COUNCIL
DRUG INFORMATION CENTER
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101
Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]
Issue 23 Volume 3 SEP 2019 | |
Drug Updates Scrub TyphusPharma News World Pharmacists Day 2019
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER1 2
DrugUpdatesNourianzforParkinsondisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TaltznowforAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Xenleta™forCABP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Rinvoq™forRheumatoidArthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TreatmentforRareBoneMarrowDisorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
WakixforNarcolepsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
RozlytrekforNSCLCandSolidTumors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NewTreatment-ResistantTBDrug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
TuralioforRareJointTumor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NewKeytrudaIndication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NubeqaforProstatecancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
FerricMaltolnowapprovedinUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6® ®Xeljanz /Xeljanz XRSafetyCommunication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
stBaqsimi™:1 GlucagonwithoutInjection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6nd ®Ruxience™:2 Rituxan Biosimilar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
®Otezla :OralUlcersduetoBehcetDisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6®FirstLyrica GenericsApproved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
RecarbrioforCutiandcIAI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Editorial
AdvisoryBoard
Dr.NavneetMarwah,Mr.SanjeevPandit,Dr.ManojKumar,Dr.RanjitSingh,
Prof.CPSVerma,Dr.PoonamSandhu,Dr.RajenderGuleria,Mr.ArvindKumar,
Mr.BihariLalGupta,Mr,HemantSharma,Mr.RakeshChandel,Mr.Praveen
Upadhya,Mr. Kamashwar Chauhan,Mr. Lokesh Kumar,Mr. Vishal Kumar,
Mr.Y.S.Chandel,Mr.BirbalSharma,Mr.ManojKumar,Mr.YogeshVerma,Mr.
SurenderNadda,Dr.Parshuram
Patron
Mr.GopalKrishanSharmaandDr.RanSingh
Editor-in-Chief
Dr.KamleshNaikandDr.M.S.Ashawat
Co-Editors
Dr.VinayPanditandMr.AnkushSharma
Content
XembifyforPrimaryImmunodeficiencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
XpovioforRRMM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
NewTioproninDoseForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Zirabev:SecondBiosimilartoAvastin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
DopteletNowforChronicITP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Darzalex:NewMultipleMyelomaComboRegimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8stSoliris:1 NMOSDAprroval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
HealthNewsMobileapplaunchedforlocatingoutletsandsearchingGenericmedicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Acontrolled-releaseoraltabletforkalaazarandfungalinfections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival . . . . . . . . . . . . . . . . . . . 10
AdditionalFAQonNewDrugsandClinicalTrialRules,2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection . . . . . . . 12
HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals . . . . . . . . . . . . . . . . . . . . . 13
FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections . . . . 13
ZydusCadilalaunchesinsomniadruginUSmarket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Doctorsshouldprovideonlygenericmedicines:DCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list . . . . . . . . . . 14
Allstategovernmentsaresupposedtodrawdrugsamplesandtestthem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Sugarinfruitjuicemayraiseriskofcancer,studyfinds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Antiparasiticdrugmayhelpfightskincancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskofleg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
NOTIFICATION(DepartmentofHealthandFamilyWelfare) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
ScrubTyphusIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
SymptomsandSign. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
WorldPharmacistsDay2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Drug Therapy Bulletin
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER1 2
DrugUpdatesNourianzforParkinsondisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TaltznowforAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Xenleta™forCABP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Rinvoq™forRheumatoidArthritis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
TreatmentforRareBoneMarrowDisorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
WakixforNarcolepsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
RozlytrekforNSCLCandSolidTumors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NewTreatment-ResistantTBDrug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
TuralioforRareJointTumor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NewKeytrudaIndication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
NubeqaforProstatecancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
FerricMaltolnowapprovedinUS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6® ®Xeljanz /Xeljanz XRSafetyCommunication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
stBaqsimi™:1 GlucagonwithoutInjection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6nd ®Ruxience™:2 Rituxan Biosimilar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
®Otezla :OralUlcersduetoBehcetDisease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6®FirstLyrica GenericsApproved . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
RecarbrioforCutiandcIAI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Editorial
AdvisoryBoard
Dr.NavneetMarwah,Mr.SanjeevPandit,Dr.ManojKumar,Dr.RanjitSingh,
Prof.CPSVerma,Dr.PoonamSandhu,Dr.RajenderGuleria,Mr.ArvindKumar,
Mr.BihariLalGupta,Mr,HemantSharma,Mr.RakeshChandel,Mr.Praveen
Upadhya,Mr. Kamashwar Chauhan,Mr. Lokesh Kumar,Mr. Vishal Kumar,
Mr.Y.S.Chandel,Mr.BirbalSharma,Mr.ManojKumar,Mr.YogeshVerma,Mr.
SurenderNadda,Dr.Parshuram
Patron
Mr.GopalKrishanSharmaandDr.RanSingh
Editor-in-Chief
Dr.KamleshNaikandDr.M.S.Ashawat
Co-Editors
Dr.VinayPanditandMr.AnkushSharma
Content
XembifyforPrimaryImmunodeficiencies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
XpovioforRRMM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
NewTioproninDoseForm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Zirabev:SecondBiosimilartoAvastin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
DopteletNowforChronicITP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Darzalex:NewMultipleMyelomaComboRegimen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8stSoliris:1 NMOSDAprroval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
HealthNewsMobileapplaunchedforlocatingoutletsandsearchingGenericmedicines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Acontrolled-releaseoraltabletforkalaazarandfungalinfections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival . . . . . . . . . . . . . . . . . . . 10
AdditionalFAQonNewDrugsandClinicalTrialRules,2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection . . . . . . . 12
HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals . . . . . . . . . . . . . . . . . . . . . 13
FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections . . . . 13
ZydusCadilalaunchesinsomniadruginUSmarket. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Doctorsshouldprovideonlygenericmedicines:DCC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list . . . . . . . . . . 14
Allstategovernmentsaresupposedtodrawdrugsamplesandtestthem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Sugarinfruitjuicemayraiseriskofcancer,studyfinds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Antiparasiticdrugmayhelpfightskincancer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskofleg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
NOTIFICATION(DepartmentofHealthandFamilyWelfare) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
ScrubTyphusIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Causes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
SymptomsandSign. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
WorldPharmacistsDay2019 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Drugs Update
NourianzforParkinsondiseaseOnAugust27,2019,theUSFDAapprovedNourianz™
(istradefylline) oral tablets indicated as adjunctive
treatment to levodopa/carbidopa in adult patients
with Parkinson disease (PD) experiencing "off"
episodes. Patients treated with Nourianz
experiencedasignificantdecreasefrombaselinein
daily "off" time comparedwith those treatedwith
placeboin4clinicaltrials.
Theprescribinginformationprescribinginformationcanbefound
atthislink.
TaltznowforASOn August 26, 2019, the US FDA approved a new
®indicationforTaltz (ixekizumab)subQinjectionfor
the treatment of adult patients with active
ankylosing spondylitis (AS), also known as
radiographicaxialspondyloarthritis(r-axSpA).Taltz,
whichisalreadyapprovedforplaquepsoriasisand
psoriaticarthritis,wasapprovedforASbasedonthe
COAST-V and COAST-W clinical trials in which a
greater proportion of patients treated with
ixekizumabachievedresponsecomparedwiththose
treatedwithplacebo.
T h e p r e s c r i b i n g i n f o rm a t i o n c a n b e f o u n d a t :
http://uspl.lilly.com/taltz/taltz.html?s=pi.
Xenleta™forCABPOnAugust19,2019,theUSFDAapprovedXenleta™
(lefamulin)IVinjectionandoraltabletsindicatedfor
the treatment of adults with community-acquired
bacterialpneumonia(CABP)causedbysusceptible
microorganisms. Xenleta, which was granted the
FDA's Qualified Infectious Disease Product
designation, was shown to have similar rates of
clinical success as moxifloxacin with or without
linezolidin2clinicaltrials.
T h e p r e s c r i b i n g i n f o rm a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21
1672s000,211673s000lbl.pdf.
Rinvoq™forRheumatoidArthritisOn August 16, 2019 the US FDA approved Rinvoq™
(upadacitinib)oralextended-release tablets indicated to
treat adult patients with moderately to severely active
rheumatoidarthritiswhohavehadinadequateresponseor
intolerance tomethotrexate.Approvalwasgrantedafter
data from clinical trials demonstrated patients
administered Rinvoq achieved clinical remission more
often than patients who received placebo plus
methotrexate. Additionally, Rinvoq met all primary and
rankedsecondaryendpointsacross theSELECTPhase3
trials.
Prescribinginformationcanbefoundat:https://www.accessdata.fda.gov/
drugsatfda_docs/label/2019/211675s000lbl.pdf.
Treatment for Rare Bone Marrow
DisorderOn August 16, 2019 the US FDA approved Inrebic(R)
(fedratinib) oral capsules for the treatment of adult
patients with intermediate-2 or high-risk primary or
secondary (post-polycythemia vera or post-essential
thrombocythemia) myelofibrosis. Inrebic is the second
FDA-approvedtreatmentoptionforthisrarebonemarrow
disease.Approvalwasbasedonresultsfromaclinicaltrial
where patients administered fedratinib experienced
greater reduction in myelofibrosis-related symptoms
comparedwith placebo at the end of 24weeks. Inrebic
carriesaboxedwarningregardingtheriskofseriousand
fatalencephalopathy,includingWernicke's.
The prescribing information can be found at: https://www.accessdata.
fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf.
WakixforNarcolepsy®On August 15, 2019, the US FDA approved Wakix
(pitolisant) oral tablets indicated for the treatment of
excessivedaytimesleepiness(EDS)inadultpatientswith
narcolepsy.WakixisthefirstnarcolepsydrugtogainFDA
approval that is not a schedule controlled substance.
ApprovalwasbasedonasignificantimprovementinEDS
Drug Therapy Bulletin
3 4 HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
This page has been intentionally kept blank!
It isamatterof immensepleasure toknow thatall the studentsand facultyof HimachalPradesh
TechnicalUniversity affiliated pharmacyColleges areenthusiastically gatheringunderthesame
umbrellatomarkthecelebrationofWorldsPharmacistdayon25thSeptember2019.
IndiaisthelargestsupplierofgenericdrugsintheWorldMarket.Thestatisticaldatashowsthatover80
percentof theantiretroviraldrugsusedglobally tocombatAcquired ImmunodeficiencySyndrome
(AIDs) are supplied by Indianpharmaceutical firms.India's biotechnology andbio-pharmaceuticals
industryisexpectedtogrowatanaveragegrowthrateofaround30percentayearandreachUS$100
billion by 2025. The profession of Pharmacy has great contribution towards total Gross Domestic
Product(GDP).
TheacademicteachinglearningplayspivotalroleinseedingstheprofessionofPharmacy.AsaVice
chancellor, I assure that I extendall thehelp topharmacy colleges for theupliftmentof thisnoble
profession.
Pharmacy is the backbone of health care system.We are committed to this year theme "Safe and
effective medicines for all”. The organized events will motivate all the undergraduate and
postgraduatestudentstounderstandtheirsocial,moralandprofessionalresponsibilitiestowardsthe
society.Weadvocatethatpatientsshouldonlyreceivethemedicinefromthepharmacistshandandwe
believethatpharmacistsarebestcounselorofmedicine.
Drugabuseandaddiction isanothersocial issuesandpharmacist canplay important role through
awarenessprogramandpatientcounselling.Pharmacistscanusetheirbroadexperienceandexpertise
toensurethatpeoplegetthedesiredresultfromthemedicines.We,believethateverycitizenmustget
accesstotreatmentforanyailmentsandprescribedmedicinemustbeprovidedinaffordableprice.Drug
misuseanddiseasemongeringisoneofthealarmingsituationinourcountry.Onthisday,Irequestall
thepharmaciststotakeoathregardingthepracticeofpharmacyinsuchanethicalapproachthatrational
useofmedicineinsocietyisachievedincomingyears.
I,highlyappreciatethecontributionofpharmacisttohealthcaresystemandIonthebehalfofHimachal
Pradesh Technical University (HPTU) congratulate all the young and aspiring pharmacists in this
auspiciousday.
(ProfessorS.P.Bansal)
Message Drugs Update
NourianzforParkinsondiseaseOnAugust27,2019,theUSFDAapprovedNourianz™
(istradefylline) oral tablets indicated as adjunctive
treatment to levodopa/carbidopa in adult patients
with Parkinson disease (PD) experiencing "off"
episodes. Patients treated with Nourianz
experiencedasignificantdecreasefrombaselinein
daily "off" time comparedwith those treatedwith
placeboin4clinicaltrials.
Theprescribinginformationprescribinginformationcanbefound
atthislink.
TaltznowforAS
On August 26, 2019, the US FDA approved a new®indicationforTaltz (ixekizumab)subQinjectionfor
the treatment of adult patients with active
ankylosing spondylitis (AS), also known as
radiographicaxialspondyloarthritis(r-axSpA).Taltz,
whichisalreadyapprovedforplaquepsoriasisand
psoriaticarthritis,wasapprovedforASbasedonthe
COAST-V and COAST-W clinical trials in which a
greater proportion of patients treated with
ixekizumabachievedresponsecomparedwiththose
treatedwithplacebo.
T h e p r e s c r i b i n g i n f o rm a t i o n c a n b e f o u n d a t :
http://uspl.lilly.com/taltz/taltz.html?s=pi.
Xenleta™forCABPOnAugust19,2019,theUSFDAapprovedXenleta™
(lefamulin)IVinjectionandoraltabletsindicatedfor
the treatment of adults with community-acquired
bacterialpneumonia(CABP)causedbysusceptible
microorganisms. Xenleta, which was granted the
FDA's Qualified Infectious Disease Product
designation, was shown to have similar rates of
clinical success as moxifloxacin with or without
linezolidin2clinicaltrials.
T h e p r e s c r i b i n g i n f o rm a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21
1672s000,211673s000lbl.pdf.
Rinvoq™forRheumatoidArthritis
On August 16, 2019 the US FDA approved Rinvoq™
(upadacitinib)oralextended-release tablets indicated to
treat adult patients with moderately to severely active
rheumatoidarthritiswhohavehadinadequateresponseor
intolerance tomethotrexate.Approvalwasgrantedafter
data from clinical trials demonstrated patients
administered Rinvoq achieved clinical remission more
often than patients who received placebo plus
methotrexate. Additionally, Rinvoq met all primary and
rankedsecondaryendpointsacross theSELECTPhase3
trials.
Prescribinginformationcanbefoundat:https://www.accessdata.fda.gov/
drugsatfda_docs/label/2019/211675s000lbl.pdf.
Treatment for Rare Bone Marrow
Disorder
On August 16, 2019 the US FDA approved Inrebic(R)
(fedratinib) oral capsules for the treatment of adult
patients with intermediate-2 or high-risk primary or
secondary (post-polycythemia vera or post-essential
thrombocythemia) myelofibrosis. Inrebic is the second
FDA-approvedtreatmentoptionforthisrarebonemarrow
disease.Approvalwasbasedonresultsfromaclinicaltrial
where patients administered fedratinib experienced
greater reduction in myelofibrosis-related symptoms
comparedwith placebo at the end of 24weeks. Inrebic
carriesaboxedwarningregardingtheriskofseriousand
fatalencephalopathy,includingWernicke's.
The prescribing information can be found at: https://www.accessdata.
fda.gov/drugsatfda_docs/label/2019/212327s000lbl.pdf.
WakixforNarcolepsy®On August 15, 2019, the US FDA approved Wakix
(pitolisant) oral tablets indicated for the treatment of
excessivedaytimesleepiness(EDS)inadultpatientswith
narcolepsy.WakixisthefirstnarcolepsydrugtogainFDA
approval that is not a schedule controlled substance.
ApprovalwasbasedonasignificantimprovementinEDS
ProfessorS.P.BansalHon’bleViceChancellor
HimachalPradeshTechnicalUniversity
Hamirpur-HP
Drug Therapy Bulletin
3 4 HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
compared with placebo in the HARMONY1 and
HARMONY1bisclinicaltrials.
Theprescribinginformationcanbefoundat:https://www.accessdata.
fda.gov/drugsatfda_docs/label/2019/0211150s000lbl.pdf.
Rozlytrek for NSCLC and Solid
TumorsOnAugust15,2019,theUSFDAapprovedRozlytrek™
(entrectinib) oral capsules indicated to treat adult
patients with metastatic non-small cell lung cancer
(NSCLC)whosetumorsareROS1-positiveandtotreat
adult andpediatric patients12 years of ageor older
withNTRKgenefusion-positivesolidtumors.Rozlytrek
isthethirdoncologydrugapprovedbytheFDAbased
on a common biomarker across different types of
tumorsratherthanthelocationinthebodywherethe
tumor originated. The FDA granted Rozlytrek
accelerated approval as well as priority review,
breakthroughtherapy,andorphandrugdesignations.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21272
5s000lbl.pdf.
NewTreatment-ResistantTBDrugOnAugust14,2019,theUSFDAapprovedpretomanid
oraltabletsindicatedaspartofacombinationregimen
with bedaquiline and linezolid for the treatment of
adults with pulmonary extensively drug resistant
(XDR), treatment-intolerant or nonresponsive
multidrug-resistant (MDR) tuberculosis (TB). Of the
patientstreatedwithpretomanidincombinationwith
bedaquilineandlinezolidinaclinicaltrial,89%were
successesat6monthsaftertheendoftherapywhich
significantly exceeded thehistorical success rates for
treatmentofextensivelydrugresistantTB.Pretomanid
istheseconddrugapprovedundertheFDA'sLimited
Population Pathway for Antibacterial and Antifungal
Drugs.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21286
2s000lbl.pdf.
TuralioforRareJointTumorOn August 2, 2019, the US FDA approved Turalio™
(pexidartinib) oral capsules indicated to treat adult
patients with symptomatic tenosynovial giant cell
tumor (TGCT) associated with severe morbidity or
functional limitations and not amenable to
improvementwithsurgery.Turalio,whichwasgranted
breakthroughtherapy,priorityreview,andorphandrug
designation by the FDA, demonstrated a significant
improvementinoverallresponseratecomparedwith
placebo in a clinical trial. Turalio carries a boxed
warningregarding theriskof seriousandpotentially
fatal liver injury and is only available through the
TuralioRiskEvaluationandMitigationStrategy(REMS)
program.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21181
0s000lbl.pdf.
NewKeytrudaIndicationOnJuly31,2019,theUSFDAapprovedanewindication
®for Keytruda (pembrolizumab) IV injection to treat
patientswithrecurrentlocallyadvancedormetastatic
squamous cell carcinoma of the esophagus whose
tumorsexpressPD-L1(combinedpositivescore(CPS)
of10orgreater)asdeterminedbyanFDA-approved
test,withdiseaseprogressionafter1ormorepriorlines
of systemic therapy.Keytruda,which isnow the first
anti-PD-1 therapy approved for this indication,
demonstrated significant improvement in overall
response rate and duration of response in the
KEYNOTE-180andKEYNOTE-181clinicaltrials.
Prescribing information can be found at: http://www.merck.com/
product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf.
NubeqaforProstatecancer®On July 30, 2019, the US FDA approved Nubeqa
(darolutamide)oraltabletsindicatedforthetreatment
of patients with non-metastatic castration resistant
prostatecancer(nmCRPC).Nubeqa,whichwasgranted
FDA'sPriorityReviewdesignation,wasapprovedbased
on the ARAMIS trial, in which patients treated with
darolutamideplusandrogendeprivationtherapy(ADT)
demonstratedasignificantimprovementinmetastasis-
freesurvivalcomparedwithplaceboplusADT.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI .p
df.
FerricMaltolnowapprovedinUS®OnJuly26,2019,theUSFDAapprovedAccrufer (ferric
maltol)oralcapsulesindicatedforthetreatmentofiron
deficiencyinadultpatients.Accrufer,whichisalready®marketedinEuropeasFeraccru ,wasapprovedbased
on studies showing a greater mean difference in Hb
from baseline in patients treated with ferric maltol
comparedwiththosetreatedwithplacebo.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21232
0Orig1s000lbl.pdf.
® ®Xel janz /Xe l janz XR Sa fe ty
Communication
On July 26, 2019, the US FDA issued a drug safety® ®communication for Xeljanz /Xeljanz XR (tofacitinib)
oraltabletsandextended-releasetabletsregardingan
increasedriskofbloodclotsandofdeathwiththe10-
mg twice daily dose used to treat patients with
ulcerative colitis. Also, the use of tofacitinib for
ulcerativecolitiswillbe limited topatientswhohave
severe side effects orwho are not effectively treated
with certain other medications. Healthcare
professionalsshoulddiscontinuetofacitinibinpatients
withsymptomsofthrombosisandadvisetheirpatients
when to seek medical attention. Additionally,
healthcare professionals and patients should report
adverseeventsorsideeffectsrelatedtotheseproducts.
The prescribing information has been updated,
includingtheBlackBoxWarning,toincludetheserisks.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/20321
4s024,208246s010lbl.pdf.
stBaqsimi™: 1 Glucagon without
InjectionOn July 24, 2019, the US FDA approved Baqsimi™
(glucagon) nasal powder indicated to treat severe
hypoglycemiainpatientswithdiabetes4yearsofageor
older.Baqsimi,thefirstglucagonproductnotrequiring
injectiontogainFDAapproval,wasapprovedbasedon2
studies showing adequately increased blood sugar
levels in adult and pediatric patients comparedwith
thosetreatedwithglucagoninjection.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21013
4s000lbl.pdf.
nd ®Ruxience™:2 Rituxan Biosimilar
On July 23, 2019, the US FDA approved Ruxience™
(rituximab-pvvr) IV injection indicated to treat adult
patients with: non-Hodgkin lymphoma, chronic
lymphocytic leukemia, and granulomatosis with
polyangiitis and microscopic polyangiitis. Ruxience,®whichisthesecondbiosimilartoRituxan (rituximab)
to gain FDA approval, was approved based on
pharmacokinetic, clinical immunogenicity, and other
clinical data demonstrating that rituximab-pvvr is
biosimilartorituximab.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76110
3s000lbl.pdf
®Otezla : Oral Ulcers due to Behcet
Disease
OnJuly19,2019,theUSFDAapprovedanewindication®for Otezla (apremilast) oral tablets to treat adult
patients with oral ulcers associated with Behcet
Disease. Approval for this indication was based on
resultsfromtheRELIEFtrialinwhichpatientstreated
withapremilasthadagreaterreductionfrombaseline
inthepainandnumberoforalulcerscomparedwith
thosetreatedwithplacebo.Otezlaisthefirsttreatment
togainFDAapproval for the treatmentoforalulcers
5 6 HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
compared with placebo in the HARMONY1 and
HARMONY1bisclinicaltrials.
Theprescribinginformationcanbefoundat:https://www.accessdata.
fda.gov/drugsatfda_docs/label/2019/0211150s000lbl.pdf.
Rozlytrek for NSCLC and Solid
TumorsOnAugust15,2019,theUSFDAapprovedRozlytrek™
(entrectinib) oral capsules indicated to treat adult
patients with metastatic non-small cell lung cancer
(NSCLC)whosetumorsareROS1-positiveandtotreat
adult andpediatric patients12 years of ageor older
withNTRKgenefusion-positivesolidtumors.Rozlytrek
isthethirdoncologydrugapprovedbytheFDAbased
on a common biomarker across different types of
tumorsratherthanthelocationinthebodywherethe
tumor originated. The FDA granted Rozlytrek
accelerated approval as well as priority review,
breakthroughtherapy,andorphandrugdesignations.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21272
5s000lbl.pdf.
NewTreatment-ResistantTBDrugOnAugust14,2019,theUSFDAapprovedpretomanid
oraltabletsindicatedaspartofacombinationregimen
with bedaquiline and linezolid for the treatment of
adults with pulmonary extensively drug resistant
(XDR), treatment-intolerant or nonresponsive
multidrug-resistant (MDR) tuberculosis (TB). Of the
patientstreatedwithpretomanidincombinationwith
bedaquilineandlinezolidinaclinicaltrial,89%were
successesat6monthsaftertheendoftherapywhich
significantly exceeded thehistorical success rates for
treatmentofextensivelydrugresistantTB.Pretomanid
istheseconddrugapprovedundertheFDA'sLimited
Population Pathway for Antibacterial and Antifungal
Drugs.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21286
2s000lbl.pdf.
TuralioforRareJointTumorOn August 2, 2019, the US FDA approved Turalio™
(pexidartinib) oral capsules indicated to treat adult
patients with symptomatic tenosynovial giant cell
tumor (TGCT) associated with severe morbidity or
functional limitations and not amenable to
improvementwithsurgery.Turalio,whichwasgranted
breakthroughtherapy,priorityreview,andorphandrug
designation by the FDA, demonstrated a significant
improvementinoverallresponseratecomparedwith
placebo in a clinical trial. Turalio carries a boxed
warningregarding theriskof seriousandpotentially
fatal liver injury and is only available through the
TuralioRiskEvaluationandMitigationStrategy(REMS)
program.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21181
0s000lbl.pdf.
NewKeytrudaIndicationOnJuly31,2019,theUSFDAapprovedanewindication
®for Keytruda (pembrolizumab) IV injection to treat
patientswithrecurrentlocallyadvancedormetastatic
squamous cell carcinoma of the esophagus whose
tumorsexpressPD-L1(combinedpositivescore(CPS)
of10orgreater)asdeterminedbyanFDA-approved
test,withdiseaseprogressionafter1ormorepriorlines
of systemic therapy.Keytruda,which isnow the first
anti-PD-1 therapy approved for this indication,
demonstrated significant improvement in overall
response rate and duration of response in the
KEYNOTE-180andKEYNOTE-181clinicaltrials.
Prescribing information can be found at: http://www.merck.com/
product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf.
NubeqaforProstatecancer®On July 30, 2019, the US FDA approved Nubeqa
(darolutamide)oraltabletsindicatedforthetreatment
of patients with non-metastatic castration resistant
prostatecancer(nmCRPC).Nubeqa,whichwasgranted
FDA'sPriorityReviewdesignation,wasapprovedbased
on the ARAMIS trial, in which patients treated with
darolutamideplusandrogendeprivationtherapy(ADT)
demonstratedasignificantimprovementinmetastasis-
freesurvivalcomparedwithplaceboplusADT.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
http://labeling.bayerhealthcare.com/html/products/pi/Nubeqa_PI .p
df.
FerricMaltolnowapprovedinUS®OnJuly26,2019,theUSFDAapprovedAccrufer (ferric
maltol)oralcapsulesindicatedforthetreatmentofiron
deficiencyinadultpatients.Accrufer,whichisalready®marketedinEuropeasFeraccru ,wasapprovedbased
on studies showing a greater mean difference in Hb
from baseline in patients treated with ferric maltol
comparedwiththosetreatedwithplacebo.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21232
0Orig1s000lbl.pdf.
® ®Xel janz /Xe l janz XR Sa fe ty
Communication
On July 26, 2019, the US FDA issued a drug safety® ®communication for Xeljanz /Xeljanz XR (tofacitinib)
oraltabletsandextended-releasetabletsregardingan
increasedriskofbloodclotsandofdeathwiththe10-
mg twice daily dose used to treat patients with
ulcerative colitis. Also, the use of tofacitinib for
ulcerativecolitiswillbe limited topatientswhohave
severe side effects orwho are not effectively treated
with certain other medications. Healthcare
professionalsshoulddiscontinuetofacitinibinpatients
withsymptomsofthrombosisandadvisetheirpatients
when to seek medical attention. Additionally,
healthcare professionals and patients should report
adverseeventsorsideeffectsrelatedtotheseproducts.
The prescribing information has been updated,
includingtheBlackBoxWarning,toincludetheserisks.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/20321
4s024,208246s010lbl.pdf.
stBaqsimi™: 1 Glucagon without
InjectionOn July 24, 2019, the US FDA approved Baqsimi™
(glucagon) nasal powder indicated to treat severe
hypoglycemiainpatientswithdiabetes4yearsofageor
older.Baqsimi,thefirstglucagonproductnotrequiring
injectiontogainFDAapproval,wasapprovedbasedon2
studies showing adequately increased blood sugar
levels in adult and pediatric patients comparedwith
thosetreatedwithglucagoninjection.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21013
4s000lbl.pdf.
nd ®Ruxience™:2 Rituxan Biosimilar
On July 23, 2019, the US FDA approved Ruxience™
(rituximab-pvvr) IV injection indicated to treat adult
patients with: non-Hodgkin lymphoma, chronic
lymphocytic leukemia, and granulomatosis with
polyangiitis and microscopic polyangiitis. Ruxience,®whichisthesecondbiosimilartoRituxan (rituximab)
to gain FDA approval, was approved based on
pharmacokinetic, clinical immunogenicity, and other
clinical data demonstrating that rituximab-pvvr is
biosimilartorituximab.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76110
3s000lbl.pdf
®Otezla : Oral Ulcers due to Behcet
Disease
OnJuly19,2019,theUSFDAapprovedanewindication®for Otezla (apremilast) oral tablets to treat adult
patients with oral ulcers associated with Behcet
Disease. Approval for this indication was based on
resultsfromtheRELIEFtrialinwhichpatientstreated
withapremilasthadagreaterreductionfrombaseline
inthepainandnumberoforalulcerscomparedwith
thosetreatedwithplacebo.Otezlaisthefirsttreatment
togainFDAapproval for the treatmentoforalulcers
5 6 HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
7 8
associatedwithBehcetDisease.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
http://www.celgene.com/content/uploads/otezla-pi.pdf.
®FirstLyrica GenericsApprovedOn July 19, 2019, the US FDA granted approval to
®multiple applications for the first generics of Lyrica
(pregabalin)oralcapsulesandoralsolutionindicated
tomanageneuropathicpain associatedwithdiabetic
peripheral neuropathy, to manage postherpetic
neuralgia,asanadjunctivetherapytotreatpartialonset
seizuresinpatients17yearsofageorolder,tomanage
fibromyalgia, and to manage neuropathic pain
associatedwithspinalcordinjury.TheFDAapproved9
pregabalin generics as part of the Drug Competition
ActionPlanbywhichtheFDAisaddressingchallenges
related to developing generics and promoting more
genericcompetitionaswellashelpingadvancepatient
accesstomoreaffordablemedicines.
RecarbrioforCutiandcIAIOn July 17, 2019, the US FDA approved Recarbrio™
(imipenem/cilastatin/relebactam)IVinjectiontotreat
complicated urinary tract infections (cUTI) and
complicated intra-abdominal infections (cIAI) caused
by susceptible gram-negative bacteria in patients 18
yearsofageorolderwhohavelimitedornoalternative
treatment options. Recarbrio,whichwas granted the
FDA's Qualified Infection Disease designation, was
determinedtobeefficaciousinpartbythefindingsof
imipenem/cilastatinefficacyandsafetyintreatingcUTI
andcIAIaswellasin2clinicaltrials.
Theprescribinginformationcanbefoundat:https://www.merck.com/
product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf.
Xembify for Primary Immuno-
deficiencies®On July 3, 2019, the US FDA approved Xembify
(immune globulin-klhw) subQ injection indicated for
treatmentofprimaryhumoralimmunodeficiency(PI)
inpatients2yearsofageorolder.Xembify,a20%subQ
immunoglobul in , demonstrated safety and
pharmacokinetics in a clinical trial of adult and
pediatricpatients.There is alsoanongoing trial that
appears consistent with safety results of the first
clinicaltrial.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.fda.gov/media/128601/download.
XpovioforRRMM
On July 3, 2019, the US FDA approved Xpovio™
(selinexor)oraltabletsindicatedincombinationwith
dexamethasoneforthetreatmentofadultpatientswith
relapsedorrefractorymultiplemyeloma(RRMM)who
have received at least 4 prior therapies and whose
diseaseisrefractorytoatleast2proteasomeinhibitors,
atleast2immunomodulatoryagents,andananti-CD38
monoclonalantibody.Xpovio,whichwasgranted fast
track and orphan drug designations, demonstrated
efficacyintheSTORMclinicaltrial.Continuedapproval
willbebasedondatafromtheongoingBostonclinical
trial.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21230
6s000lbl.pdf.
NewTioproninDoseForm®On June 28, 2019, the US FDA approved Thiola EC
(tiopronin), a new enteric coated, delayed-release®tablet dose form of Thiola (tiopronin) oral tablets.
ThiolaECis indicated, incombinationwithhighfluid
intake,alkali,anddietmodification,fortheprevention
of cystine stone formation in adults and pediatric
patients 20 kg or greater with severe homozygous
cystinuria,whoarenotresponsivetothesemeasures
alone. This new formulation may be taken with or
withoutfoodandtherequirednumberoftabletsmaybe
reducedofferingflexibledosingoptionscomparedwith
Thiola which has limiting food restrictions and may
requiremoretabletstobetaken.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21184
3s000lbl.pdf.
Zirabev:SecondBiosimilartoAvastin
On June 28 , 2019 , the US FDA approved
Zirabev™(bevacizumab-bvzr) IV injection to treat
metastatic colorectal cancer; unresectable, locally
advanced,recurrentormetastaticnon-squamousnon-
small cell lung cancer; recurrent glioblastoma;
metastatic renal cell carcinoma; and persistent,
recurrentormetastaticcervicalcancer.Zirabev,whichis®thesecondbiosimilartoAvastin (bevacizumab)togain
FDA approval, was approved based on comparative
analytical, pharmacokinetic, and clinical data which
showedclinicalequivalencetoAvastin.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76109
9s000lbl.pdf.
DopteletNowforChronicITPOnJune27,2019,theUSFDAapprovedanewindication
®for Doptelet (avatrombopag) oral tablets to treat
thrombocytopenia in adult patients with chronic
immune thrombocytopenia (ITP) who have had an
insufficientresponsetoaprevioustreatment.Doptelet,
which is also approved to treat thrombocytopenia in
adultpatientswithchronicliverdisease,demonstrated
efficacycomparedwithplaceboinaclinicaltrial.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21023
8s001lbl.pdf.
Darzalex: New Multiple Myeloma
ComboRegimenOnJune27,2019,theUSFDAapprovedanewindication
®forDarzalex (daratumumab)IVinjectiontotreatadultpatients withmultiplemyeloma in combination withlenalidomide anddexamethasone innewlydiagnosed
patients who are ineligible for autologous stem cell
transplantand inpatientswithrelapsedorrefractory
multiplemyelomawho have received at least 1 priortherapy. Darzalex demonstrated efficacy in the MAIAclinicaltrialinwhichdaratumumabincombinationwith
lenalidomideanddexamethasonesignificantlyreduced
disease progression risk or death compared withlenalidomideanddexamethasonealone.P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76103
6s020lbl.pdf.
stSoliris:1 NMOSDAprrovalOnJune27,2019,theUSFDAapprovedanewindication
®forSoliris (eculizumab)IVinjectionforthetreatment
ofneuromyelitisopticaspectrumdisorder(NMOSD)inadult patients who are anti-aquaporin-4 (AQP4)antibody positive. Soliris, the first drug to gain FDA
approvalforNMOSD,wasshowntobesafeandeffective
andmettheprimaryendpointofprolongingtimetofirst
adjudicatedrelapseandreducingtherelapseriskinthePREVENTtrial.Prescribing information can be found at http://alexion.com/
Documents/Soliris_USPI.aspx.
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
7 8
associatedwithBehcetDisease.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
http://www.celgene.com/content/uploads/otezla-pi.pdf.
®FirstLyrica GenericsApprovedOn July 19, 2019, the US FDA granted approval to
®multiple applications for the first generics of Lyrica
(pregabalin)oralcapsulesandoralsolutionindicated
tomanageneuropathicpain associatedwithdiabetic
peripheral neuropathy, to manage postherpetic
neuralgia,asanadjunctivetherapytotreatpartialonset
seizuresinpatients17yearsofageorolder,tomanage
fibromyalgia, and to manage neuropathic pain
associatedwithspinalcordinjury.TheFDAapproved9
pregabalin generics as part of the Drug Competition
ActionPlanbywhichtheFDAisaddressingchallenges
related to developing generics and promoting more
genericcompetitionaswellashelpingadvancepatient
accesstomoreaffordablemedicines.
RecarbrioforCutiandcIAIOn July 17, 2019, the US FDA approved Recarbrio™
(imipenem/cilastatin/relebactam)IVinjectiontotreat
complicated urinary tract infections (cUTI) and
complicated intra-abdominal infections (cIAI) caused
by susceptible gram-negative bacteria in patients 18
yearsofageorolderwhohavelimitedornoalternative
treatment options. Recarbrio,whichwas granted the
FDA's Qualified Infection Disease designation, was
determinedtobeefficaciousinpartbythefindingsof
imipenem/cilastatinefficacyandsafetyintreatingcUTI
andcIAIaswellasin2clinicaltrials.
Theprescribinginformationcanbefoundat:https://www.merck.com/
product/usa/pi_circulars/r/recarbrio/recarbrio_pi.pdf.
Xembify for Primary Immuno-
deficiencies®On July 3, 2019, the US FDA approved Xembify
(immune globulin-klhw) subQ injection indicated for
treatmentofprimaryhumoralimmunodeficiency(PI)
inpatients2yearsofageorolder.Xembify,a20%subQ
immunoglobul in , demonstrated safety and
pharmacokinetics in a clinical trial of adult and
pediatricpatients.There is alsoanongoing trial that
appears consistent with safety results of the first
clinicaltrial.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.fda.gov/media/128601/download.
XpovioforRRMM
On July 3, 2019, the US FDA approved Xpovio™
(selinexor)oraltabletsindicatedincombinationwith
dexamethasoneforthetreatmentofadultpatientswith
relapsedorrefractorymultiplemyeloma(RRMM)who
have received at least 4 prior therapies and whose
diseaseisrefractorytoatleast2proteasomeinhibitors,
atleast2immunomodulatoryagents,andananti-CD38
monoclonalantibody.Xpovio,whichwasgranted fast
track and orphan drug designations, demonstrated
efficacyintheSTORMclinicaltrial.Continuedapproval
willbebasedondatafromtheongoingBostonclinical
trial.
T h e p r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21230
6s000lbl.pdf.
NewTioproninDoseForm®On June 28, 2019, the US FDA approved Thiola EC
(tiopronin), a new enteric coated, delayed-release®tablet dose form of Thiola (tiopronin) oral tablets.
ThiolaECis indicated, incombinationwithhighfluid
intake,alkali,anddietmodification,fortheprevention
of cystine stone formation in adults and pediatric
patients 20 kg or greater with severe homozygous
cystinuria,whoarenotresponsivetothesemeasures
alone. This new formulation may be taken with or
withoutfoodandtherequirednumberoftabletsmaybe
reducedofferingflexibledosingoptionscomparedwith
Thiola which has limiting food restrictions and may
requiremoretabletstobetaken.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21184
3s000lbl.pdf.
Zirabev:SecondBiosimilartoAvastin
On June 28 , 2019 , the US FDA approved
Zirabev™(bevacizumab-bvzr) IV injection to treat
metastatic colorectal cancer; unresectable, locally
advanced,recurrentormetastaticnon-squamousnon-
small cell lung cancer; recurrent glioblastoma;
metastatic renal cell carcinoma; and persistent,
recurrentormetastaticcervicalcancer.Zirabev,whichis®thesecondbiosimilartoAvastin (bevacizumab)togain
FDA approval, was approved based on comparative
analytical, pharmacokinetic, and clinical data which
showedclinicalequivalencetoAvastin.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t :
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76109
9s000lbl.pdf.
DopteletNowforChronicITPOnJune27,2019,theUSFDAapprovedanewindication
®for Doptelet (avatrombopag) oral tablets to treat
thrombocytopenia in adult patients with chronic
immune thrombocytopenia (ITP) who have had an
insufficientresponsetoaprevioustreatment.Doptelet,
which is also approved to treat thrombocytopenia in
adultpatientswithchronicliverdisease,demonstrated
efficacycomparedwithplaceboinaclinicaltrial.
P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/21023
8s001lbl.pdf.
Darzalex: New Multiple Myeloma
ComboRegimenOnJune27,2019,theUSFDAapprovedanewindication
®forDarzalex (daratumumab)IVinjectiontotreatadultpatients withmultiplemyeloma in combination withlenalidomide anddexamethasone innewlydiagnosed
patients who are ineligible for autologous stem cell
transplantand inpatientswithrelapsedorrefractory
multiplemyelomawho have received at least 1 priortherapy. Darzalex demonstrated efficacy in the MAIAclinicaltrialinwhichdaratumumabincombinationwith
lenalidomideanddexamethasonesignificantlyreduced
disease progression risk or death compared withlenalidomideanddexamethasonealone.P r e s c r i b i n g i n f o r m a t i o n c a n b e f o u n d a t https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/76103
6s020lbl.pdf.
stSoliris:1 NMOSDAprrovalOnJune27,2019,theUSFDAapprovedanewindication
®forSoliris (eculizumab)IVinjectionforthetreatment
ofneuromyelitisopticaspectrumdisorder(NMOSD)inadult patients who are anti-aquaporin-4 (AQP4)antibody positive. Soliris, the first drug to gain FDA
approvalforNMOSD,wasshowntobesafeandeffective
andmettheprimaryendpointofprolongingtimetofirst
adjudicatedrelapseandreducingtherelapseriskinthePREVENTtrial.Prescribing information can be found at http://alexion.com/
Documents/Soliris_USPI.aspx.
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Pharma News
Drug Therapy Bulletin
9 10
UnionMinisterforChemicalsandFertilizers,ShriD.V.Sadananda Gowda launched a mobile application“Janaushadhi Sugam” which will enable people to
searchJanaushadhigenericmedicinesandthestoresatthetipoftheirfingers.
“Janaushadhi Sugam” mobile application would haveuser-friendlyoptionslike-tolocatenearbyJanaushadhikendra, direction guidance for location of theJanaushadhikendra through Google Map, searchJanaushadhi generic medicines, analyse productcomparisonofGenericvsBrandedmedicineinformofMRP&overallSavings,etc.
ThemobileapplicationisavailableonbothAndroid&iOSplatforms.ItcanbedownloadedfreeofcostbytheuserfromGooglePlayStoreandAppleStore.Ref:www.pharmatutor.org
MobileapplaunchedforlocatingoutletsandsearchingGenericmedicines
Researchers at Indian Institute of Technology-
Hyderabad have developed a method to produce
controlled-release oral tablets for treating fungal
infections and kala azar. The tablets were found to
release the drug Amphotericin B in a sustained and
controlled manner over a period of 10 days.
Amphotericin B is the drug of choice for fungal
infections of the abdomen and heart valves, fungal
pneumonia,andkalaazar.However,itiscostly,causes
toxicity and its bioavailability is poor. The drug is
administered through injection, which results in
uncontrolledreleaseintothebloodstream.
The researchers have developed the oral tablet byloadingthedrugontogelatinnano-fabric.Theychosegelatinesinceitisnontoxicandbiocompatible,besidesbeing biodegradable. It is used in food and medicalindustries.Thedrugwasloadedontogelatinandwas
thendrawnoutintheformofnanofibresthroughtheprocess of electrospinning. It involves use of electricforce to draw out charged threads of polymers intofibres with diameters in the order of some hundrednanometres.Inordertoimprovestructuralconsistencyinaqueousconditions,saturatedvapoursofachemicalcalled glutaraldehydewere used. The team has alsofoundthatthenano-fibrousoraltabletwasstableoverawide range of pH,whichmeans that itwould not bedestroyed in the gastrointestinal track before drugabsorptionintothebloodstream.
Explainingtherationaleforusingnanofibrestoproducetheoral tablets,researcherssaid, “nanofibres– fibresthat are a hundred thousand times thinner than thehuman hair – are increasingly being considered as amedium for controlled release of drug moleculesbecauseoftheirlargesurfaceareaandporosity”.Ref:www.pharmatutor.org
Acontrolled-releaseoraltabletforkalaazarandfungalinfections
The U.S. Food and Drug Administration is warningconsumers not to purchase or drink a product soldonline as amedical treatmentdue to a recent rise inreportedhealthissues.Since2010,theFDAhaswarned
ExternalLinkDisclaimerconsumersaboutthedangersofMiracleorMasterMineralSolution,MiracleMineralSupplement, MMS, Chlorine Dioxide (CD) Protocol,Water Purification Solution (WPS) and other similar
FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution
products. Miracle Mineral Solution has not beenapproved by the FDA for any use, but these productscontinuetobepromotedonsocialmediaasaremedyfortreating autism, cancer, HIV/AIDS, hepatitis and flu,
among other conditions. However, the solution, whenmixed,developsintodangerousbleachwhichhascausedseriousandpotentiallylife-threateningsideeffects.Ref:www.pharmatutor.org
Serum Institute ofIndia (SII) and theNational Institute ofAllergyandInfectiousDiseases (NIAID), p a r t o f t h e U . S . National Institutes ofHealth (USA), joinedhands to create thefirst-ever heat-stableRotavirus vaccine inthe world. Albert Z.
Kapikian,M.D.,apioneeringvirologistatNIAIDdefinedthemodeof transmissionofRotavirus, identified theviral proteins critical for triggering an immuneresponse, and formulated a vaccine that targetedseveralimportantRotavirusstrains.In2005,NIAIDandSerumInstituteofIndiaPvt.Ltd.(SIIPL)joinedhandsforthedevelopmentofaRotavirusVaccine.
SII worked to develop a heat stable formulation toovercomethisproblemandRotasiil, is todaytheonly
Rotavirus vaccine to have the ability to withstandextremetemperatures.Itcanbestoredattemperaturesupto25°Cthroughoutitsshelflifeof30months,whichmakesRotasiilcompletelyuniquefromothervaccinesthat require refr igerat ion for storage andtransportation. The vaccine will revolutionizehealthcare for children across the globe due to itspotency,longevityandabilitytoendureseverechangesintemperature,therebyreducingwastageandstoragecosts.
IntroductionoftheRotasiilvaccine,withitslongshelflifeandlackofneedforrefrigeration,isatimelyboonformillions affected by Rotavirus. SII and NIAID’s jointendeavor in creating the heat-stable Rotasiil vaccineeffectively fills theneed, reducing costs and relievingbottlenecksinthevaccinesupply-chain.
Thisbreakthroughinventionhasalsobeenawardedapatent for being the first-of-its-kind thermostableRotavirus vaccine by United States Patent andTrademarkOffice(USPTO).Ref:www.health.economictimes.indiatimes.com
SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil
Pancreaticcancercellsareespeciallygoodatrepairingtheir DNA when it’s damaged by chemotherapy andradiation,whichisonereasonstandardtreatmentsforthediseaseareoftenineffective.Now,researchersfromthe University of Michigan Rogel Cancer Center arereportingpromisingresultsfromanearlytrialofadrugthatblocksanenzymecancercellsneedtorepairtheirownDNA.
The drug, AstraZeneca’s AZD1775, blocks an enzymecalledWee1andinsodoingpreventspancreaticcancercells fromshielding themselvesagainst radiationandchemo.InatrialcombiningAZD1775withradiationand
Gemzar (gemcitabine), 34 patients with pancreatictumors that were too advanced to be removed withsurgeryhadamedianoverallsurvivalrateof22months.ThatbestedaprevioustrialofGemzaralone,inwhichsurvivalwasjust12to14months.
The University of Michigan researchers are nowplanningaphase2studyofthecombinationtreatment.The results of the phase 1, which was primarilydesigned to determine the appropriate dose ofAZD1775, were published in the Journal of ClinicalOncology.Ref:www.fiercebiotech.com
AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Pharma News
Drug Therapy Bulletin
9 10
UnionMinisterforChemicalsandFertilizers,ShriD.V.Sadananda Gowda launched a mobile application“Janaushadhi Sugam” which will enable people to
searchJanaushadhigenericmedicinesandthestoresatthetipoftheirfingers.
“Janaushadhi Sugam” mobile application would haveuser-friendlyoptionslike-tolocatenearbyJanaushadhikendra, direction guidance for location of theJanaushadhikendra through Google Map, searchJanaushadhi generic medicines, analyse productcomparisonofGenericvsBrandedmedicineinformofMRP&overallSavings,etc.
ThemobileapplicationisavailableonbothAndroid&iOSplatforms.ItcanbedownloadedfreeofcostbytheuserfromGooglePlayStoreandAppleStore.Ref:www.pharmatutor.org
MobileapplaunchedforlocatingoutletsandsearchingGenericmedicines
Researchers at Indian Institute of Technology-
Hyderabad have developed a method to produce
controlled-release oral tablets for treating fungal
infections and kala azar. The tablets were found to
release the drug Amphotericin B in a sustained and
controlled manner over a period of 10 days.
Amphotericin B is the drug of choice for fungal
infections of the abdomen and heart valves, fungal
pneumonia,andkalaazar.However,itiscostly,causes
toxicity and its bioavailability is poor. The drug is
administered through injection, which results in
uncontrolledreleaseintothebloodstream.
The researchers have developed the oral tablet byloadingthedrugontogelatinnano-fabric.Theychosegelatinesinceitisnontoxicandbiocompatible,besidesbeing biodegradable. It is used in food and medicalindustries.Thedrugwasloadedontogelatinandwas
thendrawnoutintheformofnanofibresthroughtheprocess of electrospinning. It involves use of electricforce to draw out charged threads of polymers intofibres with diameters in the order of some hundrednanometres.Inordertoimprovestructuralconsistencyinaqueousconditions,saturatedvapoursofachemicalcalled glutaraldehydewere used. The team has alsofoundthatthenano-fibrousoraltabletwasstableoverawide range of pH,whichmeans that itwould not bedestroyed in the gastrointestinal track before drugabsorptionintothebloodstream.
Explainingtherationaleforusingnanofibrestoproducetheoral tablets,researcherssaid, “nanofibres– fibresthat are a hundred thousand times thinner than thehuman hair – are increasingly being considered as amedium for controlled release of drug moleculesbecauseoftheirlargesurfaceareaandporosity”.Ref:www.pharmatutor.org
Acontrolled-releaseoraltabletforkalaazarandfungalinfections
The U.S. Food and Drug Administration is warningconsumers not to purchase or drink a product soldonline as amedical treatmentdue to a recent rise inreportedhealthissues.Since2010,theFDAhaswarned
ExternalLinkDisclaimerconsumersaboutthedangersofMiracleorMasterMineralSolution,MiracleMineralSupplement, MMS, Chlorine Dioxide (CD) Protocol,Water Purification Solution (WPS) and other similar
FDAwarnsconsumersaboutthedangerousandpotentiallylifethreateningsideeffectsofMiracleMineralSolution
products. Miracle Mineral Solution has not beenapproved by the FDA for any use, but these productscontinuetobepromotedonsocialmediaasaremedyfortreating autism, cancer, HIV/AIDS, hepatitis and flu,
among other conditions. However, the solution, whenmixed,developsintodangerousbleachwhichhascausedseriousandpotentiallylife-threateningsideeffects.Ref:www.pharmatutor.org
Serum Institute ofIndia (SII) and theNational Institute ofAllergyandInfectiousDiseases (NIAID), p a r t o f t h e U . S . National Institutes ofHealth (USA), joinedhands to create thefirst-ever heat-stableRotavirus vaccine inthe world. Albert Z.
Kapikian,M.D.,apioneeringvirologistatNIAIDdefinedthemodeof transmissionofRotavirus, identified theviral proteins critical for triggering an immuneresponse, and formulated a vaccine that targetedseveralimportantRotavirusstrains.In2005,NIAIDandSerumInstituteofIndiaPvt.Ltd.(SIIPL)joinedhandsforthedevelopmentofaRotavirusVaccine.
SII worked to develop a heat stable formulation toovercomethisproblemandRotasiil, is todaytheonly
Rotavirus vaccine to have the ability to withstandextremetemperatures.Itcanbestoredattemperaturesupto25°Cthroughoutitsshelflifeof30months,whichmakesRotasiilcompletelyuniquefromothervaccinesthat require refr igerat ion for storage andtransportation. The vaccine will revolutionizehealthcare for children across the globe due to itspotency,longevityandabilitytoendureseverechangesintemperature,therebyreducingwastageandstoragecosts.
IntroductionoftheRotasiilvaccine,withitslongshelflifeandlackofneedforrefrigeration,isatimelyboonformillions affected by Rotavirus. SII and NIAID’s jointendeavor in creating the heat-stable Rotasiil vaccineeffectively fills theneed, reducing costs and relievingbottlenecksinthevaccinesupply-chain.
Thisbreakthroughinventionhasalsobeenawardedapatent for being the first-of-its-kind thermostableRotavirus vaccine by United States Patent andTrademarkOffice(USPTO).Ref:www.health.economictimes.indiatimes.com
SIIintroducesthefirst-everheat-stableRotavirusvaccineintheworld,Rotasiil
Pancreaticcancercellsareespeciallygoodatrepairingtheir DNA when it’s damaged by chemotherapy andradiation,whichisonereasonstandardtreatmentsforthediseaseareoftenineffective.Now,researchersfromthe University of Michigan Rogel Cancer Center arereportingpromisingresultsfromanearlytrialofadrugthatblocksanenzymecancercellsneedtorepairtheirownDNA.
The drug, AstraZeneca’s AZD1775, blocks an enzymecalledWee1andinsodoingpreventspancreaticcancercells fromshielding themselvesagainst radiationandchemo.InatrialcombiningAZD1775withradiationand
Gemzar (gemcitabine), 34 patients with pancreatictumors that were too advanced to be removed withsurgeryhadamedianoverallsurvivalrateof22months.ThatbestedaprevioustrialofGemzaralone,inwhichsurvivalwasjust12to14months.
The University of Michigan researchers are nowplanningaphase2studyofthecombinationtreatment.The results of the phase 1, which was primarilydesigned to determine the appropriate dose ofAZD1775, were published in the Journal of ClinicalOncology.Ref:www.fiercebiotech.com
AstraZenecadrugheadstophase2inpancreaticcanceraftersmalltrialextendssurvival
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
11 12
Incase,theEthicsCommitteehasgrantedapprovalforconductofacademic clinicaltrialofapermitteddrugformulation for a new indication or new route of
administrationornewdoseornewdosageformandthe
drug is to be imported for conducting the academic
clinical trial in accordance with Rule 28 of the said Rules,noimportlicenseisrequired,ifcopyoftheethics
committeeapprovalforthesaidclinicaltrialofthedrugtobeimportedisfurnishedtotheconcernedPortofficeat the time of import along with an undertaking
mentioning thequantityof thedrugbeing imported
willbeusedexclusivelyfortheacademicclinicaltrial.
Ref:www.cdsco.gov.in
AdditionalFAQonNewDrugsandClinicalTrialRules,2019
Combi kit ofMisoprostol andMifepristone tablets (1
uncoated mifepristone 200 mg tablet + 4 uncoated
misoprostol200mgtablets)forMTPwasapprovedon
24.12.2008byCDSCOwithfollowingwarning:
“Warning: product is to be used only under the
supervisionofaserviceproviderandinamedical
facility as specified under MTP Act 2002 & MTP
Rules2003”
The issue of labeling requirements for combi kit of
MisoprostolandMifepristonewasdeliberatedin56th
DrugsConsultativeCommittee(DCC)meetingheldon
01.06.2019.Inmeeting,theDCCsuggestedthataletter
shouldbeissuedbyCDSCOtoallStateDrugsControllers
aboutthelabelingrequirementsandalsotoensurethe
effective implementation of labeling requirements as
perMTPprovisions.
You are therefore, requested to ensure the effective
implementationoflabelingrequirementsforCombikit
of Misoprostol and Mifepristone tablets as per the
provisionsofDrugsandCosmeticsAct,1940&Rules,
1945andMTPAct,2002&MTPRules,2003.
Ref:www.cdsco.gov.in
AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP)
“The Health Ministry has drawn an ambitious plan
under the 100-days agenda of the newly elected
government, wherein it has been decided to provide
Rotavirusvaccinetoeverychildacrossall36statesand
UTsbySeptember,2019.”ThiswasstatedbyDrHarsh
Vardhan,UnionMinisterofHealthandFamilyWelfare
whilespeakingontheexpansionofRotavirusvaccineto
theentirecountry.TheUnionHealthMinister further
added that under the inspirational leadership of our
beloved Prime Minister Shri Narendra Modi ji, the
Government is committed to ending morbidity and
mortality in children due to diarrhoea by 2022.
Strengthening routine immunization is an essential
investmentinIndia’schildrenandwillensureahealthy
futureofthecountry,hestressed.
DrHarshVardhanfurthersaidthatDiarrhoeaisoneof
thebiggestkillersinchildrenandRotavirusisoneofthe
most commoncausesof severediarrhoea in children
lessthan2yearsofage.“Rotavirusvaccinealongwith
propersanitation,handwashingpractices,ORSandzinc
supplementation will go a long way in reducing the
mortalityandmorbidityduetodiarrhoeainchildren,”
hementioned.TheUnionHealthMinisterfurtheradded
thattheGovernmentisalsocommittedtoincreasingthe
full immunization coverage and ensuring that the
benefitofthelife-savingvaccinesisprovidedtoevery
child.
Ref:www.pharmatutor.org
EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan
IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugsResearchers at the Indian Institute of Technology-
Madrashavefoundawaytodevelopnon-animalmodels
totestnewcancerdrugs.
Humanbody containsdifferent typesof cells.Among
them are stem cells that help in regenerating and
repairing various organs and tissues. This
characteristics of stem cells and the discovery of the
originofleukemiahaveledscientisttohypothesizethat
cancermayalsobe initiated fromcells that resemble
stem cells. Cancer stem cells are now thought to be
responsible not only for cancer initiation but also its
progression, metastasis, recurrence and drug
resistance.
Scientistsgenerallyuseanimalsinresearchconsidering
that growing cancer cells on petri dish has its
limitations.Normallytheywouldplacesamplesofcells
inadishwithsomeappropriatemediumandwaitfor
them to grow. Since the dish has a flat surface, the
growthistwo-dimensional.Thisisunlikewhathappens
inthebodywherecellsarespherical.Anothermethodis
bioreactorswhicharesmallcapsulesinwhichcellscan
growintospheroids.However,manyphysicalcuesplay
avitalroleindeterminingthewaycancercellsworkand
thesearenotavailableinbioreactors.
Studies have shown that many internal and external
conditionsdeterminetheeffectofthesephysicalfactors
oncellfateandfunctions.Inparticular,experimentsin
outerspaceandongroundhaveshownthatgravityis
oneofthesignificantconditions.Theconditionofless
gravityormicrogravitywasfoundtohelpincreasethe
proportionofcancerstemcellsincanceroustumourin
comparisontoothercells.
Researchers at IIT-Madras have comeupwith a new
strategytosimulatemicrogravityintheirlaboratoryby
usingequipmentcalledrotarycellculturesystem.With
its help, they have been able to increase the level of
cancerstemcellsinasampleofhumancolorectalcancer
cell.“Wehaveobserveddistinctfeaturesofcancerstem
cells including CD133/CD44 dual positive cells and
migration,” Prof. Rama Shanker Verma, group leader,
saidwhilespeakingtoIndiaScienceWire.
Dr. Verma said “the technique may be used for
development of organoids for drug testing, thus
avoidinganimalmodel. Inaddition, themodelcanbe
usedtounderstandthecelldeathpathwaysincancer,
for identification of target zones in and eventually
developthedrugs”.
The U.S. Food and Drug Administration approvedBaqsimi nasal powder, the first glucagon therapyapproved for the emergency treatment of severehypoglycemia that can be administered without aninjection.
Severe hypoglycemia occurs when a patient’s bloodsugar levels fall to a level where he or she becomesconfused or unconscious or suffers from othersymptomsthatrequireassistancefromanotherpersontotreat.Typically,severehypoglycemiaoccursinpeoplewithdiabeteswhoareusinginsulintreatment.Baqsimi
is approved to treat severe hypoglycemia in patientswithdiabetesagesfourandolder.
Baqsimi,whichisapowderadministeredintothenose,
willcomeinasingle-usedispenserthatcanbegivento
someonesufferingfromaseverehypoglycemicepisode.
Baqsimi increases blood sugar levels in the body by
stimulatingthelivertoreleasestoredglucoseintothe
bloodstream.Ithastheoppositeeffectofinsulin,which
lowersbloodsugarlevels.
Ref:www.pharmatutor.org
FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
11 12
Incase,theEthicsCommitteehasgrantedapprovalforconductofacademic clinicaltrialofapermitteddrugformulation for a new indication or new route of
administrationornewdoseornewdosageformandthe
drug is to be imported for conducting the academic
clinical trial in accordance with Rule 28 of the said Rules,noimportlicenseisrequired,ifcopyoftheethics
committeeapprovalforthesaidclinicaltrialofthedrugtobeimportedisfurnishedtotheconcernedPortofficeat the time of import along with an undertaking
mentioning thequantityof thedrugbeing imported
willbeusedexclusivelyfortheacademicclinicaltrial.
Ref:www.cdsco.gov.in
AdditionalFAQonNewDrugsandClinicalTrialRules,2019
Combi kit ofMisoprostol andMifepristone tablets (1
uncoated mifepristone 200 mg tablet + 4 uncoated
misoprostol200mgtablets)forMTPwasapprovedon
24.12.2008byCDSCOwithfollowingwarning:
“Warning: product is to be used only under the
supervisionofaserviceproviderandinamedical
facility as specified under MTP Act 2002 & MTP
Rules2003”
The issue of labeling requirements for combi kit of
MisoprostolandMifepristonewasdeliberatedin56th
DrugsConsultativeCommittee(DCC)meetingheldon
01.06.2019.Inmeeting,theDCCsuggestedthataletter
shouldbeissuedbyCDSCOtoallStateDrugsControllers
aboutthelabelingrequirementsandalsotoensurethe
effective implementation of labeling requirements as
perMTPprovisions.
You are therefore, requested to ensure the effective
implementationoflabelingrequirementsforCombikit
of Misoprostol and Mifepristone tablets as per the
provisionsofDrugsandCosmeticsAct,1940&Rules,
1945andMTPAct,2002&MTPRules,2003.
Ref:www.cdsco.gov.in
AdvisoryonlabelingrequirementsforcombikitofMisoprostolandMifepristonetabletsforMedicalTerminationofPregnancy(MTP)
“The Health Ministry has drawn an ambitious plan
under the 100-days agenda of the newly elected
government, wherein it has been decided to provide
Rotavirusvaccinetoeverychildacrossall36statesand
UTsbySeptember,2019.”ThiswasstatedbyDrHarsh
Vardhan,UnionMinisterofHealthandFamilyWelfare
whilespeakingontheexpansionofRotavirusvaccineto
theentirecountry.TheUnionHealthMinister further
added that under the inspirational leadership of our
beloved Prime Minister Shri Narendra Modi ji, the
Government is committed to ending morbidity and
mortality in children due to diarrhoea by 2022.
Strengthening routine immunization is an essential
investmentinIndia’schildrenandwillensureahealthy
futureofthecountry,hestressed.
DrHarshVardhanfurthersaidthatDiarrhoeaisoneof
thebiggestkillersinchildrenandRotavirusisoneofthe
most commoncausesof severediarrhoea in children
lessthan2yearsofage.“Rotavirusvaccinealongwith
propersanitation,handwashingpractices,ORSandzinc
supplementation will go a long way in reducing the
mortalityandmorbidityduetodiarrhoeainchildren,”
hementioned.TheUnionHealthMinisterfurtheradded
thattheGovernmentisalsocommittedtoincreasingthe
full immunization coverage and ensuring that the
benefitofthelife-savingvaccinesisprovidedtoevery
child.
Ref:www.pharmatutor.org
EverychildwillnowgetRotavirusVaccineasgovernmentexpandsittotheentirecountry:DrHarshVardhan
IndianInstituteofTechnologyresearcherdevelopedtotestcancerdrugsResearchers at the Indian Institute of Technology-
Madrashavefoundawaytodevelopnon-animalmodels
totestnewcancerdrugs.
Humanbody containsdifferent typesof cells.Among
them are stem cells that help in regenerating and
repairing various organs and tissues. This
characteristics of stem cells and the discovery of the
originofleukemiahaveledscientisttohypothesizethat
cancermayalsobe initiated fromcells that resemble
stem cells. Cancer stem cells are now thought to be
responsible not only for cancer initiation but also its
progression, metastasis, recurrence and drug
resistance.
Scientistsgenerallyuseanimalsinresearchconsidering
that growing cancer cells on petri dish has its
limitations.Normallytheywouldplacesamplesofcells
inadishwithsomeappropriatemediumandwaitfor
them to grow. Since the dish has a flat surface, the
growthistwo-dimensional.Thisisunlikewhathappens
inthebodywherecellsarespherical.Anothermethodis
bioreactorswhicharesmallcapsulesinwhichcellscan
growintospheroids.However,manyphysicalcuesplay
avitalroleindeterminingthewaycancercellsworkand
thesearenotavailableinbioreactors.
Studies have shown that many internal and external
conditionsdeterminetheeffectofthesephysicalfactors
oncellfateandfunctions.Inparticular,experimentsin
outerspaceandongroundhaveshownthatgravityis
oneofthesignificantconditions.Theconditionofless
gravityormicrogravitywasfoundtohelpincreasethe
proportionofcancerstemcellsincanceroustumourin
comparisontoothercells.
Researchers at IIT-Madras have comeupwith a new
strategytosimulatemicrogravityintheirlaboratoryby
usingequipmentcalledrotarycellculturesystem.With
its help, they have been able to increase the level of
cancerstemcellsinasampleofhumancolorectalcancer
cell.“Wehaveobserveddistinctfeaturesofcancerstem
cells including CD133/CD44 dual positive cells and
migration,” Prof. Rama Shanker Verma, group leader,
saidwhilespeakingtoIndiaScienceWire.
Dr. Verma said “the technique may be used for
development of organoids for drug testing, thus
avoidinganimalmodel. Inaddition, themodelcanbe
usedtounderstandthecelldeathpathwaysincancer,
for identification of target zones in and eventually
developthedrugs”.
The U.S. Food and Drug Administration approvedBaqsimi nasal powder, the first glucagon therapyapproved for the emergency treatment of severehypoglycemia that can be administered without aninjection.
Severe hypoglycemia occurs when a patient’s bloodsugar levels fall to a level where he or she becomesconfused or unconscious or suffers from othersymptomsthatrequireassistancefromanotherpersontotreat.Typically,severehypoglycemiaoccursinpeoplewithdiabeteswhoareusinginsulintreatment.Baqsimi
is approved to treat severe hypoglycemia in patientswithdiabetesagesfourandolder.
Baqsimi,whichisapowderadministeredintothenose,
willcomeinasingle-usedispenserthatcanbegivento
someonesufferingfromaseverehypoglycemicepisode.
Baqsimi increases blood sugar levels in the body by
stimulatingthelivertoreleasestoredglucoseintothe
bloodstream.Ithastheoppositeeffectofinsulin,which
lowersbloodsugarlevels.
Ref:www.pharmatutor.org
FDAapprovesfirsttreatmentforseverehypoglycemiathatcanbeadministeredwithoutaninjection
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
13 14
TheU.S.FoodandDrugAdministrationhasapprovedRecarbrio (imipenem, cilastatin and relebactam), anantibacterial drug product to treat adults withcomplicated urinary tract infections (cUTI) andcomplicated intra-abdominal infections (cIAI).Recarbrio is a three-drug combination injectioncontaining imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamaseinhibitor.
The determination of efficacy of Recarbrio wassupported in part by the findings of the efficacy andsafetyofimipenem-cilastatinforthetreatmentofcUTIandcIAI.ThecontributionofrelebactamtoRecarbriowasassessedbasedondatafrominvitrostudiesandanimal models of infection. The safety of Recarbrio,administeredviainjection,wasstudiedintwotrials,oneeachforcUTIandcIAI.ThecUTItrialincluded298adultpatients with 99 treated with the proposed dose ofRecarbrio.ThecIAItrialincluded347patientswith117
treatedwiththeproposeddoseofRecarbrio.
The most common adverse reactions observed in
patients treated with Recarbrio included nausea,
diarrhea,headache,feverandincreasedliverenzymes.
Recarbrio should not be used in patients taking
ganciclovir unless the benefits outweigh the risks asgeneralized seizures have been reported. PatientsshouldalsoavoidusingRecarbriowhentakingvalproic
acid or divalproex sodium, drugs used to manage
seizures,asareductioninvalproicacidlevelmayleadto
seizures.
Recarbrio receivedFDA’sQualified InfectiousDiseaseProduct (QIDP) designation. TheQIDP designation isgiven to antibacterial and antifungal drug productsintendedtotreatseriousorlife-threateninginfections
undertheGeneratingAntibioticIncentivesNow(GAIN)
titleoftheFDASafetyandInnovationAct.Ref:www.pharmatutor.org
FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections
Zydus Cadila announced the "launch of Ramelteontablets,8mguponreceivingthefinalapprovalfromtheUSFDA. Ramelteon is a sedative, also called ahypnotic".Ramelteon isused to treat insomnia that is
associated with having trouble falling asleep. Zydus
Cadilasaidthedrugwillbemanufacturedatthegroup'sformulations manufacturing facility at SEZ, Ahmedabad.
Ref:www.health.economictimes.indiatimes.com
ZydusCadilalaunchesinsomniadruginUSmarket
To promote usage of generic medicines, the Central
DrugsControl StandardOrganisation's (CDCSO)-Drug
ConsultantCommittee(DCC)hasproposedthatdoctors
should prescribe only generic instead of branded
medicinestopatients.Inthe56thmeetingoftheDCC,it
was proposed that Registered Medical Practitioners
(RMP)shallsupply'genericmedicines'only.However,it
hasalsobeenrecommendedthatRMPshallsupplythe
'physiciansample'freeofcost.
ItmaybenotedthatunderscheduleKoftheDrugsand
Cosmetics Rules, 1945 - RMP can supply different
categories of medicines including vaccines to theirpatients as per exemptions provided with certainconditions.
Thisisbeingdonetopromotegenericmedicinesinthe
country.Thegenericmedicinesareatleast90percent
cheaperthanthebrandedmedicines.Therearenearly
600typesofgenericmedicines.Thesemedicinescanbe
usedfortreatingdiabetes,viralfever,coughcold,kidney,
liver,cancerdiseasesetc.Ref:www.health.economictimes.indiatimes.com
Doctorsshouldprovideonlygenericmedicines:DCC
New medicines to treat cancer and cardiac diseasesalongwithantibioticsmaysoonbepartoftheNationalList of EssentialMedicines (NLEM),which forms thebasis for price regulation in India.WHOhas recentlyreviseditsguidanceonessentialmedicinesadding12ground-breakingmedicinesforfivecancertherapiestotreatmelanoma,lung,bloodandprostatecancer.Ithasalsoaddedneworalanticoagulantstopreventstroke.
Besides,theUNagencyhasstrengtheneditsadviceonantibioticusebyindicatingwhichantibioticstouseforthe most common and serious infections to achieve
better treatment outcomes and reduce the risk ofantimicrobial resistance. It has recommended threenew antibiotics for the treatment of multi-drugresistant infections be added as essential. The ideabehindthestakeholderconsultationistoevaluatetheWHO list in the Indian context by determining the“essentiality” and “affordability” factors of thesemedicines.
“ThecommitteewillhavetograpplewithseveralcriticalissuesincludinghowcloselyIndiachoosestofollowtheWHO list on addition of highly priced cancer drugs,expansionofthelisttoaddmoremedicaldevicesandcontextualizingWHOrecommendationsonclassifyingantibioticskeepinginmindlocalregulationsandaccessframeworks,”saidpublichealthexpertMaliniAisolaofAllIndiaDrugActionNetwork(AIDAN).
Over150countriesuseWHO’sEssentialMedicinesListtoguidedecisionsaboutwhichmedicinesrepresentthebest value for money, based on evidence and health
impact.EvenIndia’sNLEMisprimarilyguidedbytheUN
Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list
TheHealthMinistryhasbannedthemanufacture,saleand distribution of antibiotic, Colistin and itsformulationsforfoodproducinganimals,poultry,aquafarming and animal feed supplements in a bid topreservethedrug’sefficacyinhumans.
The ban has been imposed under provisions of theDrugsandCosmeticsAct,1940andanotificationinthisregardhasbeenissuedbytheCentre.Accordingtothenotification,itwasbroughttothenoticeoftheCentralgovernment that the use of the drug Colistin and its
formulationsforfoodproducinganimals,poultry,aquafarmingandanimalfeedsupplementsislikelytoinvolverisk to human beings.Following which the DrugTechnicalAdvisoryBoard(DTAB),thegovernment’stopadvisorybodyontechnicalmattersrelatedtodrugsinthecountryconsideredthematterandrecommendedprohibitingthesaiddrug,thenotificationstated.
“TheCentralGovernmentissatisfiedthatitisnecessaryand expedient in public interest to prohibitmanufacture,saleanddistributionofthedrugColistinand its formulations for food producing animals,poultry,aquafarmingandanimalfeedsupplements.
“Now, therefore, in exercise of powers conferred bysection26AoftheDrugsandCosmeticsAct,1940thegovernment hereby prohibits manufacture, sale anddistribution of the following drug with immediateeffect,Colistinanditsformulationsforfoodproducinganimals, poultry, aqua farming and animal feedsupplements,”thenotificationread.Ref:www.thehindubusinessline.com
HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
13 14
TheU.S.FoodandDrugAdministrationhasapprovedRecarbrio (imipenem, cilastatin and relebactam), anantibacterial drug product to treat adults withcomplicated urinary tract infections (cUTI) andcomplicated intra-abdominal infections (cIAI).Recarbrio is a three-drug combination injectioncontaining imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamaseinhibitor.
The determination of efficacy of Recarbrio wassupported in part by the findings of the efficacy andsafetyofimipenem-cilastatinforthetreatmentofcUTIandcIAI.ThecontributionofrelebactamtoRecarbriowasassessedbasedondatafrominvitrostudiesandanimal models of infection. The safety of Recarbrio,administeredviainjection,wasstudiedintwotrials,oneeachforcUTIandcIAI.ThecUTItrialincluded298adultpatients with 99 treated with the proposed dose ofRecarbrio.ThecIAItrialincluded347patientswith117
treatedwiththeproposeddoseofRecarbrio.
The most common adverse reactions observed in
patients treated with Recarbrio included nausea,
diarrhea,headache,feverandincreasedliverenzymes.
Recarbrio should not be used in patients taking
ganciclovir unless the benefits outweigh the risks asgeneralized seizures have been reported. PatientsshouldalsoavoidusingRecarbriowhentakingvalproic
acid or divalproex sodium, drugs used to manage
seizures,asareductioninvalproicacidlevelmayleadto
seizures.
Recarbrio receivedFDA’sQualified InfectiousDiseaseProduct (QIDP) designation. TheQIDP designation isgiven to antibacterial and antifungal drug productsintendedtotreatseriousorlife-threateninginfections
undertheGeneratingAntibioticIncentivesNow(GAIN)
titleoftheFDASafetyandInnovationAct.Ref:www.pharmatutor.org
FDAapprovesnewtreatmentforcomplicatedurinarytractandcomplicatedintra-abdominalinfections
Zydus Cadila announced the "launch of Ramelteontablets,8mguponreceivingthefinalapprovalfromtheUSFDA. Ramelteon is a sedative, also called ahypnotic".Ramelteon isused to treat insomnia that is
associated with having trouble falling asleep. Zydus
Cadilasaidthedrugwillbemanufacturedatthegroup'sformulations manufacturing facility at SEZ, Ahmedabad.
Ref:www.health.economictimes.indiatimes.com
ZydusCadilalaunchesinsomniadruginUSmarket
To promote usage of generic medicines, the Central
DrugsControl StandardOrganisation's (CDCSO)-Drug
ConsultantCommittee(DCC)hasproposedthatdoctors
should prescribe only generic instead of branded
medicinestopatients.Inthe56thmeetingoftheDCC,it
was proposed that Registered Medical Practitioners
(RMP)shallsupply'genericmedicines'only.However,it
hasalsobeenrecommendedthatRMPshallsupplythe
'physiciansample'freeofcost.
ItmaybenotedthatunderscheduleKoftheDrugsand
Cosmetics Rules, 1945 - RMP can supply different
categories of medicines including vaccines to theirpatients as per exemptions provided with certainconditions.
Thisisbeingdonetopromotegenericmedicinesinthe
country.Thegenericmedicinesareatleast90percent
cheaperthanthebrandedmedicines.Therearenearly
600typesofgenericmedicines.Thesemedicinescanbe
usedfortreatingdiabetes,viralfever,coughcold,kidney,
liver,cancerdiseasesetc.Ref:www.health.economictimes.indiatimes.com
Doctorsshouldprovideonlygenericmedicines:DCC
New medicines to treat cancer and cardiac diseasesalongwithantibioticsmaysoonbepartoftheNationalList of EssentialMedicines (NLEM),which forms thebasis for price regulation in India.WHOhas recentlyreviseditsguidanceonessentialmedicinesadding12ground-breakingmedicinesforfivecancertherapiestotreatmelanoma,lung,bloodandprostatecancer.Ithasalsoaddedneworalanticoagulantstopreventstroke.
Besides,theUNagencyhasstrengtheneditsadviceonantibioticusebyindicatingwhichantibioticstouseforthe most common and serious infections to achieve
better treatment outcomes and reduce the risk ofantimicrobial resistance. It has recommended threenew antibiotics for the treatment of multi-drugresistant infections be added as essential. The ideabehindthestakeholderconsultationistoevaluatetheWHO list in the Indian context by determining the“essentiality” and “affordability” factors of thesemedicines.
“ThecommitteewillhavetograpplewithseveralcriticalissuesincludinghowcloselyIndiachoosestofollowtheWHO list on addition of highly priced cancer drugs,expansionofthelisttoaddmoremedicaldevicesandcontextualizingWHOrecommendationsonclassifyingantibioticskeepinginmindlocalregulationsandaccessframeworks,”saidpublichealthexpertMaliniAisolaofAllIndiaDrugActionNetwork(AIDAN).
Over150countriesuseWHO’sEssentialMedicinesListtoguidedecisionsaboutwhichmedicinesrepresentthebest value for money, based on evidence and health
impact.EvenIndia’sNLEMisprimarilyguidedbytheUN
Newmedicinestotreatcancer,cardiacdiseasesmaysoonbecomepartofEssentialMedicines'list
TheHealthMinistryhasbannedthemanufacture,saleand distribution of antibiotic, Colistin and itsformulationsforfoodproducinganimals,poultry,aquafarming and animal feed supplements in a bid topreservethedrug’sefficacyinhumans.
The ban has been imposed under provisions of theDrugsandCosmeticsAct,1940andanotificationinthisregardhasbeenissuedbytheCentre.Accordingtothenotification,itwasbroughttothenoticeoftheCentralgovernment that the use of the drug Colistin and its
formulationsforfoodproducinganimals,poultry,aquafarmingandanimalfeedsupplementsislikelytoinvolverisk to human beings.Following which the DrugTechnicalAdvisoryBoard(DTAB),thegovernment’stopadvisorybodyontechnicalmattersrelatedtodrugsinthecountryconsideredthematterandrecommendedprohibitingthesaiddrug,thenotificationstated.
“TheCentralGovernmentissatisfiedthatitisnecessaryand expedient in public interest to prohibitmanufacture,saleanddistributionofthedrugColistinand its formulations for food producing animals,poultry,aquafarmingandanimalfeedsupplements.
“Now, therefore, in exercise of powers conferred bysection26AoftheDrugsandCosmeticsAct,1940thegovernment hereby prohibits manufacture, sale anddistribution of the following drug with immediateeffect,Colistinanditsformulationsforfoodproducinganimals, poultry, aqua farming and animal feedsupplements,”thenotificationread.Ref:www.thehindubusinessline.com
HealthMinistrybanssale,distributionofantibioticColistinforfoodproducinganimals
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
15 16
Shahid Akhter, editor, ETHealthworld spoke to Bejon
Misra, Founder Director of Patient Safety & Access
InitiativeofIndiaFoundation,NewDelhitoknowabout
the Nation Drug Survey that looked at the issue of
spuriousdrugs.
NationDrugSurvey2014-16:Keyissuesyoulookedat
There is a lot of data floating around in the public
domain which talks about India being the hub of
spuriousmedicineornotofqualitystandardmedicines.
Itwasaveryurgentrequirementthathowdowecreate
an authentic data in terms of India because India is
doing extremely well in terms of producing quality
medicinesatthemostaffordablepriceandgloballyitis
beingacknowledgedthatIndiaisthepharmacyofthe
world.
We inthehealthcaredeliverysystemonbehalfof the
patients wanted to know what it is exactly. So we
convincedthegovernmentthatweshoulddoascientific
studyintermsofthelevelofspuriousornotofquality
standardmedicinetodayfloatingaroundinthesupply
chaininourcountry.Sothatwasthewholemotivethat
howdowecomeoutwithcredibledata.
NationDrugSurvey2014-16:Outcomes
Themostimportantthingwasthatwheneveryoucreate
anydataithastobedoneinaveryscientificmanner.
That'swhywe created an extremely robust sampling
process and we engaged with the Indian Statistical
Institute to recommend the sample size and how to
createthatsample.
Thenextpointisalsomakingaverytransparentprocess
toensurethatthereisnobiasednessinthecollectionof
thesample.Sowemadesurethecitizenrepresentative
andrepresentativesfromthePharmacyCouncilofIndia
accompanied the inspectors who went to draw the
samplesfromthemarketplace.
Hence,wemadetheprocessverytransparent.Wealso
made sure that the labs are accredited labs or
governmentlabsthatarecompetenttodothesetests.
Thelabsweregiventhesamplesinamaskedmannerso
theywon'tknowwhosesamplestheyweretesting.
Soitwasallcodedanddonebytheuseoftechnologyi.e.,
wecreatedsoftwarewhichmadesurethatthereisno
biasednessoranykindofinterferenceintermsofthe
wholesamplingtestprocess.Soweensuredtodothat
very scientifically.Finally, the recommendation came
outwithaprocesswherewecreatedsoftware.Soasper
law, all state governments are supposed to draw
samplesandtest themregularly.Wesuggestedthat it
shouldalwaysbedoneinascientificmannerintermsof
collectionofthesamples.Itshouldnotbeleftwiththe
whimsand fancyof thedrug inspector towalk intoa
placeanddrawthesample.
Hence, it should be done in such a statistic and
significantmannerthatitisunbiasedandnobodycan
inter fere wi th the process . This was one
recommendationthatcameout.
Ref:www.health.economictimes.indiatimes.com
Drinkinglargeamountsoffruitjuicemayraiseyourrisk
ofcancer,accordingtoabigstudywhichhasfoundalink
betweentheregularconsumptionofallkindsofsugary
drinksandthelikelihoodofdevelopingthedisease.The
study,carriedoutinFrance,isthefirstsubstantialpiece
ofresearchtofindaspecificassociationbetweensugar
andcancer.Sugarydrinkssuchascolas,lemonadeand
energydrinkshavebeen linked toobesity,which isa
cause of cancer, but the French researchers suggest
therecouldalsobeotherreasonssugarcouldtriggerit.
Thestudy finds theassociationwithcancer is justas
strongwith fruit juices as it iswith colas. “When the
groupofsugarydrinkswassplitinto100%fruitjuices
and other sugary drinks, the consumption of both
beverage types was associated with a higher risk of
overallcancer,”itsays.Cuttingdownontheamountof
sugarydrinksweallconsume,togetherwithsugartaxes
and restrictionsonmarketing,mighthelp reduce the
cancer burden, say the authors. That does notmean
nobody should ever drink them. “As usual with
nutrition,theideaisnottoavoidfoods,justtobalance
the intake,” said Dr Mathilde Touvier, who led the
research,frominterm,theFrenchnationalinstituteof
healthandmedicalresearch.Ref:www.theguardian.com
Sugarinfruitjuicemayraiseriskofcancer,studyfinds
Australianresearchershavediscoveredthatadrugused
foralmostfourdecadestocontrolparasiticinfectionscanhelpinhibitthegrowthandspreadofmelanomainmice.Melanoma,themostserioustypeofskincancer,develops in the cells (melanocytes) that produce
melanin—thepigmentthatgivesyourskinitscolour.
Thedrug,whichisavailableover-the-counterinEurope,is a so-called anthelmintic used to control parasiticinfections.
Researchers at the Sydney-based University of New
SouthWales(UNSW)foundthatthedrug,flubendazole,
inhibited growth and metastasis of human tumoursgrowninmice.Thefindingwasaresultofathree-yearcollaborationbetweenUNSWandtheUSscientists.“We
were surprised to discover that flubendazole’s anti-
tumour effects involve its inhibition of a cell surface
proteincalledprogrammedcelldeathprotein-1orPD-1,” lead author of the study Levon Khachigian said.“WhenPD-1isboundtoanotherproteincalledPD-L1,it
helpsstoptheimmunesystemfromkillingcancercells.
PD-1suppressionreleasesthebrakesonthe immune
system and allows immune cells to find and destroytumours,” Khachigian said. “These studies associateflubendazolewithPD-1inanexperimentalsystem,”hesaid.
Theresearchhasfoundthatinmice,flubendazoleisa
novel small molecule inhibitor of PD-1. “Patients on
small molecule PD-1 inhibitors could potentially be
dosed as outpatients. This would mean greater
convenience,avoidanceof intravenousadministration
andcostsavings forchemotherapyunits,”Khachigian
said. “Whilst flubendazole is anolddrug, itsuseasa
treatment for melanoma has not yet been tested in
humantrials.
“Thereisnoregulatoryapprovalforuseofflubendazole
forcancerpatients,andthusitisnotavailableforthis
indication.Patientsshouldcontinueseekingtheadviceoftheirhealthprofessional,”hesaid.
Ref:www.indianexpress.com
Antiparasiticdrugmayhelpfightskincancer
agency’s listwhichprioritizescriticalhealthproducts
that should be widely available and affordable
throughout hea l th sys tems . However, the
pharmaceutical industry is concerned that thegovernmentmustnotlookatadoptingtheWHOlistatitwithoutevaluatingitstrategically.
“We hope the government will look at it from
essentialityandaccessibilitypointofviewandnotbring
thesedrugsunderpricecontrol.Iftheydoso,thenall
strengthsmustnotbeaddedforformulationsaddedtothelist,”anindustryexecutivesaid.
Ref:www.health.economictimes.indiatimes.com
Allstategovernmentsaresupposedtodrawdrugsamplesandtestthemregularly:BejonMisra
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
15 16
Shahid Akhter, editor, ETHealthworld spoke to Bejon
Misra, Founder Director of Patient Safety & Access
InitiativeofIndiaFoundation,NewDelhitoknowabout
the Nation Drug Survey that looked at the issue of
spuriousdrugs.
NationDrugSurvey2014-16:Keyissuesyoulookedat
There is a lot of data floating around in the public
domain which talks about India being the hub of
spuriousmedicineornotofqualitystandardmedicines.
Itwasaveryurgentrequirementthathowdowecreate
an authentic data in terms of India because India is
doing extremely well in terms of producing quality
medicinesatthemostaffordablepriceandgloballyitis
beingacknowledgedthatIndiaisthepharmacyofthe
world.
We inthehealthcaredeliverysystemonbehalfof the
patients wanted to know what it is exactly. So we
convincedthegovernmentthatweshoulddoascientific
studyintermsofthelevelofspuriousornotofquality
standardmedicinetodayfloatingaroundinthesupply
chaininourcountry.Sothatwasthewholemotivethat
howdowecomeoutwithcredibledata.
NationDrugSurvey2014-16:Outcomes
Themostimportantthingwasthatwheneveryoucreate
anydataithastobedoneinaveryscientificmanner.
That'swhywe created an extremely robust sampling
process and we engaged with the Indian Statistical
Institute to recommend the sample size and how to
createthatsample.
Thenextpointisalsomakingaverytransparentprocess
toensurethatthereisnobiasednessinthecollectionof
thesample.Sowemadesurethecitizenrepresentative
andrepresentativesfromthePharmacyCouncilofIndia
accompanied the inspectors who went to draw the
samplesfromthemarketplace.
Hence,wemadetheprocessverytransparent.Wealso
made sure that the labs are accredited labs or
governmentlabsthatarecompetenttodothesetests.
Thelabsweregiventhesamplesinamaskedmannerso
theywon'tknowwhosesamplestheyweretesting.
Soitwasallcodedanddonebytheuseoftechnologyi.e.,
wecreatedsoftwarewhichmadesurethatthereisno
biasednessoranykindofinterferenceintermsofthe
wholesamplingtestprocess.Soweensuredtodothat
very scientifically.Finally, the recommendation came
outwithaprocesswherewecreatedsoftware.Soasper
law, all state governments are supposed to draw
samplesandtest themregularly.Wesuggestedthat it
shouldalwaysbedoneinascientificmannerintermsof
collectionofthesamples.Itshouldnotbeleftwiththe
whimsand fancyof thedrug inspector towalk intoa
placeanddrawthesample.
Hence, it should be done in such a statistic and
significantmannerthatitisunbiasedandnobodycan
inter fere wi th the process . This was one
recommendationthatcameout.
Ref:www.health.economictimes.indiatimes.com
Drinkinglargeamountsoffruitjuicemayraiseyourrisk
ofcancer,accordingtoabigstudywhichhasfoundalink
betweentheregularconsumptionofallkindsofsugary
drinksandthelikelihoodofdevelopingthedisease.The
study,carriedoutinFrance,isthefirstsubstantialpiece
ofresearchtofindaspecificassociationbetweensugar
andcancer.Sugarydrinkssuchascolas,lemonadeand
energydrinkshavebeen linked toobesity,which isa
cause of cancer, but the French researchers suggest
therecouldalsobeotherreasonssugarcouldtriggerit.
Thestudy finds theassociationwithcancer is justas
strongwith fruit juices as it iswith colas. “When the
groupofsugarydrinkswassplitinto100%fruitjuices
and other sugary drinks, the consumption of both
beverage types was associated with a higher risk of
overallcancer,”itsays.Cuttingdownontheamountof
sugarydrinksweallconsume,togetherwithsugartaxes
and restrictionsonmarketing,mighthelp reduce the
cancer burden, say the authors. That does notmean
nobody should ever drink them. “As usual with
nutrition,theideaisnottoavoidfoods,justtobalance
the intake,” said Dr Mathilde Touvier, who led the
research,frominterm,theFrenchnationalinstituteof
healthandmedicalresearch.Ref:www.theguardian.com
Sugarinfruitjuicemayraiseriskofcancer,studyfinds
Australianresearchershavediscoveredthatadrugused
foralmostfourdecadestocontrolparasiticinfectionscanhelpinhibitthegrowthandspreadofmelanomainmice.Melanoma,themostserioustypeofskincancer,develops in the cells (melanocytes) that produce
melanin—thepigmentthatgivesyourskinitscolour.
Thedrug,whichisavailableover-the-counterinEurope,is a so-called anthelmintic used to control parasiticinfections.
Researchers at the Sydney-based University of New
SouthWales(UNSW)foundthatthedrug,flubendazole,
inhibited growth and metastasis of human tumoursgrowninmice.Thefindingwasaresultofathree-yearcollaborationbetweenUNSWandtheUSscientists.“We
were surprised to discover that flubendazole’s anti-
tumour effects involve its inhibition of a cell surface
proteincalledprogrammedcelldeathprotein-1orPD-1,” lead author of the study Levon Khachigian said.“WhenPD-1isboundtoanotherproteincalledPD-L1,it
helpsstoptheimmunesystemfromkillingcancercells.
PD-1suppressionreleasesthebrakesonthe immune
system and allows immune cells to find and destroytumours,” Khachigian said. “These studies associateflubendazolewithPD-1inanexperimentalsystem,”hesaid.
Theresearchhasfoundthatinmice,flubendazoleisa
novel small molecule inhibitor of PD-1. “Patients on
small molecule PD-1 inhibitors could potentially be
dosed as outpatients. This would mean greater
convenience,avoidanceof intravenousadministration
andcostsavings forchemotherapyunits,”Khachigian
said. “Whilst flubendazole is anolddrug, itsuseasa
treatment for melanoma has not yet been tested in
humantrials.
“Thereisnoregulatoryapprovalforuseofflubendazole
forcancerpatients,andthusitisnotavailableforthis
indication.Patientsshouldcontinueseekingtheadviceoftheirhealthprofessional,”hesaid.
Ref:www.indianexpress.com
Antiparasiticdrugmayhelpfightskincancer
agency’s listwhichprioritizescriticalhealthproducts
that should be widely available and affordable
throughout hea l th sys tems . However, the
pharmaceutical industry is concerned that thegovernmentmustnotlookatadoptingtheWHOlistatitwithoutevaluatingitstrategically.
“We hope the government will look at it from
essentialityandaccessibilitypointofviewandnotbring
thesedrugsunderpricecontrol.Iftheydoso,thenall
strengthsmustnotbeaddedforformulationsaddedtothelist,”anindustryexecutivesaid.
Ref:www.health.economictimes.indiatimes.com
Allstategovernmentsaresupposedtodrawdrugsamplesandtestthemregularly:BejonMisra
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
17 18
Microvasculardiseaseisindependentlyassociatedwith
a higher risk of leg amputation compared to people
withoutthedisease,accordingtonewresearchintheAmericanHeartAssociation's journalCirculation.Thestudy, funded by the American Heart Association
Strategically Focused Research Network in Vascular
Disease and the U.S. Department of Veterans Affairs,
examined amputation risk among people withmicrovascular disease or peripheral artery disease(PAD)orthosewhohadbothmicrovasculardiseaseand
PAD.
ResearchersuseddatafromtheVeteransAgingCohort
Study,whichincludedmorethan125,000veteranswho
initially did not have amputations when the studybegan.Overanaverageofnineyears,participantswith:
Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskoflegamputations
ThefollowingdraftofcertainrulesfurthertoamendtheDrugsandCosmeticsRules,1945whichtheCentralGovernment proposes to make, in exercise of thepowersconferredby sub-section(1)ofsection12andsub-section(1)ofsection33oftheDrugsandCosmeticsAct,1940 (23of1940)and in consultationswith theDrugsTechnicalAdvisoryBoardisherebypublishedforinformationofallpersonslikelytobeaffectedtherebyandnoticeisherebygiventhatthesaiddraftrulesshallbetakenintoconsideration.
• a. These rules may be called the Drugs and Cosmetics(......Amendment)Rules,2019.
b. They shall come into force on the date of their finalpublicationintheOfficialGazette.
•IntheDrugsandCosmeticsRules,1945, inrule96,after sub-rule (4), following sub-rule shall beinserted,namely:-
“(5) Every active pharmaceutical ingredient (bulkdrug)manufacturedorimportedinIndiashallbear
Quick Response code on its label at each levelpackaging that store data or information readablewith software application to facilitate tracking andtracing.Thestoreddataorinformationshallincludethefollowingminimumparticulars,namely:-
a) Uniqueproductidentificationcode,
b) NameoftheAPI,
c) Brandname(ifany),
d) Nameandaddressofthemanufacturer,
e) Batchno.
f) Batchsize,
g) Dateofmanufacturing,
h) Dateofexpiryorretesting,
i) Serialshippingcontainercode,
j) Manufacturinglicenceno.orimportlicenceno.
k) Specialstorageconditionsrequired(ifany)”.Ref:www.cdsco.gov.in
NOTIFICATION(DepartmentofHealthandFamilyWelfare)
Astrainof thecommoncoldvirushasbeen found topotentially target, infect and destroy cancer cells inpatientswithbladdercancer,anewstudyinthemedicaljournalClinicalCancerResearchreports.Notraceofthecancerwas found in one patient following treatmentwiththevirus.
Researchers from theUniversity of Surrey and RoyalSurrey County Hospital investigated the safety andtolerability of exposure to the oncolytic ('cancer-killing') virus coxsackievirus (CVA21), a naturallyoccurringstrainofthecommoncold,infifteenpatients
with non-muscle invasive bladder cancer (NMIBC).NMIBCisfoundinthetissueoftheinnersurfaceofthebladderandisthetenthmostcommoncancerintheUKwithapproximately10,000peopleeachyeardiagnosedwiththeillness.
During this pioneering study fifteen NMIBC patients,oneweekpriortoprescheduledsurgerytoremovetheirtumours,receivedCVA21viaacatheterinthebladder.Examinationoftissuesamplespost-surgerydiscoveredthat the virus was highly selective, targeting onlycancerouscellsintheorganandleavingallothercellsintact.Theviruswasfoundtohaveinfectedcancerouscellsand replicated itself causing thecells to ruptureanddie.Urinesamplestakenfrompatientsonalternatedaysdetected'shedding'fromthevirusindicatingthatonce virally infected cancer cells haddied, thenewlyreplicated virus continued to attack more cancerouscellsintheorgan.
Following treatment with the virus cell death wasidentified in themajorityof thepatients' tumours. Inone patient no trace of the cancerwas found duringsurgery.Ref:www.medicalxpress.com
Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer • microvasculardiseasehada3.7-foldincreasedriskof
lowerlimbamputation,andexperienced18%ofall
amputationsduringthestudy;
• PAD had a 13.9-fold increased risk of lower limbamputation and suffered 22% of all amputations;
microvasculardiseaseandPADhada23-foldincrease
intheriskoflowerlimbamputationwhichaccounted
for45%ofallamputations.
PADisanarrowingofthearteriesawayfromtheheartandistypicallyfoundinthelegs.Itcausescramping,painorfatigueinthelegmuscleswhilewalkingorclimbing
stairs.Ifleftuntreated,PADcanleadtogangreneandthe
need for amputation."PAD (in the legs) has long been
consideredasignthatapatientlikelyalsohasnarrowedarteriesleadingtotheheartorbrain.IfapatienthasPAD,theyhaveahigherriskofothercardiovasculardiseases,
suchasheartattacksandstrokes,"Beckmansaid."Our
studysuggeststhatmicrovasculardiseaseinanypartof
thebody,suchastheeyes,kidneysorfeet(neuropathy)maybelinkedtodecreasedbloodvesselfunctioninotherpartsof thebody,puttingpatientsat risk forpotential
lower-limbamputations."Ref:www.medicalxpress.com
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
17 18
Microvasculardiseaseisindependentlyassociatedwith
a higher risk of leg amputation compared to people
withoutthedisease,accordingtonewresearchintheAmericanHeartAssociation's journalCirculation.Thestudy, funded by the American Heart Association
Strategically Focused Research Network in Vascular
Disease and the U.S. Department of Veterans Affairs,
examined amputation risk among people withmicrovascular disease or peripheral artery disease(PAD)orthosewhohadbothmicrovasculardiseaseand
PAD.
ResearchersuseddatafromtheVeteransAgingCohort
Study,whichincludedmorethan125,000veteranswho
initially did not have amputations when the studybegan.Overanaverageofnineyears,participantswith:
Microvasculardiseaseanywhereinthebodymaybelinkedtohigherriskoflegamputations
ThefollowingdraftofcertainrulesfurthertoamendtheDrugsandCosmeticsRules,1945whichtheCentralGovernment proposes to make, in exercise of thepowersconferredby sub-section(1)ofsection12andsub-section(1)ofsection33oftheDrugsandCosmeticsAct,1940 (23of1940)and in consultationswith theDrugsTechnicalAdvisoryBoardisherebypublishedforinformationofallpersonslikelytobeaffectedtherebyandnoticeisherebygiventhatthesaiddraftrulesshallbetakenintoconsideration.
• a. These rules may be called the Drugs and Cosmetics(......Amendment)Rules,2019.
b. They shall come into force on the date of their finalpublicationintheOfficialGazette.
•IntheDrugsandCosmeticsRules,1945, inrule96,after sub-rule (4), following sub-rule shall beinserted,namely:-
“(5) Every active pharmaceutical ingredient (bulkdrug)manufacturedorimportedinIndiashallbear
Quick Response code on its label at each levelpackaging that store data or information readablewith software application to facilitate tracking andtracing.Thestoreddataorinformationshallincludethefollowingminimumparticulars,namely:-
a) Uniqueproductidentificationcode,
b) NameoftheAPI,
c) Brandname(ifany),
d) Nameandaddressofthemanufacturer,
e) Batchno.
f) Batchsize,
g) Dateofmanufacturing,
h) Dateofexpiryorretesting,
i) Serialshippingcontainercode,
j) Manufacturinglicenceno.orimportlicenceno.
k) Specialstorageconditionsrequired(ifany)”.Ref:www.cdsco.gov.in
NOTIFICATION(DepartmentofHealthandFamilyWelfare)
Astrainof thecommoncoldvirushasbeen found topotentially target, infect and destroy cancer cells inpatientswithbladdercancer,anewstudyinthemedicaljournalClinicalCancerResearchreports.Notraceofthecancerwas found in one patient following treatmentwiththevirus.
Researchers from theUniversity of Surrey and RoyalSurrey County Hospital investigated the safety andtolerability of exposure to the oncolytic ('cancer-killing') virus coxsackievirus (CVA21), a naturallyoccurringstrainofthecommoncold,infifteenpatients
with non-muscle invasive bladder cancer (NMIBC).NMIBCisfoundinthetissueoftheinnersurfaceofthebladderandisthetenthmostcommoncancerintheUKwithapproximately10,000peopleeachyeardiagnosedwiththeillness.
During this pioneering study fifteen NMIBC patients,oneweekpriortoprescheduledsurgerytoremovetheirtumours,receivedCVA21viaacatheterinthebladder.Examinationoftissuesamplespost-surgerydiscoveredthat the virus was highly selective, targeting onlycancerouscellsintheorganandleavingallothercellsintact.Theviruswasfoundtohaveinfectedcancerouscellsand replicated itself causing thecells to ruptureanddie.Urinesamplestakenfrompatientsonalternatedaysdetected'shedding'fromthevirusindicatingthatonce virally infected cancer cells haddied, thenewlyreplicated virus continued to attack more cancerouscellsintheorgan.
Following treatment with the virus cell death wasidentified in themajorityof thepatients' tumours. Inone patient no trace of the cancerwas found duringsurgery.Ref:www.medicalxpress.com
Strainofcommoncoldviruscouldrevolutionizetreatmentofbladdercancer • microvasculardiseasehada3.7-foldincreasedriskof
lowerlimbamputation,andexperienced18%ofall
amputationsduringthestudy;
• PAD had a 13.9-fold increased risk of lower limbamputation and suffered 22% of all amputations;
microvasculardiseaseandPADhada23-foldincrease
intheriskoflowerlimbamputationwhichaccounted
for45%ofallamputations.
PADisanarrowingofthearteriesawayfromtheheartandistypicallyfoundinthelegs.Itcausescramping,painorfatigueinthelegmuscleswhilewalkingorclimbing
stairs.Ifleftuntreated,PADcanleadtogangreneandthe
need for amputation."PAD (in the legs) has long been
consideredasignthatapatientlikelyalsohasnarrowedarteriesleadingtotheheartorbrain.IfapatienthasPAD,theyhaveahigherriskofothercardiovasculardiseases,
suchasheartattacksandstrokes,"Beckmansaid."Our
studysuggeststhatmicrovasculardiseaseinanypartof
thebody,suchastheeyes,kidneysorfeet(neuropathy)maybelinkedtodecreasedbloodvesselfunctioninotherpartsof thebody,puttingpatientsat risk forpotential
lower-limbamputations."Ref:www.medicalxpress.com
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
19 20
Scrub Typhus
Scrub typhus or mite-borne typhus is an infectiousdisease caused by a specific type of bacteriacalledOrientia tsutsugamushi. It is spread andmaintained by the larvae of mites. These larvae arecalled “chiggers”. They bite human skin and leave acharacteristic mark called an "eschar" (scar). Thedisease presents nonspecifically, but may rapidlyprogress to dreaded complications such as lung andliver failure. "Typhus" means fever with stupor, orsmoke.Itwasadreadeddiseaseinthepre-antibioticera,causing the deaths of thousands of soldiers duringWorldWar II. The area of maximum occurrence is atrianglebetweenJapan,RussiaandAustralia,calledthe"Tsutsugamushi Triangle". In India, scrub typhus is
oftenseenintheSouthernstatesAndhraPradeshandTamilNadu.
Introduction
SymptomsandSignThediseasebeginstomanifestitselfapproximately10-12 days after the chigger bites. The first symptom isusuallyasmallraisedmarkatthesiteofthebite,whichlater becomes a dried out, blackish spot called an“eschar” (scar). It ismostoften foundnear thegroin,armpits,neckandintheexternalgenitalregions.Theremaybeanassociatedrasharoundtheeschar,andthelymph nodes near the affected area may becomeswollen.Fevermaystartabruptly,accompaniedalmostalways by severe headache, chills, muscle pain andcough. There may also be redness of the eyes,drowsiness,vomiting,andshinpain.
Diagnosis
Thediagnosisofscrubtyphusisaidedbythepresenceofthe characteristic “eschar” (scar). It is difficult todiagnose from the clinical findings alone, as they arenonspecific,andahighdegreeofsuspicionisrequired,particularlyinendemicareas.Manylaboratorytestscanaid indiagnosingscrubtyphus, includinggeneralandspecifictests.
Generaltests:
• Completebloodcountmayshowalargenumberof whitebloodcellsandalowlevelofplatelets.
• Liverandkidneyfunctiontestsmaybeabnormal.
• ChestXrayisoftennecessaryandmayrevealfeatures oflunginvolvement.
• Ultrasound of the abdomen may be required to
confirmenlargementoftheliverorspleen.
Specifictests:
• ELISAfordetectionofantibodiestothebacterium, whichiscommonlyusednowadays.
• IndirectImmunofluorescenceantibodytest,whichis
thegoldstandard.
• Weil-Felixtest,whichisnotusedsooftennow.
• Bloodculture
• PCR(polymerasechainreaction)
TreatmentTreatment of scrub typhus should be initiated early,based on clinical suspicion. The recommendedtreatmentisdoxycycline100mgtwicedailyorallyfor7to14daysbasedontheseverityoftheillness.Inchildrenandpregnantwomen,azithromycin500mgoncedailyisused.Inplaceswherethereisresistancetodoxycyclinealone,azithromycinmaybeusedincombinationwithrifampicin. Complications such as ARDSmay requireinvasive ventilation and supportive care in the ICUsetting.
TreatmentguidelinesassuggestedintheIndianMedicalGazetteincludedoxycyclineasthetreatmentofchoice
in adults, and azithromycin during pregnancy.Alternatives to doxycycline include chloramphenicol,telithromycin, roxithromycin, rifampicin andlevofloxacin. It is important to note that rifampicinshouldnotbeusedasasingleagent.
ComplicationsofScrubTyphus
• Pneumonitis
• AcuteLungInjury(ALI)
• AcuteRespiratoryDistressSyndrome(ARDS)
• AcuteKidneyInjury(AKI)
• Myocarditis
Thepresenceofanescharisavaluablediagnosticcluetothephysician,anditispresentinapproximately50%ofaffected individuals. There may be evidence of liverenlargement and congestion of the lungs on physicalexamination. Sometimes, in case of advanced disease,there may be features of lung involvement such asintractablecough,shortnessofbreathanddrowsiness.
SeverelunginvolvementmayleadtoAcuteRespiratoryDistress Syndrome (ARDS) which may require ICUadmissionandventilatorsupport.Othermanifestationsofseveredisease includeinvolvementofthe lungs, thekidneys, thebrainand inappropriate clottingofblood,called DIC (disseminated intravascular coagulation)whichisadreadedcomplication.
Causes
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
19 20
Scrub Typhus
Scrub typhus or mite-borne typhus is an infectiousdisease caused by a specific type of bacteriacalledOrientia tsutsugamushi. It is spread andmaintained by the larvae of mites. These larvae arecalled “chiggers”. They bite human skin and leave acharacteristic mark called an "eschar" (scar). Thedisease presents nonspecifically, but may rapidlyprogress to dreaded complications such as lung andliver failure. "Typhus" means fever with stupor, orsmoke.Itwasadreadeddiseaseinthepre-antibioticera,causing the deaths of thousands of soldiers duringWorldWar II. The area of maximum occurrence is atrianglebetweenJapan,RussiaandAustralia,calledthe"Tsutsugamushi Triangle". In India, scrub typhus is
oftenseenintheSouthernstatesAndhraPradeshandTamilNadu.
Introduction
SymptomsandSignThediseasebeginstomanifestitselfapproximately10-12 days after the chigger bites. The first symptom isusuallyasmallraisedmarkatthesiteofthebite,whichlater becomes a dried out, blackish spot called an“eschar” (scar). It ismostoften foundnear thegroin,armpits,neckandintheexternalgenitalregions.Theremaybeanassociatedrasharoundtheeschar,andthelymph nodes near the affected area may becomeswollen.Fevermaystartabruptly,accompaniedalmostalways by severe headache, chills, muscle pain andcough. There may also be redness of the eyes,drowsiness,vomiting,andshinpain.
Diagnosis
Thediagnosisofscrubtyphusisaidedbythepresenceofthe characteristic “eschar” (scar). It is difficult todiagnose from the clinical findings alone, as they arenonspecific,andahighdegreeofsuspicionisrequired,particularlyinendemicareas.Manylaboratorytestscanaid indiagnosingscrubtyphus, includinggeneralandspecifictests.
Generaltests:
• Completebloodcountmayshowalargenumberof whitebloodcellsandalowlevelofplatelets.
• Liverandkidneyfunctiontestsmaybeabnormal.
• ChestXrayisoftennecessaryandmayrevealfeatures oflunginvolvement.
• Ultrasound of the abdomen may be required to
confirmenlargementoftheliverorspleen.
Specifictests:
• ELISAfordetectionofantibodiestothebacterium, whichiscommonlyusednowadays.
• IndirectImmunofluorescenceantibodytest,whichis
thegoldstandard.
• Weil-Felixtest,whichisnotusedsooftennow.
• Bloodculture
• PCR(polymerasechainreaction)
TreatmentTreatment of scrub typhus should be initiated early,based on clinical suspicion. The recommendedtreatmentisdoxycycline100mgtwicedailyorallyfor7to14daysbasedontheseverityoftheillness.Inchildrenandpregnantwomen,azithromycin500mgoncedailyisused.Inplaceswherethereisresistancetodoxycyclinealone,azithromycinmaybeusedincombinationwithrifampicin. Complications such as ARDSmay requireinvasive ventilation and supportive care in the ICUsetting.
TreatmentguidelinesassuggestedintheIndianMedicalGazetteincludedoxycyclineasthetreatmentofchoice
in adults, and azithromycin during pregnancy.Alternatives to doxycycline include chloramphenicol,telithromycin, roxithromycin, rifampicin andlevofloxacin. It is important to note that rifampicinshouldnotbeusedasasingleagent.
ComplicationsofScrubTyphus
• Pneumonitis
• AcuteLungInjury(ALI)
• AcuteRespiratoryDistressSyndrome(ARDS)
• AcuteKidneyInjury(AKI)
• Myocarditis
Thepresenceofanescharisavaluablediagnosticcluetothephysician,anditispresentinapproximately50%ofaffected individuals. There may be evidence of liverenlargement and congestion of the lungs on physicalexamination. Sometimes, in case of advanced disease,there may be features of lung involvement such asintractablecough,shortnessofbreathanddrowsiness.
SeverelunginvolvementmayleadtoAcuteRespiratoryDistress Syndrome (ARDS) which may require ICUadmissionandventilatorsupport.Othermanifestationsofseveredisease includeinvolvementofthe lungs, thekidneys, thebrainand inappropriate clottingofblood,called DIC (disseminated intravascular coagulation)whichisadreadedcomplication.
Causes
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
21 22
• Septicshock
• DisseminatedIntravascularCoagulation(DIC)
• Scrub typhus in pregnancy - Itmay cause preterm labourandNeonatalRespiratoryDistressSyndrome.
RiskFactorsforScrubTyphus
• Farmandforestworkers
• Livingattheedgeofvillages
• Wearingshortsleeves
• Workingbarehands
• Immunedeficiency
Healthtips
• Avoidplaceswheremitesareknowntobepresentin alargenumber
• Wear protective clothing when travelling to an endemicarea.Longsleevedclotheshavebeenshown tobeapreventivefactorfromgettinginfected.
• Apply mite repellents to exposed skin e.g. diethyl toluamide.
• Peoplewhohaveriskfactorsandwhohavetowork inanendemicareacanbegivenonceweeklydoseof doxycycline.Ref:www.medindia.net
World Pharmacists Day 2019
World Pharmacists Day was adopted by the International Pharmaceutical Federation (FIP)
Council at the 2009World Congress of Pharmacy and Pharmaceutical Sciences in Istanbul,
Turkey.September25waschosenbecauseitisthedatethatFIPcameintoexistencein1912.The
purposeofWorldPharmacistsDayistoencourageactivitiesthatpromoteandadvocateforthe
roleofthepharmacistinimprovinghealthineverycorneroftheworld.
The International Pharmaceutical Federation (FIP) is the global federation of national
associationsofpharmacistsandpharmaceuticalscientists,andisinofficialrelationswiththe
World Health Organization. Through its 144member organizations, it represents over four
millionpractitionersandscientistsaroundtheworld.
Eachyearnewthemeisdevelopedtoshowcasethepharmacistintheirpositiveroleonhealth.
Thethemeofthisyear'sWorldPharmacistsDay,heldonSeptember25,is"Safeandeffective
medicinesforall",accordingtotheInternationalPharmaceuticalFederation(FIP).Thetheme
aimstohighlightthekeyrolethatpharmacistsplayinprotectingpatientsafetythroughimproved
medicineuseandreducedmedicationerrors.
Pharmacistsensurethattheyprovidetherightmedicinewiththerightdosetoeverypatientwho
walksintoapharmacy.Theyalsoguidethemwithsuitableinformationaboutthemedicines,
whatistherighttimetohavethem,dotheyneedtobeeateninanemptystomachorimmediately
afterameal,willtheycausedrowsinessorweakness,etc.
Traditionally,manypeopleconsiderpharmacistsashealthcareprofessionalswhosimplyweara
whitecoatanddispensepills.Buttheroleofapharmacistisfarmorethandispensingdrugsand
fillingprescriptions.Pharmacistsareanimportantpartofhealthcaresystem.WorldPharmacists
Dayismeanttohighlightroleofpharmacists.Today,morethanever,pharmacistsarecharged
withtheresponsibilitytoensurethatwhenapatientusesamedicine,itwillnotcauseharm.
ThisWorldPharmacistsDay,let'spayourpharmaciststheirdueregardsandsalutethemfor
helpingpatientsallacrosstheworld.AveryhappyWorldPharmacistsDaytoallofyou!
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
Drug Therapy Bulletin
21 22
• Septicshock
• DisseminatedIntravascularCoagulation(DIC)
• Scrub typhus in pregnancy - Itmay cause preterm labourandNeonatalRespiratoryDistressSyndrome.
RiskFactorsforScrubTyphus
• Farmandforestworkers
• Livingattheedgeofvillages
• Wearingshortsleeves
• Workingbarehands
• Immunedeficiency
Healthtips
• Avoidplaceswheremitesareknowntobepresentin alargenumber
• Wear protective clothing when travelling to an endemicarea.Longsleevedclotheshavebeenshown tobeapreventivefactorfromgettinginfected.
• Apply mite repellents to exposed skin e.g. diethyl toluamide.
• Peoplewhohaveriskfactorsandwhohavetowork inanendemicareacanbegivenonceweeklydoseof doxycycline.Ref:www.medindia.net
World Pharmacists Day 2019
World Pharmacists Day was adopted by the International Pharmaceutical Federation (FIP)
Council at the 2009World Congress of Pharmacy and Pharmaceutical Sciences in Istanbul,
Turkey.September25waschosenbecauseitisthedatethatFIPcameintoexistencein1912.The
purposeofWorldPharmacistsDayistoencourageactivitiesthatpromoteandadvocateforthe
roleofthepharmacistinimprovinghealthineverycorneroftheworld.
The International Pharmaceutical Federation (FIP) is the global federation of national
associationsofpharmacistsandpharmaceuticalscientists,andisinofficialrelationswiththe
World Health Organization. Through its 144member organizations, it represents over four
millionpractitionersandscientistsaroundtheworld.
Eachyearnewthemeisdevelopedtoshowcasethepharmacistintheirpositiveroleonhealth.
Thethemeofthisyear'sWorldPharmacistsDay,heldonSeptember25,is"Safeandeffective
medicinesforall",accordingtotheInternationalPharmaceuticalFederation(FIP).Thetheme
aimstohighlightthekeyrolethatpharmacistsplayinprotectingpatientsafetythroughimproved
medicineuseandreducedmedicationerrors.
Pharmacistsensurethattheyprovidetherightmedicinewiththerightdosetoeverypatientwho
walksintoapharmacy.Theyalsoguidethemwithsuitableinformationaboutthemedicines,
whatistherighttimetohavethem,dotheyneedtobeeateninanemptystomachorimmediately
afterameal,willtheycausedrowsinessorweakness,etc.
Traditionally,manypeopleconsiderpharmacistsashealthcareprofessionalswhosimplyweara
whitecoatanddispensepills.Buttheroleofapharmacistisfarmorethandispensingdrugsand
fillingprescriptions.Pharmacistsareanimportantpartofhealthcaresystem.WorldPharmacists
Dayismeanttohighlightroleofpharmacists.Today,morethanever,pharmacistsarecharged
withtheresponsibilitytoensurethatwhenapatientusesamedicine,itwillnotcauseharm.
ThisWorldPharmacistsDay,let'spayourpharmaciststheirdueregardsandsalutethemfor
helpingpatientsallacrosstheworld.AveryhappyWorldPharmacistsDaytoallofyou!
HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]
DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101Toll Free : 18001210443|Phone: 9218428042/9459220253|[email protected]/[email protected]
DRUG INFORMATION CENTER
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HIMACHAL PRADESH STATE PHARMACY COUNCIL
DRUG INFORMATION CENTER
LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101
Phone: 9218428042/9459220253 | E-mail: [email protected]/[email protected]