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8 1 A P R I L 2 0 1 4 | O U T P AT I E N T S U R G E R Y M A G A Z I N E O N L I N E All spelled out If an MH emergency happens, everyone will know exactly what her specific duties are. I've printed out ID tags with instructions for every role that's involved, and I have the tags in lanyards. So now if the circulator gets a code and people start rushing in to help, instead of having to say, "Go get this, go get that," she can simply pass out the code cards. If you're the cooling nurse, for example, you get your card and you immediately know the first thing you need to do is retrieve the cold IV and bottled sterile saline from the refrigera- tor. Nothing is left to chance or memory. There are 8 kinds of cards in total. They cover anesthesia, the charge nurse, the circulating nurse, the cooling nurse, the dantrolene nurses (at least 3 people should be mixing dantrolene), the medication nurse, the recorder and additional runners. The recorder is in charge of the paper- work that needs to be done and the runners are there in case anything additional is needed — labs or extra ice, for example. In an outpatient facility, one of the most important duties is to call 911 and begin preparations for transferring the patient to a hospital. You should have a standard transfer protocol in place and make sure everyone knows where and what it is. The anesthesia provider should decide when the patient is stable enough to begin the transfer. Having those pre-printed instructions makes it a lot less chaotic. They're an easy reference at a time when it would be both easy and potentially catastrophic to forget something. The cards can also help keep people from being overwhelmed. If you're on call and there are only 4 of you, you may have to double up on some of the assignments, and do the best you can. Note, however, that the dantrolene nurses should have one job only. We stress that that's the first thing that needs to happen – you need to get that cart in the room and start mixing up your dantrolene. S U R G I C A L E M E R G E N C I E S Dantrium® Intravenous (dantrolene sodium for injection) DESCRIPTION: Dantrium Intravenous is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium Intravenous is VXSSOLHGLQP/YLDOVFRQWDLQLQJPJGDQWUROHQHVRGLXPPJPDQQLWRODQGVXI¿FLHQWVRGLXPK\GUR[LGHWR\LHOGDS+RIDSSUR[LPDWHO\ZKHQ UHFRQVWLWXWHGZLWKP/VWHULOHZDWHUIRULQMHFWLRQ863ZLWKRXWDEDFWHULRVWDWLFDJHQW DantriumLVFODVVL¿HGDVDGLUHFWDFWLQJVNHOHWDOPXVFOHUHOD[DQW&KHPLFDOO\ DantriumLVK\GUDWHG>>>QLWURSKHQ\OIXUDQ\O@PHWK\OHQH@DPLQR@ imidazolidinedione sodium salt. The structural formula for the hydrated salt is: 7KHK\GUDWHGVDOWFRQWDLQVDSSUR[LPDWHO\ZDWHUPROHVDQGKDVDPROHFXODUZHLJKWRI7KHDQK\GURXVVDOWGDQWUROHQHKDVDPROHFXODUZHLJKWRI CLINICAL PHARMACOLOGY: In isolated nerve-muscle preparation, DantriumKDVEHHQVKRZQWRSURGXFHUHOD[DWLRQE\DIIHFWLQJWKHFRQWUDFWLOHUHVSRQVHRI WKHPXVFOHDWDVLWHEH\RQGWKHP\RQHXUDOMXQFWLRQ,QVNHOHWDOPXVFOHDantriumGLVVRFLDWHVWKHH[FLWDWLRQFRQWUDFWLRQFRXSOLQJSUREDEO\E\LQWHUIHULQJZLWK WKHUHOHDVHRI&DIURPWKHVDUFRSODVPLFUHWLFXOXP7KHDGPLQLVWUDWLRQRILQWUDYHQRXVDantriumWRKXPDQYROXQWHHUVLVDVVRFLDWHGZLWKORVVRIJULSVWUHQJWK DQGZHDNQHVVLQWKHOHJVDVZHOODVVXEMHFWLYH&16FRPSODLQWVVHHDOVR35(&$87,216,QIRUPDWLRQIRU3DWLHQWV,QIRUPDWLRQFRQFHUQLQJWKHSDVVDJHRI DantriumDFURVVWKHEORRGEUDLQEDUULHULVQRWDYDLODEOH ,QWKHDQHVWKHWLFLQGXFHGPDOLJQDQWK\SHUWKHUPLDV\QGURPHHYLGHQFHSRLQWVWRDQLQWULQVLFDEQRUPDOLW\RIVNHOHWDOPXVFOHWLVVXH,QDIIHFWHGKXPDQVLWKDV EHHQSRVWXODWHGWKDW³WULJJHULQJDJHQWV´HJJHQHUDODQHVWKHWLFVDQGGHSRODUL]LQJQHXURPXVFXODUEORFNLQJDJHQWVSURGXFHDFKDQJHZLWKLQWKHFHOOZKLFK UHVXOWVLQDQHOHYDWHGP\RSODVPLFFDOFLXP7KLVHOHYDWHGP\RSODVPLFFDOFLXPDFWLYDWHVDFXWHFHOOXODUFDWDEROLFSURFHVVHVWKDWFDVFDGHWRWKHPDOLJQDQW hyperthermia crisis. It is hypothesized that addition of DantriumWRWKH³WULJJHUHG´PDOLJQDQWK\SHUWKHUPLFPXVFOHFHOOUHHVWDEOLVKHVDQRUPDOOHYHORILRQL]HGFDOFLXPLQWKHP\RSODVP ,QKLELWLRQRIFDOFLXPUHOHDVHIURPWKHVDUFRSODVPLFUHWLFXOXPE\ DantriumUHHVWDEOLVKHVWKHP\RSODVPLFFDOFLXPHTXLOLEULXPLQFUHDVLQJWKHSHUFHQWDJHRI ERXQGFDOFLXP,QWKLVZD\SK\VLRORJLFPHWDEROLFDQGELRFKHPLFDOFKDQJHVDVVRFLDWHGZLWKWKHPDOLJQDQWK\SHUWKHUPLDFULVLVPD\EHUHYHUVHGRUDWWHQXDWHG ([SHULPHQWDOUHVXOWVLQPDOLJQDQWK\SHUWKHUPLDVXVFHSWLEOHVZLQHVKRZWKDWSURSK\ODFWLFDGPLQLVWUDWLRQRILQWUDYHQRXVRURUDOGDQWUROHQHSUHYHQWVRUDWWHQXDWHV WKHGHYHORSPHQWRIYLWDOVLJQDQGEORRGJDVFKDQJHVFKDUDFWHULVWLFRIPDOLJQDQWK\SHUWKHUPLDLQDGRVHUHODWHGPDQQHU7KHHI¿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¿FDQWFDUGLRUHVSLUDWRU\FKDQJHV 6SHFL¿FPHWDEROLFSDWKZD\VIRUWKHGHJUDGDWLRQDQGHOLPLQDWLRQRI DantriumLQKXPDQVKDYHEHHQHVWDEOLVKHG'DQWUROHQHLVIRXQGLQPHDVXUDEOHDPRXQWVLQ EORRGDQGXULQH,WVPDMRUPHWDEROLWHVLQERG\ÀXLGVDUHK\GUR[\GDQWUROHQHDQGDQDFHW\ODPLQRPHWDEROLWHRIGDQWUROHQH$QRWKHUPHWDEROLWHZLWKDQXQNQRZQ structure appears related to the latter. DantriumPD\DOVRXQGHUJRK\GURO\VLVDQGVXEVHTXHQWR[LGDWLRQIRUPLQJQLWURSKHQ\OIXURLFDFLG 7KHPHDQELRORJLFKDOIOLIHRIDantriumDIWHULQWUDYHQRXVDGPLQLVWUDWLRQLVYDULDEOHEHWZHHQWRKRXUVXQGHUPRVWH[SHULPHQWDOFRQGLWLRQV%DVHGRQDVVD\V RIZKROHEORRGDQGSODVPDVOLJKWO\JUHDWHUDPRXQWVRIGDQWUROHQHDUHDVVRFLDWHGZLWKUHGEORRGFHOOVWKDQZLWKWKHSODVPDIUDFWLRQRIEORRG6LJQL¿FDQWDPRXQWV RIGDQWUROHQHDUHERXQGWRSODVPDSURWHLQVPRVWO\DOEXPLQDQGWKLVELQGLQJLVUHDGLO\UHYHUVLEOH &DUGLRSXOPRQDU\GHSUHVVLRQKDVQRWEHHQREVHUYHGLQPDOLJQDQWK\SHUWKHUPLDVXVFHSWLEOHVZLQHIROORZLQJWKHDGPLQLVWUDWLRQRIXSWRPJNJLYGDQWUROHQH 7KLVLVWZLFHWKHDPRXQWQHHGHGWRPD[LPDOO\GLPLQLVKWZLWFKUHVSRQVHWRVLQJOHVXSUDPD[LPDOSHULSKHUDOQHUYHVWLPXODWLRQLQKLELWLRQ$WUDQVLHQW LQFRQVLVWHQWGHSUHVVDQWHIIHFWRQJDVWURLQWHVWLQDOVPRRWKPXVFOHVKDVEHHQREVHUYHGDWKLJKGRVHV INDICATIONS AND USAGE: Dantrium IntravenousLVLQGLFDWHGDORQJZLWKDSSURSULDWHVXSSRUWLYHPHDVXUHVIRUWKHPDQDJHPHQWRIWKHIXOPLQDQW K\SHUPHWDEROLVPRIVNHOHWDOPXVFOHFKDUDFWHULVWLFRIPDOLJQDQWK\SHUWKHUPLDFULVHVLQSDWLHQWVRIDOODJHVDantrium,QWUDYHQRXVVKRXOGEHDGPLQLVWHUHGE\ continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, K\SHUFDUELDPHWDEROLFDFLGRVLVVNHOHWDOPXVFOHULJLGLW\LQFUHDVHGXWLOL]DWLRQRIDQHVWKHVLDFLUFXLWFDUERQGLR[LGHDEVRUEHUF\DQRVLVDQGPRWWOLQJRIWKHVNLQ and, in many cases, fever). Dantrium,QWUDYHQRXVLVDOVRLQGLFDWHGSUHRSHUDWLYHO\DQGVRPHWLPHVSRVWRSHUDWLYHO\WRSUHYHQWRUDWWHQXDWHWKHGHYHORSPHQWRIFOLQLFDODQGODERUDWRU\VLJQV RIPDOLJQDQWK\SHUWKHUPLDLQLQGLYLGXDOVMXGJHGWREHPDOLJQDQWK\SHUWKHUPLDVXVFHSWLEOH CONTRAINDICATIONS:1RQH WARNINGS: The use of Dantrium IntravenousLQWKHPDQDJHPHQWRIPDOLJQDQWK\SHUWKHUPLDFULVLVLVQRWDVXEVWLWXWHIRUSUHYLRXVO\NQRZQVXSSRUWLYH PHDVXUHV7KHVHPHDVXUHVPXVWEHLQGLYLGXDOL]HGEXWLWZLOOXVXDOO\EHQHFHVVDU\WRGLVFRQWLQXHWKHVXVSHFWWULJJHULQJDJHQWVDWWHQGWRLQFUHDVHGR[\JHQ UHTXLUHPHQWVPDQDJHWKHPHWDEROLFDFLGRVLVLQVWLWXWHFRROLQJZKHQQHFHVVDU\PRQLWRUXULQDU\RXWSXWDQGPRQLWRUIRUHOHFWURO\WHLPEDODQFH 6LQFHWKHHIIHFWRIGLVHDVHVWDWHDQGRWKHUGUXJVRQDantriumUHODWHGVNHOHWDOPXVFOHZHDNQHVVLQFOXGLQJSRVVLEOHUHVSLUDWRU\GHSUHVVLRQFDQQRWEHSUHGLFWHG SDWLHQWVZKRUHFHLYHLYDantrium preoperatively should have vital signs monitored. ,ISDWLHQWVMXGJHGPDOLJQDQWK\SHUWKHUPLDVXVFHSWLEOHDUHDGPLQLVWHUHGLQWUDYHQRXVRURUDODantriumSUHRSHUDWLYHO\DQHVWKHWLFSUHSDUDWLRQPXVWVWLOOIROORZ DVWDQGDUGPDOLJQDQWK\SHUWKHUPLDVXVFHSWLEOHUHJLPHQLQFOXGLQJWKHDYRLGDQFHRINQRZQWULJJHULQJDJHQWV0RQLWRULQJIRUHDUO\FOLQLFDODQGPHWDEROLFVLJQV RIPDOLJQDQWK\SHUWKHUPLDLVLQGLFDWHGEHFDXVHDWWHQXDWLRQRIPDOLJQDQWK\SHUWKHUPLDUDWKHUWKDQSUHYHQWLRQLVSRVVLEOH7KHVHVLJQVXVXDOO\FDOOIRUWKH administration of additional i.v. dantrolene. PRECAUTIONS: General:&DUHPXVWEHWDNHQWRSUHYHQWH[WUDYDVDWLRQRIDantriumVROXWLRQLQWRWKHVXUURXQGLQJWLVVXHVGXHWRWKHKLJKS+RIWKHLQWUDYHQRXVIRUPXODWLRQDQG potential for tissue necrosis. :KHQPDQQLWROLVXVHGIRUSUHYHQWLRQRUWUHDWPHQWRIODWHUHQDOFRPSOLFDWLRQVRIPDOLJQDQWK\SHUWKHUPLDWKHJRIPDQQLWROQHHGHGWRGLVVROYHHDFKPJYLDO of i.v. DantriumVKRXOGEHWDNHQLQWRFRQVLGHUDWLRQ Information for Patients:%DVHGXSRQGDWDLQKXPDQYROXQWHHUVSHULRSHUDWLYHO\LWLVDSSURSULDWHWRWHOOSDWLHQWVZKRUHFHLYHDantrium Intravenous that V\PSWRPVRIPXVFOHZHDNQHVVVKRXOGEHH[SHFWHGSRVWRSHUDWLYHO\LHGHFUHDVHLQJULSVWUHQJWKDQGZHDNQHVVRIOHJPXVFOHVHVSHFLDOO\ZDONLQJGRZQVWDLUV ,QDGGLWLRQV\PSWRPVVXFKDV³OLJKWKHDGHGQHVV´PD\EHQRWHG6LQFHVRPHRIWKHVHV\PSWRPVPD\SHUVLVWIRUXSWRKRXUVSDWLHQWVPXVWQRWRSHUDWHDQ DXWRPRELOHRUHQJDJHLQRWKHUKD]DUGRXVDFWLYLW\GXULQJWKLVWLPH&DXWLRQLVDOVRLQGLFDWHGDWPHDOVRQWKHGD\RIDGPLQLVWUDWLRQEHFDXVHGLI¿FXOW\VZDOORZLQJ DQGFKRNLQJKDVEHHQUHSRUWHG&DXWLRQVKRXOGEHH[HUFLVHGLQWKHFRQFRPLWDQWDGPLQLVWUDWLRQRIWUDQTXLOL]LQJDJHQWV +HSDWRWR[LFLW\VHHQ with Dantrium Capsules: Dantrium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antriumIRUYDU\LQJSHULRGVRIWLPH2YHUWKHSDWLWLVKDVRFFXUUHGDWYDU\LQJLQWHUYDOVDIWHULQLWLDWLRQRI WKHUDS\EXWKDVEHHQPRVWIUHTXHQWO\REVHUYHGEHWZHHQWKHWKLUGDQGWZHOIWKPRQWKRIWKHUDS\7KHULVNRIKHSDWLFLQMXU\DSSHDUVWREHJUHDWHULQIHPDOHV LQSDWLHQWVRYHU\HDUVRIDJHDQGLQSDWLHQWVWDNLQJRWKHUPHGLFDWLRQVLQDGGLWLRQWRDantrium (dantrolene sodium). DantriumVKRXOGEHXVHGRQO\LQ FRQMXQFWLRQZLWKDSSURSULDWHPRQLWRULQJRIKHSDWLFIXQFWLRQLQFOXGLQJIUHTXHQWGHWHUPLQDWLRQRI6*27RU6*37 )DWDODQGQRQIDWDOOLYHUGLVRUGHUVRIDQLGLRV\QFUDWLFRUK\SHUVHQVLWLYLW\W\SHPD\RFFXUZLWKDantrium therapy. Drug Interactions: DantriumLVPHWDEROL]HGE\WKHOLYHUDQGLWLVWKHRUHWLFDOO\SRVVLEOHWKDWLWVPHWDEROLVPPD\EHHQKDQFHGE\GUXJVNQRZQWRLQGXFHKHSDWLF PLFURVRPDOHQ]\PHV+RZHYHUQHLWKHUSKHQREDUELWDOQRUGLD]HSDPDSSHDUVWRDIIHFW DantriumPHWDEROLVP%LQGLQJWRSODVPDSURWHLQLVQRWVLJQL¿FDQWO\ DOWHUHGE\GLD]HSDPGLSKHQ\OK\GDQWRLQRUSKHQ\OEXWD]RQH%LQGLQJWRSODVPDSURWHLQVLVUHGXFHGE\ZDUIDULQDQGFOR¿EUDWHDQGLQFUHDVHGE\WROEXWDPLGH &DUGLRYDVFXODUFROODSVHLQDVVRFLDWLRQZLWKPDUNHGK\SHUNDOHPLDKDVEHHQUHSRUWHGLQSDWLHQWVUHFHLYLQJGDQWUROHQHLQFRPELQDWLRQZLWKFDOFLXPFKDQQHO EORFNHUV,WLVUHFRPPHQGHGWKDWWKHFRPELQDWLRQRILQWUDYHQRXVGDQWUROHQHVRGLXPDQGFDOFLXPFKDQQHOEORFNHUVVXFKDVYHUDSDPLOQRWEHXVHGWRJHWKHU during the management of malignant hyperthermia crisis. $GPLQLVWUDWLRQRIGDQWUROHQHPD\SRWHQWLDWHYHFXURQLXPLQGXFHGQHXURPXVFXODUEORFN Carcinogenesis, Mutagenesis, and Impairment of Fertility:6SUDJXH'DZOH\IHPDOHUDWVIHG Dantrium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incidence of hepatic lymphangiomas and hepatic angiosarcomas. 7KHRQO\GUXJUHODWHGHIIHFWVHHQLQDPRQWKVWXG\LQ)LVFKHUUDWVZDVDGRVHUHODWHGUHGXFWLRQLQWKHWLPHRIRQVHWRIPDPPDU\DQGWHVWLFXODUWXPRUV $PRQWKVWXG\LQ+D0,&5PLFHUHYHDOHGQRHYLGHQFHRIFDUFLQRJHQLFDFWLYLW\ 7KHVLJQL¿FDQFHRIFDUFLQRJHQLFLW\GDWDUHODWLYHWRXVHRIDantriumLQKXPDQVLVXQNQRZQ 'DQWUROHQHVRGLXPKDVSURGXFHGSRVLWLYHUHVXOWVLQWKH$PHV67\SKLPXULXPEDFWHULDOPXWDJHQHVLVDVVD\LQWKHSUHVHQFHDQGDEVHQFHRIDOLYHUDFWLYDWLQJV\VWHP 'DQWUROHQHVRGLXPDGPLQLVWHUHGWRPDOHDQGIHPDOHUDWVDWGRVHOHYHOVXSWRPJNJGD\DSSUR[LPDWHO\WLPHVWKHPD[LPXPUHFRPPHQGHGGDLO\GRVHRQ DPJP 2 EDVLVVKRZHGQRDGYHUVHHIIHFWVRQIHUWLOLW\RUJHQHUDOUHSURGXFWLYHSHUIRUPDQFH Pregnancy: 3UHJQDQF\&DWHJRU\&DantriumKDVEHHQVKRZQWREHHPEU\RFLGDOLQWKHUDEELWDQGKDVEHHQVKRZQWRGHFUHDVHSXSVXUYLYDOLQWKHUDWZKHQ JLYHQDWGRVHVVHYHQWLPHVWKHKXPDQRUDOGRVH7KHUHDUHQRDGHTXDWHDQGZHOOFRQWUROOHGVWXGLHVLQSUHJQDQWZRPHQDantrium IntravenousVKRXOGEH XVHGGXULQJSUHJQDQF\RQO\LIWKHSRWHQWLDOEHQH¿WMXVWL¿HVWKHSRWHQWLDOULVNWRWKHIHWXV Labor and Delivery: In one uncontrolled study, 100 mg per day of prophylactic oral DantriumZDVDGPLQLVWHUHGWRWHUPSUHJQDQWSDWLHQWVDZDLWLQJODERU DQGGHOLYHU\'DQWUROHQHUHDGLO\FURVVHGWKHSODFHQWDZLWKPDWHUQDODQGIHWDOZKROHEORRGOHYHOVDSSUR[LPDWHO\HTXDODWGHOLYHU\QHRQDWDOOHYHOVWKHQIHOO DSSUR[LPDWHO\SHUGD\IRUGD\VEHIRUHGHFOLQLQJVKDUSO\1RQHRQDWDOUHVSLUDWRU\DQGQHXURPXVFXODUVLGHHIIHFWVZHUHGHWHFWHGDWORZGRVH0RUHGDWD DWKLJKHUGRVHVDUHQHHGHGEHIRUHPRUHGH¿QLWLYHFRQFOXVLRQVFDQEHPDGH Nursing Mothers:'DQWUROHQHKDVEHHQGHWHFWHGLQKXPDQPLONDWORZFRQFHQWUDWLRQVOHVVWKDQPLFURJUDPVSHUP/GXULQJUHSHDWLQWUDYHQRXVDGPLQLVWUDWLRQ RYHUGD\V%HFDXVHRIWKHSRWHQWLDOIRUVHULRXVDGYHUVHUHDFWLRQVLQQXUVLQJLQIDQWVIURPGDQWUROHQHDGHFLVLRQVKRXOGEHPDGHZKHWKHUWRGLVFRQWLQXHQXUVLQJ RUWRGLVFRQWLQXHWKHGUXJWDNLQJLQWRDFFRXQWWKHLPSRUWDQFHRIWKHGUXJWRWKHPRWKHU Geriatric Use:&OLQLFDOVWXGLHVRIDantrium IntravenousGLGQRWLQFOXGHVXI¿FLHQWQXPEHUVRIVXEMHFWVDJHGDQGRYHUWRGHWHUPLQHZKHWKHUWKH\UHVSRQG GLIIHUHQWO\IURP\RXQJHUVXEMHFWV2WKHUUHSRUWHGFOLQLFDOH[SHULHQFHKDVQRWLGHQWL¿HGGLIIHUHQFHVLQUHVSRQVHVEHWZHHQWKHHOGHUO\DQG\RXQJHUSDWLHQWV ,QJHQHUDOGRVHVHOHFWLRQIRUDQHOGHUO\SDWLHQWVKRXOGEHFDXWLRXVUHÀHFWLQJWKHJUHDWHUIUHTXHQF\RIGHFUHDVHGKHSDWLFUHQDORUFDUGLDFIXQFWLRQDQGRI concomitant disease or other drug therapy. ADVERSE REACTIONS: 7KHUHKDYHEHHQRFFDVLRQDOUHSRUWVRIGHDWKIROORZLQJPDOLJQDQWK\SHUWKHUPLDFULVLVHYHQZKHQWUHDWHGZLWKLQWUDYHQRXVGDQWUROHQH LQFLGHQFH¿JXUHVDUHQRWDYDLODEOHWKHSUHGDQWUROHQHPRUWDOLW\RIPDOLJQDQWK\SHUWKHUPLDFULVLVZDVDSSUR[LPDWHO\0RVWRIWKHVHGHDWKVFDQEHDFFRXQWHG IRUE\ODWHUHFRJQLWLRQGHOD\HGWUHDWPHQWLQDGHTXDWHGRVDJHODFNRIVXSSRUWLYHWKHUDS\LQWHUFXUUHQWGLVHDVHDQGRUWKHGHYHORSPHQWRIGHOD\HGFRPSOLFDWLRQV VXFKDVUHQDOIDLOXUHRUGLVVHPLQDWHGLQWUDYDVFXODUFRDJXORSDWK\,QVRPHFDVHVWKHUHDUHLQVXI¿FLHQWGDWDWRFRPSOHWHO\UXOHRXWWKHUDSHXWLFIDLOXUHRIGDQWUROHQH 7KHUHDUHUHSRUWVRIIDWDOLW\LQPDOLJQDQWK\SHUWKHUPLDFULVLVGHVSLWHLQLWLDOVDWLVIDFWRU\UHVSRQVHWRLYGDQWUROHQHZKLFKLQYROYHSDWLHQWVZKRFRXOGQRWEH ZHDQHGIURPGDQWUROHQHDIWHULQLWLDOWUHDWPHQW The administration of intravenous DantriumWRKXPDQYROXQWHHUVLVDVVRFLDWHGZLWKORVVRIJULSVWUHQJWKDQGZHDNQHVVLQWKHOHJVDVZHOODVGURZVLQHVV and dizziness. 7KHIROORZLQJDGYHUVHUHDFWLRQVDUHLQDSSUR[LPDWHRUGHURIVHYHULW\ 7KHUHDUHUDUHUHSRUWVRISXOPRQDU\HGHPDGHYHORSLQJGXULQJWKHWUHDWPHQWRIPDOLJQDQWK\SHUWKHUPLDFULVLVLQZKLFKWKHGLOXHQWYROXPHDQGPDQQLWRO QHHGHGWRGHOLYHULYGDQWUROHQHSRVVLEO\FRQWULEXWHG 7KHUHKDYHEHHQUHSRUWVRIWKURPERSKOHELWLVIROORZLQJDGPLQLVWUDWLRQRILQWUDYHQRXVGDQWUROHQHDFWXDOLQFLGHQFH¿JXUHVDUHQRWDYDLODEOH7LVVXHQHFURVLV VHFRQGDU\WRH[WUDYDVDWLRQKDVEHHQUHSRUWHG 7KHUHKDYHEHHQUDUHUHSRUWVRIXUWLFDULDDQGHU\WKHPDSRVVLEO\DVVRFLDWHGZLWKWKHDGPLQLVWUDWLRQRILYDantrium7KHUHKDVEHHQRQHFDVHRIDQDSK\OD[LV ,QMHFWLRQVLWHUHDFWLRQVSDLQHU\WKHPDVZHOOLQJFRPPRQO\GXHWRH[WUDYDVDWLRQKDYHEHHQUHSRUWHG 1RQHRIWKHVHULRXVUHDFWLRQVRFFDVLRQDOO\UHSRUWHGZLWKORQJWHUPRUDODantriumXVHVXFKDVKHSDWLWLVVHL]XUHVDQGSOHXUDOHIIXVLRQZLWKSHULFDUGLWLVKDYH EHHQUHDVRQDEO\DVVRFLDWHGZLWKVKRUWWHUPDantrium Intravenous therapy. 7KHIROORZLQJHYHQWVKDYHEHHQUHSRUWHGLQSDWLHQWVUHFHLYLQJRUDOGDQWUROHQHDSODVWLFDQHPLDOHXNRSHQLDO\PSKRF\WLFO\PSKRPDDQGKHDUWIDLOXUH6HH SDFNDJHLQVHUWIRUDantrium (dantrolene sodium) Capsules for a complete listing of adverse reactions.) 7KHSXEOLVKHGOLWHUDWXUHKDVLQFOXGHGVRPHUHSRUWVRIDantriumXVHLQSDWLHQWVZLWK1HXUROHSWLF0DOLJQDQW6\QGURPH106Dantrium Intravenous is not LQGLFDWHGIRUWKHWUHDWPHQWRI106DQGSDWLHQWVPD\H[SLUHGHVSLWHWUHDWPHQWZLWKDantrium Intravenous. )RUPHGLFDODGYLFHDERXWDGYHUVHUHDFWLRQVFRQWDFW\RXUPHGLFDOSURIHVVLRQDO7RUHSRUW6863(&7('$'9(56(5($&7,216FRQWDFW-+3DW RU0(':$7&+DW)'$RUKWWSZZZIGDJRYPHGZDWFK OVERDOSAGE: %HFDXVHDantrium IntravenousPXVWEHDGPLQLVWHUHGDWDORZFRQFHQWUDWLRQLQDODUJHYROXPHRIÀXLGDFXWHWR[LFLW\RIDantrium could not EHDVVHVVHGLQDQLPDOV,QGD\VXEDFXWHVWXGLHVWKHLQWUDYHQRXVIRUPXODWLRQRIDantriumZDVUHODWLYHO\QRQWR[LFWRUDWVDWGRVHVRIPJNJGD\DQG PJNJGD\:KLOHPJNJGD\LQGRJVIRUGD\VHYRNHGOLWWOHWR[LFLW\PJNJGD\IRUGD\VFDXVHGKHSDWLFFKDQJHVRITXHVWLRQDEOHELRORJLFVLJQL¿FDQFH 6\PSWRPVZKLFKPD\RFFXULQFDVHRIRYHUGRVHLQFOXGHEXWDUHQRWOLPLWHGWRPXVFXODUZHDNQHVVDQGDOWHUDWLRQVLQWKHVWDWHRIFRQVFLRXVQHVVHJOHWKDUJ\ coma), vomiting, diarrhea, and crystalluria. )RUDFXWHRYHUGRVDJHJHQHUDOVXSSRUWLYHPHDVXUHVVKRXOGEHHPSOR\HG ,QWUDYHQRXVÀXLGVVKRXOGEHDGPLQLVWHUHGLQIDLUO\ODUJHTXDQWLWLHVWRDYHUWWKHSRVVLELOLW\RIFU\VWDOOXULD$QDGHTXDWHDLUZD\VKRXOGEHPDLQWDLQHGDQGDUWL¿FLDO UHVXVFLWDWLRQHTXLSPHQWVKRXOGEHDWKDQG(OHFWURFDUGLRJUDSKLFPRQLWRULQJVKRXOGEHLQVWLWXWHGDQGWKHSDWLHQWFDUHIXOO\REVHUYHG7KHYDOXHRIGLDO\VLVLQ DantriumRYHUGRVHLVQRWNQRZQ DOSAGE AND ADMINISTRATION:$VVRRQDVWKHPDOLJQDQWK\SHUWKHUPLDUHDFWLRQLVUHFRJQL]HGDOODQHVWKHWLFDJHQWVVKRXOGEHGLVFRQWLQXHGWKH DGPLQLVWUDWLRQRIR[\JHQLVUHFRPPHQGHGDantrium IntravenousVKRXOGEHDGPLQLVWHUHGE\FRQWLQXRXVUDSLGLQWUDYHQRXVSXVKEHJLQQLQJDWDPLQLPXP GRVHRIPJNJDQGFRQWLQXLQJXQWLOV\PSWRPVVXEVLGHRUWKHPD[LPXPFXPXODWLYHGRVHRIPJNJKDVEHHQUHDFKHG ,IWKHSK\VLRORJLFDQGPHWDEROLFDEQRUPDOLWLHVUHDSSHDUWKHUHJLPHQPD\EHUHSHDWHG,WLVLPSRUWDQWWRQRWHWKDWDGPLQLVWUDWLRQRIDantrium Intravenous VKRXOGEHFRQWLQXRXVXQWLOV\PSWRPVVXEVLGH7KHHIIHFWLYHGRVHWRUHYHUVHWKHFULVLVLVGLUHFWO\GHSHQGHQWXSRQWKHLQGLYLGXDO¶VGHJUHHRIVXVFHSWLELOLW\WR PDOLJQDQWK\SHUWKHUPLDWKHDPRXQWDQGWLPHRIH[SRVXUHWRWKHWULJJHULQJDJHQWDQGWKHWLPHHODSVHGEHWZHHQRQVHWRIWKHFULVLVDQGLQLWLDWLRQRIWUHDWPHQW Pediatric Dose:([SHULHQFHWRGDWHLQGLFDWHVWKDWWKHGRVHRIDantrium Intravenous for pediatric patients is the same as for adults. Preoperatively: Dantrium IntravenousDQGRU Dantrium CapsulesPD\EHDGPLQLVWHUHGSUHRSHUDWLYHO\WRSDWLHQWVMXGJHGPDOLJQDQWK\SHUWKHUPLD VXVFHSWLEOHDVSDUWRIWKHRYHUDOOSDWLHQWPDQDJHPHQWWRSUHYHQWRUDWWHQXDWHWKHGHYHORSPHQWRIFOLQLFDODQGODERUDWRU\VLJQVRIPDOLJQDQWK\SHUWKHUPLD Dantrium Intravenous: The recommended prophylactic dose of Dantrium IntravenousLVPJNJVWDUWLQJDSSUR[LPDWHO\KRXUVEHIRUH DQWLFLSDWHGDQHVWKHVLDDQGLQIXVHGRYHUDSSUR[LPDWHO\KRXU7KLVGRVHVKRXOGSUHYHQWRUDWWHQXDWHWKHGHYHORSPHQWRIFOLQLFDODQGODERUDWRU\VLJQV RIPDOLJQDQWK\SHUWKHUPLDSURYLGHGWKDWWKHXVXDOSUHFDXWLRQVVXFKDVDYRLGDQFHRIHVWDEOLVKHGPDOLJQDQWK\SHUWKHUPLDWULJJHULQJDJHQWVDUHIROORZHG $GGLWLRQDODantrium IntravenousPD\EHLQGLFDWHGGXULQJDQHVWKHVLDDQGVXUJHU\EHFDXVHRIWKHDSSHDUDQFHRIHDUO\FOLQLFDODQGRUEORRGJDVVLJQVRI PDOLJQDQWK\SHUWKHUPLDRUEHFDXVHRISURORQJHGVXUJHU\VHHDOVR&/,1,&$/3+$50$&2/2*<:$51,1*6DQG35(&$87,216$GGLWLRQDOGRVHV PXVWEHLQGLYLGXDOL]HG Oral Administration of Dantrium Capsules:$GPLQLVWHUWRPJNJGD\RIRUDODantrium in three or four divided doses for 1 or 2 days prior to surgery, ZLWKWKHODVWGRVHEHLQJJLYHQZLWKDPLQLPXPRIZDWHUDSSUR[LPDWHO\WRKRXUVEHIRUHVFKHGXOHGVXUJHU\$GMXVWPHQWFDQXVXDOO\EHPDGHZLWKLQWKH UHFRPPHQGHGGRVDJHUDQJHWRDYRLGLQFDSDFLWDWLRQZHDNQHVVGURZVLQHVVHWFRUH[FHVVLYHJDVWURLQWHVWLQDOLUULWDWLRQQDXVHDDQGRUYRPLWLQJ6HH DOVRWKHSDFNDJHLQVHUWIRU Dantrium Capsules. Post Crisis Follow-Up: Dantrium CapsulesWRPJNJGD\LQIRXUGLYLGHGGRVHVVKRXOGEHDGPLQLVWHUHGIRUWRGD\VIROORZLQJDPDOLJQDQWK\SHUWKHUPLD crisis to prevent recurrence of the manifestations of malignant hyperthermia. Intravenous DantriumPD\EHXVHGSRVWRSHUDWLYHO\WRSUHYHQWRUDWWHQXDWHWKHUHFXUUHQFHRIVLJQVRIPDOLJQDQWK\SHUWKHUPLDZKHQRUDODantrium administration is not practical. 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