Outpatient Surgery Magazine

Game Changers in Surgery - June 2019 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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Dantrium ® Intravenous (dantrolene sodium for injection) DESCRIPTION Dantrium Intravenous is a sterile, nonpyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium Intravenous is supplied in 70 mL vials containing OIFCPVTQNGPGUQFKWOOIOCPPKVQNCPFUWHſEKGPVUQFKWOJ[FTQZKFGVQ[KGNFC R*QHCRRTQZKOCVGN[YJGPTGEQPUVKVWVGFYKVJO.UVGTKNGYCVGTHQTKPLGEVKQP752 YKVJQWVCDCEVGTKQUVCVKECIGPV DantriumKUENCUUKſGFCUCFKTGEVCEVKPIUMGNGVCNOWUENGTGNCZCPV%JGOKECNN[ DantriumKUJ[FTCVGF=== PKVTQRJGP[NHWTCP[N?OGVJ[NGPG?COKPQ? imidazolidinedione sodium salt. The structural formula for the hydrated salt is: 6JGJ[FTCVGFUCNVEQPVCKPUCRRTQZKOCVGN[YCVGT OQNGUCPFJCUCOQNGEWNCT YGKIJVQH6JGCPJ[FTQWUUCNV FCPVTQNGPGJCUCOQNGEWNCTYGKIJVQH CLINICAL PHARMACOLOGY +PKUQNCVGFPGTXGOWUENGRTGRCTCVKQPDantriumJCUDGGPUJQYPVQRTQFWEGTGNCZCVKQP D[CHHGEVKPIVJGEQPVTCEVKNGTGURQPUGQHVJGOWUENGCVCUKVGDG[QPFVJGO[QPGWTCN LWPEVKQP+PUMGNGVCNOWUENGDantriumFKUUQEKCVGUVJGGZEKVCVKQPEQPVTCEVKQPEQWRNKPI RTQDCDN[D[KPVGTHGTKPIYKVJVJGTGNGCUGQH%CHTQOVJGUCTEQRNCUOKETGVKEWNWO6JG administration of intravenous DantriumVQJWOCPXQNWPVGGTUKUCUUQEKCVGFYKVJNQUU QHITKRUVTGPIVJCPFYGCMPGUUKPVJGNGIUCUYGNNCUUWDLGEVKXG%05EQORNCKPVU UGG CNUQ24'%#76+105+PHQTOCVKQPHQT2CVKGPVU+PHQTOCVKQPEQPEGTPKPIVJGRCUUCIGQH DantriumCETQUUVJGDNQQFDTCKPDCTTKGTKUPQVCXCKNCDNG +PVJGCPGUVJGVKEKPFWEGFOCNKIPCPVJ[RGTVJGTOKCU[PFTQOGGXKFGPEGRQKPVUVQ CPKPVTKPUKECDPQTOCNKV[QHUMGNGVCNOWUENGVKUUWG+PCHHGEVGFJWOCPUKVJCUDGGP postulated that "triggering agents" (e.g., general anesthetics and depolarizing PGWTQOWUEWNCTDNQEMKPICIGPVURTQFWEGCEJCPIGYKVJKPVJGEGNNYJKEJTGUWNVUKP an elevated myoplasmic calcium. This elevated myoplasmic calcium activates acute EGNNWNCTECVCDQNKERTQEGUUGUVJCVECUECFGVQVJGOCNKIPCPVJ[RGTVJGTOKCETKUKU It is hypothesized that addition of Dantrium to the "triggered" malignant hyperthermic OWUENGEGNNTGGUVCDNKUJGUCPQTOCNNGXGNQHKQPK\GFECNEKWOKPVJGO[QRNCUO+PJKDKVKQP QHECNEKWOTGNGCUGHTQOVJGUCTEQRNCUOKETGVKEWNWOD[DantriumTGGUVCDNKUJGU VJGO[QRNCUOKEECNEKWOGSWKNKDTKWOKPETGCUKPIVJGRGTEGPVCIGQHDQWPFECNEKWO +PVJKUYC[RJ[UKQNQIKEOGVCDQNKECPFDKQEJGOKECNEJCPIGUCUUQEKCVGFYKVJVJG OCNKIPCPVJ[RGTVJGTOKCETKUKUOC[DGTGXGTUGFQTCVVGPWCVGF'ZRGTKOGPVCNTGUWNVU KPOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGUYKPGUJQYVJCVRTQRJ[NCEVKECFOKPKUVTCVKQPQH intravenous or oral dantrolene prevents or attenuates the development of vital sign CPFDNQQFICUEJCPIGUEJCTCEVGTKUVKEQHOCNKIPCPVJ[RGTVJGTOKCKPCFQUGTGNCVGF OCPPGT6JGGHſECE[QHKPVTCXGPQWUFCPVTQNGPGKPVJGVTGCVOGPVQHJWOCPCPFRQTEKPG OCNKIPCPVJ[RGTVJGTOKCETKUKUYJGPEQPUKFGTGFCNQPIYKVJRTQRJ[NCEVKEGZRGTKOGPVU KPOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGUYKPGNGPFUUWRRQTVVQRTQRJ[NCEVKEWUG QHQTCNQTKPVTCXGPQWUFCPVTQNGPGKPOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGJWOCPU 9JGPRTQRJ[NCEVKEKPVTCXGPQWUFCPVTQNGPGKUCFOKPKUVGTGFCUFKTGEVGFYJQNGDNQQF concentrations remain at a near steady state level for 3 or more hours after the KPHWUKQPKUEQORNGVGF%NKPKECNGZRGTKGPEGJCUUJQYPVJCVGCTN[XKVCNUKIPCPFQTDNQQF gas changes characteristic of malignant hyperthermia may appear during or after anesthesia and surgery despite the prophylactic use of dantrolene and adherence to EWTTGPVN[CEEGRVGFRCVKGPVOCPCIGOGPVRTCEVKEGU6JGUGUKIPUCTGEQORCVKDNGYKVJ attenuated malignant hyperthermia and respond to the administration of additional KXFCPVTQNGPG UGG&15#)'#0&#&/+0+564#6+106JGCFOKPKUVTCVKQPQHVJG TGEQOOGPFGFRTQRJ[NCEVKEFQUGQHKPVTCXGPQWUFCPVTQNGPGVQJGCNVJ[XQNWPVGGTUYCU PQVCUUQEKCVGFYKVJENKPKECNN[UKIPKſECPVECTFKQTGURKTCVQT[EJCPIGU 5RGEKſEOGVCDQNKERCVJYC[UHQTVJGFGITCFCVKQPCPFGNKOKPCVKQPQHDantrium in JWOCPUJCXGDGGPGUVCDNKUJGF&CPVTQNGPGKUHQWPFKPOGCUWTCDNGCOQWPVUKP DNQQFCPFWTKPG+VUOCLQTOGVCDQNKVGUKPDQF[ƀWKFUCTGJ[FTQZ[FCPVTQNGPGCPFCP CEGV[NCOKPQOGVCDQNKVGQHFCPVTQNGPG#PQVJGTOGVCDQNKVGYKVJCPWPMPQYPUVTWEVWTG appears related to the latter. DantriumOC[CNUQWPFGTIQJ[FTQN[UKUCPFUWDUGSWGPV QZKFCVKQPHQTOKPIPKVTQRJGP[NHWTQKECEKF 6JGOGCPDKQNQIKEJCNHNKHGQHDantriumCHVGTKPVTCXGPQWUCFOKPKUVTCVKQPKUXCTKCDNG DGVYGGPVQJQWTUWPFGTOQUVGZRGTKOGPVCNEQPFKVKQPU$CUGFQPCUUC[UQHYJQNG DNQQFCPFRNCUOCUNKIJVN[ITGCVGTCOQWPVUQHFCPVTQNGPGCTGCUUQEKCVGFYKVJTGFDNQQF EGNNUVJCPYKVJVJGRNCUOCHTCEVKQPQHDNQQF5KIPKſECPVCOQWPVUQHFCPVTQNGPGCTG DQWPFVQRNCUOCRTQVGKPUOQUVN[CNDWOKPCPFVJKUDKPFKPIKUTGCFKN[TGXGTUKDNG %CTFKQRWNOQPCT[FGRTGUUKQPJCUPQVDGGPQDUGTXGFKPOCNKIPCPVJ[RGTVJGTOKC UWUEGRVKDNGUYKPGHQNNQYKPIVJGCFOKPKUVTCVKQPQHWRVQOIMIKXFCPVTQNGPG6JKUKU VYKEGVJGCOQWPVPGGFGFVQOCZKOCNN[FKOKPKUJVYKVEJTGURQPUGVQUKPINGUWRTCOCZKOCN RGTKRJGTCNPGTXGUVKOWNCVKQP KPJKDKVKQP#VTCPUKGPVKPEQPUKUVGPVFGRTGUUCPV GHHGEVQPICUVTQKPVGUVKPCNUOQQVJOWUENGUJCUDGGPQDUGTXGFCVJKIJFQUGU INDICATIONS AND USAGE Dantrium IntravenousKUKPFKECVGFCNQPIYKVJCRRTQRTKCVGUWRRQTVKXGOGCUWTGUHQT VJGOCPCIGOGPVQHVJGHWNOKPCPVJ[RGTOGVCDQNKUOQHUMGNGVCNOWUENGEJCTCEVGTKUVKEQH malignant hyperthermia crises in patients of all ages. Dantrium Intravenous should DGCFOKPKUVGTGFD[EQPVKPWQWUTCRKFKPVTCXGPQWURWUJCUUQQPCUVJGOCNKIPCPV hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous FGUCVWTCVKQPJ[RGTECTDKCOGVCDQNKECEKFQUKUUMGNGVCNOWUENGTKIKFKV[KPETGCUGF WVKNK\CVKQPQHCPGUVJGUKCEKTEWKVECTDQPFKQZKFGCDUQTDGTE[CPQUKUCPFOQVVNKPIQHVJG UMKPCPFKPOCP[ECUGUHGXGT Dantrium Intravenous is also indicated preoperatively, and sometimes postoperatively, VQRTGXGPVQTCVVGPWCVGVJGFGXGNQROGPVQHENKPKECNCPFNCDQTCVQT[UKIPUQHOCNKIPCPV J[RGTVJGTOKCKPKPFKXKFWCNULWFIGFVQDGOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNG CONTRAINDICATIONS 0QPG WARNINGS The use of Dantrium Intravenous in the management of malignant hyperthermia crisis is not a substitute for previously known supportive measures. These measures must be individualized, but it will usually be necessary to discontinue the suspect triggering agents, attend to increased oxygen requirements, manage the metabolic acidosis, institute cooling when necessary, monitor urinary output, and monitor for electrolyte imbalance. 5KPEGVJGGHHGEVQHFKUGCUGUVCVGCPFQVJGTFTWIUQPDantrium TGNCVGFUMGNGVCNOWUENG YGCMPGUUKPENWFKPIRQUUKDNGTGURKTCVQT[FGRTGUUKQPECPPQVDGRTGFKEVGFRCVKGPVUYJQ receive i.v. Dantrium preoperatively should have vital signs monitored. +HRCVKGPVULWFIGFOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGCTGCFOKPKUVGTGFKPVTCXGPQWU or oral DantriumRTGQRGTCVKXGN[CPGUVJGVKERTGRCTCVKQPOWUVUVKNNHQNNQYCUVCPFCTF OCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGTGIKOGPKPENWFKPIVJGCXQKFCPEGQHMPQYP VTKIIGTKPICIGPVU/QPKVQTKPIHQTGCTN[ENKPKECNCPFOGVCDQNKEUKIPUQHOCNKIPCPV J[RGTVJGTOKCKUKPFKECVGFDGECWUGCVVGPWCVKQPQHOCNKIPCPVJ[RGTVJGTOKCTCVJGTVJCP RTGXGPVKQPKURQUUKDNG6JGUGUKIPUWUWCNN[ECNNHQTVJGCFOKPKUVTCVKQPQHCFFKVKQPCN i.v. dantrolene. PRECAUTIONS General: %CTGOWUVDGVCMGPVQRTGXGPVGZVTCXCUCVKQPQHDantrium solution into the surrounding tissues due to the high pH of the intravenous formulation and potential for tissue necrosis. When mannitol is used for prevention or treatment of late renal complications of malignant hyperthermia, the 3 g of mannitol needed to dissolve each 20 mg vial of i.v. Dantrium UJQWNFDGVCMGPKPVQEQPUKFGTCVKQP Information for Patients: $CUGFWRQPFCVCKPJWOCPXQNWPVGGTURGTKQRGTCVKXGN[KV KUCRRTQRTKCVGVQVGNNRCVKGPVUYJQTGEGKXGDantrium Intravenous that symptoms of OWUENGYGCMPGUUUJQWNFDGGZRGEVGFRQUVQRGTCVKXGN[ KGFGETGCUGKPITKRUVTGPIVJ CPFYGCMPGUUQHNGIOWUENGUGURGEKCNN[YCNMKPIFQYPUVCKTU+PCFFKVKQPU[ORVQOU UWEJCUőNKIJVJGCFGFPGUUŒOC[DGPQVGF5KPEGUQOGQHVJGUGU[ORVQOUOC[RGTUKUV HQTWRVQJQWTURCVKGPVUOWUVPQVQRGTCVGCPCWVQOQDKNGQTGPICIGKPQVJGT JC\CTFQWUCEVKXKV[FWTKPIVJKUVKOG%CWVKQPKUCNUQKPFKECVGFCVOGCNUQPVJGFC[QH CFOKPKUVTCVKQPDGECWUGFKHſEWNV[UYCNNQYKPICPFEJQMKPIJCUDGGPTGRQTVGF%CWVKQP UJQWNFDGGZGTEKUGFKPVJGEQPEQOKVCPVCFOKPKUVTCVKQPQHVTCPSWKNK\KPICIGPVU *GRCVQVQZKEKV[UGGPYKVJDantrium Capsules: Dantrium (dantrolene sodium) has CRQVGPVKCNHQTJGRCVQVQZKEKV[CPFUJQWNFPQVDGWUGFKPEQPFKVKQPUQVJGTVJCPVJQUG TGEQOOGPFGF5[ORVQOCVKEJGRCVKVKU HCVCNCPFPQPHCVCNJCUDGGPTGRQTVGFCVXCTKQWU FQUGNGXGNUQHVJGFTWI6JGKPEKFGPEGTGRQTVGFKPRCVKGPVUVCMKPIWRVQ OIFC[KUOWEJNQYGTVJCPKPVJQUGVCMKPIFQUGUQHOIQTOQTGRGTFC[ 'XGPURQTCFKEUJQTVEQWTUGUQHVJGUGJKIJGTFQUGNGXGNUYKVJKPCVTGCVOGPVTGIKOGP OCTMGFN[KPETGCUGFVJGTKUMQHUGTKQWUJGRCVKEKPLWT[.KXGTF[UHWPEVKQPCUGXKFGPEGF D[DNQQFEJGOKECNCDPQTOCNKVKGUCNQPG NKXGTGP\[OGGNGXCVKQPUJCUDGGPQDUGTXGFKP RCVKGPVUGZRQUGFVQDantriumHQTXCT[KPIRGTKQFUQHVKOG1XGTVJGRCVKVKUJCUQEEWTTGF CVXCT[KPIKPVGTXCNUCHVGTKPKVKCVKQPQHVJGTCR[DWVJCUDGGPOQUVHTGSWGPVN[QDUGTXGF DGVYGGPVJGVJKTFCPFVYGNHVJOQPVJQHVJGTCR[6JGTKUMQHJGRCVKEKPLWT[CRRGCTUVQ DGITGCVGTKPHGOCNGUKPRCVKGPVUQXGT[GCTUQHCIGCPFKPRCVKGPVUVCMKPIQVJGT medication(s) in addition to Dantrium (dantrolene sodium). DantriumUJQWNFDGWUGF QPN[KPEQPLWPEVKQPYKVJCRRTQRTKCVGOQPKVQTKPIQHJGRCVKEHWPEVKQPKPENWFKPIHTGSWGPV FGVGTOKPCVKQPQH5)16QT5)26 (CVCNCPFPQPHCVCNNKXGTFKUQTFGTUQHCPKFKQU[PETCVKEQTJ[RGTUGPUKVKXKV[V[RGOC[QEEWT YKVJDantrium therapy. Drug Interactions: DantriumKUOGVCDQNK\GFD[VJGNKXGTCPFKVKUVJGQTGVKECNN[RQUUKDNG VJCVKVUOGVCDQNKUOOC[DGGPJCPEGFD[FTWIUMPQYPVQKPFWEGJGRCVKEOKETQUQOCN GP\[OGU*QYGXGTPGKVJGTRJGPQDCTDKVCNPQTFKC\GRCOCRRGCTUVQCHHGEVDantrium OGVCDQNKUO$KPFKPIVQRNCUOCRTQVGKPKUPQVUKIPKſECPVN[CNVGTGFD[FKC\GRCO FKRJGP[NJ[FCPVQKPQTRJGP[NDWVC\QPG$KPFKPIVQRNCUOCRTQVGKPUKUTGFWEGFD[ YCTHCTKPCPFENQſDTCVGCPFKPETGCUGFD[VQNDWVCOKFG %CTFKQXCUEWNCTEQNNCRUGKPCUUQEKCVKQPYKVJOCTMGFJ[RGTMCNGOKCJCUDGGPTGRQTVGF KPRCVKGPVUTGEGKXKPIFCPVTQNGPGKPEQODKPCVKQPYKVJECNEKWOEJCPPGNDNQEMGTU+VKU TGEQOOGPFGFVJCVVJGEQODKPCVKQPQHKPVTCXGPQWUFCPVTQNGPGUQFKWOCPFECNEKWO EJCPPGNDNQEMGTUUWEJCUXGTCRCOKNPQVDGWUGFVQIGVJGTFWTKPIVJGOCPCIGOGPVQH malignant hyperthermia crisis. #FOKPKUVTCVKQPQHFCPVTQNGPGOC[RQVGPVKCVGXGEWTQPKWOKPFWEGFPGWTQOWUEWNCTDNQEM Carcinogenesis, Mutagenesis, and Impairment of Fertility:5RTCIWG&CYNG[ female rats fed Dantrium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increased incidence of hepatic lymphangiomas and hepatic angiosarcomas. 6JGQPN[FTWITGNCVGFGHHGEVUGGPKPCOQPVJUVWF[KP(KUEJGTTCVUYCUCFQUG TGNCVGFTGFWEVKQPKPVJGVKOGQHQPUGVQHOCOOCT[CPFVGUVKEWNCTVWOQTU#OQPVJ UVWF[KP*C/+%4OKEGTGXGCNGFPQGXKFGPEGQHECTEKPQIGPKECEVKXKV[ 6JGUKIPKſECPEGQHECTEKPQIGPKEKV[FCVCTGNCVKXGVQWUGQHDantriumKPJWOCPUKUWPMPQYP &CPVTQNGPGUQFKWOJCURTQFWEGFRQUKVKXGTGUWNVUKPVJG#OGU56[RJKOWTKWODCEVGTKCN OWVCIGPGUKUCUUC[KPVJGRTGUGPEGCPFCDUGPEGQHCNKXGTCEVKXCVKPIU[UVGO &CPVTQNGPGUQFKWOCFOKPKUVGTGFVQOCNGCPFHGOCNGTCVUCVFQUGNGXGNUWRVQOI MIFC[ CRRTQZKOCVGN[VKOGUVJGOCZKOWOTGEQOOGPFGFFCKN[FQUGQPCOIO 2 DCUKUUJQYGFPQCFXGTUGGHHGEVUQPHGTVKNKV[QTIGPGTCNTGRTQFWEVKXGRGTHQTOCPEG Pregnancy:2TGIPCPE[%CVGIQT[%DantriumJCUDGGPUJQYPVQDGGODT[QEKFCNKP VJGTCDDKVCPFJCUDGGPUJQYPVQFGETGCUGRWRUWTXKXCNKPVJGTCVYJGPIKXGPCVFQUGU UGXGPVKOGUVJGJWOCPQTCNFQUG6JGTGCTGPQCFGSWCVGCPFYGNNEQPVTQNNGFUVWFKGUKP RTGIPCPVYQOGPDantrium IntravenousUJQWNFDGWUGFFWTKPIRTGIPCPE[QPN[KHVJG RQVGPVKCNDGPGſVLWUVKſGUVJGRQVGPVKCNTKUMVQVJGHGVWU Labor and Delivery: In one uncontrolled study, 100 mg per day of prophylactic oral DantriumYCUCFOKPKUVGTGFVQVGTORTGIPCPVRCVKGPVUCYCKVKPINCDQTCPFFGNKXGT[ &CPVTQNGPGTGCFKN[ETQUUGFVJGRNCEGPVCYKVJOCVGTPCNCPFHGVCNYJQNGDNQQFNGXGNU CRRTQZKOCVGN[GSWCNCVFGNKXGT[PGQPCVCNNGXGNUVJGPHGNNCRRTQZKOCVGN[RGTFC[ HQTFC[UDGHQTGFGENKPKPIUJCTRN[0QPGQPCVCNTGURKTCVQT[CPFPGWTQOWUEWNCTUKFG GHHGEVUYGTGFGVGEVGFCVNQYFQUG/QTGFCVCCVJKIJGTFQUGUCTGPGGFGFDGHQTGOQTG FGſPKVKXGEQPENWUKQPUECPDGOCFG Nursing Mothers:&CPVTQNGPGJCUDGGPFGVGEVGFKPJWOCPOKNMCVNQYEQPEGPVTCVKQPU (less than 2 micrograms per mL) during repeat intravenous administration over FC[U$GECWUGQHVJGRQVGPVKCNHQTUGTKQWUCFXGTUGTGCEVKQPUKPPWTUKPIKPHCPVUHTQO FCPVTQNGPGCFGEKUKQPUJQWNFDGOCFGYJGVJGTVQFKUEQPVKPWGPWTUKPIQTVQFKUEQPVKPWG VJGFTWIVCMKPIKPVQCEEQWPVVJGKORQTVCPEGQHVJGFTWIVQVJGOQVJGT )GTKCVTKE7UG%NKPKECNUVWFKGUQHDantrium IntravenousFKFPQVKPENWFGUWHſEKGPV PWODGTUQHUWDLGEVUCIGFCPFQXGTVQFGVGTOKPGYJGVJGTVJG[TGURQPFFKHHGTGPVN[ HTQO[QWPIGTUWDLGEVU1VJGTTGRQTVGFENKPKECNGZRGTKGPEGJCUPQVKFGPVKſGFFKHHGTGPEGU KPTGURQPUGUDGVYGGPVJGGNFGTN[CPF[QWPIGTRCVKGPVU+PIGPGTCNFQUGUGNGEVKQPHQT CPGNFGTN[RCVKGPVUJQWNFDGECWVKQWUTGƀGEVKPIVJGITGCVGTHTGSWGPE[QHFGETGCUGF hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. ADVERSE REACTIONS 6JGTGJCXGDGGPQEECUKQPCNTGRQTVUQHFGCVJHQNNQYKPIOCNKIPCPVJ[RGTVJGTOKCETKUKU GXGPYJGPVTGCVGFYKVJKPVTCXGPQWUFCPVTQNGPGKPEKFGPEGſIWTGUCTGPQVCXCKNCDNG VJGRTGFCPVTQNGPGOQTVCNKV[QHOCNKIPCPVJ[RGTVJGTOKCETKUKUYCUCRRTQZKOCVGN[ /QUVQHVJGUGFGCVJUECPDGCEEQWPVGFHQTD[NCVGTGEQIPKVKQPFGNC[GF VTGCVOGPVKPCFGSWCVGFQUCIGNCEMQHUWRRQTVKXGVJGTCR[KPVGTEWTTGPVFKUGCUGCPF or the development of delayed complications such as renal failure or disseminated KPVTCXCUEWNCTEQCIWNQRCVJ[+PUQOGECUGUVJGTGCTGKPUWHſEKGPVFCVCVQEQORNGVGN[TWNG out therapeutic failure of dantrolene. There are reports of fatality in malignant hyperthermia crisis, despite initial satisfactory TGURQPUGVQKXFCPVTQNGPGYJKEJKPXQNXGRCVKGPVUYJQEQWNFPQVDGYGCPGFHTQO dantrolene after initial treatment. 6JGCFOKPKUVTCVKQPQHKPVTCXGPQWU&CPVTKWOVQJWOCPXQNWPVGGTUKUCUUQEKCVGFYKVJNQUU QHITKRUVTGPIVJCPFYGCMPGUUKPVJGNGIUCUYGNNCUFTQYUKPGUUCPFFK\\KPGUU 6JGHQNNQYKPICFXGTUGTGCEVKQPUCTGKPCRRTQZKOCVGQTFGTQHUGXGTKV[ There are rare reports of pulmonary edema developing during the treatment of OCNKIPCPVJ[RGTVJGTOKCETKUKUKPYJKEJVJGFKNWGPVXQNWOGCPFOCPPKVQNPGGFGFVQ FGNKXGTKXFCPVTQNGPGRQUUKDN[EQPVTKDWVGF 6JGTGJCXGDGGPTGRQTVUQHVJTQODQRJNGDKVKUHQNNQYKPICFOKPKUVTCVKQPQHKPVTCXGPQWU FCPVTQNGPGCEVWCNKPEKFGPEGſIWTGUCTGPQVCXCKNCDNG6KUUWGPGETQUKUUGEQPFCT[VQ GZVTCXCUCVKQPJCUDGGPTGRQTVGF 6JGTGJCXGDGGPTCTGTGRQTVUQHWTVKECTKCCPFGT[VJGOCRQUUKDN[CUUQEKCVGFYKVJ the administration of i.v. Dantrium6JGTGJCUDGGPQPGECUGQHCPCRJ[NCZKU +PLGEVKQPUKVGTGCEVKQPU RCKPGT[VJGOCUYGNNKPIEQOOQPN[FWGVQGZVTCXCUCVKQP JCXGDGGPTGRQTVGF 0QPGQHVJGUGTKQWUTGCEVKQPUQEECUKQPCNN[TGRQTVGFYKVJNQPIVGTOQTCNDantrium WUGUWEJCUJGRCVKVKUUGK\WTGUCPFRNGWTCNGHHWUKQPYKVJRGTKECTFKVKUJCXGDGGP TGCUQPCDN[CUUQEKCVGFYKVJUJQTVVGTODantrium Intravenous therapy. 6JGHQNNQYKPIGXGPVUJCXGDGGPTGRQTVGFKPRCVKGPVUTGEGKXKPIQTCNFCPVTQNGPG CRNCUVKECPGOKCNGWMQRGPKCN[ORJQE[VKEN[ORJQOCCPFJGCTVHCKNWTG 5GG RCEMCIGKPUGTVHQTDantrium (dantrolene sodium) Capsules for a complete listing of adverse reactions.) 6JGRWDNKUJGFNKVGTCVWTGJCUKPENWFGFUQOGTGRQTVUQHDantrium use in patients YKVJ0GWTQNGRVKE/CNKIPCPV5[PFTQOG 0/5Dantrium Intravenous is not KPFKECVGFHQTVJGVTGCVOGPVQH0/5CPFRCVKGPVUOC[GZRKTGFGURKVGVTGCVOGPVYKVJ Dantrium Intravenous. For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical, Inc. at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. OVERDOSAGE $GECWUGDantrium IntravenousOWUVDGCFOKPKUVGTGFCVCNQYEQPEGPVTCVKQPKPCNCTIG XQNWOGQHƀWKFCEWVGVQZKEKV[QHDantriumEQWNFPQVDGCUUGUUGFKPCPKOCNU+PFC[ UWDCEWVGUVWFKGUVJGKPVTCXGPQWUHQTOWNCVKQPQHDantriumYCUTGNCVKXGN[PQPVQZKE VQTCVUCVFQUGUQHOIMIFC[CPFOIMIFC[9JKNGOIMIFC[KPFQIUHQT FC[UGXQMGFNKVVNGVQZKEKV[OIMIFC[HQTFC[UECWUGFJGRCVKEEJCPIGUQH SWGUVKQPCDNGDKQNQIKEUKIPKſECPEG 5[ORVQOUYJKEJOC[QEEWTKPECUGQHQXGTFQUGKPENWFGDWVCTGPQVNKOKVGFVQ OWUEWNCTYGCMPGUUCPFCNVGTCVKQPUKPVJGUVCVGQHEQPUEKQWUPGUU GINGVJCTI[EQOC vomiting, diarrhea, and crystalluria. (QTCEWVGQXGTFQUCIGIGPGTCNUWRRQTVKXGOGCUWTGUUJQWNFDGGORNQ[GF +PVTCXGPQWUƀWKFUUJQWNFDGCFOKPKUVGTGFKPHCKTN[NCTIGSWCPVKVKGUVQCXGTVVJG RQUUKDKNKV[QHET[UVCNNWTKC#PCFGSWCVGCKTYC[UJQWNFDGOCKPVCKPGFCPFCTVKſEKCN TGUWUEKVCVKQPGSWKROGPVUJQWNFDGCVJCPF'NGEVTQECTFKQITCRJKEOQPKVQTKPIUJQWNF DGKPUVKVWVGFCPFVJGRCVKGPVECTGHWNN[QDUGTXGF6JGXCNWGQHFKCN[UKUKPDantrium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ŏUFGITGGQHUWUEGRVKDKNKV[VQOCNKIPCPVJ[RGTVJGTOKCVJGCOQWPV CPFVKOGQHGZRQUWTGVQVJGVTKIIGTKPICIGPVCPFVJGVKOGGNCRUGFDGVYGGPQPUGVQH the crisis and initiation of treatment. Pediatric Dose: 'ZRGTKGPEGVQFCVGKPFKECVGUVJCVVJGFQUGQHDantrium Intravenous for pediatric patients is the same as for adults. Preoperatively: Dantrium IntravenousCPFQTDantrium CapsulesOC[DG CFOKPKUVGTGFRTGQRGTCVKXGN[VQRCVKGPVULWFIGFOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNG as part of the overall patient management to prevent or attenuate the development of ENKPKECNCPFNCDQTCVQT[UKIPUQHOCNKIPCPVJ[RGTVJGTOKC Dantrium Intravenous: The recommended prophylactic dose of Dantrium IntravenousKUOIMIUVCTVKPICRRTQZKOCVGN[JQWTUDGHQTGCPVKEKRCVGF CPGUVJGUKCCPFKPHWUGFQXGTCRRTQZKOCVGN[JQWT6JKUFQUGUJQWNFRTGXGPV QTCVVGPWCVGVJGFGXGNQROGPVQHENKPKECNCPFNCDQTCVQT[UKIPUQHOCNKIPCPV hyperthermia provided that the usual precautions, such as avoidance of GUVCDNKUJGFOCNKIPCPVJ[RGTVJGTOKCVTKIIGTKPICIGPVUCTGHQNNQYGF #FFKVKQPCNDantrium IntravenousOC[DGKPFKECVGFFWTKPICPGUVJGUKCCPF UWTIGT[DGECWUGQHVJGCRRGCTCPEGQHGCTN[ENKPKECNCPFQTDNQQFICUUKIPUQH OCNKIPCPVJ[RGTVJGTOKCQTDGECWUGQHRTQNQPIGFUWTIGT[ UGGCNUQ%.+0+%#. 2*#4/#%1.1);9#40+0)5CPF24'%#76+105#FFKVKQPCNFQUGUOWUVDG individualized. Oral Administration of Dantrium Capsules: #FOKPKUVGTVQOIMIFC[QHQTCN DantriumKPVJTGGQTHQWTFKXKFGFFQUGUHQTQTFC[URTKQTVQUWTIGT[YKVJVJG NCUVFQUGDGKPIIKXGPYKVJCOKPKOWOQHYCVGTCRRTQZKOCVGN[VQJQWTUDGHQTG UEJGFWNGFUWTIGT[#FLWUVOGPVECPWUWCNN[DGOCFGYKVJKPVJGTGEQOOGPFGF FQUCIGTCPIGVQCXQKFKPECRCEKVCVKQP YGCMPGUUFTQYUKPGUUGVEQTGZEGUUKXG ICUVTQKPVGUVKPCNKTTKVCVKQP PCWUGCCPFQTXQOKVKPI5GGCNUQVJGRCEMCIGKPUGTVHQT Dantrium Capsules. Post Crisis Follow-Up: Dantrium CapsulesVQOIMIFC[KPHQWTFKXKFGFFQUGU UJQWNFDGCFOKPKUVGTGFHQTVQFC[UHQNNQYKPICOCNKIPCPVJ[RGTVJGTOKCETKUKUVQ prevent recurrence of the manifestations of malignant hyperthermia. Intravenous DantriumOC[DGWUGFRQUVQRGTCVKXGN[VQRTGXGPVQTCVVGPWCVGVJG TGEWTTGPEGQHUKIPUQHOCNKIPCPVJ[RGTVJGTOKCYJGPQTCNDantrium administration is not practical. The i.v. dose of DantriumKPVJGRQUVQRGTCVKXGRGTKQFOWUVDG KPFKXKFWCNK\GFUVCTVKPIYKVJOIMIQTOQTGCUVJGENKPKECNUKVWCVKQPFKEVCVGU PREPARATION 'CEJXKCNQHDantrium IntravenousUJQWNFDGTGEQPUVKVWVGFD[CFFKPIO.QHUVGTKNG YCVGTHQTKPLGEVKQP752 YKVJQWVCDCEVGTKQUVCVKECIGPVCPFVJGXKCNUJCMGPWPVKNVJG UQNWVKQPKUENGCT&GZVTQUG+PLGEVKQP7525QFKWO%JNQTKFG+PLGEVKQP752 CPFQVJGTCEKFKEUQNWVKQPUCTGPQVEQORCVKDNGYKVJDantrium Intravenous and should PQVDGWUGF6JGEQPVGPVUQHVJGXKCNOWUVDGRTQVGEVGFHTQOFKTGEVNKIJVCPFWUGF YKVJKPJQWTUCHVGTTGEQPUVKVWVKQP5VQTGTGEQPUVKVWVGFUQNWVKQPUDGVYGGPuVQu% uVQu( 4GEQPUVKVWVGFDantrium IntravenousUJQWNFPQVDGVTCPUHGTTGFVQNCTIGINCUUDQVVNGU HQTRTQRJ[NCEVKEKPHWUKQPFWGVQRTGEKRKVCVGHQTOCVKQPQDUGTXGFYKVJVJGWUGQHUQOG INCUUDQVVNGUCUTGUGTXQKTU (QTRTQRJ[NCEVKEKPHWUKQPVJGTGSWKTGFPWODGTQHKPFKXKFWCNXKCNUQHDantrium IntravenousUJQWNFDGTGEQPUVKVWVGFCUQWVNKPGFCDQXG6JGEQPVGPVUQHKPFKXKFWCN XKCNUCTGVJGPVTCPUHGTTGFVQCNCTIGTXQNWOGUVGTKNGKPVTCXGPQWURNCUVKEDCI5VCDKNKV[ FCVCQPſNGCV2CT2JCTOCEGWVKECNKPFKECVGEQOOGTEKCNN[CXCKNCDNGUVGTKNGRNCUVKEDCIU CTGCEEGRVCDNGFTWIFGNKXGT[FGXKEGU*QYGXGTKVKUTGEQOOGPFGFVJCVVJGRTGRCTGF KPHWUKQPDGKPURGEVGFECTGHWNN[HQTENQWFKPGUUCPFQTRTGEKRKVCVKQPRTKQTVQFKURGPUKPI CPFCFOKPKUVTCVKQP5WEJUQNWVKQPUUJQWNFPQVDGWUGF9JKNGUVCDNGHQTJQWTUKVKU TGEQOOGPFGFVJCVVJGKPHWUKQPDGRTGRCTGFKOOGFKCVGN[RTKQTVQVJGCPVKEKRCVGFFQUCIG administration time. 2CTGPVGTCNFTWIRTQFWEVUUJQWNFDGKPURGEVGFXKUWCNN[HQTRCTVKEWNCVGOCVVGTCPF discoloration prior to administration. HOW SUPPLIED Dantrium Intravenous (NDCKUCXCKNCDNGKPXKCNUEQPVCKPKPICUVGTKNG N[QRJKNK\GFOKZVWTGQHOIFCPVTQNGPGUQFKWOOIOCPPKVQNCPFUWHſEKGPV UQFKWOJ[FTQZKFGVQ[KGNFCR*QHCRRTQZKOCVGN[YJGPTGEQPUVKVWVGFYKVJO. UVGTKNGYCVGTHQTKPLGEVKQP752 YKVJQWVCDCEVGTKQUVCVKECIGPV 5VQTGWPTGEQPUVKVWVGFRTQFWEVDGVYGGPuVQu% uVQu( 5GG752%QPVTQNNGF 4QQO6GORGTCVWTG#XQKFRTQNQPIGFGZRQUWTGVQNKIJV 4ZQPN[ &KUVTKDWVGFD[ Par Pharmaceutical %JGUVPWV4KFIG0; 4 15, %

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