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Dantrium ® Intravenous (dantrolene sodium for injection) DESCRIPTION Dantrium Intravenous is a sterile, non-pyrogenic, lyophilized formulation of dantrolene sodium for injection. Dantrium Intravenous is supplied in 70 mL vials containing 20 OIFCPVTQNGPGUQFKWOOIOCPPKVQNCPFUWHſEKGPVUQFKWOJ[FTQZKFGVQ[KGNFC R*QHCRRTQZKOCVGN[YJGPTGEQPUVKVWVGFYKVJO.UVGTKNGYCVGTHQTKPLGEVKQP752 YKVJQWVCDCEVGTKQUVCVKECIGPV DantriumKUENCUUKſGFCUCFKTGEVCEVKPIUMGNGVCNOWUENGTGNCZCPV Chemically, DantriumKUJ[FTCVGF=== PKVTQRJGP[NHWTCP[N?OGVJ[NGPG?COKPQ? imidazolidinedione sodium salt. The structural formula for the hydrated salt is: 6JGJ[FTCVGFUCNVEQPVCKPUCRRTQZKOCVGN[YCVGT OQNGUCPFJCUCOQNGEWNCT YGKIJVQH 6JGCPJ[FTQWUUCNV FCPVTQNGPGJCUCOQNGEWNCTYGKIJVQH CLINICAL PHARMACOLOGY In isolated nerve-muscle preparation, DantriumJCUDGGPUJQYPVQRTQFWEGTGNCZCVKQP D[CHHGEVKPIVJGEQPVTCEVKNGTGURQPUGQHVJGOWUENGCVCUKVGDG[QPFVJGO[QPGWTCN junction. +PUMGNGVCNOWUENGDantriumFKUUQEKCVGUVJGGZEKVCVKQPEQPVTCEVKQPEQWRNKPI RTQDCDN[D[KPVGTHGTKPIYKVJVJGTGNGCUGQH%CHTQOVJGUCTEQRNCUOKETGVKEWNWO The administration of intravenous DantriumVQJWOCPXQNWPVGGTUKUCUUQEKCVGFYKVJNQUU QHITKRUVTGPIVJCPFYGCMPGUUKPVJGNGIUCUYGNNCUUWDLGEVKXG%05EQORNCKPVU UGG CNUQ24'%#76+105+PHQTOCVKQPHQT2CVKGPVU Information concerning the passage of DantriumCETQUUVJGDNQQFDTCKPDCTTKGTKUPQVCXCKNCDNG In the anesthetic-induced malignant hyperthermia syndrome, evidence points to 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 manner. 6JGGHſECE[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 infusion is completed. %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 currently accepted patient management practices. 6JGUGUKIPUCTGEQORCVKDNGYKVJ attenuated malignant hyperthermia and respond to the administration of additional KXFCPVTQNGPG UGG&15#)'#0&#&/+0+564#6+10 The administration of the 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 EGNNUVJCPYKVJVJGRNCUOCHTCEVKQPQHDNQQF 5KIPKſECPVCOQWPVUQHFCPVTQNGPGCTG DQWPFVQRNCUOCRTQVGKPUOQUVN[CNDWOKPCPFVJKUDKPFKPIKUTGCFKN[TGXGTUKDNG %CTFKQRWNOQPCT[FGRTGUUKQPJCUPQVDGGPQDUGTXGFKPOCNKIPCPVJ[RGTVJGTOKC UWUEGRVKDNGUYKPGHQNNQYKPIVJGCFOKPKUVTCVKQPQHWRVQOIMIKXFCPVTQNGPG This is VYKEGVJGCOQWPVPGGFGFVQOCZKOCNN[FKOKPKUJVYKVEJTGURQPUGVQUKPINGUWRTCOCZKOCN RGTKRJGTCNPGTXGUVKOWNCVKQP KPJKDKVKQP #VTCPUKGPVKPEQPUKUVGPVFGRTGUUCPVGHHGEV QPICUVTQKPVGUVKPCNUOQQVJOWUENGUJCUDGGPQDUGTXGFCVJKIJFQUGU 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. 5KPEGVJGGHHGEVQHFKUGCUGUVCVGCPFQVJGTFTWIUQP DantriumTGNCVGFUMGNGVCNOWUENG YGCMPGUUKPENWFKPIRQUUKDNGTGURKTCVQT[FGRTGUUKQPECPPQVDGRTGFKEVGFRCVKGPVUYJQ receive i.v. Dantrium preoperatively should have vital signs monitored. +HRCVKGPVULWFIGFOCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGCTGCFOKPKUVGTGFKPVTCXGPQWU or oral DantriumRTGQRGTCVKXGN[CPGUVJGVKERTGRCTCVKQPOWUVUVKNNHQNNQYCUVCPFCTF OCNKIPCPVJ[RGTVJGTOKCUWUEGRVKDNGTGIKOGPKPENWFKPIVJGCXQKFCPEGQHMPQYP triggering agents. /QPKVQTKPIHQTGCTN[ENKPKECNCPFOGVCDQNKEUKIPUQHOCNKIPCPV J[RGTVJGTOKCKUKPFKECVGFDGECWUGCVVGPWCVKQPQHOCNKIPCPVJ[RGTVJGTOKCTCVJGTVJCP RTGXGPVKQPKURQUUKDNG These signs usually call for the administration of additional 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. DantriumUJQWNFDGVCMGPKPVQEQPUKFGTCVKQP Information for Patients: Based upon data in human volunteers, perioperatively, it KUCRRTQRTKCVGVQVGNNRCVKGPVUYJQTGEGKXGDantrium Intravenous that symptoms of OWUENGYGCMPGUUUJQWNFDGGZRGEVGFRQUVQRGTCVKXGN[ KGFGETGCUGKPITKRUVTGPIVJ CPFYGCMPGUUQHNGIOWUENGUGURGEKCNN[YCNMKPIFQYPUVCKTU In addition, symptoms UWEJCUőNKIJVJGCFGFPGUUŒOC[DGPQVGF 5KPEGUQOGQHVJGUGU[ORVQOUOC[RGTUKUV HQTWRVQJQWTURCVKGPVUOWUVPQVQRGTCVGCPCWVQOQDKNGQTGPICIGKPQVJGT hazardous activity during this time. Caution is also indicated at meals on the day of CFOKPKUVTCVKQPDGECWUGFKHſEWNV[UYCNNQYKPICPFEJQMKPIJCUDGGPTGRQTVGF Caution UJQWNFDGGZGTEKUGFKPVJGEQPEQOKVCPVCFOKPKUVTCVKQPQHVTCPSWKNK\KPICIGPVU Hepatotoxicity seen with Dantrium Capsules: Dantrium (dantrolene sodium) has a RQVGPVKCNHQTJGRCVQVQZKEKV[CPFUJQWNFPQVDGWUGFKPEQPFKVKQPUQVJGTVJCPVJQUG recommended. 5[ORVQOCVKEJGRCVKVKU HCVCNCPFPQPHCVCNJCUDGGPTGRQTVGFCV various dose levels of the drug. 6JGKPEKFGPEGTGRQTVGFKPRCVKGPVUVCMKPIWRVQ OIFC[KUOWEJNQYGTVJCPKPVJQUGVCMKPIFQUGUQHOIQTOQTGRGTFC[ 'XGP URQTCFKEUJQTVEQWTUGUQHVJGUGJKIJGTFQUGNGXGNUYKVJKPCVTGCVOGPVTGIKOGPOCTMGFN[ KPETGCUGFVJGTKUMQHUGTKQWUJGRCVKEKPLWT[ .KXGTF[UHWPEVKQPCUGXKFGPEGFD[DNQQF EJGOKECNCDPQTOCNKVKGUCNQPG NKXGTGP\[OGGNGXCVKQPUJCUDGGPQDUGTXGFKPRCVKGPVU GZRQUGFVQDantrium for varying periods of time. 1XGTVJGRCVKVKUJCUQEEWTTGFCV XCT[KPIKPVGTXCNUCHVGTKPKVKCVKQPQHVJGTCR[DWVJCUDGGPOQUVHTGSWGPVN[QDUGTXGF DGVYGGPVJGVJKTFCPFVYGNHVJOQPVJQHVJGTCR[ 6JGTKUMQHJGRCVKEKPLWT[CRRGCTUVQ DGITGCVGTKPHGOCNGUKPRCVKGPVUQXGT[GCTUQHCIGCPFKPRCVKGPVUVCMKPIQVJGT medication(s) in addition to Dantrium (dantrolene sodium). DantriumUJQWNFDGWUGF QPN[KPEQPLWPEVKQPYKVJCRRTQRTKCVGOQPKVQTKPIQHJGRCVKEHWPEVKQPKPENWFKPIHTGSWGPV FGVGTOKPCVKQPQH5)16QT5)26 Fatal and non-fatal liver disorders of an idiosyncratic or hypersensitivity type may occur YKVJDantrium therapy. Drug Interactions: DantriumKUOGVCDQNK\GFD[VJGNKXGTCPFKVKUVJGQTGVKECNN[RQUUKDNG VJCVKVUOGVCDQNKUOOC[DGGPJCPEGFD[FTWIUMPQYPVQKPFWEGJGRCVKEOKETQUQOCN enzymes. *QYGXGTPGKVJGTRJGPQDCTDKVCNPQTFKC\GRCOCRRGCTUVQCHHGEVDantrium OGVCDQNKUO $KPFKPIVQRNCUOCRTQVGKPKUPQVUKIPKſECPVN[CNVGTGFD[FKC\GRCO FKRJGP[NJ[FCPVQKPQTRJGP[NDWVC\QPG $KPFKPIVQRNCUOCRTQVGKPUKUTGFWEGFD[ YCTHCTKPCPFENQſDTCVGCPFKPETGCUGFD[VQNDWVCOKFG %CTFKQXCUEWNCTEQNNCRUGKPCUUQEKCVKQPYKVJOCTMGFJ[RGTMCNGOKCJCUDGGPTGRQTVGF KPRCVKGPVUTGEGKXKPIFCPVTQNGPGKPEQODKPCVKQPYKVJECNEKWOEJCPPGNDNQEMGTU It is TGEQOOGPFGFVJCVVJGEQODKPCVKQPQHKPVTCXGPQWUFCPVTQNGPGUQFKWOCPFECNEKWO EJCPPGNDNQEMGTUUWEJCUXGTCRCOKNPQVDGWUGFVQIGVJGTFWTKPIVJGOCPCIGOGPVQH malignant hyperthermia crisis. #FOKPKUVTCVKQPQHFCPVTQNGPGOC[RQVGPVKCVGXGEWTQPKWOKPFWEGFPGWTQOWUEWNCTDNQEM Carcinogenesis, Mutagenesis, and Impairment of Fertility: 5RTCIWG&CYNG[HGOCNG rats fed DantriumHQTOQPVJUCVFQUCIGNGXGNUQHCPFOIMIFC[ UJQYGFCPKPETGCUGFKPEKFGPEGQHDGPKIPCPFOCNKIPCPVOCOOCT[VWOQTUEQORCTGF YKVJEQPEWTTGPVEQPVTQNU #VVJGJKIJGUVFQUGNGXGN CRRTQZKOCVGN[VJGUCOGCUVJG OCZKOWOTGEQOOGPFGFFCKN[FQUGQPCOIO 2 DCUKUVJGTGYCUCPKPETGCUGKPVJG KPEKFGPEGQHDGPKIPJGRCVKEN[ORJCVKEPGQRNCUOU +PCOQPVJUVWF[KP5RTCIWG &CYNG[TCVUHGFFCPVTQNGPGUQFKWOVJGJKIJGUVFQUGNGXGN CRRTQZKOCVGN[VJGUCOGCU VJGOCZKOWOTGEQOOGPFGFFCKN[FQUGQPCOIODCUKURTQFWEGFCFGETGCUGKPVJG time of onset of mammary neoplasms. (GOCNGTCVUCVVJGJKIJGUVFQUGNGXGNUJQYGFCP increased incidence of hepatic lymphangiomas and hepatic angiosarcomas. 6JGQPN[FTWITGNCVGFGHHGEVUGGPKPCOQPVJUVWF[KP(KUEJGTTCVUYCUCFQUG related reduction in the time of onset of mammary and testicular tumors. #OQPVJ UVWF[KP*C/+%4OKEGTGXGCNGFPQGXKFGPEGQHECTEKPQIGPKECEVKXKV[ The significance of carcinogenicity data relative to use of Dantrium in humans is WPMPQYP &CPVTQNGPGUQFKWOJCURTQFWEGFRQUKVKXGTGUWNVUKPVJG#OGU56[RJKOWTKWODCEVGTKCN OWVCIGPGUKUCUUC[KPVJGRTGUGPEGCPFCDUGPEGQHCNKXGTCEVKXCVKPIU[UVGO &CPVTQNGPGUQFKWOCFOKPKUVGTGFVQOCNGCPFHGOCNGTCVUCVFQUGNGXGNUWRVQOI MIFC[ CRRTQZKOCVGN[VKOGUVJGOCZKOWOTGEQOOGPFGFFCKN[FQUGQPCOIO 2 DCUKUUJQYGFPQCFXGTUGGHHGEVUQPHGTVKNKV[QTIGPGTCNTGRTQFWEVKXGRGTHQTOCPEG Pregnancy: Pregnancy Category C: DantriumJCUDGGPUJQYPVQDGGODT[QEKFCNKP VJGTCDDKVCPFJCUDGGPUJQYPVQFGETGCUGRWRUWTXKXCNKPVJGTCVYJGPIKXGPCVFQUGU seven times the human oral dose. 6JGTGCTGPQCFGSWCVGCPFYGNNEQPVTQNNGFUVWFKGUKP RTGIPCPVYQOGP Dantrium 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 3 days. Because of the potential for serious adverse reactions in nursing infants from FCPVTQNGPGCFGEKUKQPUJQWNFDGOCFGYJGVJGTVQFKUEQPVKPWGPWTUKPIQTVQFKUEQPVKPWG VJGFTWIVCMKPIKPVQCEEQWPVVJGKORQTVCPEGQHVJGFTWIVQVJGOQVJGT Geriatric Use: Clinical studies of Dantrium IntravenousFKFPQVKPENWFGUWHſEKGPV PWODGTUQHUWDLGEVUCIGFCPFQXGTVQFGVGTOKPGYJGVJGTVJG[TGURQPFFKHHGTGPVN[ HTQO[QWPIGTUWDLGEVU 1VJGTTGRQTVGFENKPKECNGZRGTKGPEGJCUPQVKFGPVKſGFFKHHGTGPEGU KPTGURQPUGUDGVYGGPVJGGNFGTN[CPF[QWPIGTRCVKGPVU In general, dose selection for 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 intravascular coagulopathy. +PUQOGECUGUVJGTGCTGKPUWHſEKGPVFCVCVQEQORNGVGN[TWNG out therapeutic failure of dantrolene. There are reports of fatality in malignant hyperthermia crisis, despite initial satisfactory TGURQPUGVQKXFCPVTQNGPGYJKEJKPXQNXGRCVKGPVUYJQEQWNFPQVDGYGCPGFHTQO dantrolene after initial treatment. The administration of intravenous DantriumVQJWOCPXQNWPVGGTUKUCUUQEKCVGFYKVJ NQUUQHITKRUVTGPIVJCPFYGCMPGUUKPVJGNGIUCUYGNNCUFTQYUKPGUUCPFFK\\KPGUU 6JGHQNNQYKPICFXGTUGTGCEVKQPUCTGKPCRRTQZKOCVGQTFGTQHUGXGTKV[ There are rare reports of pulmonary edema developing during the treatment of OCNKIPCPVJ[RGTVJGTOKCETKUKUKPYJKEJVJGFKNWGPVXQNWOGCPFOCPPKVQNPGGFGFVQ FGNKXGTKXFCPVTQNGPGRQUUKDN[EQPVTKDWVGF 6JGTGJCXGDGGPTGRQTVUQHVJTQODQRJNGDKVKUHQNNQYKPICFOKPKUVTCVKQPQHKPVTCXGPQWU FCPVTQNGPGCEVWCNKPEKFGPEGſIWTGUCTGPQVCXCKNCDNG Tissue necrosis secondary to GZVTCXCUCVKQPJCUDGGPTGRQTVGF 6JGTGJCXGDGGPTCTGTGRQTVUQHWTVKECTKCCPFGT[VJGOCRQUUKDN[CUUQEKCVGFYKVJ the administration of i.v. Dantrium. 6JGTGJCUDGGPQPGECUGQHCPCRJ[NCZKU +PLGEVKQPUKVGTGCEVKQPU RCKPGT[VJGOCUYGNNKPIEQOOQPN[FWGVQGZVTCXCUCVKQP JCXGDGGPTGRQTVGF 0QPGQHVJGUGTKQWUTGCEVKQPUQEECUKQPCNN[TGRQTVGFYKVJNQPIVGTOQTCNDantrium use, UWEJCUJGRCVKVKUUGK\WTGUCPFRNGWTCNGHHWUKQPYKVJRGTKECTFKVKUJCXGDGGPTGCUQPCDN[ CUUQEKCVGFYKVJUJQTVVGTODantrium Intravenous therapy. 6JGHQNNQYKPIGXGPVUJCXGDGGPTGRQTVGFKPRCVKGPVUTGEGKXKPIQTCNFCPVTQNGPG aplastic CPGOKCNGWMQRGPKCN[ORJQE[VKEN[ORJQOCCPFJGCTVHCKNWTG 5GGRCEMCIGKPUGTVHQT Dantrium (dantrolene sodium) Capsules for a complete listing of adverse reactions.) 6JGRWDNKUJGFNKVGTCVWTGJCUKPENWFGFUQOGTGRQTVUQHDantrium use in patients YKVJ0GWTQNGRVKE/CNKIPCPV5[PFTQOG 0/5 Dantrium 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 Because Dantrium 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[QDUGTXGF The value of dialysis in Dantrium QXGTFQUGKUPQVMPQYP DOSAGE AND ADMINISTRATION #UUQQPCUVJGOCNKIPCPVJ[RGTVJGTOKCTGCEVKQPKUTGEQIPK\GFCNNCPGUVJGVKECIGPVU UJQWNFDGFKUEQPVKPWGFVJGCFOKPKUVTCVKQPQHQZ[IGPKUTGEQOOGPFGF Dantrium IntravenousUJQWNFDGCFOKPKUVGTGFD[EQPVKPWQWUTCRKFKPVTCXGPQWURWUJDGIKPPKPI CVCOKPKOWOFQUGQHOIMICPFEQPVKPWKPIWPVKNU[ORVQOUUWDUKFGQTVJGOCZKOWO EWOWNCVKXGFQUGQHOIMIJCUDGGPTGCEJGF +HVJGRJ[UKQNQIKECPFOGVCDQNKECDPQTOCNKVKGUTGCRRGCTVJGTGIKOGPOC[DGTGRGCVGF It is important to note that administration of Dantrium IntravenousUJQWNFDG EQPVKPWQWUWPVKNU[ORVQOUUWDUKFG The effective dose to reverse the crisis is directly FGRGPFGPVWRQPVJGKPFKXKFWCNŏUFGITGGQHUWUEGRVKDKNKV[VQOCNKIPCPVJ[RGTVJGTOKCVJG COQWPVCPFVKOGQHGZRQUWTGVQVJGVTKIIGTKPICIGPVCPFVJGVKOGGNCRUGFDGVYGGP onset of 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[JQWT This dose should prevent 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 scheduled surgery. #FLWUVOGPVECPWUWCNN[DGOCFGYKVJKPVJGTGEQOOGPFGF FQUCIGTCPIGVQCXQKFKPECRCEKVCVKQP YGCMPGUUFTQYUKPGUUGVEQTGZEGUUKXG ICUVTQKPVGUVKPCNKTTKVCVKQP PCWUGCCPFQTXQOKVKPI 5GGCNUQVJGRCEMCIGKPUGTVHQT 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 solution is clear. &GZVTQUG+PLGEVKQP7525QFKWO%JNQTKFG+PLGEVKQP752CPF QVJGTCEKFKEUQNWVKQPUCTGPQVEQORCVKDNGYKVJDantrium Intravenous and should not DGWUGF 6JGEQPVGPVUQHVJGXKCNOWUVDGRTQVGEVGFHTQOFKTGEVNKIJVCPFWUGFYKVJKP JQWTUCHVGTTGEQPUVKVWVKQP 5VQTGTGEQPUVKVWVGFUQNWVKQPUDGVYGGPuVQu% u VQu( 4GEQPUVKVWVGFDantrium IntravenousUJQWNFPQVDGVTCPUHGTTGFVQNCTIGINCUUDQVVNGU HQTRTQRJ[NCEVKEKPHWUKQPFWGVQRTGEKRKVCVGHQTOCVKQPQDUGTXGFYKVJVJGWUGQHUQOG INCUUDQVVNGUCUTGUGTXQKTU (QTRTQRJ[NCEVKEKPHWUKQPVJGTGSWKTGFPWODGTQHKPFKXKFWCNXKCNUQHDantrium IntravenousUJQWNFDGTGEQPUVKVWVGFCUQWVNKPGFCDQXG The contents of individual XKCNUCTGVJGPVTCPUHGTTGFVQCNCTIGTXQNWOGUVGTKNGKPVTCXGPQWURNCUVKEDCI 5VCDKNKV[ FCVCQPſNGCV2CT2JCTOCEGWVKECNKPFKECVGEQOOGTEKCNN[CXCKNCDNGUVGTKNGRNCUVKEDCIU CTGCEEGRVCDNGFTWIFGNKXGT[FGXKEGU *QYGXGTKVKUTGEQOOGPFGFVJCVVJGRTGRCTGF KPHWUKQPDGKPURGEVGFECTGHWNN[HQTENQWFKPGUUCPFQTRTGEKRKVCVKQPRTKQTVQFKURGPUKPI and administration. 5WEJUQNWVKQPUUJQWNFPQVDGWUGF 9JKNGUVCDNGHQTJQWTUKVKU 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[ /CPWHCEVWTGFD[ Par Pharmaceutical Companies, Inc. 5RTKPI8CNNG[0; + 15, $