VECAMYL
(MECAMYLAMINE Hydrochloride Tablets, USP)
Carcinogenesis, Mutagenesis, Impairment of Fertility
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PRODUCT OVERVIEW:
Pregnancy
Mecamylamine Hydrochloride Tablet
Pregnancy Category C."OJNBMSFQSPEVDUJPOTUVEJFTIBWFOPUCFFODPOEVDUFEXJUI.FDBNZMBNJOF)$M*UJT
DESCRIPTION
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SFQSPEVDUJWFDBQBDJUZ.FDBNZMBNJOF)$MTIPVMECFHJWFOUPBQSFHOBOUXPNBOPOMZJGDMFBSMZOFFEFE
*UJT/UFUSBNFUIZMCJDZDMP<>IFQUBOBNJOFIZESPDIMPSJEF*UTFNQJSJDBMGPSNVMBJT
Nursing Mothers
$)/t)$MBOEJUTTUSVDUVSBMGPSNVMBJT
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TIPVMECFNBEFXIFUIFSUPEJTDPOUJOVFOVSTJOHPSUPEJTDPOUJOVFUIFESVHUBLJOHJOUPBDDPVOUUIF
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JNQPSUBODFPGUIFESVHUPUIFNPUIFS
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Pediatric Use
4BGFUZBOEFGGFDUJWFOFTTJOQFEJBUSJDQBUJFOUTIBWFOPUCFFOFTUBCMJTIFE
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ADVERSE REACTIONS
$)3
5IFGPMMPXJOHBEWFSTFSFBDUJPOTIBWFCFFOSFQPSUFEBOEXJUIJOFBDIDBUFHPSZBSFMJTUFEJOPSEFSPG
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NPMFDVMBSXFJHIUPG
Gastrointestinal:*MFVTDPOTUJQBUJPOTPNFUJNFTQSFDFEFECZTNBMMGSFRVFOUMJRVJETUPPMT
WPNJUJOHOBVTFB
BOPSFYJBHMPTTJUJTBOEESZOFTTPGNPVUI
.FDBNZMBNJOF)$MJTTVQQMJFEBTUBCMFUTGPSPSBMVTFFBDIDPOUBJOJOHNHNFDBNZMBNJOF)$M*OBDUJWF
JOHSFEJFOUTBSFDBMDJVNQIPTQIBUF%$:FMMPX'%$:FMMPXMBDUPTFNBHOFTJVNTUFBSBUFDPSOTUBSDI Cardiovascular:0SUIPTUBUJDEJ[[JOFTTBOETZODPQFQPTUVSBMIZQPUFOTJPO
BOEUBMD
Nervous System/Psychiatric:$POWVMTJPOTDIPSFJGPSNNPWFNFOUTNFOUBMBCFSSBUJPOTUSFNPSBOE
CLINICAL PHARMACOLOGY
QBSFTUIFTJBTTFF8"3/*/(4
.FDBNZMBNJOF)$MSFEVDFTCMPPEQSFTTVSFJOCPUIOPSNPUFOTJWFBOEIZQFSUFOTJWFJOEJWJEVBMT*UIBTB
Respiratory:*OUFSTUJUJBMQVMNPOBSZFEFNBBOEGJCSPTJT
HSBEVBMPOTFUPGBDUJPOUPIPVST
BOEBMPOHMBTUJOHFGGFDUVTVBMMZUPIPVSTPSNPSF
"TNBMM
Urogenital:6SJOBSZSFUFOUJPOJNQPUFODFEFDSFBTFEMJCJEP
PSBMEPTBHFPGUFOQSPEVDFTBTNPPUIBOEQSFEJDUBCMFSFEVDUJPOPGCMPPEQSFTTVSF"MUIPVHIUIJT
Special Senses:#MVSSFEWJTJPOEJMBUFEQVQJMT
BOUJIZQFSUFOTJWFFGGFDUJTQSFEPNJOBOUMZPSUIPTUBUJDUIFTVQJOFCMPPEQSFTTVSFJTBMTPTJHOJGJDBOUMZSFEVDFE
Miscellaneous:8FBLOFTTGBUJHVFTFEBUJPO
Pharmacokinetics and Metabolism
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OVERDOSAGE
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QPTUVSBM
FYDSFUFETMPXMZJOUIFVSJOFJOUIFVODIBOHFEGPSN5IFSBUFPGJUTSFOBMFMJNJOBUJPOJTJOGMVFODFENBSLFEMZ IZQPUFOTJPOOBVTFBWPNJUJOHEJBSSIFBDPOTUJQBUJPOQBSBMZUJDJMFVTVSJOBSZSFUFOUJPOEJ[[JOFTTBOYJFUZ
CZVSJOBSZQ)"MLBMJOJ[BUJPOPGUIFVSJOFSFEVDFTBOEBDJEJGJDBUJPOQSPNPUFTSFOBMFYDSFUJPOPG
ESZNPVUINZESJBTJTCMVSSFEWJTJPOPSQBMQJUBUJPOT"SJTFJOJOUSBPDVMBSQSFTTVSFNBZPDDVS
NFDBNZMBNJOF
1SFTTPSBNJOFTNBZCFVTFEUPDPVOUFSBDUFYDFTTJWFIZQPUFOTJPO4JODFQBUJFOUTCFJOHUSFBUFEXJUIHBOHMJPO
.FDBNZMBNJOF)$MDSPTTFTUIFCMPPECSBJOBOEQMBDFOUBMCBSSJFST
CMPDLFSTBSFNPSFUIBOOPSNBMMZSFBDUJWFUPQSFTTPSBNJOFTTNBMMEPTFTPGUIFMBUUFSBSFSFDPNNFOEFEUP
BWPJEFYDFTTJWFSFTQPOTF
INDICATIONS AND USAGE
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5IFPSBM-% PG.FDBNZMBNJOF)$MJOUIFNPVTFJTNHLH
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DOSAGE AND ADMINISTRATION
CONTRAINDICATIONS
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.FDBNZMBNJOF)$MTIPVMEOPUCFVTFEJONJMENPEFSBUFMBCJMFIZQFSUFOTJPOBOENBZQSPWFVOTVJUBCMFJO TIPVMECFNPEJGJFECZJODSFNFOUTPGPOFNHUBCMFUBUJOUFSWBMTPGOPUMFTTUIBOEBZTVOUJMUIFEFTJSFE
VODPPQFSBUJWFQBUJFOUT*UJTDPOUSBJOEJDBUFEJODPSPOBSZJOTVGGJDJFODZPSSFDFOUNZPDBSEJBMJOGBSDUJPO
CMPPEQSFTTVSFSFTQPOTFPDDVSTUIFDSJUFSJPOCFJOHBEPTBHFKVTUVOEFSUIBUXIJDIDBVTFTTJHOTPGNJME
.FDBNZMBNJOF)$MTIPVMECFHJWFOXJUIHSFBUEJTDSFUJPOJGBUBMMXIFOSFOBMJOTVGGJDJFODZJTNBOJGFTUFECZ QPTUVSBMIZQPUFOTJPO
BSJTJOHPSFMFWBUFE#6/5IFESVHJTDPOUSBJOEJDBUFEJOVSFNJB1BUJFOUTSFDFJWJOHBOUJCJPUJDTBOE
5IFBWFSBHFUPUBMEBJMZEPTBHFPG.FDBNZMBNJOF)$MJTNHVTVBMMZJOUISFFEJWJEFEEPTFT)PXFWFSBT
TVMGPOBNJEFTTIPVMEHFOFSBMMZOPUCFUSFBUFEXJUIHBOHMJPOCMPDLFST0UIFSDPOUSBJOEJDBUJPOTBSFHMBVDPNB MJUUMFBTNHEBJMZNBZCFTVGGJDJFOUUPDPOUSPMIZQFSUFOTJPOJOTPNFQBUJFOUT"SBOHFPGUXPUPGPVSPS
PSHBOJDQZMPSJDTUFOPTJTPSIZQFSTFOTJUJWJUZUPUIFQSPEVDU
FWFONPSFEPTFTNBZCFSFRVJSFEJOTFWFSFDBTFTXIFOTNPPUIDPOUSPMJTEJGGJDVMUUPPCUBJO*OTFWFSFPS
VSHFOUDBTFTMBSHFSJODSFNFOUTBUTNBMMFSJOUFSWBMTNBZCFOFFEFE1BSUJBMUPMFSBODFNBZEFWFMPQJODFSUBJO
WARNINGS
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TZTUFNFGGFDUT5SFNPSDIPSFJGPSNNPWFNFOUTNFOUBMBCFSSBUJPOTBOEDPOWVMTJPOTNBZPDDVSSBSFMZ5IFTF "ENJOJTUSBUJPOPG.FDBNZMBNJOF)$MBGUFSNFBMTNBZDBVTFBNPSFHSBEVBMBCTPSQUJPOBOETNPPUIFS
IBWFPDDVSSFENPTUPGUFOXIFOMBSHFEPTFTPG.FDBNZMBNJOF)$MXFSFVTFEFTQFDJBMMZJOQBUJFOUTXJUI
DPOUSPMPGFYDFTTJWFMZIJHICMPPEQSFTTVSF5IFUJNJOHPGEPTFTJOSFMBUJPOUPNFBMTTIPVMECFDPOTJTUFOU
DFSFCSBMPSSFOBMJOTVGGJDJFODZ
4JODFUIFCMPPEQSFTTVSFSFTQPOTFUPBOUJIZQFSUFOTJWFESVHTJTJODSFBTFEJOUIFFBSMZNPSOJOHUIFMBSHFS
EPTFTIPVMECFHJWFOBUOPPOUJNFBOEQFSIBQTJOUIFFWFOJOH5IFNPSOJOHEPTFBTBSVMFTIPVMECF
8IFOHBOHMJPOCMPDLFSTPSPUIFSQPUFOUBOUJIZQFSUFOTJWFESVHTBSFEJTDPOUJOVFETVEEFOMZIZQFSUFOTJWF
SFMBUJWFMZTNBMMBOEJOTPNFJOTUBODFTNBZFWFOCFPNJUUFE
MFWFMTSFUVSO*OQBUJFOUTXJUINBMJHOBOUIZQFSUFOTJPOBOEPUIFSTUIJTNBZPDDVSBCSVQUMZBOENBZDBVTF
GBUBMDFSFCSBMWBTDVMBSBDDJEFOUTPSBDVUFDPOHFTUJWFIFBSUGBJMVSF8IFO.FDBNZMBNJOF)$MJTXJUIESBXO
5IFinitial regulation of dosageTIPVMECFEFUFSNJOFECZCMPPEQSFTTVSFSFBEJOHTJOUIFFSFDUQPTJUJPOBUUIF
UIJTTIPVMECFEPOFHSBEVBMMZBOEPUIFSBOUJIZQFSUFOTJWFUIFSBQZVTVBMMZNVTUCFTVCTUJUVUFE0OUIFPUIFS UJNFPGNBYJNBMFGGFDUPGUIFESVHBTXFMMBTCZPUIFSTJHOTBOETZNQUPNTPGPSUIPTUBUJDIZQPUFOTJPO
IBOEUIFFGGFDUTPG.FDBNZMBNJOF)$MTPNFUJNFTNBZMBTUGSPNIPVSTUPEBZTBGUFSUIFSBQZJTEJTDPOUJOVFE 5IFeffective maintenance dosageTIPVMECFSFHVMBUFECZCMPPEQSFTTVSFSFBEJOHTJOUIFFSFDUQPTJUJPOBOE
PRECAUTIONS
CZMJNJUBUJPOPGEPTBHFUPUIBUXIJDIDBVTFTTMJHIUGBJOUOFTTPSEJ[[JOFTTJOUIJTQPTJUJPO*GUIFQBUJFOUPSB
General
SFMBUJWFDBOVTFBTQIZHNPNBOPNFUFSJOTUSVDUJPOTNBZCFHJWFOUPSFEVDFPSPNJUBEPTFJGSFBEJOHTGBMM
5IFQBUJFOUhTDPOEJUJPOTIPVMECFFWBMVBUFEDBSFGVMMZQBSUJDVMBSMZBTUPSFOBMBOEDBSEJPWBTDVMBSGVODUJPO
CFMPXBEFTJHOBUFEMFWFMPSJGGBJOUOFTTPSMJHIUIFBEFEOFTTPDDVSTHowever, no change should be instituted
8IFOSFOBMDFSFCSBMPSDPSPOBSZCMPPEGMPXJTEFGJDJFOUBOZBEEJUJPOBMJNQBJSNFOUXIJDINJHIUSFTVMUGSPN without the knowledge of the physician.
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$MPTFTVQFSWJTJPOBOEFEVDBUJPOPGUIFQBUJFOUBTXFMMBTDSJUJDBMBEKVTUNFOUPGEPTBHFBSFFTTFOUJBMUP
DPSPOBSZBSUFSJPTDMFSPTJTPSBGUFSBSFDFOUDFSFCSBMBDDJEFOUSFRVJSFTDBVUJPO
TVDDFTTGVMUIFSBQZ
5IFBDUJPOPG.FDBNZMBNJOF)$MNBZCFQPUFOUJBUFECZFYDFTTJWFIFBUGFWFSJOGFDUJPOIFNPSSIBHF
Other Antihypertensive Agents
QSFHOBODZBOFTUIFTJBTVSHFSZWJHPSPVTFYFSDJTFPUIFSBOUJIZQFSUFOTJWFESVHTBMDPIPMBOETBMUEFQMFUJPOBT 8IFO.FDBNZMBNJOF)$MJTHJWFOXJUIPUIFSBOUJIZQFSUFOTJWFESVHTUIFEPTBHFPGUIFTFPUIFSBHFOUTBTXFMM
BSFTVMUPGEJNJOJTIFEJOUBLFPSJODSFBTFEFYDSFUJPOEVFUPEJBSSIFBWPNJUJOHFYDFTTJWFTXFBUJOHPSEJVSFUJDT BTUIBUPG.FDBNZMBNJOF)$MTIPVMECFSFEVDFEUPBWPJEFYDFTTJWFIZQPUFOTJPO)PXFWFSUIJB[JEFTTIPVME
%VSJOHUIFSBQZXJUI.FDBNZMBNJOF)$MTPEJVNJOUBLFTIPVMEOPUCFSFTUSJDUFECVUJGOFDFTTBSZUIFEPTBHF CFDPOUJOVFEJOUIFJSVTVBMEPTBHFXIJMFUIBUPG.FDBNZMBNJOF)$MJTEFDSFBTFECZBUMFBTUQFSDFOU
PGUIFHBOHMJPOCMPDLFSNVTUCFBEKVTUFE
HOW SUPPLIED
4JODFVSJOBSZSFUFOUJPONBZPDDVSJOQBUJFOUTPOHBOHMJPOCMPDLFSTDBVUJPOJTSFRVJSFEJOQBUJFOUTXJUI
7FDBNZM¬.&$".:-".*/&)ZESPDIMPSJEF5BCMFUT641
BSFTMJHIUMZZFMMPXSPVOEDPNQSFTTFEUBCMFUT
QSPTUBUJDIZQFSUSPQIZCMBEEFSOFDLPCTUSVDUJPOBOEVSFUISBMTUSJDUVSF
DPEFE.1POPOFTJEFBOEPOUIFPUIFSTJEF5IFZBSFTVQQMJFEBTGPMMPXT
NDC69413-558-40 JOCPUUMFTPG
'SFRVFOUMPPTFCPXFMNPWFNFOUTXJUIBCEPNJOBMEJTUFOUJPOBOEEFDSFBTFECPSCPSZHNJNBZCFUIFGJSTU
TJHOTPGQBSBMZUJDJMFVT*GUIFTFBSFQSFTFOU.FDBNZMBNJOF)$MTIPVMECFEJTDPOUJOVFEJNNFEJBUFMZBOE
STORAGE CONDITION
SFNFEJBMTUFQTUBLFO
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Information for patients
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TJUUJOHQPTJUJPO5IJTFGGFDUNBZCFJODSFBTFECZBMDPIPMJDCFWFSBHFTFYFSDJTFPSEVSJOHIPUXFBUIFS(FUUJOH Distributed by: Turing Pharmaceuticals LLC, New York, NY 10036
VQTMPXMZNBZIFMQBMMFWJBUFTVDIBSFBDUJPO
Drug Interactions
3FW04/15
1BUJFOUTSFDFJWJOHBOUJCJPUJDTBOETVMGPOBNJEFTHFOFSBMMZTIPVMEOPUCFUSFBUFEXJUIHBOHMJPOCMPDLFST
5IFBDUJPOPG.FDBNZMBNJOF)$MNBZCFQPUFOUJBUFECZBOFTUIFTJBPUIFSBOUJIZQFSUFOTJWFESVHTBOEBMDPIPM