Dext Rome Th Orphan

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    DEXTROMETHORPHAN (Systemic)

    Introduction

    Revised: 6/11/99

    VA CLASSIICATION (Prim!ry)RE302

    Commonly used brand name(s):Balminil DM;Balminil DM Children;Benylin Adult FormulaCough Suppressant;Benylin DM;Benylin DM 12 Hour;Benylin DM For Children 12 Hour;Benylin DM for children;Benylin Pediatric Cough Suppressant;Broncho!rippolDM;Calmylin"1;Cough#;Creo$erpin;Delsym;Delsym Cough Formula;Dia%e$&SS DM Syrup;Hold DM;'offe( DM;)o*ahiste( DM;)o*ahistine DM;Pertussin CS Children+s Strength;Pertussin DM,(tra Strength;-o%itussin Ma(imum Strength Cough Suppressant;-o%itussin Pediatric;-o%itussin Pediatric Cough Suppressant;Sucrets . Hour Cough Suppressant;$riaminic DM/ong /asting For Children;$rocal;0ics .. Cough -elief

    Note: For a listin o! dosae !orms and brand names by "ountry availability# see Dosage Formsse"tion(s)$

    C!te"ory

    %ntitussive$ 23#2'#26

    Indic!tions

    Acce#ted

    Cou (treatment)e*trometor+an is indi"ated !or te tem+orary sym+tomati" relie! o!

    non+rodu"tive "ou due to minor troat and bron"ial irritation o""urrin ,it "olds or inaled

    irritants$ 1# -# 10# 1 20# &0# & &'# &6# &.# &-# &9# '0# '1# '2# '3# ' ''

    P$!rm!co%o"y&P$!rm!co'inetics

    Mec$!nism o !ction&Eect

    u++resses te "ou re!le* by a dire"t a"tion on te "ou "enter in te medulla o! te brain$ 1# -# 20# &0# &1# &2# &3

    *iotr!nsorm!tion

    e+ati"$ Ra+idly and e*tensively metabolied to de*tror+an (a"tive metabolite)$ 1# 2.

    Onset o !ction

    sually ,itin oneal! our#1#

    20

    a!ter 10 to 20m doses every & ours or 30 m every 6 to- ours -# &0$

    Dur!tion o !ction

    + to 6 ours$ 1# 20

    Note: 4e e*tendedrelease oral +olistire* sus+ension delivers de*trometor+an !rom an ion

    e*"ane "om+le* over a +eriod o! 9 to 12 ours$ 105ne 60m dose o! +olistire*

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    de*trometor+an delivers a +lasma "on"entration similar to t,o 30m doses o!

    de*trometor+an ydrobromide iven every 6 ours &0$

    E%imin!tion

    rimarily renal (e*"reted as un"aned de*trometor+an and demetylated metabolites#

    in"ludin de*tror+an)$1#

    10#

    1'#

    20#

    3'

    Prec!utions to Consider

    Pre"n!ncy&Re#roduction

    renan"y%de7uate and ,ell"ountrolled studies in umans ave not been done$ -# 23# 2 2'#26# &0# &2# & &'# &6# &.# &9# '1# '3# '&

    *re!st+eedin"

    8t is not no,n ,eter de*trometor+an is distributed into breast mil$ o,ever# +roblems in

    umans ave not been do"umented$ -# 23# 2 2'# 26# &0# &2# & &'# &6# &.# &9# '1# '3# '&$

    Pedi!trics

    %++ro+riate studies on te relationsi+ o! ae to te e!!e"ts o! de*trometor+an ave not been+er!ormed in te +ediatri" +o+ulation$ o,ever# no +ediatri"ss+e"i!i" +roblems ave been

    do"umented to date$ 11# 1-

    ,eri!trics

    No in!ormation is available on te relationsi+ o! ae to te e!!e"ts o! de*trometor+an ineriatri" +atients$

    Dru" inter!ctions !nd&or re%!ted #ro-%ems

    4e !ollo,in dru intera"tions and/or related +roblems ave been sele"ted on te basis o! teir

    +otential "lini"al sini!i"an"e (+ossible me"anism in +arenteses ,ere a++ro+riate)not

    ne"essarily in"lusive ( ; maonoamine o*idase (>%5) inibitors# in"ludin !uraolidone# +eneline# +ro"arbaine#

    seleiline# and tranyl"y+romine -#&0#&1#&2#&3#&&'#&6#&.#&-#&9#'0#'1#'3#'''

    ("on"urrent use ,it de*trometor+an# and also use o! monoamine o*idase inibitors ,itin 2 to3 ,ees o! de*trometor+an# may "ause adreneri" "risis# "olla+se# "oma# diiness#e*"itation# y+ertension# y+er+yre*ia# intra"erebral bleedin# letary# nausea# +sy"oti"

    beavior# s+asms# and tremors 1# 3# '# 6# 20# 23# 2 2'# 26# 32# 33# '&)

    %miodarone or

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    Fluo*etine or

    ?uinidine

    (inibition o! te "yto"rome &'026 enyme system by amiodarone# !luo*etine# or 7uinidine

    may "ause a de"rease in te e+ati" metabolism o! de*trometor+an# ,i" may result inin"reased de*trometor+an serum "on"entrations@ ier "on"entrations o! de*trometor+an

    ave been asso"iated ,it an in"reased in"iden"e o! side e!!e"ts 1# 31# 3.)

    moin toba""o

    (inibition o! "ou re!le* by de*trometor+an may lead to retention o! se"retions -# 10# 19# &2#&3# & &'# &6# &.# &-# &9# '0# '1# '3# ' '')

    Medic!% consider!tions&Contr!indic!tions

    4e medi"al "onsiderations/"ontraindi"ations in"luded ave been sele"ted on te basis o! teir

    +otential "lini"al sini!i"an"e (reasons iven in +arenteses ,ere a++ro+riate)not ne"essarily

    in"lusive ( ; ma

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    Side&Ad.erse Eects

    Note: 4o*i" +sy"osis (y+era"tivity# visual and auditory allu"inations) as been re+orted a!ter

    inestion o! 300 m or more o! de*trometor+an$ -# 16# 1.# &0

    Res+iratory de+ression as been re+orted to o""ur ,it very i doses$1#

    .#

    -#

    11#

    13#

    &0#

    &2#

    &3

    e*trometor+an abuse and de+enden"e may o""ur rarely# es+e"ially !ollo,in +roloned use

    o! i doses$ 2-# 29

    4e !ollo,in side/adverse e!!e"ts ave been sele"ted on te basis o! teir +otential "lini"al

    sini!i"an"e (+ossible sins and sym+toms in +arenteses ,ere a++ro+riate)not ne"essarily

    in"lusive:

    T$ose indic!tin" need or medic!% !ttention on%y i t$ey continue or !re -ot$ersome

    8n"iden"e less !re7uent or rare

    Confusion 23,24,25,26@ constipation 23,24,25,26@ headache ,4!@ mild di""iness1#-#23#2'#

    26#&0#&1#&2#&3@ mild drowsiness1#-#23#2'#26#&0#&1#&2#&3@ nausea or #omiting1#-#23#2'#26#&0#&1#&2#&3@ stomach pain1#&1#&2#&3

    O.erdose

    For more in!ormation on te manaement o! overdose or unintentional inestion# cont!ct !

    Poison Contro% Center & &'# &6# &.# &-# &9# '0# '1# '3# ' ''(see Poison Control Center/isting)$

    C%inic!% eects o o.erdose

    Clini"al e!!e"ts o! overdose

    4e !ollo,in e!!e"ts ave been sele"ted on te basis o! teir +otential "lini"al sini!i"an"e

    (+ossible sins and sym+toms in +arenteses ,ere a++ro+riatenot ne"essarily in"lusive:

    &2#&3

    ym+toms o! overdose$taxia(sainess and unsteady ,al)@ blurred #ision@

    coma@ confusion %,4,3%@ drowsiness or di""iness 4,3%@ respirator& depression %(slo,ed

    breatin)@ se#ere nausea or #omiting 4,3%@ se#ere unusual excitement, ner#ousness,

    restlessness, or irritabilit& %,4,3%@ urinar& retention(di!!i"ulty in urination)

    Tre!tment o o.erdose

    4reatment is sym+tomati" and is dire"ted to,ard te a!!e"ted body systems$ astri" lavae#assisted res+iration# vital sin monitorin# and intravenous (i$v$) nalo*one are some o! te

    +ossible +res"ribed treatments$ 1.# &0# &2# &3

    P!tient Consu%t!tion

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    %s an aid to +atient "onsultation# re!er toAd*ice for the Patient4 De(tromethorphan 5Systemic68n+rovidin "onsultation# "onsider em+asiin te !ollo,in sele"ted in!ormation ( ; maissed dose: 8! on a s"eduled dosin reimen4ain as soon as +ossible@ not tain i! almost

    time !or ne*t dose@ not doublin doses

    ro+er storae

    Prec!utions /$i%e usin" t$is medic!tion

    Ce"in ,it +ysi"ian i! "ou +ersists a!ter medi"ation as been used !or . days@ i! sore

    troat +ersists !or more tan 2 days '&@ i! i !ever# sin ras# or "ontinuin eada"e is

    +resent ,it "ou -# &0# &1# &2# &3# & &'# &6# &.# &-# &9# '0# '1# '3# ' ''@ or i! astma &0or

    i blood +ressure &1is +resent

    sin loenes ,it "aution to +revent "oin

    Or!% Dos!"e orms

    DEXTROMETHORPHAN H0DRO*ROMIDE LO1EN,ES

    2su!% !du%t !nd !do%escent dose

    %ntitussive5ral# ' to 1' m every t,o '&to !our &6# ''ours# as needed$

    2su!% !du%t #rescri-in" %imits

    + to to 90 m &6+er day$

    2su!% #edi!tric dose

    %ntitussiveCildren u+ to 2 years o! ae: osae must be individualied by +ysi"ian$ Cildren

    2 to 6 years o! ae: 5ral# ' m every !our ours# as needed '&$

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    Cildren 6 to 12 years o! ae: 5ral# ' to 1' m every t,o '&to si* &6ours# as needed$Cildren12 years o! ae and older: ee &sual adult and adolescent dose$

    Note: %dministration o! a s+e"i!i" +rodu"t to a +ediatri" +atient de+ends u+on te ability toa"ieve suitable dosae !or te ae o! te "ild$

    2su!% #edi!tric #rescri-in" %imits

    Cildren 2 to 6 years o! ae: 30 m +er day '&$

    Cildren 6 to 12 years o! ae: 60 m +er day &6# ' ''$

    2su!% "eri!tric dose

    ee &sual adult and adolescent dose$

    Stren"t$(s) usu!%%y !.!i%!-%e

    $$' m (54C)DCough# 7.(beno"aine 2 m) ("orn syru+) (mentol) (su"rose) DHold DM 77

    ( "orn syru+) (su"rose)

    .$' m (54C)D$rocal 78

    1' m (54C)DSucrets . Hour Cough Suppressant .8( "orn syru+) (mentol) ( su"rose)

    CanadaNot "ommer"ially available$

    P!c'!"in" !nd stor!"e

    tore belo, &0 C (10& F)# +re!erably bet,een 1' and 30 C ('9 and -6 F)# in a ,ell"losed

    "ontainer# unless oter,ise s+e"i!ied by manu!a"turer$ &6# '&

    rote"t !rom moisture '&$

    DEXTROMETHORPHAN H0DRO*ROMIDE S0R2P 2SP

    2su!% !du%t !nd !do%escent dose

    %ntitussive5ral# 30 m every si* to eit ours 23# &1# &2# & &'# &.# '0# '1# '2# '3# as

    needed$

    2su!% !du%t #rescri-in" %imits

    + to 120 m +er day$ 23# &2# & &.# '0# '1# '3

    2su!% #edi!tric dose

    %ntitussiveCildren u+ to 2 years o! ae: osae must be individualied by +ysi"ian$ 2'# &1#&3# & &'# &9# '1# '2# '3

    Cildren 2 to 6 years o! ae: 5ral# 3$' m every !our ours &9or .$' m every si* to eit ours23# 2'# &1# &3# & &'# '1# '2# '3$

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    Cildren 6 to 12 years o! ae: 5ral# . m every !our ours &9or 1' m every si* to eit ours23# 2'# &1# &3# & &'# &.# '0# '1# '2# '3$

    Cildren 12 years o! ae and older: ee &sual adult and adolescent dose$

    Note: osae must be individualied !or "ildren u+ to 6 years o! ae# !or de*trometor+an

    syru+s "ontainin al"ool&9#

    '0

    $

    2su!% #edi!tric #rescri-in" %imits

    Cildren 2 to 6 years o! ae: + to 30 m +er day 23# 2'# &3# & '1# '3$

    Cildren 6 to 12 years o! ae: + to 60 m +er day 23# 2'# &3# & &.# '0# '1# '3$

    2su!% "eri!tric dose

    ee &sual adult and adolescent dose$

    Stren"t$(s) usu!%%y !.!i%!-%e

    $$3$' m +er ' m (54C)DPertussin CS Children+s Strength .9(al"ool!ree) (su"rose)

    .$' m +er ' m (54C)DBenylin Pediatric Cough Suppressant 7:(al"ool!ree) (suar!ree)

    D-o%itussin Pediatric Cough Suppressant .7(al"ool!ree) (suar!ree)

    10 m +er 1' m (54C)DCreo$erpin 7(al"ool 2'G)

    1' m +er ' m (54C)DBenylin Adult Formula Cough Suppressant 71(al"ool!ree) (suar!ree)

    DDia%e$&SS DM Syrup 72(al"ool!ree ) (suar!ree) DPertussin DM ,(tra Strength 7

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    %ntitussive5ral# 60 m every t,elve ours# as needed$ -# 2 &-

    2su!% !du%t #rescri-in" %imits

    + to 120 m +er day$ -# 2 &-

    2su!% #edi!tric dose

    %ntitussiveCildren u+ to 2 years o! ae: osae must be individualied by +ysi"ian$ -# 2 &0#

    &-

    Cildren 2 to 6 years o! ae: 5ral# 1' m every t,elve ours# as needed$ -# 2 26# &0# &-

    Cildren 6 to 12 years o! ae: 5ral# 30 m every t,elve ours# as needed$ -# 2 26# &0# &-Cildren 12 years o! ae and older: ee &sual adult and adolescent dose$

    2su!% #edi!tric #rescri-in" %imits

    Cildren 2 to 6 years o! ae: + to 30 m +er day -# 2 26# &0# &-$

    Cildren 6 to 12 years o! ae: + to 60 m +er day -# 2 26# &0# &-$

    2su!% "eri!tric dose

    ee &sual adult and adolescent dose

    Stren"t$(s) usu!%%y !.!i%!-%e

    $$30 m (e7uivalent o! de*trometor+an ydrobromide) +er ' m (54C)DDelsym Cough

    Formula .=(al"ool!ree) ( i !ru"tose "orn syru+) (su"rose)

    Canada1' m (e7uivalent o! de*trometor+an ydrobromide) +er ' ml (54C)DBenylin DM For

    Children 12 Hour 28(al"ool!ree) (su"ralose) (su"rose!ree)

    30 m (e7uivalent o! de*trometor+an ydrobromide) +er ' m (54C)DBenylin DM 12 Hour 2.

    (al"ool!ree) ( su"ralose) (su"rose!ree) DDelsym =(al"ool!ree) ( "orn syru+) (ranulated

    suar) D$riaminic DM /ong /asting For Children .

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    3%>% ru evaluations$ 't ed$ Ci"ao: %meri"an >edi"al %sso"iation@ %+ril 19-3: 2'&$

    &Reynolds HEF# editor$ >artindale# te e*tra +arma"o+eia$ 2-t ed$ ondon: 4earma"euti"al ress# 19-2: 1261$

    'ansten # orn HR$ ru intera"tions$ 't ed$ iladel+ia: ea &Febier# 19-': 23'$

    65lin AR# editor$ ru !a"ts and "om+arisons$ t$ ouis: Fa"ts and Com+arisons 8n"# 1992: 196$

    .%>% ru evaluations$ 't ed$ Ci"ao: %meri"an >edi"al %sso"iation# %+ril 19-3: '6&$

    -elsym (Novartis)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"als and s+e"ialties$3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ &.1$

    9Calmylin I1 (4e"nilab)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"als ands+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ 2.2$

    10%>% ru evaluations$ 6t ed$ Ci"ao: %meri"an >edi"al %sso"iation# e+tember 19-6: 3-&$

    11Committee on rus$ se o! "odeine and de*trometor+an"ontainin "ou syru+s in+ediatri"s$ ediatri"s 19.-@ 62(1): 11-22$

    12>ansy # Hasinsi R$ E!!e"ts o! de*trometor+an in man$ arma"oloist 19.0@ 12: 231$

    13Rammer # olmren # andler $ Fatal into*i"ation by de*trometor+an: a re+ort on t,o"ases$ Forensi" "i 8nt 19--@ 3.(&): 2336$

    1&8r,in R# Curley FH# ratter >R$ 4e e!!e"ts o! drus on "ou$ Eur H Res+ir is u++l 19-.@1'3: 1.3-1$

    1'Jo++el C# 4en"er H# 8be J$ rinary metabolism o! de*trometor+an in man$%rneimittel!ors"un 19-.@ 3.(11): 130&6$

    16odds %# Revai R$ 4o*i" +sy"osis due to de*trometor+an$ >ed H %ust 196.@ 2: 231$

    1.aul K# Kandell ># Robertson K5$ e*trometor+an to*i"ity: reversal by nalo*one$ediatri"s 19..@ '9: 11.9$

    1-Kei++l $ 4era+euti" a++roa"es to te "ommon "old in "ildren$ Clin 4er 19-&@ 6(&): &.'-2$

    19%>% ru evaluations$ 6t ed$ Ci"ao: %meri"an >edi"al %sso"iation# e+tember 19-6: 3-3$

    20Reynolds HEF# editor$ >artindale# te e*tra +arma"o+eia$ 29t ed$ ondon: 4e

    arma"euti"al ress# 19-9: 90-$

    21Aron"ori++ol> ((4e"nilab)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"alsand s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ 2'.$

    22Jo!!e* > (Rouier)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"als ands+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ -93$

    23Aenylin > (Karnerambert)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"als ands+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ 212$

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    2&Aenylin > 12 our (Karnerambert)$ 8n: illis >C# editor$ C Com+endium o!+arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$212$

    2'Aenylin > !or "ildren (Karnerambert)$ 8n: illis >C# editor$ C Com+endium o!

    +arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$212$

    26Aenylin > !or "ildren 12 our (Karnerambert)$ 8n: illis >C# editor$ C Com+endium o!+arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$212$

    2.Fossati %# Limer"ati ># Ca+uto R# et al$ %bsor+tion and metabolism o! de*tror+an andde*trometor+an administered via te nasal route in te uinea+i$ ru 8nvest 1993@ 6(3):1&&-$

    2-5rrell >K# Cam+bell $ e+enden"e on de*trometor+an ydrobromide$ A>H 19-6@ 293:12&2$

    29Flemin >$ e+enden"e on de*trometor+an ydrobromide$ A>H 19-6@ 293: '9.-$

    30Kaler H# Matam N$ Aenylin (de*trometor+an) abuse and mania$ A>H 1993 %+r 3@ 306:-96$

    31an M# Aritto >R# Lalderau J# et al$ e*trometor+an: enan"in its systemi"availability by ,ay o! lo,dose 7uinidinemediated inibition o! "yto"rome &'026$ Clinarma"ol 4er 1992 Hun@ '1(6): 6&.''$

    3254C label ,arnins o! intera"tions ,it R* >%5 inibitor drus$ FC Re+orts$ in eet '&: Hun 1992$

    3354C de*trometor+an label ,arnin about intera"tions ,it R* >%5 inibitor$ Keelyarma"y Re+orts$ 4e reen eet# >ay 1992$

    3&Aalminil > (Rouier)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"als ands+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ 196$

    3'Ju+!er %# "mid A# !a!! $ arma"oeneti"s o! de*trometor+an 5demetylation in man$Oenobioti"a 19-6@ 16('): &2133$

    36Aalminil > "ildren (Rouier)$ 8n: illis >C# editor$ C Com+endium o! +arma"euti"alsand s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$ 196$

    3.Revie,ers= res+onses to monora+ revision o! 2/1'/9&$

    3-8r,in R# Curley FH# Aennett F>$ %++ro+riate use o! antitussives and +rotussives$ rus 1993@&6(1): -091$

    39eal # et al$ se o! "odeine and de*trometor+an"ontainin "ou syru+s in +ediatri"s$ediatri"s 19.-@ 62(1): 11-22$

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    &04riamini" > lon lastin !or "ildren (Novartis)$ 8n: illis >C# editor$ C Com+endium o!+arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$1-2930$

    &1Robitussin +ediatri" (KiteallRobins)$ 8n: illis >C# editor$ C Com+endium o!+arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$

    1'.9-0$

    &2Novaiste* > (oe"st >arion Roussel)$ 8n: illis >C# editor$ C Com+endium o!+arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$1213&$

    &3Novaistine > (oe"st >arion Roussel)$ 8n: illis >C# editor$ C Com+endium o!+arma"euti"als and s+e"ialties$ 3&t ed$ 5tta,a: Canadian arma"ists %sso"iation@ 1999$ +$1213&$

    &&Robitussin >a*imum trent Cou u++ressant (KiteallRobins)$ 8n: R ysi"ians=des re!eren"e !or non+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@199-$ +$ -39$

    &'Robitussin ediatri" Cou u++ressant (KiteallRobins)$ 8n: R ysi"ians= desre!eren"e !or non+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$-39$

    &6u"rets & our Cou u++ressant (mitline Aee"am)$ 8n: R ysi"ians= desre!eren"e !or non+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$.-&$

    &.Li"s && Cou Relie! (ro"ter and amble)$ 8n: R ysi"ians= des re!eren"e !ornon+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$ .&2$

    &-elsym 12 our Cou Formula (>edeva)$ 8n: R ysi"ians= des re!eren"e !or

    non+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$ 691$

    &9ertussin C Cildren=s trent (Alaire*)$ 8n: R ysi"ians= des re!eren"e !ornon+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$ 626$

    '0ertussin > E*tra trent (Alaire*)$ 8n: R ysi"ians= des re!eren"e !or non+res"ri+tiondrus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$ 62'$

    '1Aenylin %dult Formula Cou u++ressant (Karnerambert)$ 8n: R ysi"ians= desre!eren"e !or non+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$-0'$

    '2iabe4uss > yru+ (5rto>"Neil)$ 8n: R ysi"ians= des re!eren"e$ '3rd ed$ >ontvale#

    NH: >edi"al E"onomi"s Co 8n"@ 1999$ +$ 2260$

    '3Aenylin ediatri" Cou u++ressant (Karnerambert)$ 8n: R ysi"ians= des re!eren"e!or non+res"ri+tion drus$ 19t ed$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 199-$ +$ -06.$

    '&CouO +a"ae labelin (A$F$ %s"er)# Re" '/1./99$

    ''old > +a"ae labelin (A$F$ %s"er)# Re" '/1./99$

  • 5/28/2018 Dext Rome Th Orphan

    12/12

    '6Red Aoo 1999$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 1999$ +$ -.& (>edi7ue)$

    '.Red Aoo 1999$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 1999$ +$ 6-6 (ee)$

    '-Red Aoo 1999$ >ontvale# NH: >edi"al E"onomi"s Co 8n"@ 1999$ +$ 69& (ilar*)$

    Co+yritP 2001 >i"romede*# 8n"$ %ll rits reserved$