Download ]LACHMAN CONSULTANT SERVICES, INC. Westbury, NY 11590

]LACHMAN CONSULTANT SERVICES, INC.
Westbury, NY 11590
Typhoid VacdIne--Cont.
025 call, administered~eubeuteveooelA m-0.1 mL, mQacu"
teneoaelY.(inEredermall9) . .
..
.
Under conditions of continued m, repeated exposure, a
homier dose should be eim et lent every ihree .Ynam. In
inatances where an roberval of come than three Years has
elapsed since primary immunisation or the last booster
done, a single becalm dose is considered safficiand ; it is run,
necessary to repeat the primary Immunizing scries.
ADMAII9TBATION
. .
.
.
Shake Vial vigorously before sofflodnessing each class .
]Before injection, the rubber diepheagm ofthe vial and the
skin over the site to be injected should 6e claimed and pre.
pound with a suitable gasconade.
After insertion ofthe needle. "pirate to help avoid imdvertmt injection into e blood vessel. .- :'
. _
_
, .. . .
HOW BUPPLdD
'
Typhoid Vaccine, USP is supplied in vials of 5 mL and 10
containing
ml, each
8 units Pe mT. .
AorPnacnEin4'Wo~~^affon"-9urite ta':-Au(aesfonnl Spuira,
Wyetk-eyerst Pharmaceutical., P.O. Boz 8899, PhdmYlplii6,
PA 19101, oreonewl your local WyeWAyenO repreaeemftue.
WYGESIG"
fmiJe'zikl ,
.
.
.
iP~PoxYM~wr NCI +o4aae4momPheN :
Tddeb
.
.
..
. .
C14229-1
Iseiied FebmaxY 9,1994-. .. .
.
.
, . .. . .
with a
ft it i
dilodde, whieh:can L¢ represented by the following etrocUvel Outside:
. . . .; .
.
. . ..
o.
oc<9k
.. .
In-d8s1
Ihyelumnidaspl~.~: . .
.
.
.
~ .
. .
.~ . ..~ ~.
.
.
. .
DESCRIPTION . . _ . . ., . . . . - :.--; : . . . .
.
:.. .
wydeeei a.bnetan -easione~ is e P+'eFarstiori'of highly pvri5ed bovine testicular Lveluro¢iilesa: The arect chemical
;
~.
._
.
.
..
.
j) .xn
_
xO
Acetaminophen is a white, crystalline powder, possessing a
slightly bitter tests. It in soluble in boiling "ter and Daily
soluble in alwhal. Chemically, it is N-Aee69l-P-arrouPhmal.
which carn be prevented by the following structural formula
i .
WYDASE~
.
.. , ..
and
(°yyyxcxi ~_5-elfi{(
,
U.S. GWl.Iiceoae .Na 3:-~.
.
D6RCRI'CION -"
W.y¢esic tablets contain 65 mg ProicoslyPhesie HCl and 650
..
. on immumvavon mo[mmn9 am commonly
men
Weekly Report 29 (N
.7} 76, 1980. ~ '
.
Maniilsetucedby
. .- .
. :.
47YeW Laboratories . : ~
.
..
A WYe66-A9eiat CamPen9
. . .
. . .. .
.
..
Marietta,.PA47547.
- @ $
V N~e
CLINICAL PHARMACOLOGY
similar pleama rnnaentreEime. Following edminieEration of
65,130, or 195 mg oYpmpoayphme hydrochloride, the bioaveils6ilii,y of peopoaypLene is equivalent to that of 100,
200. or 300'm¢ resoectivelv a1 DroDaiYOLefie nfl08918te:
gs.After a 66 mg oral dose of pxopqxyphene bypink plasme levels of D.O6 to 01 meWmi. are
vacuum, wood moune an
is supplied is a sterile,
isee-oPP~PO+YPhaoe et&hovrintexvak lead in
plastic concentrations, with a plateau after the
vial
sd in the livec.tA.:P~d naMohas a hel&life~of 6 to 12 burns,
*4mis; 30 to 36 hours .
sueli ge
nocpro-
mg
to ":Uwt .
.
. . .
.
.
HOW SUPPLIED
Wydeseg Lyophilized to supplied as follows :
- :xne:oooe-0iatoi;f1cq .vi.I :aas4a-a.-
, .
'T,
- . .i . .
Store at ewNaIW room,}ampersW.ra Ma city plans. Stom
aside recons6tutedsolu6on6elow HOT (86Fl, ties within
20 hours.
.. . .
- .
Following raroMti(W99. ;tore vial in upright POSkwn .
1,500 U8P (TR) units ofhyslurwidase,. .
"
,
: 000&0149-01, 10 ML vial, as single vials.
ND(
Not Recormnencled for IV Use.
gain at coortrWkd room tampentui" in e dry plans. Stom
inside reeomtitufedsolution below90°C186°Fl :IIsYwilhi6
:
-. .r, .- ., .
:.
asasys: :
Following naonatitulion, users vial 1. upright puddic.
Wydase0 SYabilizad Solution is supplied as wassf
Y60 .SJSP (TR) units of Lysturonidste .per mi.
... "
NDC 0008-0170-01 . 1 mLvial. se aiLgleviek. '. ::
. . . . ..
NDC 000"170-02, 10 mL vial; on single vials.
Not Recornerreaded for IV Use.
Scene m ti rohipxetae'
Do not use if solution is discolored w contains a precipl':
. . .
. .
teta.
Manufactured by :
Wyeth Laboratariea
.
AWyeth-Ayeret Compevy'
Philadelphia, PA 19101
CI4224-i Iseusd Febevarg 5,1984
.
. . .
prolonged . Any ieGSwrdiaC conduction delay attributable
to high mocevtratiom of nmyrnPowhaoe may, be of mletive;p long duration.
ACPfONS
Propozypheve'v a mild. nmmtic analgesic structurally re,
lated to methadone . Tfid Patenc9 of DroPo+7Pherse, bydro,
chloride is from twofiLirda :to?4aal that of adeive.
Propozypheoe hydrochlmidE.end scetpmimPhen provide
the analgesic activity of ptopo"pheme -napsylate and the
-ea~~~1Y ~aaetaminuPL ea
==1 of piopes''ypLene budstttaminuPhen PTaanalgesia
duces greater
than that produced L9 either pro.
poxyphene nor acutammopher, alone .
INDICATIONS
W3'beeic is indicnbed for the reliefafmild-tocasderate pain,
either when painispresent aloneorwhen itisaccompanied
by fevec
CONTEilINDICATYONB
Hypersensitivity to ProPORYPh¢YE " t0 emst+ :mpfi¢u .
I WARNINGS
I Do not prescribe yiopoxyphene for patient, who am
suicidal or addiction-prom.
Pruaihe WoPOxYPhorre with caution fdi'Datimti taiI iM tranquilizers w endMMessonrt dmgs and patients
I Tell your patients net to exceed the recommended
daseanEftimrtLwirNrtakrdakohol:'-'
r
.
ProPOxS'Dlieoa products in excessive dome, either alone
~ or in :mmbmetim.wiN'nther CNS depressions, ieelud-
iog'.alcehok are s major cam o£ dxug related deaths,
PrupnryP6en, when (Aft in higher-then-.._m."..m ded
doses over IonH pounds 04 time. can produce drug dependevce characterized by psychic dependence aid, less frequanEl9. physical dependence and tolerance, Roopusyphers,
will only partially suppress the withdrawal syndrome iv iedividvela physically dependent on morphine or other m'catim. The abuse liability of propimyphesis, is qualitatively
similar to that of codeine although quantitatively less, and
yropoxyphene should be prescribed! with the came degree of
cavdan appropriate In the rew of codeine.
USAGE IN AAMMATORY PATIENTS:
may impair
P~'~qudfor the P<ibormane of Potentially heaattlwe
tub, auCN as driving ecae,w operating machinery The P%6ient should ;tis cautioned aaardingly
PRECAUTIONS
GENERAL
.
.
Pmparyphene should be administered wish caution to petieata with hepatic or renal imPassonsont sonce higher serum
co~ntratima or delayed elimination may occur
As is the case with many mwlicinel agents, PTOPos9PhPne
way slow the metabolism ofa concomitantly administered
drug. Should this occur, the higher serum concentrations of
that drug may suit in increased phascoo rrologic or ad.
effects of that drug. Such concretion, have hems reported
when ProPnst9Ptiome was sdministered to patients on mmtidepresaents, a¢tironwleant8. .or wufain.L'ke drugs.
USAGE INBREGNANCK
3eYe iuse in pxe~eneS hm uot.been enoddiheog mission to
possible adverse e8ects an fatal. develuPmeaG lnetences of
withdrawal symptom m the nwuate haw base reported
following asege during Pregama47. Therefore, Prows9Phere
should cot 6e used iv FregmvL .women wlese, in the judgmeut of the Physician, the potential benefits outweigh the
possible hazard&
USAGE IN NURSING'MOTHERS:
Loa levels M ProPoxSPboe have bass deteiSed in human
mfOc In poetpertum studies involving moving mothers who
were given ProP^s9PLme, m adverse e8'ecb were noted i¢
infanta receiving mother'a milk. -~ . :
USAGE IN CHII.ARSN:
.
: : .
. . .,,
. . : ..
Proposyphene is not rsom,meadad.for'use in"ahiidreo:'be
. docameniW olroical axParenm has base -ivsoScient
Yo eate6lish apfaty end a suitable dceage regimen in the Pediatric age group.
A patient Information Sheet is available for this product
.
&e tat following -Haw Supplied' sation below.
ADVERSE REACTIONS . .
In a euiveYcondvded in hmpiteliaedPetienta, lees than 1%
of patients te7dnS PropoSSPbaoe hydrochloride at termsmended doses experienced aide affecfs.1Le =at frequently
reported have been do .., aedation, vaueee, awl v^m4
mg. Some oft6ese adverse reactions maybe alleviated ifthe
patient has down.
Other adverse reactions include constipation, abdominal
pain, skin rashes, Rbh4heedednea0
. headache, weakness,
euphoria, dSBPborie, and minor visual disturbances.
6eaukreported
in association with
Liver dyefunMion has
both active components of propoxyphene end acetem+oo~
plies, tables.
R,Pos9Phene theraP9 has been associated with abnormd
IiveaPovction tesla and, mom is*, witL metmosss of x~
seaside jaundice.
Hepatic necrooie may result from acute overdoses of sce4
ammoP4eu (eee "dianagemehf.`of Oveidasage'). In ehma+c
s6o1iethanol abusers, this 6bs been reported rarely with
term use of ere~emivophed'daees dES W 10 H~~F'~e,tetities have accurred .
MANAGSIMENT OF OVER)Dq8AG6
In all eases of auspecFed overdoeaga call 9ow reBb°el Pot-
son control Cancer W obtain the count uP-te-dflte ivform% . _' :;"
Van about the treatmort of oveodosege: 1Lia'iemmmevdetiou is msde 6emus0 in general, information regarding the
treaLment of wordoea4e maY A-- Be moxeiaPiil9 tLan.do
.
.
landing. insists, .
Initial consideration should ,he given to the management, of
tLe~.CN3 efforts ofHroWS9Phemos ooeadoa4e..Resuedmfive
reassures; should be mitiatea correctly
be sorcerous or counties,
retain and reaching
pressaw is corrected
promptly Cardiac ar
be present. A eombix
mus, owing fureteine
if large amounts of realiesdartee have elm been ingested.
Death may ma,
. . .. .
:
. .
TREATMENT OF PHOPOXYPHENE OVERDO6AG8: '
Attention should be directed th at to establishing . pointed
In, adults, hepatic Euiicity hnamxal9-been :reported with
same overdoses of leas Um 10 .4 and fecatitiee with lem
than LS g. Importantly, young 2WfidcEn mean W be more re-
an acetammooLen meMase. Critical and~lahaaaa to 'iz Wars, poatngeaGOn . Early s9mFtuma =owing a
potent udly.heptatmosic overdoes may include. owners, cum,
itin8, diaPhmwsis, and general melaide: . ;
The stomach should be emptied promptly by berage, or by
ivdvetion .Kemesiswith syrup MiPacac.PaEimidedEimatd
d'.f]I09oSnGtyOfadrug ingested BTBnnWncml9 - ti
A1 Therefore, if'art eeetemfiooPLm .overdwe is suspected, a
amen acetacriumphen assay should be obtained as early as
possible, but as aoonm!Shan four home .fdRowing royestiou.
I.iver-fiiueti8n studies should be obtamed .iuimallY m3 rt
peetedat24-liooriNervale :
`
The antidote. N-ecetydcyNeine. :ehoWd be adhuioiaiered as
early so Pereu114preferably within 16 homersoftLeovetdme
mgestibn for optimal results, 'but in any Uses, widde, 24
hours.' Following [eeoJary, Sure ame no residual,'etiuchual
m Rwc6ionel hepatic abnormalities.
'
..
.
.
ANIMAL TOXICOLOGY,
piupdsyp5ene nsPeqlate
.
.
The
edly
2 .1
.
. . ~ . FIGURE L,' -.
ACUTE ORAL TOXICITY OF PROPOXYPHENE
..
. .
Species . . . .
m
OVERU03AGF',;TtI
. - :LDW(mblalelkg)
. : .' '&uPUYYPheGC
. HydrwNoride .
Manse . . . .
~'. " .282 m 39 . ..
.,_0
.-. . .. . .,
.45 . .
R84
230 i :44
-d7$ly .. .
Rabbit
.
. .ca. e2 . .,
Dog
.
m . .100 . ; . ._
a.zv : :
'
.
-
.
ProPoor9nhme .
Napaylate .
915 > 163
_ 1.62'
.
647-95
.
' . .1.14
.
. _ >1
..
.
>f1 .SE . ,
. .'->388
. . ->o
:aa . .
SomeiudivationaFthe relative inaolulnlitysndreterdedsb
earytim of pmpqxyp6ene napsylate wee obtained Dy meea!V?ngDleem'apmpoayphmekvelsm2groupnot'4ilogetollovriug oral administration of eqmmoler dome oTthe2 asks.
Although man oFttie midi'sla in this eaporiment di'ed, S of
the 4 dugs g'ven'HTOIoa,9Pliwas~Y~b?~'+~ as. Wrist mu-
0.1 mr/kgbady weight, may be
wlsioe sidearm awing the them interval ~ornspoodrug w
the peak Photons levels . The 4 animals ree~eiva the hapay.
late salt wen afaric but not acutely L.
'
der
may
m~. WywY
Electrocexitiagrsplui moniWriv4 u essm4el . R'umpt carroutine of Lypom acidosis, and electrolyte dietnrbatice
(whose Dreseent) will help prevent these ceittiec c~plications and will increme .tLe effectivencom of agents
tered to restore m~mal caidiee fiwction .
-
In addition to the use of a narcotic anfagnp ;et, t6¢ petient
easy +E9ui[e model Lit atiVO with an aDticonvulsaPtto M'
coal mnniluoun . AnalePtie drip QFm eaampl4 es8eine or
emphetamme) sliuuld noE 6e uaed be,mnsa ofth¢atepdency
to precipitate coserJeione.
.
.
General supportive measeuee,:in addition to ospgen,in-
age¢ta .;
coal can
;flats should be made to aeFermi6e whet
such as alcohol, barbiturates, traingu8iaere
aluminum, were alsomoleated, same them
aPreffibon as well eacaoea sPedsc :toriceffe
OF ACETAMINOPHEN OVERDOSA(
.,ad inBoadhw of an emotions" of ancitame
to 7 d§9a sfter overdaxge. . : . .
Acute renal feilure may accompany the hepatic .dyefimetion
and his been noted in patients. who do net e#Ifibikmgm of
.fnlminant hepatic failure. Typically, renal impairment is
more apparent 6 to 9 d99setien ingestion of the couroodurse.
TREAY'MENT:OFACETAMQdOPHENOVERDOSAGE .Ao
etaminophm in sooner. wexdoeage mny come, hepatic tasicity in rearm Patienta. In all cones, of suspected overdom;
you may wish to call Your Tegi^oa~~Poieon ixnter..for sm"vtavce in diagnosis and far directions in the nee dN-ecet.ylcyateive as an antidote .
.
. ..
DOSAGE AND ADMIN[INTRATION
The product is given orally. The cartel dae is §5 m8 ProPqypham HCl and 650 mg aceteminophee avail, 4 hours as
needed for Pam . The mydmum recommended dose of lam.
poxyp}- HG7 u 390 mg per day.
'
Consideration should 6e given W a reduced total daily dosage in patients with hepatic br renal impeoimenc
NOW SUPPLIED
a'98esics (P+aPossPhene AL7 and acetamroopLm)Tabiefs .
65wp:npnyphene and 650 mg acatanconorpher, are avail,
able as follows..
NbC 0008-0OBG, green, capeuleahsped,xrored ; Slm-caa'Eed
tablet occulted °WYEffP' end °85", in bottles of 100 and 500
tablets, and in REDIPAKIP machine of 100 tablets (10 blister
stripe 4 10) .
:
..
Keep tightly closed.
protest &am right.
Store ateo'NWIadroamtpnperafuro .20'-25CIB8°-7TFi.
Dispesne in fight. figMvnisHMCmhinxas defined I. ths,
USE
PATIEW INFORMATION
Audvcte containin8 PruicanhOW are Used to Pillars Pain.
LIMIT YOUR INTAKE OF ALCOHOL WHILE TAKING
THIS DRUG. Make a. year doctor knows i£.you are taklna .timu9uilisexa . sleep e'ulaantidePrements, antihiatam'^es. - any cilia drugs that make yen sleepy Combuting
ProPOSYPLenewith alcohol orthesedrop meacessive-choose
is dangerous.
Use mxe wlu7e drivinga mi ornaiogmacLi¢sa mNyouece
how the drub sSecte you
; because propooyphers car, make
You sleepy. Do nod take more of the drug than your doctor
. Dspandwea has aacuned when patients have
:
prose-led
taken pmP^sSPha¢eJur a lung period of time at dasPs
greater than recommended.
The rest of this Worst 6mrs.9oa mom iutormatim about
ProPa4Phroa~ Pleme mad it and keep it for, forther use.
Uses for Proporciffhoss,
Products communing DmPOS9Pheue are wed Forthe card of
mild to moderate pain. Products which contain proporyDhon¢ plus aummun-plar, arm Presented far the relief of
van w pain associated with favor
Before taking Prolmoryphoses
Make-mm yaw doctor knows dymet ban . over had an arm
air reaction W nrooozvohene or eceMminneJ+.m_ :
. .
The effect of ProPO89P6ene in children ander 12 has not
been studied . Therefore, me of the drug in this age group as
ad uncommitted.
Xowmab .RwpoaypMnw- : . .
.
. ..
:
FoDaw year doctor's directions exactly Do netIncrease tlre
mom
you take xdtkoutymu doctots approval. Ifyou miss
a does aftLe drug, do but take Swore as much the neat tmu.
. .
.
,
.
_ ,
Do not take -HroPeuirPbene-during pregmency unless your
doctor lmowaYou are pieguant and specifically moommends
its care, Cases oftemporar9dePendeucein the newhmn have
occurred when the mother has taken propoxyp5eae mveis2mllv in the weeks before delivery. As a general principle,
no drug. should 6e taken' during progvency-malees it is
G.T ..-:+ra~m ;m
sure your doctor
preasenE
pattern any hesexdoua task mtil you have men 9arao, m
9POnee W this drug .
: . . ". . . . . " . ProPO+9PbenemaPincreasetheconcentration intLe .Lud7'd
mediratiom eueh as entimagdmte ('blaod thronera°). and,
depreassixts, w drugs wed for epilepsy. The result may be
consensus msdverae efiectsofthree meilieatems.Make eure
your doctor knows if you are taking m9 of these medica-
d dome over along 'Par+od of time.
of need for the drug and a feeling
normally without it .
rypyeog,: plane or '7a combipatiov
imaueci6aeuese and death
..
If the ProParoYPhece product contsins aeetaminnPhen, the
syroPtemis
methods
nsmes,
wmitin4: lack of apm'QducaSe
petite, and abdominal pain. Liver damage may aear: .
In any suspected o°endosa6e %awatio4 contact ywT docWi
ar, nearest hospital emergency raom. GET EMERGENCY
HELP IMMEDIATELY KEEP THIS AND ALL DRUGS
OUT OF THE REACH OF CHILDREN .
Possible 5ds Effects,
When ympoxypLme is Taken as directed, vde effects are m6'e4uant. Among those reported are drowameaB, diativme,
nausea. and warning. If them efforts; a ., it my help if
yon lie down and rmG
. ere mmtiPaEOn; sb
Laos frequently reported side effects
dominsl pain, akin more, Iigh4heededueas,Leadache ;
weakness miemviaaaldisC~rbences.sudfeeline%afelatiau
or diecbmiort.
. .. .. .
. .
If side efle&s oaur and roncem 3'ou . wMact Y~ dewr.
ONerYdormetion
...
..
act give
, Do act