Draft Label incz
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`wfis*
`PRESCRIBING INFORMATION
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`II
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`II
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`VontroI®
`wanna diphenidol
`
`Antivertigo and
`anliemetlc agent
`‘Vontrol' may cause hallucinations.
`disorientation or conlusion. For
`this reason. its use is limited to pa-
`tients who are hospitalized or under
`comparable continuous. close.
`professional
`supervision. Even
`then the physician should carefully
`weigh the benefits against the posp
`sible risks and give due consider-
`ation to alternate therapeutic mea-
`sures.
`DESCRIPTION
`Duohemool. a a-dIcrer‘vI-t-oxoev-ome
`butancl,-vs a compouf‘: ‘Ict resalec to
`the anIIh-stamines.
`cnenothzazznes.
`barbiturates. or Other agents 'Mlh anu-
`vertigo or ant:emetic actzon it Has this
`configuration
`
`0H
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`-v‘v";
`
`s
`Each Iouna orange ‘Jontrd taclet
`aecosseo SKF and 25 and some:ns
`dionemooi nyorocmonoe eouIvaIent o
`diohen-col 25 mg Inactve ngrecnenis
`consist ofacaca. talcum sullare. :eflu-
`!ose. FDISC renew No 5 (lanrazmeI
`FDGIC Yellow No 6 magnesmm
`stearaIe ano starcn
`ACTIONS
`'Vontrol' {Unchemcol SKSFI aocarentlv
`exerts :I soec-l-c antwengc eflec. an the
`vestibular aooaratus to :omoi vertigo
`and mum: :ne cnerncreceotor :ngget
`zone to coma nausea and vom-ling
`INDICATIONS (SEE VIRNINGS)
`1) VERTIGO— VonIroI'
`-s
`'nducated n
`Denohera Ilaovnnmmei venvgo and
`assoc:aIeo nausea ano vom-Img. as
`seen -n such conoJ-ons as: Me-
`nueres disease.
`'n-cole- and ~nner-
`ear surgery (lacyrI—sms)
`1
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`IIFEIIO‘IED
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`AUG —5m
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`000188
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`Draft Labeling
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`2) NAUSEA AND VCMlilNG—Vonirol'
`-s ndicaled .n ire control at nausea
`and vom.:ing. as seen in such cond-
`tions as oostooeaive states malig-
`nant neoplasms and labyrinthine
`disturbances.
`
`CONTRAINDICATIONS
`Known hypersensit-nry to the drug is a
`contrainctation. Anuria is a contrain-
`dicaiion {Since a=:rcximateiy 90% ol
`the drug .5 excreted n the urine. renal
`shutdown could cease system-c accu-
`mutation.)
`WARNINGS
`
`u—‘1.
`
`‘Vontrol' (diphenidol. SKIP) may
`cause hallucinations. dlsorlenlation
`or contusion. For this reason. Its
`use is limited to patients who are
`hospitalized or under comparable.
`continuous. close. professional su-
`pervision. Even then. the physician
`should carefully weigh the benefits
`against the possible risks and give
`due consideration to alternate ther-
`apeutic measures.
`The inexoence ol auditory and visual
`hallucmaticns. disorientation and con
`iUSion appears to be less than 72% or
`approximately one in 350 patients. The
`reaczion has usually occmred within
`three days or starting the drug in recom-
`mended dosage and has subsided
`spontaneOusly usually within three days
`after discontinuation ol
`the drug._Pa~
`tients on Vonlrol‘ mid be observed
`closely and in the event at such a reac-
`tion the drug should be stopped.
`Usage in Pregnancy
`Use or any drug -n pregnancy. lactation
`or in women of childbearing age re
`dunes that the potential benelits oi the
`drug be weighed against as [>0er
`hazards to the mower and child.
`In animal teraiogeness and reproduc-
`tion studies ol
`'Vontrol' (dipnenidol.
`SKAF).
`there were 10 Significant diller-
`ences between drug-ireated groups
`and untreated cor-trot groups. except as
`noted under anin-ai Reproduction Stua-
`-es
`(see
`‘Pharrnacology [animatlf
`column 4)
`in 936 patients who received Vomror‘
`during pregnancy.
`the inCidences 0'
`normal and abnormal birth were com-
`Daracle to those reported in the litera-
`ture for the average populaiion at one
`nan! patients. Ana .n'no .nsrance was
`there any evuence that 'Vontrol‘ slaved
`a part in birth aonormalily (see in Preg-
`nancy.‘ colurnn S)
`'Vontrol' s not inacated lor use in nau-
`sea and maing at pregnancy. once
`the :heraceutic vaue and satay in this
`indication have not yet been deter-
`ruined.
`
`PREQUTIONS
`'Vonirol‘
`The aniiemeric acuon ol
`(oronenodd. SKAfl may mask 99': oi
`overdose at qus leg. digitalis: or
`may Obscure diagnoss or conditions
`such as means cosmetion and brain
`tumor
`
`Althouqn there have been no reoons or
`blood dyscras-as Mm ‘Vontrol‘. oaiienrs
`should be observed regulany lor any
`idiOSyncratic reacbons.
`2
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`Draft Labeling
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`vontrol' has a weak oerloneral antucho
`llnerg-c effect and sn0uld be used mm
`care m Datlents mm glaucoma. obstruc-
`twe lesrons ol the gastrormesnnal and
`genntounnary tracts. such as stenosarg
`oeottc ulcer. prostatrc hypenroohy. ay-
`|onc and duodenal obstructon. and or-
`ganlc cardtospasm.
`'Vontrol' Tablets contam FOE-C YelICw
`NO. 5 (tanraztne) WHICH may Cause aller-
`gic-type reactrons (-ncludmg broncmal‘
`asthma) tn certarn susceprble nonwo-
`uals. Although the overall .nc:dence ol
`FOtsC Yellow No. 5 (tartrazme) sensnv-
`-ty :n the general populatuon .s low. 1 s
`frequently seen In patients who also
`have asp-run hypersensumty.
`Usage in Children
`'Vontrol‘ IS not recommended for use tn
`chlldren under 50 pounds. (See Dosage
`and Adrnrmsrralson~Chrldren )
`ADVERSE REACTIONS
`Audutory and wsual hallucxnatnons. ans»
`onentatron and contusron have been
`reported. Drowsrness, overstrmulallcn,
`depresston. sleep dlslurbance. cry
`mOuth. 9.1.
`rrrttatron (nausea and anl-
`oestron). or blurred v-s:on may occur.
`Rarely. slight drzztness. stun rash. mal—
`aise. headache. or heartburn may
`occw M-ld |aundrce at duesmnable re
`lanonsh-p to the use at
`‘Vontrot'
`(diphemdol. soar) has been reported.
`Sl-gnt. transrent lowering ol blood pres-
`sure has been reported -n a lew pa-
`trents.
`(See laboratory studtes under ‘Pharma-
`cology [human]? column 4 )
`
`-
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`"
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`DOSAGE AND ADMINISTRATION
`(555 mnumcsl
`ADULTS—FOR VERTIGO OR NAU-
`SEA AND VOMITING
`The usual dose as one tablet (25 mg)
`every tour hours as needed. Some sa-
`nents may fequlfe two tablets (50 mg).
`CHILDREN—FOR NAUSEA AND
`VOMITING
`These recommendatxons are for nausea
`and vomrtmg only There has been no
`expertence mm ‘Vontrol'
`tn vertvgo n
`htln-rn
`Umt doses In duldren are best calm-
`Iated by body wergnt. usualy o 4 mg:
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`. «gm 6)
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`Chrlorens doses usually should not be
`grven more often man every four hours
`However.
`1! symptoms oerslst alter the
`first dose. acmmlstlatton may be re-
`peated alter one now. Thereaner doses
`may be grven every tour hours as
`needed. .—-“—
`The total dose n 24 hours snoula not
`emceea 2.5 mgflb.
`NOTE; The drug is not recommended
`for use in cmldren under 50
`unds.
`The
`or c I
`re
`Pounds ts one tablet (25 mg).
`OVERDOSAGE
`In the event at Overdosage. the oatrent
`should be managed according to ms
`Symptoms. Treatment :s mortally suo-
`Dortwe. mm mamtenance ol blooa
`oressure and ran-rattan. plus carelul
`observation. Early gastrc lavage may
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`dosa e
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`d
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`058
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` Mini
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`De nccaled oeoe'd.mg on the amount
`"0! ovevoose and fame c! symotoms,
`HOW SUPPLIED
`Tablets contam-ng 25 mg dlohemdd.
`as me hydrocmcroe. n comes ol 100
`PHARMACOLOGY (animal)
`'Vomrof (duphemcot sun exer!s as
`ant-emetic eflec: emf-arty Dy mmomng
`me cnemoreceotd 'J-qge! zone as ew-
`
`'erd' has orw weak oarasympamo
`lyncvachvflv and no Significant seoauve.
`uanaudmng or armhxsxamumc acuon ct
`effects on blood otesure. bean rate
`resurahon 0! me aectrocaldiogram.
`Sucacme and cvomc mucky SNdIeS :n
`raxs and dogs. :1 when Iatge doses 0!
`'Vonlroi‘. as me Hydromlonde salt. were
`aomznnstevec clay and unlfamusculany
`(0! penods up to one year. revealed no
`529me eflecs on hematdogy. hvev
`Iuncuon. bane; Nanci-on at 04000 glu-
`cose oetermmazons. Hrslocognca! exam-
`-nanon ol the was nssues dud not Ye
`veal any sugnlcam lesoons annbmable
`to aarmntslrabcn oi 'Vonlroi'
`
`manna. gesson and Iactahon I0! each
`of mo tuners There wefe no sagrulcanl
`OMetences between drug-treated and
`untreated come! group‘s mm regatc lo
`conCeohon me. me: suze. Iwe Dunn or
`wand-(y m enter at me two lines. Theta
`was no col-gamma! anomaly ammg me
`oflsomg. In racms. 'Vomrd'. as me ny-
`droa'uonoe gL was (ed -n the was In
`'
`1
`noses at 5 mgmg. o: 75 mgnng. (ac
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`mm muses. runnersoi resorohon
`sues or wave 'enfies. Theta was 3450
`no sans-cm s:
`d'fluerca he-
`w .193“: :0 me lad oetcemage o1
`undetdeve-ooeo Muses Hawever.
`when can aeve calcuialeo on the ass
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`000188
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`l
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`Draft Labeling
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`were stunned '0! ‘2 weeks and t7 ‘0' 24
`weeks. and one n 48 volunteers at
`whom 36 were glue-e0 tor 12 weeks
`tn :he first study Vontrol' as the hydro
`chlortde salt. was qrven orally tn :ady
`doses that were started at 75 mo cur-
`mg the first week and graduated 40 to
`200 mg by the loom week In the sec-
`ond study, one grooo tecervec 'Vontrol‘
`orally, as the hydrochlorrde salt.
`tttratEO
`up to 500 mg, early. then down to 200
`mg datly. another grouo recewed a
`maxrmum at 200 mg dauy tn the «ma
`study. oattents rece-ved oral doses at
`200 mg to 300 mg of 'Vontrol' catty. as
`the hydrochloride or oarnoate salts
`The stud:es Included these laboratory
`determ-nattons: comolete blood counts
`(incluatng hemoglootn and hernatocrzt
`determrnatrons). urrnalyses (lnctucmg
`mtcroscoorc exarnunatron). serum alka-
`tine phosonatase. serum Dal-rum. and
`bromsutphalern retentlon. The Stud-es
`also included records at welgnl and
`blood pressure and. th one. electrocar-
`dtograms.
`In two ol these stuclres, dun-cal labora-
`tory changes were seen anong volum
`teers :n both treated and control grouos
`The changes :nduded. extrasystcles.
`wh-te Cells In the unne. tncrease tn on}
`thrombtn ttme. nse tn hematocrtt. nse n
`leucocvtes. use an eosmoph-ls. and rse
`or reduczron tn neutronh-ls. At no tme n
`any study and changes :41
`the treated
`grcmo drlter srgmhcantly from those n
`the control grouo.
`'Vontrol', as the hydrochloride salt. was
`guven orally to 17 chrldren (aged five to
`15). Total oarly doses ranged "cm 90 to
`240 mg. Comotete blood counts and. 0
`some pat-ants. unnatyses were done
`belore treatment and alter alaororu~
`mately tow days at
`treatment. There
`was no sagnrlrcant dullerer'ce between
`pre- and post-treatment BbOraloly oe
`termrnattons In any chad. No SlOe erteczs
`were seen.
`EXCRETION
`Followtng oral aa-mmstrat-on or 'Vontrul'
`(dronemdol. SKLF)
`to dogs. as :ne
`hydrochlonde or oarnoate salts. and to
`humans. as the hydrochlonoe sa, sea;
`olood concentramn ol the drug gener-
`altyocalrsmoneandahalltomree
`hours In dogs and rats. “may at at
`an om dose at C‘Nabeled 'Vontru‘ s
`excreted m the unne and leces on“
`three to four days. as deterrmnea by va-
`dloacttvuty counts Aporox-matetv the
`same percentage ot an adrnmlsered
`dose acoeared tn the unne ol dogs '6-
`lawmq anther oral admtnlstratton ol the
`hydrocntonde sal or rectal aanrnrstra-
`tron ol the free base.
`IN PREGNANCY
`Investtgators heat loll0wuo 'ecords an
`936 oatrents who had received "Mrot'
`(daohemdol. SKLF) at some trme mnng
`pregnancy. pnmawly during the firs tn-
`mester
`
`0t the 936 women. 864 (92%| had nor-
`mal Dumas at normal rntants.
`Seventy-two (8%! ot the women exoen~
`enced some um aonormaldy Ol
`the
`72. 9x patterns had premature om om-
`erwrse normal unlanls. 40 patents
`5
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`000190
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`Draft Labeling
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`aborted. 10 had staticnhs. an: ‘6 had
`News with Miscevéanecus defects
`These vnctucec hermas,
`:ongenual
`"123't (MEGS. hyatcceonavgs. meme:
`‘SPaDISf'nuS. aner‘ceahalus
`60137990
`mnylO. and hyooscaana
`These Incxcer‘ces 31 armor-at Durm are
`lower :han these gene'afly reooned -n
`the hierature k)! the average oooulanon
`of oregnam pauems Ana «1 '10 mslance
`was there any evvcence Ma: The aamm-
`vslranon o! "Ionuol' sieves a can m cm
`abnonnahty
`
`DATE OF ISSUANCEm
`
`G) Smuhxhne Becki-an Covoovabm “5
`
`Smith Kllno Ianch Labor-lode
`0mm 01
`'
`SrmlhKlme Becxrnan Caucasian
`Phuaaelohua Pa. 19101
`
`VNL‘O—
`
`WIAUSJ‘
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`000191
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