ML20236P433
| ML20236P433 | |
| Person / Time | |
|---|---|
| Site: | Davis Besse  |
| Issue date: | 08/06/1986 |
| From: | AFFILIATION NOT ASSIGNED |
| To: | |
| References | |
| ML-I-SOS-001, ML-I-SOS-1, NUDOCS 8708120359 | |
| Download: ML20236P433 (4) | |
Text
_ _ _ _ _ _ _ _ . . _ _ _ _ _ _ .
so - a s; - M G T - SOS- I gS g PDlb li8 s M.-
~
1110 Product ine:rmatun Mead Johnson Labs.--Cont. 'ha'" hrP""5**'ity to any e its mmpoents. ble l=* or Precautions: nancy" r head on his or her samrument of your me6 cal needs, your Generet: Before instituting therapy with QUESTRAN tcho. Peshetre 1 lastyramine resint 6seases contributing to increased blood doctor has preecribed this drug for yoit Do not give the drug itad, a J ,% I Q
\
V /
g, ,,7,,, ,g,,
Shown in Product Identifwatson Serra, page 416 cholesterol such es hypothyroi6sm. 6abetse melbtua, no-phrotic syndmme, dyspmteinemies and obstructin Lver In cal tyrar 1) disease should be looked for and specifically treated. A favor- g ..
able trend in cholesterol reduction should occur during the ,g /V Ny/
,QUESTftANT POWDER first month of QUESTRAN therapy N therapy should be l
D"8P'dd (Cho6eetyramine Resen Powder)
B continued to sustain cholsterol reduction if adequate cho-Imterol reducuan is not attained, QUISTRAN therapy f %$[
should be discontinued l Descriptioru QUlFTRAN Powder (choleeryramme resin Chmnic use of QUMTRAN may be associated with in-powder), the chlande malt of a beme anion exchange resin, a cremsed bleedm' g tendency due to hypoprothrombinemia cholesterol lowering agent, is intended for oral admuustra- 88'aciated mth Vitamin K deficiency This will usually re-tion Cholestyramine resin e quite hydrophihe, but insoluble spond promptly to parenteral Vitamin Ka and recurnneem in water. N choleeryramine noin in QUENTRAN is not can be prevented by oral adminiswatiac of Vitamin Ki Re- . . . ,
absorbed fmm the digestive tract- Nine grams of duction of nerum or red cell folate has been reported over ~ -
'N C3 QUETRAN Powder contain 4 grams of anhydrous Cholestyramine reem It a represented by the following long term adminstration of QUDTRAN Supplementation with folic acid abould be considered in thene casem g; d [ h g/'O/3 ' J 1 i structural- formula. bre is a possibihty that pmlonged use of QUESTRAN, D -
smee it is a chloride form of anion exchange ruin, may pro-c Q.- 4 duce hyperchloremic acidasm. This would especially be tre i
- -CH-'"C"s-C"-O's N(
3 in younger and smaller patients where the relative damage CO _ may be higher.
'dE - " Z QUESTRAN may pmduce or worsen pre.eristing constipe-M CN - tion. Dosage should be reduced or 6scontinued in such cases.
C' c@ Fecal impaction and aggravation of hemorrhoids may occur.
.Q'~ --CH-CH 2 ~* ' W effort should be made to avert severe mnstipation and Eveherent problems in those ratients with clinically eymp-it, t 12 o '= -a tomatic coronary artery daease.
LSRepresentation of structun of mam polytnene poups This product contains FDec Yellow No 5 (tartrazinen which W Th!e product contains the fouowing inacuve agre6ents- may cause allergic type nections (includmg bronchial acacia. citnc acid, FD&C Yeuow No. 5 (tartrastne), TD&C asthma) in certam susceptible in6viduala Although the Yellow No. 6. flavor (natural and artificially, polyeurbate 80, overallincidence of FDisc Yellow No. 5 ttartraziner sensitiv-propylene glycol alginata, and sucrose. ity in the general population is low, it is frequently seen in Clinical Pharmacology: Cholesterol a probably b sole patients who also have aspirin bypersensitmty.
procursor of bile acida During normal d,gention, bile acids information for Patients- Inform your physician if you are an secreted into the intestinm. A major portion if the bile pregnant or plan to baixrme pregnant or are breast feedhg acids is absorbed from the intestma! tract and nturned to Dnnk plea of fluids and mis each 9. gram dame of b byer via the enterohepatic ctreulation. Only very small QUES Powder in at least 2 to 6 ounces of fluid before amounts of bile acids an found m normal serunL taking.
QUESl"MN resin adsorbs and combines mth the bile acids Latioratory Tests: Serunt cholestarollevels should be deter-in the intestine to form an insolubie comples which is es- mined frequently during ta first few months of therepy and creted in the feces. 'Dus results in a partial removal of bile periodically thereafter. f> rum triglymnde levels should be O &cids from the enterohepatic circulation by preventing their measured periodicaDy to a doet whether significant change C/ almorption have occurred.
% increased focal loss of bile acids due to QLTSTRAN ad- Orve Internettone: QUESTRAN may delay or reduce the ministration leads to an increased oxidation of cbdesterol to absorption of conmmitant oral medication such as phenylbu-bile acids, a decrease in beta hpoprotem or low density hpa- tazone, warfarm. chlornthiarade (acidicA as well as tetracy.
protem plasma levels and a deemass in serum cholesterol cline, penictlha G. phenobarbital, thyrmd and thy- une levels. Although in man QUESTRAN (cholestyramme resin) preparations, and (igitalia N ducontinuan.w of produces an merease in hepatic synthess of cholesterol. QUESTRAN (cholestyramine reatn) could pahe a hazard to plasma cholesterol levels fall. health if a potentially tone drug such as &gitahs has been In patients with partial bihary obstniction, the reduction of titrated to a mainterara icvel while the patient was eerum bile acid levels by QLEFTRAN reduces exmss bile taking QUESTRAN acida deposited in the dermal tissue with resultant decrease Because cholestyramine binds bile acids. QUESTRAN may in pruntua. interfere with normal f et digestion and absorption and thus Indications and Uenge: 1) QUETTRAN is i*=ted as may prennt absorption of fat soluble vitamme such as A. D adjuneuve Wrapy to &et for h reduha of elevated and K. When QUEtrTRAN is ginn for long periods of time, nrum cholesterol m patients mth prunary by wrchulestar- concomitant supplementation with water mm:ible (or paren-olemia televated low density hpoprotein [LDL cholecaroD teral) form of vitamins 4 and D should be canadered) who do not respond adequately to 6et. QUIFT MN may be SLNCE OUESTitAN MAY BIND CyTHER DRUGS GitT.N useful to lower LDL cholesterol in patients who also have CONCURRENTLY, PATIEh"IS SHOULD TAKE (YTHER hypertrglycendemia. but it is not indated where hypertre DRUGS AT LEAST ONE HOUR BEIVRE OR 44 HOURS glycendemia is the abnortnality of nat concern. AFTER OutSTR AN(OR 4T ASGREAT AN LNTERVAL AS in a large, placetocontroDed, multi <:hnic study, the LRC, POSSIBLD'IV AVOIDIMPEDLNGTHEIR ABSORPTION.
CPP'!=, hypercholesterolemic sulycts tr=sted mth QUIS carcinogens 6a. Mutagensels and impenrment of Fort &ty In TRAN had sigmftcant reductions a total and now4ansity studies conducted in rats in which cholestyramine resta was hpoprotein cholesterol 1DIrCL Over the arvetryear study used as a tool to investigate the role of vanous intestinal penrel the QUESTRAN group expenenced a 19% reduction factors, such as fat, bile salts and nuerobial flora. in the de-in the combined rate of coronary heart 6sease death plus velopment of intestinal tumore induced by potent carcuu>
notefstal rnyocardial infarction (cumulatti, meidences of gens. the inndence of such tumore was otmernd to be gnater 7% Questran and 8 6% placebot The subjects included in m cholestyramine resin treated rats than in control ruta the sudy wen nuddle-aged men tage 3540 with scrum cho- The relevance of this laboratory observation from stubes to leeterol levels abon 265 mg'd! mod no pronous history of rats to the clinical use of QUINTRAN e not known la the heart disease it is not clear to what extent these findmgs can LRC CPPT study refernd to above, h total incidenne of be extrapolated to other segments of the bypercholesterole- fata] and non fatal neoplasms was sunilar in both treatment
! 4 mac population not stu6ed. groupa When the many dJimnt estegonen of tumors are q Dietary therapy specific for the type of hyperhpoproteine- exammed, various ahmentary system cancers wm some-4g nua is the in2tial treatment of choses Fm budy weight what more prevalent in the cholestyramine group b small o p" may be an important factor and calone restncton for wnght norma! nation should be addnmoed pnar to drug therapy a numbere and the multiple categones prevent conclusions gl from bems drawn. However,in new of the fact that cholas-OO the overenght N use of drugs ohnund be considered only tyramine resin is confmed to the GI treet and not absorbed.
@f) when reasonable attempta have baen made to obtam esta- and m light of the animal expenments referred to above.
( (D Q factory results with nundrug aw&da If the deemma ulti.
mately is to use drugs the panent should be metructed that further follow up of the LRC. cpl'T participants is planned
,( ::C this does not reduce the unportance of adhenng to 6et.
for cause-specific mertahty and cancer morbubty.
Pregnancy Smee QUESTRA.N m not absorbed systema-0 2* QUISTRAN m in6cated for the rebaf of prurtrus associ- cally, it is not espected to cause fetal harm when adm mm-DO ated with partial bthary obstruetaart QL1F!1 TAN has been tered during pregnancy in r--LJ damages Nrv are.
OO shown to have a vanable effect on serum cholesterol in the== however, no adequate and well controlled stu&es in pres' CM patienta Patienes mth pruna*y biLary cirrtes may exhibit nant women and h known interference with skrptaon of
- an elevated cholesterol as part of their d- fat soluble citamma may be detnmental even a the presence CD of supplementation.
Contraindications QL1371LAN e cimitramdicated in N patente enth compieta bthary obstruction where tale a not Wre6ng tAethere: Cautaan should be exerttand when g escreted mto h intsenne and in those in&vuhians who ha ve QUEffrRAN is administered to e nursms mother N posei-J
e b
O O
O
- s
- 7
%#$ 'g[6[a \ \
sg b i3
%t o\
gs t
- \,
- \ t O
- K,x\\p\o us ,
st gS vi J
,* ,~.
w cr z, 5 v 9
PDR im GnAlwRysmc consult revi ions pg g g // y ble lack of proper vitamin absorpuan described in fyoM OF REDUCTiom IN CHOLtsigAOL narsy" sectaan may han an effect on nuretag to AfDoCTON IN CORON ARY HEA'tT t
q , 'cho- Ped 6stric Usa Aa expenence in Lafants and '
DISEAM RISK Total
- d hd, a practacal dosage schedule has not bem bduction Ia d*ulating pedaatre doenge,44 4 mg of anh Cholesterol m CHD Rak CCN[/{ cyramme runn an catained in 100 mg of The effxte of long term drug administatmut a eng effect in mairheine lowered cholestemi levels e No.
439 496 towenac, 44%
11 5 %
10 M 26.1 %
39 3 %
92 r)(
( [d panents, are unknown.
Adverse Ramrtnomat N owat common adwres constipataan. When used as e i.holeswrol
_3 19 0 %
g2per besarch Chnics Coronary Prunary h+
Es ults (1) bduction in incidence of Coronary k h h)j predaspums factore for mmt complaints of high done and increened age (more tt.an 60 yees ab
@ N Relabonship of Mauon m inc>
Coronary Heart Ibesse to Cholesterol Ionenng 7 instances of canetipataan are mild, trarment, and 251.3M4 4 gg [ ' ,
f h- with conventional therapy Some pataents qquhe rary decrease in dosage or discontinuanon of t%.,
Imes Frequent Adverse Remetaana Abdomina!
u*f7 19" fistulence, nauma venutmg. diarrhea, heartburs 3 indsestive feeling and stantorrhea, bleedmg to hypoprothrornbanemas (Vitamin K deficieraf en rfensean)
Vitamin A (one case of night blindnem reporta0 gn ciencies, byperchlorenac acida, in children, j, renh and irntataan of the skin, tongue and One too month old baby with bihary atneia had as tion prestimed to be due to QUESTRAN M _
resta) after three days administrabon of 9 grans 44 i
developed acute intestanal arpas and dad Occasional calcifand material has been observed la ary tree, including calcification of the gall b;adem tients to whom cholestyramme reatn has been spea "
ever, this may be a mamfestation of the hver J - 4 6
drug related.
One pataent expenenced biliary colic on each of sions on which he took QUESTRAN. One pataset as acute abdornmal symptzen comples was famed as "
" pasty mese"in the trea.sverse colon on :-ray.
Other events (not necesarily drug-relate 6 repssend 9@
taents taking QUFERAN include-Gastrointamtmal-G rectal blechng black sendt rhondal bleeding, bles6ng fun known duodmai edun&
phagia, hiccu;m, ulcer attack, sour taste, pancreauma W pain, divertacuhtas Hematoksic-Decreased prothrombin tune, odysdB anemia.
Hypersensiuvity-Urtacaria, asthma, wheenns abasand breath.
BdunculoskeletaLBeckache, munde and Jotat Pussh 88" tis.
Neurologio-Hendache, anxiety, vertigo, daannesh tinnitus, syncope, drowemens, femoral nerve ps*,
sial Eye-Uweitta.
RenaWHematuna, dysuria. burnt odor to unen, Qd Escmilaneous- *Kesht kra, weight gain, incrosse swourc Orenlosage glands. edema, dental bleedmaOverdoange of QUISTRAN has d up reported Should tve damage occur, however, the M tial harm would be obstruction of the gestrotniassed .
The locataou of swh pow,ttal obstruction, the 8
structaan, and the prueence or absence of nortaal # ..
would detenr.tne treatment.
Dosage aM M=tnwention: ne reco dune u on+ packet er one accopful(9 grams of Powder contain 4 grams of anhydrous cholesty's one to sta times dai!y Damage may be adjusted as j, meet the patient's oseda QUEST R AN should not be taken in rts dry form QUESTRAN Powder wtth weier er other M beesting. See Properetton Instructions-Preparation: N ular of QUESTRAN "
ream)may vary somewhat from batch to betch, b8 y suon dose not affect of one the forformance packat or one le*3ofj the M d -
the contents QUESTRAN in a glass or cup. Add g- 34 ousous g,, sed the noer carbonatai benrage of your choeda ,# ,g untform consistency. '
QUESTR/,N may also be mixed eith highly M -
pulpy frurts with a h 4 mowture content such as or crushed ptneappla j Kew Supphed QUESTRAN is avadabis in j Sgram packets and in cans contaming 3*8 # t grams of QUFF BN Powder contain 4 g**88 #
t%nlentyramme resta. f O
VIC (08"onaC41 Cartons of 50 packets -
l NLC 00et068006 Cann,3*e gm ClirAcal Studiesc N N!H has concluded a 1 domund doubl* Wind pireebocontroued stud 8 renaard em on the effect oflowent.g pis8888 en sorceary hasrt daense (CHD risk <the r,k d nary deset or non-fatal myocardial mfarct#j lestem! was lowend by a combination of a tarol-lower:ms dat and QUEEFTRAN The dass taanah.ip between the amount of QUESTRAh a
thelowgnns pQ@ c]ho esterolanW i
% @)
1910 l Pr Winthrtp Bfoor>Crnt. LMN' Deseremad tw wmM= IM ** *d d "
Divuion oOterline N Inc alummum carinnate Magnesium hydrozade abould not be stend mth KANTE One case d gnad mal M O) 5 gj Mandacearei biertSg gasmanna, neem i m um -
uticals lac aeisure has been reported in a pabent with chronic hypocal.
camm of renal fadure who was gwen KAYEXAIATE mth arter 6f' m g magnesium hydroxide as laxative. Also, the simultaneous ti oral administration of KAYEXALATE with no=6arbable IGFT 1 : Nonal=
- caboo<iomsung antacids and taxat ves may reduce the res-bras 99tf hyo woMe teWts, an's ptassium eschange capabsbty.
Precautions: Cauuan is advised when KAYEXALATE t76, /, , is admWistered to patients whe cannot tolersta even a small Each teMet w . 10 mg or 15 40 olbydrw increase in amhum loads he, severe congesuve heart failure, chluppdf'apadh tegr pac w ofish severe hypertension, or marked odemat la such instances anecRarm audium. sudi asulfate per taNet as compenastory restnction of so&um intake fmm other antoxidant, etarch ta sou cas may b in&cated.
Hp o upph If constipation occurs, patients should be tasted with sort >
ISUPREL 1 Mtti j tal(from 10 to 20 mL of 70 percent syrup every two hours or as needed to produce one or two watery stools daily), a mes-L GlD le of 60 :
U ., g ' g ,6EE W 15 mg- sure which also reduces any tendency to focal impacuan. +
_ __ S .t y t.n Adverse Reactions: KAYEXALATE may cause some degree of gastne irntation. Anciezia, nausea, vomiting, and constipation may occur especially af high domes an given.
KAYEKALATE! B tino, hypokalemia, hypocalcemia, and significant au&um j brend of sodium polystynne autfonate. USP r4ention may occur Occasionally &arrhes develops large dames in elderly in&viduals may cause focal impaction tame Cation-Exchange Ramla uta cat h Act may be enated thmut usage d the resin in enemas as desenbed under Dtaage ad Admine trauon.Intestinalotstruct on due to concretwas of alu-
Description:
The drug is a hght brown to brown. finel3 , minum hydroxide, whnn tand in comtiration mth ground, powdered fo a, of ou& urn polystynne sulfonate, a KAYEXALATE, has been reported entioneschange restn prepared in the so&um pnase mth an Dosage and Ad=lalatration: Suspension of this drug an intro eschange capacity of approumately 3.1 mEq ha two should be fns% pnpared and om stmed beyond 24 houm approximately 1 mI4 of potassium per gram The su&um content is approximately 100 mg W l mE& per gram of the The average daily adult dose of the resin is 15 g to 60 g his drug is best pmvided by administermg 16 g (approzunately 4 leoel Acuan: As the team passes along the intestine or as re ta=aW of KAYEXALATE, one to four times daily. One tained in the colon aner admmatration by enema, the ao gram of KAYEXALATE contains (1 mEq of sodium, one sum ions are partially released and are replaced by pota> level teaspoon contains approximately 3.5 g af sium ions. For the most part, th s action occurr in the large KAYEXALATE and 15 mEq of audium. (A heaping teaspoon intastine, which emerets potassium ions to a gnater degne may contain as much as 10 g to 12 g of KAYEXALATE, than does the small notestine The efficiency of this procem is brand of sodium polystyrene sulfonate.) Since the sa vue s hmited and unpre&ctably variable It commonly approte diciency d sodium-potassium exchange teams is apoxv
& mates the order of 33 percent but the range is so large that mately 33 percent, about one third of the run's actual so.
V definitive indices of electrolyte balance must be clearly mon. dium content is being delivered to W body.
in smaller childna and infants lower doses should be em-d stion. KAYEXALATE is in&cated for the treatment ployed by using as a guade a rate of1 mR f potasuum per ce effecuve lowering of aerum potanium gram of noin as the basis for calculaw.,
with KAYEXALATE may take hours to days, treatment Each dose should be swen as a suspension in a small quan.
with tha drug alone may be insufficient to rs,ndly correct tity of water or, far greater palatability, in eyrup. ne seven hyperkalemia associated mth states of raped tassue amount of fluid usually ranges from 20 mL to 100 ml. de-breakdown (eg, burns and renal failun) or hyperkalemia ao pending on the dame, or may be simply determined by allow-marked as to consutute a me& cal emergency Therefore, ing 3 mL to 4 mL per gram of resin. Sorbitol may be adminis-other defmitive measures, including balysis, should always tered in order to combat constipation.
be considered and may be imperative. The team may be intmduced iso the stomach through a Senous potasium deficiency can accur fnm plastic tube and, if desired, mixec wi.a a diet appropriate for KAYEXALATE therapy. ne effect must be canfdly con- a patient in nnal failure.
trolled by frequent serum potasaium determmauers withm N resin may also be given, although with less effective each 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> period. Since intrace!!ular potassium dere resulta, in an enema consisting ifor adulta) of 30 g to 50 g ev-ciency is not always reflected by serum potasium levels, the ery six hours. E.ch dame is admmistered as a warm emulsion level at which treatment mth KAYEXALATE abouid be (at body temperature)in 100 mL oNqvsous vehicle. such as dismntmued must be determined ind.vidually for each sorbitol. The emulsion should be ag"ated gently durms ad-taent important side tc mahinf this determmauan are ministr suon The enema should be wtamed as long as possh patients clmical con 6uon and electrocar6arram Early ble and followed by a cleanung enema.
chnical signs of severe hypokalemia include a pattern of l trntable confusion and delayed thought procesmas Electrie ;
After an irutral cleansing enema, a soft, large sim Tnnch >
car 6agrapbcally, severe hypokalemia a often associated 1 2 nibber tube is inserted into the rectum for a satance of mth a lengthened QT anterval, mdenmg flattening. or sn. l about 20 cm, mth the tip well into the sigmoid colon, and eersion of the T weve and peomment U wevm. Also,carttiac .
taped in place N resin is then suspended in the appropre arrhythmias may occur, such as premature atrial, nadal, and ese amount of aqueous vehicle at body temperature and in- l wentneular contractions and supraventneular and wentrie- treduced by gravity, while the parucles are kept in suspen- I ular tachycardias N toxic effects of digitals an hkely to anon by tirnng N suspension is Cushed with 50 mL or 100 l
be exaggerated Marked hypokalemia can also be manifested att of Ausd, followmg which the tube is clamped and left in g by seven muscle wenknesa, at tunes extendmg into frank plam If back leakage occura. the bps an elevated on ptllows j paralyse er a knee < hest postuon is taken temporarily A numewhat IJke all cationeschange resina., KAYEXALATE is nd t* thicker suspension may be used, but can should be taken tally selecuve tror pocassumi in its actions, and small that no pasta is formed, because the latter has a greatly re amounts of other cations such as magnesiurn and calciurn duced exchange surface and will be particularly meffecuve if can also in- lost dunny treatment Accordmgly, patiente dew in be metM W& N sp-mWWW recewmg KAYT.XALATL should be monitand for all app F , g _
cable electrolyte daturbanem Systemic alkalosis has bee irngated mth nonao6um conta.nmg soluton at body tem-7, , j Persture in order to remove the ream Two quarts of flushmg
.p. "oral y in b ona rbabl cati o mg duturn may be necemmary ne ntums an dramed con-1 tQ antacids and taxauves such as magnesium h maide and
, stantly through a Y tube connection.
N mtensity and durmuon of therapy depend upon the as-Continued on nest pope versty and resistance of hypertajema.
E.AYEXALATE, brand of natum polystyrene sulfonate, This product informerer> sres effectree es of December 2. abould not be heated for to do so may altar the exchange 199g On theer and other products of WmthropBen prpperg,,, og y pyga_
Laborerpress. dershf Anformerson map 6e abesJned on e How Supplied. Jar of 1 pound (453 6 g) pureertf Assis br duect snouery to the Professionet Semoes MDC 002+10"M1 popeorment 90 Para Avenue. New Yort NY 10016(212] gw 2x A
, i