Free Motion for Miscellaneous Relief - District Court of Arizona - Arizona

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I I I I I I when slllnillcanl dlarrhea uncun, lhs drug should ha dlsuuntinund. Larga lmwul endoscopy
almulrl he cgmsldsrad tn establish a dsfinltivn diaqnusls in nasa: M sworn diarrhea.
f ' -' ® Antiperisgqltnc agents such as auiaies and diphenoxylate with airopine may pr0W0n¤ and/0r wurscn
O U the cundmon. annumypin has been 10unu zu be effective in the tmatmsm 01 amibiciicessuciatad
gseudnmeimbranuus rgolltisllarunulijud py irpsrnuéum agfrlii/ii {he usual gqult dosage ist5C;%rE§ tu
CLIN DA | ¤ ¤»~%l1""£.nW3»%°3¥"§§WQs3E,.’l§§lL5“&WW.‘v£§é° ZW; $1130 WW‘§§l1“§"W2L'1L°£%“Wl'3£n1¤‘§mln {Fe
N 1 /, tu be ggmlnimsred cnncurrsnuy, W1 may be advimlu to separatetheilme ufadministratiun cnf each
FUR EXTERNAL USE ONLY AVOID CONTACT WITH EYES "Y“¤-
1 m DIBITHQH. colitis, and pseudomsmbranuus ccliljs have been observed tn begin upto several weeks
1 DESCHIPTIDN only iullnwnng cessation ufaral and parenteral iherapy with clindamycin.
` Clindam cin Phosphate Gel, 1ur tn im! use, c¤n1a` nl' da ` W1 ha; , USR at ir · PHEMUTIUNS
tion aquxnalem to 1u mg ullnuamygirl per gram ms In mum D usp Q E cm-msn a General: Clindamynin phosphate should be prescribed wWth caution in atopic individuals.
Dlindamycin phosphate is a water soluble ester ur the ssml-synthetic antiniuun pmuueeu by a UW! |¤¥•¤’¤¤¤¤¤¥i ?"¤d¤W'¤F¤W¤ has ¤¤¤¤ 5h¤W*" TU WW-'E "¤L"'°mU$¤¤Ia* b'°°kW'W9 ¤'°¤°""°$ mm
TIS)-chI0r¤·suhs1Itu|1on 01the 7{R}·|1ydm;(y|gruup ur the param alllllllllljll |llll;¤ll·l»yl;ll_ mal/enhance jhe actncrl qf umer neuromuscular bluckmg agents, Therefore It should ba used with
The gal contains allantoin, carbuynar 934R msthylparaben. polyethylene glycol 400, pmpylene calmun m pmlems rmfvlng sum agents _ _
glycol, sodrum hydrnxlda and punfled water. Prunnulgclrt —Pragnancy Carsgary B. Rspruqucimn sgtudnes _havs been Ber-
*W= 5*~·=*¤*¤* *¤~¤¤·¤ 15 r¤¤~=¤·¤¤¤ ¤=*·=»= E%’l§"r%°!,Jl?g§§?§l$'W% WEEE F§W2§.§.W"W%"£W§§n"éilW'W¤2LE2lr‘lE'»5&ilWWl§'L?“»{‘;T’#»°W2 {»?$1’JL“i.'L‘lL“cWW‘?
P1-lz gamycin. '[her[¤ are,dh¤ulrever,tnd¤ adequate aim wail-célntinllenistudies Wn pregnanghworéwn.
ecause amma repro uctncn s u ies pre nut aways pr ic ive u human response, is rug
HAC H ll Cl should be used durrng pregnancy only a1 dearly needed.
~._ Nurslng Nlniham: It is not known whethsrclindamynin is excreted in human milk fullnwing use 01 ‘ `
\<\<0H3 clindswéygn phusppagg, Hewelxgerh orally awdthparenisiallrfadministereg ciindamycin h¤S bt-1BH
H 0 W repo a cl appear ln ream mi . ecausa 0 s lauren Wa ur serious a verse reactions in nurs-
' ` ` . decision should be made whether tu discontinue nursing urtu discontinue the drug,
H0 O aicuunt the importance ul the drug to the mother.
OH - Putumpg: gse: Salety and aifeciiveness in pediatric patients under thu age 01 12 has nut been
1 liscllz es as e .
V ADVEFISE REAGHDNS
°\P,°'1 lr: 1EbcIini?1qI lstudzges uf various furmulmiczlns nf CWJmdamy{:in Phosphate Tupicaiésclution businlg
FDH . Rgaeiemgnrinllzf an nar amwg c.umpara1pr rugs as c¤nt{¤§,IpetWents experience a num er 0
_ 0 gsm a verse ermatolugnc events [ses tab e sow].
Molecular Furmula: ClgH3,lGiN20BF'S Mglggular Wgighi; 50497 .
‘ The chemi¤aW name mr clindamycin phosphate is 7(S]~ch$0rn-7-deoxylincumynln-Zqahusprlate. Number Dr pawns mpomng mms _
CLINICAL PMRMAWLUGY ·»» Treatment Emergent Adverse Event Solutncnn Gel Lninun
ggwgggg 5_:g1g:tr:B1;c!?Br?§1$[;2?i$f:% Eiulgtnlvyzign v/Im rapid in viva hydrolysis converts this cum- '1=553 (M MMS [“',°] n=16u [rm
. ‘ B ‘ 11 1 10 17 11
Cross resistance has been demonstrated between clindarnynin and Iéncomyuin. Wtgglralég 7)] 1§é1U; 17 {T1;
, Anlauunism has been demonstrated between clindamynm and ¤ly:nr¤myl;an_ Burning/Iiching SD 11g # (—) # (-W
l Following multiple tupica: applications uf clmdamynin phosphate at a cuncentrati ` alsntt DW"°SS ws 1 ) 34 23} 29 18)
; 10 mgclindamycin per mL in an isopropyl alcohol and water solution, ve Iumslgélévuf cling 5[HIh°r%·l Sk- 26166}
W uqmycm are present nn the ssrum (D-3 ng/mL) and Jess than 0,2% uf1he recovered in I n-ESS ly In { ) ( ) [ )
1 urine as cdmdamycin. ` ‘ Sfgngecordeu E1 (H) * W') 11 (7)
W 5£R‘i3{§$%°?l§°WW§£’l—2a§C?E%"l2°”$2§}*%‘°“ '"§°’"°°'§£°“ ‘1“EW"L2 me Fm '?l°"‘ ”°"2'”"°*E"‘s
_ _ n n my 2 e coma ones or app nan u n mycfn hcnsp ate
]'0p•caiSc•Il.ntn0n fur4 weeks was 597 mcg/g 01 mmsdunal material ranl;le0·1490 . Clinda cin IW | ’ ’ ‘ ' W1 ` ` h |It' h` W1
gaVtggiswlfllgW51ggEFi_lf”g`€?¤E7T62G§€ff$m agnfs cuW'tums1psrlidI[|\ql§;slS_4 mc?,·ml_l_ gm lmygglds P{:yWén3d"$atl;i1;§¤W¤F¤ Wv admrnmred clnnuamycm as been assumawu wrt were Gl, ls W lc
cllndamycln B BE gc msg mm appmxlma By % m 2% Buuwmg ”p"°°1'°" °* Cases 01 diarrhea, bloody diarrhea and colitis (including pseudumemhranous colitis) have been
l ' reported as adverse reactions Wn patients treated with oral and parenteral inrmulatinns uf clun-
. Q | . . . . , . , . .
W is indicated in the treatment 01 acne vulgaris In view 01 the tanfal damycm and may with mpicm mmdamycm me WARNINGSL
fm diarrhea. bloody diarrhea and useudomamnramus annals, me pn mlm sllllulll Ennsfdgr Ah¤°'“'“a* PSWF and ¤?$U°*'“€$*'“€| d'$tUV¤¤"Q€$,i;$ We': a? ¤'3'?‘*}¤\?3¤¥N¤ !¤"*¤¤Wm$ MVS ¤’$°
R'g$téW§[sE¤é*gn are FNUVB appropriate. (See cuumnnnnlcgrrnnsl wglllllllllg ml 3¤:;£|F;¢;EE*¤ ¤$5¤¤¤&¤¤¤ WIU11 H use 01 tonrca urmu ations 0 c ln amycm.
c0HTH*|ND|cAT|D"sl TupWcaWiy applied clindarnycin topical solution can be absorbed in suHicien1 amounts tu product
Clindamycin Phosphate Gal is contraindicated in individuals with a hislury 01 hynursensihvfty to System Effem (seg WARNINGS
preparations containing ciindamycin ur Irnnumynlnl a histury 01 regional el-llmlls Of ulllgmllve wl. DOSAGE AND ADMINISTRATION
ms, ur an history 01 antibiotic-associaiad colitis. i}upIy;1 a thin Wilm uf Clindamycin Phosphate Gel twice daily t0 aifscted area. Keep container tightly
wnmuuss ¤¤S¤ -
Urallg and par¤nIgralIy_a¤minl¤ier¤d nfindamyuln has Icon assoulalsd lrflh ncvara culllls WDW SUPPLIED l l _ _ _ _ _
wm: may result an patmnt mln. use ur ans tamu! turmulannm ur nllnlamynln man; In Clrndamycvn Phusnhafe Gel cvntamrnu ¤|·¤d¤r¤y¤¤¤ ¤h¤S¤¤¤i¤ ¤¤¤¤·¢¤W¤¤¥T¤ WD ¤'¤¤ ¤W¤¤¤¤mY¤¤¤ W
anmlmun lu lh: amanmac frum lhs sum mmm. ummm, hlnndy umma. mu mus; mam is available ¤¤ *¤¤f¤W|¤wi¤¤ Sim
g*;:m:;l;il:`**¤¤¤¤¤m*¤¤¤¤ ¤¤***W*> hm ¤¤·¤ ¤•»¤¤¤¤ ¤W¤•• 1¤• Mw M i¤•»¤¤•l mf mremic sn glam mm unc uma-0202-so su gram was unc 0168-0202-60
Studies Indicate a InxI¤(:% produced blzglnstrldla is one prlmaay cause nl nntihlnllnmaociated stm at wmmued mum tsmpmme 15 30 C (59 86 FW Fromm fmm hmm;
MIIHS. The cnlllls I: una ly character d hy savers crsistenl dlarmea and snare abdominal
ora mln and may he asauclmd with tins passage al hnand and muws. Endnsnopln uamlnatlnn 5 Fpqgm 5 cl; EEOEBBA
mayavaal fseunlumumhrannus calltls. Stnnl nurture: fur Clustrldlum nllfllelln and mul assay ;`l;·lvl_;lg;l prgllaha lm; fas
, lor . dllint ¤ tuxln may hs helpful dlannmically. llqalllllléla NY lly4;· plllgq
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Case 2:04-cv—00644-JAT—LOA Document 47 2 Flled 11/ Q

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i Information for the Patient: Patients usin to ical corticosteroids should receive the lol-
1 . 9 D
1 rj;) ® lowing information and instructions.
1 1. This medication is to be used as directed bythe physician. It is tor external
gse only. Avoid contact with the eyes.
2. atients should be advised not to use this medication tcrany disorder other
E A 0 E y than torwhich it was prescribed.
\ 0_0257°I Q_'|7°’ 3. The treated skin area should not be bandaged og otherwise covered or
wrapped as to be occlusive unless directe by t e physician.
1 m 1 4. Patients should report any signs ot local adverse reactions especially under
1 on V occlusive dressing. _ - V _ _ 1 _
1 osscnrpncni rrramcanotone Aeetuntue cream use uoritsrnsrnerncinoione Acetoniue 5- F‘¤’¤¤*$.°l P¤d¤¤*¤¤ l>¤l¤.¤¤*S $*t¤¤*<* he 89*556 FM t¤ ¤5¤ light l•¤·¤¤ diapers
1 [Pregne-1,4-dlene-3.20-diorte, e-iiucror1,21-uinydrcxy-te,11-{(1-mathyietnyiioenei¤is· °* P'¤5l*·= PMS 01* 8 ¤h*'d being treated *¤ the ¤¤¤l>¤r ma- es time Qat-
i loxyi]-, (11|3,16c¢)-], with the empirical formula C21H11FO6 and molecular weight 434.50. m9“*$ ma? °°l'$ml-its °t>¤'¤$*V€ $955*095-
1 CAS 76-25-5. Laboratory Tests: The lolluwing tests may be helptut in evaluating the HPA axis sup-
_ · 7 * ’7 · 7 ‘—· 7 —· 7*1;*51 7 7 77 7 7V —· 7 ‘1 pression: Urinary free cortisol test; ACTH stimulation test.
| I I Carcinogenesis, Mutagenesis, and Impairment ot Fertility: t.ong·terrn animal studies
1 ly CH3 °€_,-·o.._c/ Glu rgpve not 1t>ecn_perfurrned to evrpluate ttlle carcinogenic potential or the et:1ect on fertility
y i-io 1 __O/ ~·e,CH1 toplca corticosteroids. Stu ies to etermine mutagenicity with pre nisolone and
~ ` hydrocortlsone have revealed negative results.
, H
l I EH, 1 P;1¤§l'l¤g¤y Caléggry C: Corticosteruids aaa genejralty teratogenic in laboratory animals
. w en a ministers systemicaly at reletivey low osage levels. The more potent corti-
l rh costeroids have been shown to be teratogenic after dermal application in laboratory ani- -
1 mals.T6l11eE:e are no adequate and well-controlled gudies irynregnant wpmen on terato-
4 » genic cts from topically applied corticosteroi s. Ther ore, topica corticosteroids
L -- Y -_ O, __ . ._ K, _. K,. _ ____ _ ._ Y K al should be used during pregnancy only if the potential benetitiustitiesthe potential riskto
Tnarncinolone Acetonide Cream USP, 0,025% contains: 0.25 mg of Triamcinolone the tetus. Drugs ot this class should not he used extensively on pregnant patients, in
Aoetonide per gram in a base containing Emulsilying Wax, Cetyl AIcohol,_ isopropyl large amounts, or tor prolonged periods oftime.
Palmitaui S°'b“°' S*'·"Lm°"'· G"/°°""· '—a°t‘° ADM B°"ZY' Alwhm am Purmgd Wan"- Nursing Mothers: It is not known whether topical administration ol corticosteroids could
Tri¤m¤i¤¤l¤¤¤ ·°*°°“’"iGE’ CF°?"'“ USR q·l?"’ °°"““i"S’ 1 mg °fT"a""°'“°'°"'B A°"J"?mdB result in sufficient systemic absorption to produce detectabte quantities in breast milk.
¤¤r sem ·¤ ¤ bass ¤¤¤t=¤¤·¤s E¤¤¤l$·lv·¤¤ WM- ¤¤*v* M¤¤l1s*· l5¤r>r¤¤v* •°¤l¤i·t¤*¤· syeemreiiy administered. corticosteroids se S6Cl'€‘l6d rms breast milk in quantities na
S°"b‘1°' S°'““°“· G'V°°"'“· '—a°“C Mid- B""ZV' ·°“°°"'°‘ and l"¤<·i·¤¤ Wale"- . Iikeh; to have a deleterious effect on the intant. Nevertheless caution should be exercised
Triamcinolone Acetonide Cream USP 0.5% contains: 5 mg`ofTrlamcinol0ne Acetonida when 101111:31 mrt1cDS1E1.01ds are adm1mS1erBd 10 E nursmg vjcman
per gram in a base containing Emulsilying Wax. Cetyl Icohol, isopropyl Palmitate; _ , _ _ ' V _ _ _
Sorbitol salutes, ciyeerin. tactic Asa. ssmyi Alcohol are Purified water. *’¤¤*=trl= UN- F'·=·=t¤frt¤ r>·=*·¤¤¢S m¤r_¤¤r¤¤¤Str¤*¤ sr=2¤¢¤r s¤¤<>¤¤¢·¤l#tr M =¤¤*·=·=l wt-
ci.inicAi. pnaamacotoovz Topical corticosteroids snare suit-trtrtammstory, enti-pru- ¤°S*B’¤*d·*¤¤¤¤€¤ HPA mils WPPPSSWU and Cueliings, $V¤¤"¤m° mail ’·"?**¥·'€ ¤¤'*¤”*‘5
ritic and vasooonstrictive actions. The mechanism of anti-inttarnmatory activity of the top- UBCJUSG Oi? ISFQEF Still'? 8U•'f9¤6_¤V§8 F0 DOW W¤#QhU21l¤- Ht•‘Q¤1h¤l¤l’¤l¤—DiiUll¤l‘y'·¤dYB¤-
ical corticosteroids is unclear. various laboratory methods, including vasoconstrictor Pl lHPA>?"'$ 5UPP'B55'°'?·_Cu“h"1QSS!l"*'!'°""°·and """€*°'a“‘a' h¥E
assays, are used to compare and predict potencies amdfor clinical elticacies ot the lopi- "P°[‘°d 'F‘ °h“q"°“ "°°'?""“Q ml-"°a] °°"“°°°?°"°ids· Ma"'"°'·*?u°“s.° rem s'·' .'
cal corticosteroids. There is some evidence to sug est that s recognizable correlation mn '" ':"'“dr9“ '"'zlude I""”m` 9'°‘”"h "°1a'da“°"·.°°'aY?d W€'9"!t gm".- mw pmsma CD'?'1
@11315 bmwsen V¤sOcOn51,1m,rpO1Sncy and thsrapquuc mgm in mam sol levels, and absence ot response to ACTH stiiréulaticn. Maniteetetions ol intnigrania
Pharmacokinetics: The extent ot percutaneous absorption ct topical corticosteroids is ·,_ hl;1P°_"?“5'9"' 'nclulie b'-"9‘F“J *°“*%1"‘€""’c‘=;*1;1.1'C1°$ *15**91% ba"? .b'?*°*"1_: |1’aP‘ °""'g1
determined by many factors including the vehicle, the Integrity ofthe epidermal barrier, A "“'"'*`?t"a“°U 01 t°P'ca*°?'1*cDSl9'°' Sm '_ ren 5 °*·' . B "m'F° tv t .3 $155* 5““"u
andthe use of occlusive dressings.TopicaI corticosteroids can be abeorbedtrom normal P¤mPat'D*°_ mth an BHECUVE msmpeum "°9'm€'“- Chr°"“° °°mc°Sl€"°' t map? malt
intact skin. Inflammation and/or other disease processes in the skin incwase percuta— 'm""`l‘="° “"“" ""E 9*0**}* and d°*’“'°P'“9“l °*°h"d"°“-
neous absorption. Dcclusive dressings substantially increase the percutaneous absorp- ADVERSE REACTIONS: The following local adverse reactions are reported infrequent-
tion or topical corticosteroids. Thus, ooclusive dressings ma? be a valuable therapeutic hy with topical corticosteroids, but may occur more frequentiy with the use ol occlusive
adjunct tor treatment ol resistant dermatoses (See DOSAG AND ADMINISTRATION]. dressings These reactions are lished in an approximate decreasing order ot occurrence:
Once absorbed through the skin, topical corticosteroids are handled through pharrna¤:u· buming, itching, irritation, dryness, folliculitis, hypertrichosis, acneiforrn eruptions,
kinetic pathways similar to eystemically administered corticosteroids. Corticcsteroids are hypoplgmentetion, perioral dermatitis. allergic contact dermatitis, maceration ot the skin,
bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily seco ary infection, skin atrophy. striae and miliaria.
mgntmf- S°"‘° °* WB *°¤‘°¤' °°'“°°S*°'°*°$ and ovsnoosaes; Tapestry apgred;¤Eag¤AsJte+rrg?1;¤m be absorbed in eurrieierit ameunu
· to oduce tem' effects e Fl I .
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the DJQAGE 115;; A1;:”1N15m$`“;N_ A 1 10111G Lmcted MSB as S 111111'11111 as 10110wS,
kmammamw and prurmc mannggmmns Di °°m°°s1Er°m`r°sp°nsh'° d°rmat°s°s` Triamcinolone Acetoriide Cream lj5Pp%y025% two to four times daily· Triamcanolone
CDNTFIAINDICATIONS: Topical corticosteroids are contraindicated in those patients Acgmmds Cream USP U -1% and 0_5ty; mic m11.1me11m6S dam, dapandigg on me SEVSF
wm" E hiS'°‘Y cf hVp”'Se“Sm""W °° aw °1 the °°"‘¤°“E'“S Of me F““pa'ah°“· ity ot the condition Occlusive dressings may be used tor the management of psoriasis
PRECAUTIONS: G°"°'al’ S.YSt“""i" °°S°'p“““ Of mplcal °°m°°$*""’idS has p'Y’d'·'°Bd I or recalcitrent conditions. ll an lntection develops the use ot occlusive dressings should
reversible hypolhaIamic-pituitary-adrenal [HPA) axis suppression, mariilestations of be d15c¤1111111_1Bd and ap111.Dp11a1E an11m1cmD1a11hémp1, 1,1s1111_11Bd_
Cushing’s syndrome,bhyperglycen·1ia, anrd glucosuria in so11t-1*te patients. Conditionsjgwhich Hgw S1-1pPL1ED_
augment systemic a sorption inc ude t e application ol e more potent sterol . use . ‘ . - - g -
over large surface areas, prolonged use, and the addition of ccclusive dressings. 1';a":§m°;3S:sM°t%‘§é §1z§[B$‘I£?1g‘D25% I%ag"P§;L":I€QBsA°m?{1‘31§
Therefore. patients receiving a large dose of a potent topical steriod applied to a large S0 g1_am1u11e5 NDC 0168000360 BO g1Sm1ub€S NDC 015B_DD0_1_BG
surface area or under an occlusive dressing should be evaluated periodically for evi- g 1 1_b1a1,S NDC 016a_m04_16
dence of HPA axis suppression by using the urinary tree cortisol and ACTH stimulation _ _ A _ U P %
l tests. lf HPA axis suppression is noted. an attempt should be made to withdraw the drug, Tg°”‘°'“°1!-1*1;*; 1f1’”'°“"*1°BSCB”11$‘ 1 E? · 0-5
to reduce the lrequency of application, or to substitute e lesés potent steroid. Recovery of 1 gram S DC ° ' ' ·
HPA axis tunction is generally prompt and complete upon iscontinuatlon ofthe drug. 11 __ 11 D
infrequently, signs and symptoms ot steroid withdrawal may occur, requiring supple- Sl¤(¤ ¤\ ¤0¤lT¤||€d l’0¤l'¤ t9mP¤Fa1l-W6 75*30 C (59 ‘B6 Fl 1
mental systemic corticosteroids. Children may absorb proportionally larger amounts ot Amid ¤>tl-TBSSWG htm- PF¤t°¤UV¤m ll'°¤Z•l‘ -
torgixl corticosteroids ar1d thus be gigore susceptible to systemic toxicity (See PRECAU-
Tl S-Pediatric sei. l irritation velops, topical corticosteroids should be discontin-
ued and appropnate therapy instituted. tn the presence ot dermatclogical inlections, the _ `2°215E [ "=2°2;g§7
use of an appropriate anti-lungal or antibacterial agent shoukil be tnstituted. lf a favorable i MELWLLE NEW YORK 111,47 · ' mm
response does not occur promptly, the corticosteroid should be discontinued until the '
infection has been adequately controlled.1G 1 I I I 1 H I
ver
7 is . ...-·- ;_t-e —·(
Case 2 ·04-cv—00644 JAT LOA D
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Case 2:04-cv-00644-JAT-LOA

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Case 2:04-cv-00644-JAT-LOA

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