Journal of the Pharmacy Society of Wiscons in • November/December 2009 • www.pswi.org
`
`Medications for
`Inn1ates
`
`2009 PSW Annual Meeting
`
`JJ
`
`I
`
`.1.
`Substitution of Generic Drugs foi
`Brand Name Drugs
`PSW Young Pharmacist
`Leadership Conference
`
`;
`
`WPQC: How Can I Get ln~olved?,; ·
`.,f.!: i
`' .
`
`-,~
`lume 12 • Issue 6
`
`0 3J.S3 003'M 3::>lf,ll3S Nll f1.L3ll
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`1 of 6
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`Almirall EXHIBIT 2031
`
`Amneal v. Almirall
`IPR2019-00207
`
`

`

`PbannacotberapJ' Perspective
`
`Dapsone Topical Gel for Acne
`
`by J''1,1ryA11n Sr,i,,,r, l'harmD
`Co/u,,:n Editor: 1,u \.t'rrnn,U'n. J-4S. PJ'h. Director, Unttr for Drug Po/iry Unit•trtif)• ofWtlc1J11Ji11 Ho1pita! ana' Clinia
`
`I ntroduction: Oral dapsone has
`
`been available for almost 60 years
`for the treatme n t of de rmatitis
`herpctiformis and HanS(:n's di$,:ase.
`H isco rically, oral dapsone had been
`used to treat s,:vere acne wlth doses
`of 25-300 mg d~ ily; however, che use was
`limited by hematological reactions incl uding
`dose-dependent hemolysis. Patients with
`glucose- 6-p h osphate d ehydroge nas e
`(G6PD) deficiency are more sensi cive to
`the hemolytic effecrs since rhc lack of G6PD
`can lead ro hemolysis and hemoglob in
`b reakdown. This limitari on led to the
`development of ropical dapsone therapy.
`Because of che risk associated wich oral
`dapsone therapy, the inicial FDA approval
`for t opical dapsone in 2005 requ ired
`screening of patients for G6PD deficiency
`prior to therapy initiation and monitoring
`of blood counrs and reciculocytes in patients
`with a history of anem ia. This requi rement
`was removed in 2008 an d the product
`(Ac.o ne, Allergan Pharmaceuticals) was
`re-launched in 2009.1
`Four primary factors interact co produce
`acne; sebum is produced by the sebaceous
`gla nd , Propionibacterium acnes, a gram
`positive anaerobe, colonizes the follicles,
`the keracinizacion process is altered an d
`inflammatory mediators arc rd cascd into
`the skin. 3 All fac cors lead co multiple
`sires for inrervemion in ;1cne creatmenc.
`Acne is described as either inflammatory
`or noninflammatory, based on the types
`of lesions that are present and patients
`typically may present with multiple lesion
`types. Infla mmatory lesions are described as
`papules or pustules while noninflam marory
`lesions are called comedones - either open
`comedo (blackheads) or closed comcd o
`(v1hiteheads).
`G uidelines for rhe management of acne
`focus on multimodal therapy, and therapeutic
`options are outlined in Ap pendix A o n
`page 75.)·5 A key poinc fo r the crcarment
`options include that topical therapies are
`the standard of care.' 1bpical retinoids ace
`
`. S~MMARY .
`.
`. .
`.
`:
`.
`.
`. .
`.
`,
`.
`,·
`.
`lndicat.io11~: Dapsone gel ls i!')dicated for the topical treatrne~t of acne vulgaris: . .
`.
`• ·_p ir~:·oapsohe sbould t,e a:pplied to affected are~·s·t.vr9<! daify and gently rubbed into ·-·
`: the. acne·areas·uritil no medica.ilon remains vfsi~le., ·.
`. : .
`. ; . .
`·
`· :
`::, ..• ·.
`· Monitoring parameters·: If no improvetnenfis seen. after 12 weeks of therapy, dapsone •
`. . ,
`.
`. ,
`. '.
`. . •
`.
`'
`..
`d <ipical should be discontinued.
`. Pidfatri~s: ihe safety and efficacy in ~hildren young~j than ~2 years ha~e not be~n
`.established
`.
`. .
`.
`.
`. . .
`.
`.
`. .
`•
`Pregna ncy Qategory: C
`, . •
`.
`Breastfeeding: Oral dapsone· is secreted In breast ml!k·and despite low systemic
`absorption· of topical (lapsone,. sysiernic absorption ot'ioptcal dapsone may occur.
`-· Us~ iri Tac"tati~ff women s hOUld tie ·done l'.lnty lf lh"EI potential"beneft.t•oiJtweighs the risk: • ·
`Contrainclications: None
`.
`.
`.
`.
`.
`.
`Precautions and Warnings: o;a! dapsone has dose-related ii'emolysis a hd hemolytic
`anemia and individuais with G6Pb deficiency a re. more ·prone to hemolysis. No clinically ·
`relevant hemolysis oi anemia was noted in patients treated \.;,;ih dapsone topical gel, .
`. II ·signs and syni.ptoms of hem.otytic ar,emia occur, dapsone topical get stiotild be .
`discontinued. Periphe;al rieuropattiy has been reported with oral'dapsone therapy,
`bui was not seen in clinical trials with dapsone topical"geL Ora[ dapsqne therapy has:
`been ·associated with. skin reactions which have not been observed in clinical ·trials ·
`With ~s6iie topical gel: ··
`· · · · · ·· · · - ·· · ,: · · · · · · ··
`·
`· · - · · • .. ;
`.
`Cost: The average wholesale price for a 30 gm tube of 5% topical dapsone gel ~
`£142.80; a 60 gm lube. is $297.50.
`·
`·
`
`impo rr-.i.nt since recinoids are useful for both
`comedonal and inflammarory acne. Benzoyl
`peroxide, in combination with clindamycin
`or erythromycin, helps to decrease bacterial
`resistance rhat may occur wich antibiotic
`therapy alone (oral or topical). O ther
`therapies such as salicylic acid or az.cbic
`acid are options; howeve r, their efficacy
`data are less robuSt. Topical dapsone was
`not included in che recommendations for
`rhcrapy at this ti me.
`
`PHARMACO LOGY/PHARMACOKINETICS
`D apso ne topical acts on ncutrop hi ls
`to interfere with messa ge sig nalin g
`by inte r rup ting recruirment of more
`neutrophils to dei:reasc the inflam matory
`cascade and to red uce the formation of
`neutrophil-gene r,ned demucrive oxygen(cid:173)
`bearing molecules that cause ski n irritation.6
`It is also thought that the gel delivery system
`may enh ance breakup of the sebum barrier
`to promote dapsone perm eation into the
`stratum corncum to act d irectly at ,he sire
`2 of6
`
`of inflammation. ~ 'hile o ral dapsone has
`antimicrobial activiry, topical dapsone has
`not been tested in vivo for an ti microbial
`acrivity.
`
`"The pharmacokinetics of si ngle-dose oral
`dapsone 100 mg were compared to topical
`dapsone twice daily fot 2 weeks.l Topical
`dapsone achieves levels rhat are I 00-fold
`less than oral da psone. Low systemic
`availability is noted, with topical dapsone
`and the metabolites of dapsone (N-aceryl(cid:173)
`dapsone) accounting for about l % of
`systemic exposure:. 1he long-term plasma
`dapsoneand N-acetyl dapsone levels remain
`consistent from week I to week 52. Steady
`Slat<: is reached withi n 2 weeks and levels fall
`rapidly upon ueatment cessation. The time
`ro reach maximum serum concentrarions
`(Tm) was 6 hours with topical dapsone,
`as compared to 3.8 hours for JOO mg oral
`dapso ne. Tbe maximu m concentration
`(C~,) was 19.7 J: J0.2 ng/mL for topical
`dapsoneand 1375 ± 517.3 ng/mL for 100
`
`

`

`mg oral dapsone. The d imination half-life
`for wpical dapsonc is 42 hours. Dapsone
`is metabolized 10 an inactive metabolite,
`N-acecyl dapsone.
`
`--·scare.
`0
`
`I
`
`2
`
`3
`
`4
`
`CLINICAL TRIALS
`Multiple sca!es tO assess and eval uate acne
`are available and there is no consensus
`which scale best ide ntifies effective/
`efficacious therapeutic in terventions in
`acne managemenr.7 The Global Acne
`Assessment ScaJe (GMS) was used in the
`majority of the dapsone topical studies. The
`5-poim scale is summarized below and the
`definirion of success varies. but typically is
`defined as none or minimal acne ar study
`endpoint. In most dapsone t0pical clinical
`trials, the definition of acne vulg-.iris was
`a minimum of 20 in Aamrnatory lesions,
`primarily located on the face. The GMS
`docs not assess scarring, impact on qualiry
`oflife and is invesdga1or-ra1ed, not patient(cid:173)
`rarcd.
`Drados and colleagues reported the results
`from rwo randomized srudies demonstrating
`the eHicacy and safety of dapsone topical. 6
`The multicenter, randomized, double(cid:173)
`blind, vehicle-concrolled, 12-week studies
`evaluated subjects age 12 or older with a
`diagnosis of acne vulgar is. Subjects needed
`berween 20-50 papules or pustules and 20-
`100 comedones above che mandible line
`at baseline to be eligible for enrollment.
`Subjects were excluded if chere was severe
`cystic acne, acne conglobaca (severe nodular
`acne), concurrent use of topical drugs, any
`therapy chat could impact acne, antibiotics
`or anti-inflammatory agenrs 4 weeks prior,
`syscemic im:nunosup pressants tha t arc
`known to impact acne, isotretinoin within
`past 3 months, allergy or sensitivity co
`dapsone, sulfa drugs, or excipients in gel,
`noc on effecrive pregnancy deterrent or
`srable hormonal contraception. Subjects
`were evaluated at 2, 4, 6, 8, and 12 weeks
`using the GMS, and assessing the number
`of total lesions, inflammatory lesions, and
`noninflammatory lesions. The primary
`efficacy endpoints were the proportion of
`parients chat achieve success on GMS and
`che mean percentage decrease from baseline
`in chc number of lesions.
`TI1ere were 1,506 subjects in clie dapsone(cid:173)
`treated group and 1,504 subjects in the
`vehicle-treated group. Approximately
`equal numbers of subjects discontinued the
`treatment in each group (15. 9% dapsone-
`
`68 J PSW NovemberlDecembor 2009
`
`Amou.ut .. , ....
`
`, . 40 0 . . .. . . •
`
`..
`
`...
`
`fABLE I. GLOBAl. ACNE ASSESSMfNT SCAl [
`..
`Descclptiq,i
`Ko ~:idenc:e of fads.) acne vulg--.i.ris
`few comedone.c: are presen t;
`few p:i.pules/pustules m2r be ?resent
`Several to many comedones ·arc present;
`a few papulcs/ pwrnies arc present
`Many comedones and papules!pusrules arc present;
`no nodulocrstic !esions arc allowed
`Signincanr degree of inAammatory disease; papules/ pusrules
`arc predominant fe~rurc; 3. tC:w :1od.ulocystic les.ions may be
`pre.sent; come<lones ra.ay be present.
`
`1'one
`
`:Yunimal
`
`Mild
`
`Moderate
`
`Severe
`
`treated and 17.5% vehicle-treated). Few
`dapsone-ueaced su bjects discontinued
`due t0 lack of efficacy (0.6%} or adverse
`events (0.4%). Most patiems (58.4%) had
`moderate acne and 33.8% had mild acne
`at baseline. Dapsone-treated patients were
`more likelv to have treatment success at 12
`weeks (p<:001). Dapsone•treated paticntS
`had greater reductions in noninflammatory
`and coral lesions at 12 weeks than vehicle(cid:173)
`treated patients (p<0.00 I). Response was
`seen as early as 2 weeks and was significant
`for reduction in inflam matory lesions ac
`week 4 (p=0.008). Overall success rates at
`week 12 arc summarized in the table below.
`Adverse events were reported by 58.2%
`of dapsonc-treatcd patientS and 58.6% of
`vehicle-treated patients; most evems were
`mild to moderate in intensity and did no t
`result in cherapy discontinuation. Most
`commonly reported events included dryness
`(20% dapsone, 18.9% vehicle), erychcma
`(16.3% dapsonc, 16.1% vehicle), burning
`(1.4% dapsone, 1.6% vehicle) and prurirus
`{1 % dapso ne, I .3% vehicle). O ther
`non-application sire reactions inch1ded
`nasopharyngitis (4.8% dapsone, 6.3%
`vehklc), headache (3. 1 % dapsone, 3.3%
`vehicle), upper respiratory infection (3.2%
`dapsone, 2.9% vehicle) and pharyngitis
`(2. 5% dapsone, 2.6% vehicle). No
`hematological laboratory abnormalities
`were noted in the trial.
`The study only assessed the s hort(cid:173)
`term efficacy of dapsone topical and only
`evaluated monotherapy. This study was
`
`listed in the package labelj ng; however,
`patients with minimal acne at baseline were
`nor included in , he analysis presented so
`numbers and success rates may differ.
`'The long-term safcry of dapsone was
`reported by Lucky and colleagues; efficacy
`was also reported, but was not a primary
`scudy endpoint.9 The multicenter, open(cid:173)
`label non-comparative 12-monrh study
`assessed patienrs age 12 and older with a
`diagnosis of acne vulgaris. The exclusion
`criteria were similar to Draelos et al."
`Assc$smencs occurred ar 1, 3, 4, 6, 9 and
`12 months and included acne lesion counts,
`inflammatorv lesions, noninflammatory
`lesions and ~ocal lesions. T he primary
`analysis was safety; however, efficacy was
`evaluated as mean percent reduction
`from basdine in lesion counts. The study
`protocol allowed for courses of antibiotics
`or ami-inflammacory agents for shore ,erm
`use and if afte r 3 mon ths, systemic or
`topical acne therapy was deemed necessary,
`add-on therapy was allowed and recorded
`a.s "prohibited concomitant medications.~
`There were 506 subjects enrolled in
`che in1en t-10-crea1 population and 340
`(67.2%) completed the trial. There were
`15.6% of subjects lost 10 follow-up and
`0.8% d iscontinued chc smdy due 10 lack
`of efficacy. A total of 11 1 subjects (22%)
`used prohibited concomitant medications
`during the evaluation period. Dapsone
`was well tolerated with 68% of patients
`experiencing an adverse event, with 9.5%
`of the events deemed related to dapsone
`
`TAB! F 2. rFRCENT Of P,HIE!\ rs AUIIE\,INl, GAA~ SlJl.l.LSS \\'H.K 11
`
`Vehicle gel
`
`·, ~udyl -.'
`
`44.2%'
`
`35.9%
`
`Stucly2
`36.9%'
`29.S%
`
`· -.-,· Combmediwtlts .
`10.S%'
`32.8%
`
`3 of6
`
`

`

`fABLE .i. CHANGE IN LESION COlJNTS
`.. .... ..... ....... ,.,
`. · -· .. 8asclui~ (n~so5) .. I 2 'm.i>nr.h'• (~--337)
`M~a:n l ;e:stbn <":..olihu : .. .
`13. J ( l.1j
`18.4 (i)·
`{n!:a..11~mato1y lesion counrs, n (SE)
`Noninflammatory lesion counts. n (SE)
`Total lesion counts, n (SE)
`
`25.l (1.9)1'
`-13.5 (2.5)'
`
`38.5 (1.9)
`
`86.6 (2.6)
`
`SE-= m.ndard <1tor. 'p<U.001. 11p,<0,002
`
`therapy. D ryness, rash, sunburn, burning
`and eryrhema were th e most common
`adverse events reported by 2.9%, 2.5%,
`2.3%, 1.6% and 1.6%, respectively. The
`reactions were reported as mild to moderate
`in intensity by 90% of che pacien rs an d
`scudy disco ntin uation due co reactions
`occurred with l O patients overall and those
`reactio ns occurred early in the first few
`weeks of rhe study.
`Efficacv as .issessed bv mean lesion
`co unrs ov~r rime is summ;rized in table 3
`above. Inflammatory lesions were reduced
`by 58.2%, while noninflammatory lesions
`decreased by 19.5% and roral lesions by
`49%.
`A post- hoc analys is ass essed the
`parienrs that had "p rohibited concomitant
`medications" use during the trial and
`their outcomes d id nor di ffer significantly
`from rhose without prohibited meditlltion
`use. "JJ:,js study w.is primarily designed co
`evaluate long-term safety and, therefore, was
`open-label and did nor have a comparison
`group.
`~ As a subset of che overall randomized
`studies as reported by Draelos and Lud.-y,
`che s:afery and effica<..)' of dapsone therapy in
`adolescents (age 12- 15 years) were reported
`by Raimer. '° Of che 3,5 I 6 enrollees. there
`were l ,306 adolescem patients chat were
`in cluded in the p ivotal trials and the satecy
`trials as described above. Less than 2% of
`adolesce ncs discontinued rhe scud ies due to
`lack of efficacf or rolerabilicy. The p ercent
`reduction in ~cne lesions is summarized in
`cable 4.
`Success, as defined by a CAAS equal to 0
`or J was achieved bv 40. J % dapsone-rreared
`adolescents comp;;ed co 28.2% vehide(cid:173)
`treared adolescents, p<.001. "These resulrs
`were similar to the adult population. Safety
`results were not different for adolescents,
`with applicadon sire reactions being
`ceporccd by 2% of adolescents.
`
`ADVERSE EFFECTS
`Pierre er al e"aluated 64 patien ts with a
`diagnosis of G61'D defic iency using topical
`
`dapsonc for acne vulgaris 10 assess chc
`hematoiogic safety of topical dapsone."
`Subjects were rrcared with dapsone topical
`or vehicle for 12 weeks, followed by 12
`weeks of the alternate cherapy after a 2-week
`washout period. Plasma dapsone, N-aceryl
`dapsone concenrracions, hemoglobin,
`bilirubin, reciculocyte counts, haproglobin
`and lacca te dehydrogenase levels were
`assessed at baseline, 2 weeks and 12 weeks
`for each creacmem. 1he largest decrease in
`hemoglobin was 1.7 g/dL during vch,cle
`creatmenc and I.5 g/dl duri ng dapsonc
`trcarmenc. Only 5% (3/56} of subjects
`had hemoglobin concentrations decrease
`below normal during both treatment phases.
`Overall, the mean decrease in hemoglobin
`from baseline was 0.32 g/dL afrer 2 weeks
`
`I AIU I· .. ,. J>rR<TNT RU>IJC: no:-.: IN
`I L~ION Oll'N rs FROM BASn INI'
`· TYpc ofi_esion
`Oapsone Vehicle
`gel
`gel
`-36.8
`-44.9'
`-i5.8
`-26.9'
`
`Inflammatory lesion
`Noninl!ammacory
`lesion
`-34.6·
`Total lesion
`'p<0.001 AVOVA u, ing k .m ll'Qu.1n:J noc;,l~
`
`-248
`
`of dapsone therapy. No ocher laborntory
`changes occurred in ihe study to suggest
`cli nicaUy relevant hemolysis and no clinical
`signs or symptoms of hemo lytic anemia
`were reported.
`Local side effects included dryness
`(14%), erythema (9%), and oiliness/peeling
`(13%) and were reporccd as mild d uring the
`clinical trials.' Most reported the incidence
`of applicadon sire event as m ild and similar
`local effect~ were reported in the vehicle(cid:173)
`tr~ued grou p. One patient nored facial
`swelling during a clinical trial wich dapsone
`topical and d iscominued rherapy.
`Systemic effec1s norecl i ncluded
`psychiatric effects (suicide attempc,
`depression and tonic-donic movements).
`In clinical trial~, 9 of2372 dapsone-rrcaced
`patients compared to 3 of vehicle-created
`
`4 of6
`
`pa:icncs reported depr:~ion. Psychosis was
`also reported by 2 of 2372 dapsone-ueared
`patients and non~ in rhe vehicle-cre:ncd
`group.
`
`DRUG INTERACTIONS
`When used in combination wi th oral
`trimethoprim/sulfamcchoxazole (TMP(cid:173)
`sulfa) double s1m1g1h 160 mg/800 mg,
`the levels ( based on area-unde r-the(cid:173)
`curve concentrations} of dapsone and ics
`metabolites increased by 40% (dapsone)
`a nd 20% (N-aceryl-dapsonc); dapsone
`hydroxy lamine was more than double
`the systemic exposure wirh TMP-sulfaY
`The Tm,, of dapsone and its metabolites
`remained unchanged with TMP-sulfa. The
`combina1ion of oral Ti\fP-sulfa and copical
`dapsone may inc rease the likelihood of
`hemolysis in patients with G6PD deficiency.
`Oral daosonc or ancimalarial medicarions
`should ;or be used in combination with
`topic..-il dapsone because of the increased
`potential for he molyi:ic reaccions.
`When d a psone gel is appl ie d
`i n combination wirh topical benzoyl
`pe roxide, a tempora ry local yellow or
`orange discoloration of the skin and fucial
`hair was reported by 7 of 95 subjects; the
`discoloration resolved in 4 co 57 days.'
`
`DOSING ANO HOW SUPPLIED
`Dapsone oopical is formulated a. an aqueous
`gel wirh each gram containing .50 mg of
`dapsone and is avai labie in a 30 or 60 gram
`rube. Dapsone should be applied to affected
`area.s twice daily and gently rubbed inco
`rhe acne areas until no med icacion remai ns
`visible. If no improvement is seen afte r 12
`weeks of tlierapy, dapsone topical should
`be discontinued.
`Muhiple options a.re available for the
`management of acne and are summariied
`in the table 5 on the next page. Each
`produ<..'t is available in multiple form ulatlons
`(cream, locion, wash, gel, ointment, etc),
`va rious concentrations and container sizes.
`Products may last longer than one month,
`depending upon area of coverage so direct
`cost comparisons from p roduct ro product
`below may not apply.
`
`CONCLUSION
`Allergan, the manufacturer of dapsonc
`to pical c ream, rece ntly was sent a
`warning lener from die FDA regard ing
`advercisemenrs rhac appeared to be false
`
`

`

`or misleading because it overstated the
`efficacy a11d safety of dapsone copical gel."'
`The ad did not adequately address rhe
`drug interactions wich ben1,oyl peroxide
`(temporary skin and hair discoloration)
`and O\'Crstate<l the eflicac}' which was not
`supponed by clinical ,rials (sraced thac the
`drug "worked fast," with a substantial effect
`ar 2 weeks}.
`Guidelines for acne management
`em phasize multimodal therapy. None of
`rhe guidelines specifically mention a role
`for dapsone, although ic lits into rhe anri(cid:173)
`inflammatory and antimicrobial category.
`Dermatologists are interested in the use
`of dapsone top ical since it is an additional
`option for :herapy; however, they have
`limited experience with its llSC at 1his time.
`D apsone is a new entity for the
`management of acne that is now available
`in a ropical formulation co bypass the
`hematologic complications of oral dapsone
`therapy. The available clinical trials have all
`assessed dapsone topical as monotherapy
`only and potential inceracrions (positive
`o r negative) with other t0pical acne
`formulations ha\'e nor been investigated.
`Future data regarding combination with
`benwyl peroxide and treti noin products will
`be coming soon as per the manufacturer.
`Because of concerns about long-term oral
`antibiotic use and bacterial resistance,
`dapsone topical offers an alternative for
`those who have had suboptimal response
`with cu rrendy available therapies.
`11
`would likely be used in pa tientS that have
`not tolerated bem.oyl peroxide or the
`antimicrobial agents and would nor replace
`trerinoin products. Multiple topical options
`are availa ble for management of mild ro
`moderate acne. Lack of comparative data
`with dapsone limits the 1herapy co patients
`who have not had success on other more
`cost effecrlve ueatmenr options. •
`
`MaryAnn Steiner is a Senior CHnical l'harmaci$[
`in rhc Center for Drug Potier, Un iversity of
`W isconsin Hospital and Clinics, Deparmiem of
`Pharmacy.
`
`REFERENCES
`1. Ac.tone~ {d.2;,sone). f pxk.a._~ imc1t,. lr\•inc. CA:
`• .\ii~:\: Revbed Seprcmbct 2008.
`2. 'fh!boutnt DM, \Viilmc I. Sharata H. ( t aJ.
`Vh,rm.Jcoidnccia. of d•pson; gd. ) \I,!) for ,he. 1rc;11mcnt of ~,c
`'-'Ule;;1..;$. Clin i>h:armw'lkinct 2{:<)7~ /4":697-712.
`:}, :-lhibou-=or O. GolirtKlr M, OOmli V, (l al .~ in~igtm inm
`the l'!Unagt>.men! of aC'ne: An update from 1he C.!ohal Anl.an(,(
`ro !,nprow Ou~es in A.:nc Gmor , J Am Ac.ad f">(,nurol
`200-); G,&t5, !iuppi 1;:S~-SS-0.
`4. St,:iuss JS, Krowchu.k or. l<r&n JJ. (' I .-J. Gu1<k:ines of
`
`70 J PSW November/December 2009
`
`· Dru~·i'>rod&ci .... .
`saliciic acid
`
`Specifit -~foiluct · · +•M • ..
`num~rou..s OT'C pw;.h.u:ts
`
`T.\Bll ~- TRE,\T:\-IF.NT 01'1 IONS FOR ACNE
`Mc~h·afitsni(Ofic1·ion &tiniatcci AWP ·· ·· . ..
`V:i.rks by product, ail
`com«lol,-tic
`rcl2.1ivcly incxp.:nsivc-
`
`bcnzoyi peroxide
`
`l:lrevox-yi 4% gel
`42.5 i,ram,
`
`c.lind•myci n/
`benzoyl peroxide
`
`lknzadin I %/5% gel
`35 gram pump
`
`cryrhromycin/
`benzoyl peroxide
`
`!knz;,mycin 3%15% gel
`/46.6 grams
`
`$89.25
`
`$ 154.88
`
`$217.16
`
`kcra mlyric efftcts.
`antimicrobial .tctiviry,
`an,i-infla.mmawry,
`helps to de,:riasc
`bactcrhd rc..sisr:incc
`in comhinnion wi:h
`1ntimicrohi:1!.c.
`
`antimicrobial Jcrivity.
`aJH i-ir1Ham nnlury.
`helps t0 decrease
`bacrcrlal resl.>rnnce
`ir. combination wir.h
`antim icrobirils
`
`a.ruimiCrobial activit)'(cid:141)
`a.n ti-in Rammatory,
`help; 10 decrcnsc
`bac,crial resistar.ce
`in combi nation with
`anrimicrnblal~
`
`sulfac.ernmide sodium Klaron I 0% lotion
`10%
`118ml
`
`a_nrimicrobial .1c1iviry
`
`$126.02
`
`rretinoio
`
`0.025% cream
`0.05% cream
`Re,in A Micro 0.1% gel
`45 grams
`
`inhibit
`microa,,mc-done,
`anti~infiammacory
`p roperties
`
`a<lapalcnc
`
`O ificrin 0.1 % cream
`45 grams
`
`inhibit
`microcomedone,
`anri~inRammarory
`propcrries
`
`S53.20
`S78.86
`$182.55
`
`Si99.50
`
`a:tdaic acid
`
`Aulcx 20% cream
`50 grn ms
`
`comedolvtic ~nd
`ancimk~bial activity
`
`5179.(;8
`
`ad.ipa!ene /
`benzoyl peroxide
`
`EpiDuo 0. 1%/2.5% gd
`45 grams
`
`inhibit
`microcomcdonc,
`anci .. inAnmm::irory
`propc:rtic.~.
`3n!imjcrobfaJ aaivlry-
`
`ra1.arott"nc
`
`dapsonc
`
`lazorac 0. I% cream/gel
`30 grams
`0.05% crc:am/gcl
`30 grams
`Acwnc 5%gcl
`30 grams
`
`inhibit
`microcomcdonc,
`anti..,lnf!ammatory
`propcn ics
`
`anti-inflammatory
`propmies
`
`$209.49
`
`$145.80
`
`$137.24
`
`Sl42.80
`
`a rc for acne" "·ulgaris managcmcnr. J Am Aud i)ermaml 2007:
`SMSJ,663.
`5. b<"ngkin AL. l hibou:01 l)M. t.Kr<tt C:i'lmmit1tt
`r«omm:ndatiom :Or acnt man:as<mcot. P~iarri.;'.4 2-006:
`118,l !SS•ll99.
`6 . Ao ;:,~ Gtl AMCP Fe>rmu1ary Oouirr. Al!C'tga.n (nc;:,;
`Rc,·isc.1 Ooobcr 2008.
`i . Tan J, Cum:m :..i~".tHl.fl,.~ f<x the c"a.la:1iio:J uf ;awc s,;,-cricy.
`Expert R.:v ~rm:uol 2008: 3:$9$·603.
`S. Dradru 2, Uth.'f E. M..,loru.-y JM, c:1 al. Twu r.1ntk,miv.cd
`n t.:JlQ \.~OhH~\\r.,tc thr: \'.ffi ... ~y ar~ ~ainr uf tb:pwn.: ~d. S%
`for rhc 1rCJ:cmc:ttt1'f acn,c ,·ulll::i.r:.s. I AJri Ac.J Oc:rmatvl 2007;
`;.6:459 r:i •r:10.
`-
`.
`
`9. Lucky A. Maloney JM. Robcm J. « al. Da!)SOnt gel '.,% for
`,he «e21mcn; o f acne w!g.arij! ufcr;1.1nd efficac:y of lont!crm
`(1 )'t21r) o~:i.tn~nt. J l)u:g (k rm 2o07: 6 :98 1~9S7.
`I0J U,imcr S, Ma!OrK)' J.\f, Bourcie.r .\i. et ;il. F.fficacyand
`sa.fco/ of d.ip,$0!1c ;d 5% fo! the tr~itm~m oi , cot vuJs;ris in
`;1doks,c;:enN. U :1is 200$: 8 1: 17 1- 1?&.
`I i.Pi~ut: W'N', Tay!or S. Parise~ 0. -::"t :1}. Hcm~u:,!,ogk $t.ftl) of
`d:ipiM,: g,:t 5%, for IO('ical rrc.a:!'n(nt oi ;m1c vu!t.i(:$. . .\.ic-h
`Dc...,m:uot 2008: t -i-4:1'>64--1 570.
`12.US fl)OO :1:r'M.I Drug Ac.lnil,,ist.r.11ion. l1n~ 'C11o t1s ,
`Cuinj)l::uu:,:, Ei,f .. ,n:c!nc:,:, :w..i Cdrt:1in:,.! Jn..,:•tl~,,ni(IO~
`Avaibl>tc ~,: h1rp://...,-ww.fJ a.11•tiv/lCE.CIIEnfon.:cmcnLl\i.:tivnJ
`\'V.a.rr.inK.Lcnc"N/ u cm 17'>7\)'::1.htm. :\c,.,:\¾J: :\1,1,g1,0t 17. 200').
`
`5 of 6
`
`

`

`J.e,ion Type
`
`-·
`
`t ~t choice
`
`:\h ematives
`
`APPENDIX A: GLOBAL Al.LIANO A('Nl. TIU:ATMFN I AI.GO!tlTI IM·
`~~ - .
`Comc<lo nal Mix«i and Papula r/Pu,cular Mixed and Papuhr/Pu.mtlar Nodular
`Nodular/C'.onglobata
`
`Topical
`rednoid
`
`Topic>.! rc1inoid +
`topical antimicrobial
`
`Ah topical
`Air topical rctinoid or
`rerinoid or
`amimicrobfa] +
`azebic acid or other topical rctinoid or
`a,.elaic acid
`salicylic acid
`
`Or,.I 3n tibiot.ic +
`topical rc:rinoid ±
`BPO
`
`Alt oral antibiotic •
`ah topical retinoid t
`BPO
`
`Orai ancibiotjc + copicaJ
`rctinoid + BPO
`
`Oral iso u etinoin
`
`,
`
`Or.tl isocre:inoin or ah
`oral andbiodc + al[ mpkal High dose oral an1ib:oric + ,
`topical minoid + ll PO
`:
`:etinoid ± SPO/aielajc add
`
`Alternatives for females As above
`
`As above
`
`Oral anriandrogcn +
`ropical recinoid/a1.dsic acid
`.t mpica1 .;nrir.:icmbial
`
`Oral antia.ndrogw • ropical
`rcrinoid/± ora! antibiotic :t
`ale onr,m icrobis l
`
`High do~ oral
`antiandrogcn + topia1J
`rctinoid ± alt topicaJ
`antimicrobial
`
`.'
`
`Main rcnance cberapy
`1 5.PO• bc-n:a:.yl pctu.Ud.:; Ake :i.itan:uc:
`
`Topical reriooid
`
`Topic.al rctinoid :1 llPO
`
`$uppo~~ our adve_rtisers
`
`• McKesso~
`Boy-Seii a Pharmacy
`. Ministry Health yare_.
`Columbia St. Marys .
`.
`. .
`Phartr,acists Mutual Co:
`.
`Froedtert. Hospital
`·· -!.:al<eCountry Systems · ··:" --PharmacyOua!ityCommiim8l1i·- ·· :, • .: ..
`Medical Staffir.,g Network
`.
`.
`.
`
`ADVERTISING iNFORMATION
`· Adi, ,on1,:ac;s. im.ertfr~n ~Tflm. paxm,m~. n11d all q1htr tV!llfed ·,"'()mm,;ni,a~itJ~J
`can I,, ,.,;,ue,ud :tt 60,J-827-9100. •• infa~m.;.ort· · : · ·
`·
`~NV/.PSWlDRG.<CO~Mv'NIC~~JON~KETING.POF .
`
`C1lendar
`
`February 23-24, 2010
`PSW Legislative Day
`Inn on the Park, Madison
`
`.·
`March 5-6, 2010
`Immunization Training for Pharmacists
`PSW Headquarters, Madison.'
`March 16-17, 2010
`PSW Senior Care Conference ·
`Country Springs Hotel, Wauk~sha .
`April 22-23, 2010
`PSW Educational Conference
`Monona Terrace, Madison
`
`August 26-27, 2010
`Immunization Training for Pharmacists
`NEW Holiday Inn, Stevens Point
`August 26-28, 2010
`PSW Annual Meeting
`NEW Holiday Inn, Stevens Point
`
`Oc1ober 22-23, 201 0
`Technician Educational Forum
`Olympia Resort & Convention Center, Oconomowoc
`
`As 2009 comes tu an end, PSW would like lo
`thank all uf our members and advnlisl'rs fur
`their continul'd support.
`We wish you all a very happy 20 IO!
`
`PJJ\i Ol' r1AK.E5 JA.Bl.l:
`
`Vaccine Timing
`
`Combination
`
`Simulraneou,
`
`Minimum ln t~rval
`(if no, simultaneous)
`
`Two Jnacciv:ued
`lnactivam:I and Live
`
`Two Live
`
`Yes
`Yes
`Yes
`
`None
`N('l:ie
`
`4 weeks
`
`6 of6
`
`