- Journal of the Pharmacy Society of Wisconsin 0 November/December 2009 - www.pswi.org
`
`Medications for
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`Inmates
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`-
`
`O4
`
`2009 PSW Annual Meeting
`
`24 Substitution of Generic Drugs fq
`Brand Name Drugs
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`29
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`PSW Young Pharmacist
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`Leadership Conference
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`35 WPQC: VGalet Infirolved
`{42"
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`lume 12 - Issue 6
`[ume 12 . Issue 6
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` GHLSHHDEIH HDIAHEIS NtifllEiH
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`1 of 6
`1 0f 6
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`Almirall EXHIBIT 2013
`Almirall EXHIBIT 2013
`Amneal V. Almirall
`Amneal v. Almirall
`IPR2018-00608
`IPR2018-00608
`
`

`

`Dapsone Topical Gel for Acne
`
`&y ?laryAnn Steiner, PharmD
`
`Cot~mn Ec:itor: :~’e Verrr~e~den, ]dS, P.Ph, Director, Center ~r Drug Po[iej, gniversily of =Y/’.scomin Hos?ita] at!r! (.Tinics
`
`I ntroduction: Oral dapsone has
`
`been avai]able ~br almost 60 years
`for the treatmen t of dermatitis
`herpetiformJs and Hansen’s disease,
`Histo ricall?; era! dapsone had been
`used re treat severe aene with doses
`of 25-300 mg daily; however, the use was
`limited by hematological reactions including
`dose-dependent hemolysis. Patients with
`glucose-6-phosphate dehydrogenase
`(G6PD) deficiency are more sensitive to
`the hemolytic effects since the lack of G6PD
`can lead to hemolysis and hemoglobin
`breakdown. This limitation led to the
`development of topical dapsone therapy,
`Because of the risk associated with oral
`dapsone therapy, the initial FDA approval
`for topical dapsone in 2005 required
`screening of patients for G6PD deficiency
`prior to therapy initiation and monitoring
`of blood coun ts and reticule .cytes in patients
`with a history of anemia. This requirement
`was removed in 2008 and the product
`(Aczone, Allergan Pharmaceuticals) was
`re-launched in 2009)
`Four primary factors interact to produce
`
`SUMMARY
`Indications: Dapsone gel is indicated for the topical treatment ot acne vulgans.
`" Dose.’ Dapsone should be applied to affected areas twica dai’y and gently rubbed into ....
`the aene areas until no medication remains visible.
`Monitoring parameters: If no imDrovemen’, is seen after 12 weeks of therapy, dapsone
`topical should be discontinued.
`Pediatrics: The safety and efficacy in children younger than 12 years have not been
`established,
`Pregnancy Category: C
`Breastf, eeding: Orat dapsone is secreted in breast milk and despite low systemic
`absorption of topical dapsone, systemic absorption ot topical dapsone may occur,
`use ifi lacta~ihg ~v6;-fleii Should be doneonly ffthe potential benefit oub,~eighs the risk.-
`Contraindications: None
`Precautions and Warnings: Ora! dapsone i~as dose-related hemolysis and hemolytic
`anemiaandindividualswithG6PDdeficiencyaremorepronetohemolysis. Noclinicaily
`relevant hemolysis or anemia was noted in patients treated with dapsone topicat gel.
`!f signs ana symptoms of hemol~tc anemia occur, dapsone topical gel should be
`discontinued. Peripheral neuropathy has been reported with oral dapsone therapy,
`but was not seen in clinical trials with dapsone !cereal get. Ora! dapsone therapy has
`been associated with skin reactions which have not been observed in clinical trials
`;with d0,psode topical gel: ......................
`Cost: The average wholesale price for a 30 gm tube of 5% topical dapsone gel is
`$142.80;a 60 gm tube is$297.50.
`
`important since retinoids are useful for both of inflammation. "~,~.ile oral dapsone h,~s
`comedonal and inflammatory acne. Benzoyl
`antimicrobial activiw, topical dapsone has
`ache; sebum is produced by the sebaceous
`peroxide, lncomblnadonwithclindamycin not been rested ira rive for antimicrobial
`gland, Propionibacterium ac~es, a gram
`or erythromycin, helps ro decrease bacterial
`activit):
`positive anaerobe, colonizes the follicles,
`resistance rhat may occur with antibiotic
`the keratinization process is altered and
`"itle pharmacokinefics of single-dose oral
`therapy alone (oral or topical). Other
`inflamrnatoW mediators are re]eased into
`therapies such as salicylic acid or azelaic dapsone t00 mgwere compared to topical
`the skin.3 All factors lead to multiple
`acid are options; however, their efficacy dapsone twice daiiy for 2 weeks.2 Topica!
`sites for intervention in ache treatment,
`Acne is described as either inflammatory data are less robust. Topical dapsone was dapsone achieves !ovals that are 100-fold
`not included in the recommendations for
`less than oral dapsone. Low systemic
`or noninflammatory, based on the types
`therapy at this time.
`availability, is noted, with topical dapsene
`of lesions that are present and patients
`and ~e metabolites of dapsone (N-acetyl-
`.typically may present with multiple lesion
`_types. lnflammaroLy lesions are described as PHARMACOLOGYIPHARMACOKINETICS dapsone) accounting for about 1% of
`systemic exposure. The !ong-term plasma
`papules or pustLdes while noninflammatory Dapsone topical acts on neutrophils
`to interfere with message signaling dapsoneandN-aceryldapsonelevelsremain
`lesions are ca!led comedones - either open
`consistent fromweek 1 towee]< 52. Steady
`by interrapting recruitment of more
`comedo (blackheads) or closed comedo
`state is reached wkhi.’~ 2 weeks and levels fa!l
`neutrophils to decrease the inflammatory
`(whiteheads).
`cascade and to reduce the formation of
`rapidly upon treatment cessarion_ The time
`Guidelines for the management of n0ne
`~0cusonmultimodaltberapy, andthcrapeufic neutrophil-generated destructive ox’ygen-
`re reach maximum serum concentrations
`bearlng molecules that cause skin irritation Jr
`(T=) was 6 hours with topical dapsone,
`opdons are outlined in Appendix A on
`irisalso thought that thegetdeiivep!systena
`as compared to 3.8 hours for t00 mg oral
`page 75.>5 A key point for the treatment
`mayenhance breakup of the sehum barrier dapsone. The maximum concentration
`options include that topical therapies are
`to promote dapsone permeation into the (C) was 19.7 ± 10.2 ng,’mL for topic;d
`the standard of care? Topical retinoids are
`¯
`stratum corneum to act directly at the site dapsone and 1375 +- .517.3 ng!mL for 100
`
`2 of 6
`
`

`

`mg oral dapsone. The elimination half-life
`for topical dapsone is 42 hours. Dapsone
`is metabolized to an inactive metabo!ite,
`N-acetyl dapsone.
`
`[-
`
`0
`
`None
`
`2
`
`3
`
`Mild
`
`Moderate
`
`4
`
`Severe
`
`Few co:nedoneg are present;
`Few papules/pustu!es may be present
`Several to many eomedones are present;
`a few papules!pu~t~es are present
`Many comedonesandpapu]es/pusmies are present;
`no nod~ocTstic lesions are a!lowed
`
`Signi£cant degree of[nflammatorydisease; papules/pustules
`are predominant feanlre; a few nodu]oo:~tic lesions may be
`present; comedones rna2,- be present.
`
`CLINICAL TRIALS 1 Minim~
`Multiple scales ro assess and evaluate acne
`are available and there is no consensus
`which scale best identifies effective/
`efficacious therapeutic interventions in
`acne management.7 The Global Acne
`Assessment Scale (GAAS) was used in the
`majoriv of the dapsone topical studies. The
`5-point scale is summarized below and the
`definition of success varies, but typicJly is
`treated and 17.5% vehicle-treated). Few
`listed in :he package labeling; however,
`defined as none or minimal ache at study dapsone-treated subjects discontinued
`patients with minimal acne at baseline were
`endpoint. In most dapsone topical clinical
`due to lack of e~cacy (0.6%) or adverse
`not included in the analysis presented so
`trims, the definition of ache vulgaris was
`numbers and success rates may differ.
`events (0.4%). Most patients (58.4%) had
`a minimum of 20 inflammatory, lesions, moderate ache and 33.8% had mild ache
`The long-term safeW of dapsone was
`primarily !orated on "doe face. The GAAS
`reported by Lucky and colleagues; efficacy
`at baseline. Dapsone-treated patients were
`does not assess scarring, impact on quality more likely to have treatment success a~ 12 was also reported, but was not a prim~ry
`of life and is investigator-rated, not patient- weeks (p<.001). Dapsone-treated patients
`stud), endpoinr.9 The multicenter, open-
`rated,
`label non-comparative 12-month study
`had greater reductions in noninflammatory
`Draelos and colleagues reported the results
`and total lesions at 12 weeks than vehicle-
`assessed patients age t2 and cider with a
`from two randomized studies demonstrating
`treated patients (p<0.001). Response was
`diagnosis of ache vulgaris. The exclusion
`thee"~cacyandsafe.ty°fdaps°ne t°Pteal.8
`seen as early as 2 weeks and was significant
`criteria were similar to Draelos et al.~
`The multicenter, randomized, double-
`for reduction in inflammatory lesions at Assessments occurred at t, 3, 4, 6, 9 and
`blind, vehicle-controlled, 12-week studies week 4 (p=0.008). Overall success razes at
`!2 mon-&s and included acne lesion counts,
`Evaluated subjects age 12 or cider with a week 12 are summarized in the table below,
`inflammatory lesions, noninflammatory
`diagnosis ofacnevulgaris. Subjects needed
`Adverse events were reported by 58.2%
`lesions and rotal lesions. The primary
`between 20-50 papules or pustules and 20-
`of dapsone-treated patients and 58.6% of
`analysis was safety; however, efficacy was
`100 comedones above the mandible line
`vehicle-treated patients; most events were
`evaluated as mean percent reduction
`at baseline to be etigib!e for enrollment, mild to moderate in intensity and did not
`from baseline in lesion counts. The study
`Subjects were excluded if there was severe
`result in therapy discontinuation. Most
`protocol allowed for courses of antibiotics
`cystic ache, acne conglobata (severe nodular
`commonly reported events included dryness
`or anti-infla’nmatory agents for short term
`ache), concurrent use oFtopica! drugs, any
`(20% dapsone, 18.9% vehicle), eryzhema
`use and if after 3 months, systemic or
`therapy that could impact ache, antibiotics
`(16.3% dapsone, 16.1% vehicle), burning
`topical ache therapy was deemed necessary,
`or anti-inflammatoW agents 4 weeks prior,
`(1.4% dapsone, 1.6% vehicle) and pruritus
`add-on therapy was allowed and recorded
`systemic immunosuppressants thor are
`(1% dapsone, 1.3% vehicle). Other
`as"prohibited concomitant medications."
`known to impact ache, isocretinoin within
`non-application site reactions inclt!ded
`There were 506 subjects enrolled in
`past 3 months, allergy or sensitivity to
`nasopharyngitis (4.8% dapsone, 6.3%
`the intent-to-treat population and 340
`dapsone, sulfa drugs, or excipients in gel,
`vehicle), headache (3.1% dapsone, 3.3%
`(67.2%) completed the trio]. There were
`not on effective pregnancy deterrent or
`vehicle), upper respiratory infection (3.2%
`15.6% of subjects lost to follow-up and
`stable hormonal contraception. Subjects
`0.8% discontinued the study due to tack
`dapsone, 2.9% vehicle) and pharyngitis
`were evaluated at 2, 4, 6, 8, and 12 weeks
`ofefficaW. A total of 111 subjects (22%)
`(2.5% dapsone, 2.6% vehicle). No
`using the GAAS, and assessing the number
`hematological laboratory abnormalities
`used prohibited concomitant medications
`of total lesions, inflammatory lesions, and were noted in the trial,
`during the evaluation period. Dapsone
`noninflammatory lesions. The primary
`The study only assessed the short- was well tolerated with 68% of patients
`efficacy endpoints were ~e proportion of
`term efficaq" of dapsone topical and only
`experiencing an adverse event, with 9.596
`patients that achieve success on GAAS and
`evaluated monotherapy. This study was of the events deemed related to dapsone
`~he mean percentage decrease from baseline
`in the number of lesions.
`There were 1,506 subjects in the dapsone-
`treated group and 1,504 subjects in the
`vehicle-treated group. Approximately
`equ~J numbers of subjects discontinued the
`treatment in each group (15.9% dapsone-
`
`Dapsone gel
`Vehide gel
`~p~ 00u b9<.0(12; s ...... defined as GAAS=0 o, 1.
`
`44.2%’
`35.9%
`
`36.9%~
`29.8%
`
`40.5%’
`32.8%
`
`68 JPSW Novembet/Deeomber 2009
`
`3 of 6
`
`

`

`] SE ..... dard e,ror, ’p<0.00!, ’p<0 002
`
`pa~ienxs reported depression. Psychosis was
`also reported by 2 o[-2372 dapsone-treared
`patients and none in the vehicle-treated
`group.
`
`DRUG INTERACTIONS
`When used in combination with orat
`trimethoprim/sulfa:acthoxazole (TMP-
`sulfa) double strength 160 mgi800 rag,
`therapy. Dryness, rash, sunburn, burning daosone for acne vulgaris ro assess the
`¯
`"
`’
`the ]evels (based on area-under-the-
`and erythema were the .most common hematologic safe~y of topical dapsoneJ~
`curve concentrations) of dapsoae and ks
`adverse events reported by 2.9%, 2.5%, Subjects were treated with dapsone topical
`metabo!ites increased by 40% (dapsone)
`or vehicle for 12 weeks, followed by 12
`2.3%, 1.6% and 1.6%, respectively. "1"he
`and 20% (N-acery]-dapsone); dapsone
`reactions were reported as mild to moderate weeks of the alternate therapy after a 2-week
`Eydroxyiarnine was snore than double
`in intensity by 90% of the patients and washout period. Ptasmadapsone, N-acewl
`the sysre:vdc exposure with TMP-sulfa.~’2
`study discontinuation dv:c to reactions
`dapsone concentrations, hemoglobin,
`Tne ~F of dapsone and its merabolites
`occurred with 10 patients overalland those
`bilirubin, reticulocyte counts, haptoglobin
`remained unchanged withTMP-sulfa. T~e
`reactions occurred early in the first few and lactate dehydrogenase levels were
`combination ofoFai TMP-sulfa and mpic"J
`wee.<s of the study,
`assessed at baseline, 2 weeks and 12 weeks
`dapsone may increase the like]ihood of
`Efficacy as assessed by mean lesion
`for each treatment. "Ihelargest decrease in hemolysisinpatientswithG6PD deficiency;
`counts over time is summarized in table 3
`hemoglobin was t.7 g/dL during vehicle
`Oral dapsone or antimalarlai medications
`above. Inflammatory lesions were reduced
`treatment and 1.5 g/dL during dapsone
`should not be used in combination with
`treatment. Only 5% (3/56) oi" subjects
`by 58.2%, while ilonii~ammatory lesions
`topical dapsone because of the increased
`decreased by t9.5% and total lesions by
`had hemoglobin concentrations decrease
`potential ~:or hemol~ic reactions.
`49%.
`beimv normal duringborh treatment phases,
`When dapsone gel is applied
`A post-hoe analysis assessed the Overall, the mean decrease in hemoglobin
`in combination with topical benzoyl
`from baseline was 0.32 g/dL after 2 weeks
`patients that had "prohibited concomitant
`peroxide, a temporary local yellow or
`medications" use during the trial and
`orange discoloration of the skin and facial
`their outcomes did not differ significantly
`~|lk*l[Qlol[{lllli’illl~lllt{llitl|~li*lllRl~ll hair was reported by 7 of 95 subjects; the
`from those wkhout prohibited medication
`discoloration re~olved in 4 ro 57 days.’
`: Daps0n4 Vehicle
`6fiesi0n
`v~se. ~Eis study was primarily designed to
`gel
`gel
`eva!’aa te long-term safeD" and, therefore, was .....
`DOSING AND HOW SUPPLIED
`-44.9"
`-36.8
`open-label and did not have a comparison
`Inflammatory lesion
`Dapsone topicalis formulatcdas an aqueous
`group.
`-26.9~
`-:5.8
`gel with each gram containing 50 mg of
`As a subset of the overall randomized
`dapsone and is available in a 30 or 60 gram
`studies as reported by Draelos and LuckT,
`tube. Dapsone should be applied to affected
`the safety and efficacy of dapsone therapy in
`areas twice daffy and gently rubbed into
`adolescents (age 12-15 years) were reported
`the ache areas until no medication remains
`by Raimer.~ Of the 3,516 enrollees, there of dapsone therapy. No other laboratory
`visible. If no improvement, is seen aAer 12
`were t,306 adolescent patients that were
`changes occurred in the study to suggest weeks of therapN dapsone topical should
`included in the pivot~ trims and the safew
`clinically relevant hemolysis and no clinical
`be discontinued.
`trirds as described above. Less than 2% of
`signs or symptoms of hemolytic anemia
`Multiple options are available for the
`adoiescents discontinued the studies due to were reported,
`management of ache and are summarized
`lack ofe~cac! or tolcrability. Thepercent
`Local side effects inctuded dryness
`in the table 5 on the next page. Each
`reduction in ache lesions is summarized in
`(14%), erythema (9%), and oiliness!peeling
`product is available in multiple formulations
`table4.
`(13%)andwerereportedasmilddur]ngthe
`(cream, lotion, wash, gel, ointment, ere),
`Success, as defined by a GAAS equal to 0
`clinical trials.* Most reported the incidence
`various concentrations and container sizes.
`or I was achieved by 40.1% dapsone-treated of application site event as mild and similar Products may last longer than one month,
`adolescents compared to 28.2% vehicle-
`lord effects were reported in the vehicle-
`depending upon area of coverage so direcr
`treated adolescents, p<.00t. ’Ihese resu!cs
`treated group. One patient noted facial
`cost compaisons ~’rom product to product
`were similar to the adult population. Safety
`swelling during a clinica! trio, with dapsone
`below may nor appl>
`resuhs were not different for adolescents,
`topical and discontinued therapy.
`with application site reactions being
`Systemic effects noted included CONCLUSION
`reported by2% of adolescents,
`psychiatric effects (suicide attempt, Allergan, the manufacturer of dapsone
`depression and tonie-clonic movements),
`topical cream, recently was sent a
`ADVERSE EFFECTS
`1.~ clinical trials, 9 of 2372 dapsone-rreated warning letter from the FDA regarding
`Pierre et al evaluated 64 patients wkh a patients compared to 3 of vehicle-treated
`advertisements that appeared to be false
`dk~gnosis ofG6P D deficiency using topical
`
`Noninflammatory
`lesion
`Total lesion
`-34.6"
`"p<0.001 avovA ~i,lg k~, ,q~d ,,~t,,d
`
`24.8
`
`JPSW Nn~,~rn~r,D~t’~m~r ~nn~ Rg
`
`4 of 6
`
`

`

`or misleading because it overstated ~he
`efficaw and safeg¢ of dapsone topical gel2 x
`The ad did not adequately address the
`drug interactions with ~’~enzoy~ peroxide
`(temporary skin and hair discoloration)
`and overstated the efficacy which was no:-
`supported by clinical trials (stated that the
`drug "worked fast," with a subs~anti~ effect
`at 2 weeks),
`Guidelines for acne *,management
`emphasize multimodal therapy. None of
`the guidelines specifically mention a role
`¯
`for dapsone, although it fits into the and-
`inflammato .ry and antimicrobial category,
`Dermatologists are interested in the use
`of dapsone topical since it is an additional
`option for therapy; however, they have
`limited experience with its use at this time.
`Dapsone is a new entity for the
`management of acne that is now available
`in a topical formulation to bypass the
`hematologic complications of oral dapsone
`therapy. The available clinical trials have al!
`assessed dapsone topical as monotherapy
`only and potential interactions (positive
`or negative) with other topical acne
`formulations have not been investigated.
`Future data regarding combination with
`benz~yl peroxide and tretinoin 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 currently available therapies, h
`would likely be used in patients ~at have
`noz tolerated benzoyl peroxide or the
`antinticrobial agents and woud no~ repiace
`tretinoin products. Multiple topical options
`are available for management of mild to
`moderate ache. Lack of comparative data
`with dapsone limits the therapy to patients
`who have not had success on o~ber more
`cost effective treatment options¯ ¯
`
`MaryAnn Steiner is a Senior Clinical Pharmacist
`in ~he Center for Drug Po]ic); University, 0["
`Wisconsin Hospital and Clinics, Department of
`Pharmac?:
`
`REFERENCES
`1. Ac~one Ge~ (dapmne). [package imert], irvin¢, CA:
`,Mier~am Revised September 2008.
`.
`2. "!l~iboumt DM, Willmer/Sharata H, et a].
`Pharmacokinedcs of do.one gd, 5% for the treatment ofacnc
`
`;’ulgaris. (2iin Pham~acokiner 2{R17; 46:69%7 2.
`
`3 "ihibouro~ D, Go}Jnick F4. Betto]i V,, er a. New in~ighr~ imo
`the management of ache: A~ upd,,~te from rke (;loba A llar~ce
`to Improve Ouraomes in Ac~e Grnup. j Am Acad [)ermato!
`2005’; 605, Supp ] ]:S !-$50.
`4. Strauss IS, Krowchuk DI{ Leyden ]j, et at. Guide ines of
`
`70 dPSW November/Deoember2009
`
`13~i~i, di~t- : Sls~e~p~oa~,:: :::
`
`sa~ic¢!ic acid
`
`n,amerous OTC products
`
`comedoiTtic
`
`F~timateaAwP ’-’
`
`Varies by product, ail
`relatively inexpensive
`
`benzoyi peroxide
`
`Brevoxyi 4°/o geI
`r 42.5 grams
`
`keratolytic effects,
`antimicrobiai activia
`
`.$89.25
`
`dindarnyeini
`benzoy] peroxide
`
`Benr.aelin 1%/5% gel
`35 gram pump
`
`erychromycin/
`[benzoyiperoxide
`
`Benzamycin 3%/’5% gel
`46.6grams
`
`anti’inflaxmna~’°rb
`!:clps ~.o decrease
`baetcri~J resistance
`in combination with
`antimicrr, biais
`
`antimierobiaI acti-¢iry,
`anti-inflammatory,
`helps m decrease
`bacterialresistance
`in combination with
`antimicrobizls
`
`antimicrobial activi,y,
`antiqnflamma~or};
`helps to decrease
`bacterial resistance
`in combination with
`antimicrobials
`
`$154.88
`
`5217.16 ........
`
`suff’acemmidesodium Kiaron 10%lotion
`10%
`118 mL
`
`antimicrobial acdvi,.w
`
`$126.02
`
`tretinoin
`
`0.025%cream
`0.05% cream
`RetinAMicro0.1% gel
`45 grains
`
`inhibit
`microcomedoae,
`anti-inflammatory
`properties
`
`adapalene
`
`Differin 0.1% cream
`!45 grams
`
`inhibit
`microcomedone,
`anti-inflammatory
`properties
`
`$53.20
`$78.86
`$182.55
`
`$199.50
`
`azelaicaeid
`
`Azclcx20%eream
`50 grams
`
`comedolyricand
`l anrimicrobial activity
`
`S179.68
`
`adapalene/
`benz,ayl peroxide
`
`EpiDuoO.1%12.5% gel
`45 grams
`
`tazarotene
`
`dapsone
`
`Tazorae 0.1% cream/gel
`30 grams
`0.05% cream/gel
`30 grams
`Attune 5% ge]
`30 grams
`
`inhibit
`miciocomcdonc,
`anti-intqam mat°W
`properties,
`antimicrobial a~ivi~
`inhibit
`microcomedone,
`’ anti-inflammatory
`properties
`] anti-inflammatory
`properties
`
`$209 49
`
`$145.80
`
`$t37.24
`$142.80
`
`care for acne vulgaris managemem. J Am Acad DermatM 2007;
`56:65 ~-663.
`5. ~aenglein AL, "ihiboutot DM. Expert commkree
`tetortm~endationx oi acne managemeat. Pediatrics 2006;
`
`l 18:1 : 8S-1 t99.
`6. Aczone Gel AMCP Formulary Dossier. Al]ergan Inc,;
`Revised October 2008.
`
`7. "ion J, Ctar.~nt auto, ares for tJa¢ evaluation of acnc ~zverlt)’.
`Expert .q.cv Dt;rmato12008; 3:59%603.
`
`8. Draelos Z, Carter E, Malotncv JM ct al. Two randomiz£d
`s~udics demoaslrat¢ tll~ c~cacy and ~a,rcts’ ofdapsonc he,1 5%
`for ~hc tream~cn~ ofacne vulgarJs J .~n Acad Dcrma~o12007;
`56:43!) e~-elO.
`
`9. Lucky A, Maloney JM, Roberts J, et aL Do.one gel 5% for
`the rrea{menr of ache vuigaris: ga levy and e~raO’ of long ~erm
`(i year treatment, j Drug Derm 2007; 6:981~9S7.
`!0.Raimer g, 3, alon¢)’ j’~, Bo rcie M. et al. ~cat3, and
`c
`o
`~a,e,.W of dapsane ~ei 5 Ya for the tre~vrc, enr o¢acne vu]~arls in
`ado escents Ct ti~ 2008: S t:17i-17S.
`1LPietie ~ Taylor S, Pati~er D, et al. klematologic safer) of
`dapsoa¢ gO, 5%, }~ar topical tream~¢nt of ache vulgali~. :%:ch
`Dcrmato12008; t ’i4:156’i-1570.
`t 2.US Food and Drug Administration. inspections,
`Coinp~iaucc En[~.Jt~.caicn:, znd Clh~lin;L! Investigations.
`Available at: http:/lwwwd~ka.gov]lCECI/En~orcemenu\ctions/
`WarningLetters/ucm179769.~trn..kcess~d: A~ust 17, 2009
`
`5 of 6
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`MILD
`
`Comedonal
`
`Mixed and Papular/Pustular Mixed and ?apular/Pusmiar
`
`Nodu!ar/Congloba:a
`
`Severity
`
`! esion Type
`
`tat choke
`
`;-"dternatives
`
`Topica!
`retinold
`
`Topical retinoid +
`ro pical ant!microbial
`
`Alt topic&i retinoid or
`Air top!cat
`retlnoid or
`ant!microbial +
`azdaic acid or other topicgJ redr.oid or
`s&Iiwlic acid azelaic acid
`
`Oral antibiotic ÷
`topical retlnoid _--’
`BPO
`
`Orad ~sorrerino~n
`
`Oral iso:rednoin er &i:
`Ah oral antibiotic +
`oral ant!bloat ~ ak to:!ca]
`&It topica’d retiaoid ±
`BPO rednoid ± EFO/azda~c add topical retinoid ÷ BPO
`
`High dose oral antibiotic +
`
`Oral anriandrogen +
`top!cat rednoid/azelaic acid
`± topical anrimlcrobial
`’
`
`High dose orai
`O~a[ antiaadrogcn ÷ topical
`rerinoid]± ora! an:!biotic i am!androgen + topical
`rednoid := alt toplc~J
`air ant!microbial
`ant!microbial
`
`Topic.,~! rerinoid + BPO
`
`-klternatives for females As above
`
`As above
`
`Maintemanee therapy
`
`8PO= ben~yl pcroxida Air= £temate
`
`Topical retinoid
`
`Support our advertisers
`
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`
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`Ada; gom’fa¢#, insertioTz #rdzrs, paytntn~, and al! oth~r relat#d communic~ttiot~
`
`:a~be~ques’.edat60&827-92COo~in~@ps~n, org
`
`WV~KFSWI onc~COMMUNICAT~’ON,P~dARKETING PDF
`
`Feoruary 23-24, 2010
`PSW Legislative Day
`Inn on the Park, Madison _.. .
`. .
`.i
`.
`March 5-6 2010
`Immunization Training for Pharmacists , .....
`PSW Headqt, arters, Madison
`-
`-
`.
`
`March 16-17 2010
`PSW Senior Care Conference
`Country Springs Hotel, W’auR~sha
`
`-
`
`" :
`
`"
`
`,
`
`¯
`
`~
`
`"
`
`April 22-23, 2010
`PSW Educational Conference ’
`Monona Terrace, Madison
`
`August 26-27, 2010
`Immunization Training for Pharmacists
`NEW Helic~ay Inn, Stevens Point
`
`August 26-28, 2010
`PSW Annual Meeting
`NEW Ho!iday Inn, Stevens Point
`
`October 22-23, 2010
`Technician Educational Forum
`Olympia Resort & Convention Center, Oconomowoc
`
`Vacciac Timing
`
`Combination
`
`Simultaneous
`
`Two Inactivated
`
`Inactivated and Live
`
`Two Live
`
`Yes
`
`Yes
`
`Yes
`
`Minimum lnrerva]
`(if not s[mukaneous)
`
`None
`
`None
`
`4 weeks
`
`J~SW Nov~ember December 2009 71
`
`6 of 6
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