Azelaic Acid Gel

Azelaic Acid Gel

Daim ntawv noj tshuaj: cov neeg
Hoob tshuaj: Cov tshuaj pleev pob txuv , Cov tshuaj tiv thaiv kab mob rosacea

Tshuaj kho los ntawm Varixcare.cz. Hloov kho zaum kawg ntawm Lub Xya Hli 22, 2021.



Ntawm Nplooj Ntawv no
Nthuav dav

Kev Qhia thiab Kev Siv rau Azelaic Acid Gel

Azelaic Acid Gel, 15% tau qhia rau kev kho mob ntawm cov mob papules thiab pustules ntawm me me mus rau nruab nrab rosacea. Txawm hais tias qee qhov txo qis ntawm erythema uas tau muaj nyob hauv cov neeg mob nrog papules thiab pustules ntawm rosacea tshwm sim hauv kev tshawb fawb soj ntsuam, kev ua tau zoo rau kev kho erythema hauv rosacea thaum tsis muaj papules thiab pustules tsis tau tshuaj xyuas.



Azelaic Acid Gel Dosage thiab Kev Tswj

  • Thov thiab maj mam zaws ib txheej nyias nyias ntawm Azelaic Acid Gel rau hauv thaj chaw cuam tshuam ntawm lub ntsej muag ob zaug ib hnub (thaum sawv ntxov thiab yav tsaus ntuj).
  • Siv tsuas yog cov xab npum me me lossis xab npum ntxuav kom huv ua ntej thov Azelaic Acid Gel.
  • Cov tshuaj pleev ib ce tuaj yeem siv tom qab thov Azelaic Acid Gel tau qhuav lawm.
  • Zam kev siv cov khaub ncaws hnav lossis qhwv.
  • Qhia cov neeg mob kom tsis txhob noj zaub mov ntsim, zaub mov kub thiab dej qab zib, haus cawv.
  • Cov neeg mob yuav tsum tau rov tshuaj xyuas yog tias tsis muaj kev txhim kho pom tom qab ua tiav 12 lub lis piam ntawm kev kho.
  • Tsis yog rau qhov ncauj, qhov muag lossis siv sab hauv.

Hom Tshuaj thiab Lub Zog

Azelaic Acid Gel, 15% yog xim dawb mus rau daj daj opaque gel. Txhua gram ntawm Azelaic Acid Gel muaj 0.15 gm ntawm azelaic acid (15% w/w).

Contraindications

Tsis muaj



Ceeb Toom thiab Ceev faj

Hypersensitivity

Cov tshuaj tiv thaiv tsis haum, suav nrog mob angioedema, lub qhov muag o, lub ntsej muag o, ua tsis taus pa, tso zis tawm hws, thiab ua rau tawv nqaij tsis zoo, tau tshaj tawm thaum lub sijhawm saib xyuas kev lag luam.

Kuv puas tuaj yeem noj aleve thiab tylenol ua ke

Zam kev siv Azelaic Acid Gel hauv cov neeg mob uas paub tias ua rau muaj kev tsis haum rau ib feem ntawm cov gel. Yog tias muaj kev kub siab dhau los thaum kho, txiav tawm Azelaic Acid Gel thiab teeb tsa kev kho kom tsim nyog.

Cov tawv nqaij ua xua

Cov tawv nqaij ua xua (piv txwv li khaus, hlawv lossis ua xua) tuaj yeem tshwm sim thaum siv Azelaic Acid Gel, feem ntau yog thawj ob peb lub lis piam ntawm kev kho mob. Yog tias qhov rhiab lossis khaus khaus loj tuaj thiab mob ntxiv, txiav kev kho mob thiab teeb tsa kev kho kom tsim nyog.



Muaj cov ntawv ceeb toom cais ntawm hypopigmentation tom qab siv azelaic acid. Txij li thaum azelaic acid tsis tau kawm zoo hauv cov neeg mob uas muaj lub ntsej muag tsaus, saib xyuas cov neeg mob no rau cov cim qhia ntxov ntawm hypopigmentation.

Qhov muag thiab Mucous Membranes khaus

Zam kev sib cuag nrog lub qhov muag, qhov ncauj thiab lwm yam hnoos qeev. Yog tias Azelaic Acid Gel tau kov lub qhov muag, ntxuav lub qhov muag nrog dej ntau thiab tham nrog kws kho mob yog tias qhov muag tsis pom kev[saib Cov Teeb Meem Tsis Zoo (6.2) ].

Exacerbation ntawm Asthma

Qhov ua rau mob hawb pob tau tshaj tawm hauv cov neeg mob siv azelaic acid formulations suav nrog Azelaic Acid Gel. Tham nrog tus kws kho mob yog tias mob hawb pob nrog siv Azelaic Acid Gel.

Cov Teeb Meem Tsis Zoo

Kev Ntsuam Xyuas Kev Kho Mob

Vim tias kev sim tshuaj tau ua nyob hauv ntau qhov xwm txheej sib txawv, cov txiaj ntsig tsis zoo tshwm sim hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem sib piv ncaj qha rau tus nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab yuav tsis cuam tshuam txog cov txiaj ntsig tau pom hauv kev coj ua. Hauv ob lub tsheb tswj hwm thiab ib qho kev tswj hwm Asmeskas kev sim tshuaj, tshuaj kho kev nyab xeeb tau tshuaj xyuas hauv 788 cov ncauj lus uas siv ob zaug-ib hnub Azelaic Acid Gel rau 12 lub lis piam (N = 333) lossis 15 lub lis piam (N = 124), lossis gel tsheb (N = 331) rau 12 lub lis piam. Hauv tag nrho peb qhov kev sim, cov xwm txheej cuam tshuam nrog kev kho mob feem ntau yog: hlawv/ua pob/ua pob (29%), khaus khaus (11%), nplai/tawv nqaij qhuav/xerosis (8%) thiab erythema/khaus (4%). Hauv qhov kev sim tshuaj tswj hwm, tag nrho cov kev phiv tshuaj (suav nrog hlawv, ua pob/ua pob, ua kom qhuav/nruj/ntsuas, khaus, thiab erythema/khaus/liab) yog 19.4% (24/124) rau Azelaic Acid Gel piv rau 7.1% ( 9/127) rau qhov sib piv sib xyaw gel ntawm 15 lub lis piam.

yog meloxicam lossis nsaid
Rooj 1: Cov Teeb Meem Tsis Zoo tshwm sim hauv ≧ 1% ntawm Cov Ntsiab Lus hauv Rosacea Trials los ntawm Pawg Kho Mob thiab Qhov Siab Tshaj Plaws *
Azelaic Acid Gel, 15%
N: 457 ua
(100%)
Tsheb
N = 331 ib
(100%)
Me me
N = 99 ib
(22%)
Nruab nrab
N = 61 hli
(13%)
Loj
N = 27 hli
(6%)
Me me
N = 46 hli
(14%)
Nruab nrab
N = 30 hli
(9%)
Loj
N = 5
(2%)
*
Cov ncauj lus yuav muaj> 1 qhov xwm txheej tsis zoo ntawm daim tawv nqaij; yog li, qhov sib npaug ntawm qhov xav tau ntawm cov ntsiab lus yuav dhau tus lej ntawm yam uas muaj yam tsawg 1 qhov xwm txheej tsis zoo ntawm daim tawv nqaij.
Kub hnyiab/ua rau/tingling 71 (16%) 42 (9%) 17 (4%) 8 (2%) 6 (2%) nees nkaum ib%)
Pruritus 29 (6%) 18 (4%) 5 (1%) 9 (3%) 6 (2%) 0 (0%)
Scaling/tawv nqaij qhuav/xerosis 21 (5%) 10 (2%) 5 (1%) 31 (9%) 14 (4%) 1 (<1%)
Erythema/khaus 6 (1%) 7 (2%) 2 (<1%) 8 (2%) 4 (1%) nees nkaum ib%)
Tiv tauj kab mob dermatitis 2 (<1%) 3 (1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%)
Edema 3 (1%) 2 (<1%) 0 (0%) 3 (1%) 0 (0%) 0 (0%)
Pob txuv 3 (1%) 1 (<1%) 0 (0%) 1 (<1%) 0 (0%) 0 (0%)

Hauv cov neeg mob siv cov tshuaj azelaic acid, cov xwm txheej tsis zoo hauv qab no tau tshaj tawm: ua rau mob hawb pob, vitiligo, ua rau me me, me me ua rau me me, hypertrichosis, reddening (cov tsos mob ntawm keratosis pilaris) thiab ua rau mob herpes labialis rov tshwm sim.

Kev Kawm Tolerability Hauv Zos

Azelaic Acid Gel thiab nws lub tsheb ua rau muaj kev tsis txaus siab ntawm qhov chaw thov hauv tib neeg kev nyab xeeb ntawm daim tawv nqaij. Azelaic Acid Gel ua rau muaj kev khaus ntau dua li nws lub tsheb hauv kev kawm ua kom khaus. Qee qhov kev txhim kho hauv kev ua kom khaus tau pom nyob rau lub sijhawm ntawm kev sim tshuaj, tab sis qhov kev txhim kho no yuav yog vim muaj kev tso tawm. Tsis tau tshaj tawm phototoxicity lossis photoallergenicity tau qhia hauv tib neeg kev kawm txog kev nyab xeeb ntawm daim tawv nqaij.

Kev Paub Tom Qab Kev Lag Luam

Cov kev tsis zoo hauv qab no tau txheeb pom tom qab pom zoo ntawm Azelaic Acid Gel. Vim tias cov tshuaj tiv thaiv no tau tshaj tawm los ntawm cov pejxeem ntawm qhov tsis paub meej, nws ib txwm tsis tuaj yeem kwv yees kwv yees tau zaus lossis tsim kom muaj kev sib raug zoo nrog kev siv tshuaj:

Qhov muag: iridocyclitis thaum raug lub qhov muag raug rau Azelaic Acid Gel

Hypersensitivity: angioedema, qhov muag o, lub ntsej muag o, urticaria.

Kev ua pa: ua rau mob hawb pob ntau ntxiv, ua tsis taus pa, hawb pob.

Kev Sib Tham Tshuaj

Tsis tau muaj kev tshawb fawb txog kev cuam tshuam ntawm Azelaic Acid Gel nrog lwm cov tshuaj.

Siv HAUV TUS NEEG TSEEM CEEB

Cev xeeb tub

Teratogenic Effects: Cev xeeb tub qeb B

Tsis muaj kev tshawb fawb txaus thiab tswj tau zoo hauv poj niam cev xeeb tub. Yog li ntawd, Azelaic Acid Gel yuav tsum tau siv thaum cev xeeb tub nkaus xwb yog tias cov txiaj ntsig muaj txiaj ntsig ua rau muaj kev pheej hmoo txaus rau tus menyuam hauv plab.

Dermal embryofetal kev txhim kho kev lom tshuaj lom tsis tau ua nrog azelaic acid, 15% gel. Kev tshawb fawb txog kev loj hlob ntawm lub qhov ncauj tau ua nrog azelaic acid hauv nas, luav, thiab cynomolgus liab. Azelaic acid tau siv thaum lub sijhawm ua haujlwm ntawm tag nrho peb hom tsiaj. Embryotoxicity tau pom hauv nas, luav, thiab liab ntawm qhov ncauj ntawm azelaic acid uas ua rau qee leej niam muaj tshuaj lom. Pom tau tias muaj embryotoxicity hauv nas tau muab 2500 mg/kg/hnub [162 zaug qhov kev pom zoo tshaj plaws ntawm tib neeg cov tshuaj (MRHD) raws li thaj tsam ntawm lub cev (BSA)], luav muab 150 mg/kg/hnub lossis 500 mg/kg/hnub (19 lossis 65 zaug MRHD raws li BSA) thiab cov liab cynomolgus muab 500 mg/kg/hnub (65 zaug MRHD raws li BSA) azelaic acid. Tsis muaj kev cuam tshuam los ntawm teratogenic tau pom hauv qhov ncauj qhov kev tshawb fawb kev txhim kho hauv nas, luav thiab cynomolgus liab.

Kev hais lus peri- thiab tom qab yug menyuam txoj kev loj hlob tau kawm hauv nas. Azelaic acid tau siv txij hnub cev xeeb tub 15 txog hnub 21 tom qab yug menyuam mus txog qib koob tshuaj ntawm 2500 mg/kg/hnub. Embryotoxicity tau pom hauv nas ntawm qhov ncauj ntawm 2500 mg/kg/hnub (162 zaug MRHD raws li BSA) uas ua rau qee leej niam muaj tshuaj lom. Ib qho ntxiv, cuam tshuam me ntsis hauv kev txhim kho tom qab yug menyuam hauv plab tau sau tseg hauv nas ntawm qhov ncauj ntawm qhov ncauj uas ua rau qee leej niam muaj tshuaj lom (500 mg/kg/hnub thiab 2500 mg/kg/hnub; 32 thiab 162 zaug MRHD raws li BSA) . Tsis muaj kev cuam tshuam rau kev sib deev kom loj hlob ntawm tus menyuam hauv plab tau sau tseg hauv txoj kev tshawb fawb no.

Niam laus

Nws tsis paub tias azelaic acid tau tso tawm hauv tib neeg cov kua mis; txawm li cas los,hauv vitrokev tshawb fawb siv kev lim ntshav sib npaug tau ua los tshuaj xyuas lub peev xwm ntawm kev faib cov mis nyuj rau tib neeg. Cov kev tshawb fawb pom tias, ntawm azelaic acid concentration ntawm 25 µg/mL, cov mis/ntshav faib coefficient yog 0.7 thiab cov mis/tsis faib yog 1.0. Cov ntaub ntawv no qhia tias kev tso tshuaj mus rau hauv niam mis yuav tshwm sim. Txij li tsawg dua 4% ntawm kev siv tshuaj pleev ib ce ntawm 20% azelaic acid qab zib tau ua kom zoo, kev nqus ntawm azelaic acid rau hauv niam mis tsis xav tias yuav ua rau muaj kev hloov pauv tseem ceeb los ntawm cov hauv paus azelaic acid hauv cov mis. Txawm li cas los xij, kev txiav txim siab yuav tsum txiav kom tsis txhob tu menyuam lossis txiav cov tshuaj, suav nrog qhov tseem ceeb ntawm cov tshuaj rau leej niam.

Kev Siv Menyuam Yaus

Kev nyab xeeb thiab ua tau zoo ntawm Azelaic Acid Gel hauv cov neeg mob menyuam yaus tsis tau tsim los.

Kev siv Geriatric

Kev tshawb fawb soj ntsuam ntawm Azelaic Acid Gel tsis suav nrog cov naj npawb txaus ntawm cov neeg muaj hnub nyoog 65 xyoos thiab tshaj saud los txiav txim seb lawv puas txawv ntawm cov hluas.

ntsiav tshuaj nrog 2172 ntawm nws

Azelaic Acid Gel Nqe lus piav qhia

Azelaic Acid Gel, 15%, yog cov kua dej uas muaj cov azelaic acid, ib txwm muaj tshwm sim los ntawm dicarboxylic acid. Tshuaj lom neeg, azelaic acid yog 1,7-heptanedicarboxylic acid. Cov mis mos molecular rau azelaic acid yog C.9H16LOS YOG4. Nws muaj cov qauv hauv qab no:

Azelaic acid muaj qhov hnyav hnyav ntawm 188.22. Nws yog cov dawb, tsis muaj ntxhiab crystalline khoom. Nws yog cov dej tsis zoo hauv dej ntawm 20 ° C (0.24%) tab sis dawb do yaj hauv dej npau thiab hauv ethanol.

Azelaic Acid Gel yog xim dawb rau xim daj dawb opaque gel rau kev siv tshuaj pleev; txhua gram muaj 0.15 gm azelaic acid (15% w/w) hauv cov kua dej hauv qab uas muaj benzoic acid (raws li kev khaws cia), carbomer homopolymer hom C, edetate disodium, lecithin, nruab nrab saw triglycerides, polysorbate 80, propylene glycol, ua kom huv dej, thiab sodium hydroxide los kho pH.

Azelaic Acid Gel - Chaw Kho Mob Kws Tshuaj

Mechanism of Action

Cov txheej txheem (s) uas azelaic acid cuam tshuam nrog cov xwm txheej tshwm sim hauv rosacea tsis paub.

Pharmacodynamics

Lub pharmacodynamics ntawm azelaic acid koom nrog kev kho mob rosacea tsis paub.

Pharmacokinetics

Kev nqus ntawm cov kua dej azelaic tom qab siv cov tshuaj Azelaic Acid Gel tsis tuaj yeem txiav txim siab tau. Lub ntsiab lus ntshav azelaic acid ntau hauv cov ntsiab lus rosacea kho nrog Azelaic Acid Gel ob zaug ib hnub rau tsawg kawg 8 lub lis piam yog nyob ntawm thaj tsam ntawm 42 ng/mL txog 63.1 ng/mL. Cov txiaj ntsig no nyob hauv qhov siab tshaj plaws ntawm 24.0 ng/mL txog 90.5 ng/mL pom hauv cov ntsiab lus rosacea kho nrog lub tsheb nkaus xwb. Qhov no qhia tias Azelaic Acid Gel tsis nce ntshav azelaic acid ntau dua li cov txiaj ntsig tau los ntawm kev noj zaub mov zoo thiab cov metabolism hauv lub cev.

Hauv vitrothiab tib neeg cov ntaub ntawv qhia txog qhov tsis txaus ntseeg ntawm cov metabolism hauv3H-azelaic acid tom qab siv cov tshuaj 20% azelaic acid qab zib. Azelaic acid feem ntau yog tso tawm tsis hloov pauv hauv cov zis, tab sis hla qee qhov oxid-oxidation mus rau cov saw luv dicarboxylic acids.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Kev Tsis Txaus Siab ntawm Fertility

Kev tshawb fawb tsiaj ntev-ntev tsis tau ua los ntsuas qhov muaj peev xwm ua rau muaj mob qog noj ntshav ntawm azelaic acid. Hauv 26-lub lim tiam dermal carcinogenicity kawm siv transgenic (Tg.AC) nas, Azelaic Acid Gel thiab tsheb gel, thaum thov ib zaug lossis ob zaug ib hnub, tsis nce tus naj npawb poj niam Tg.AC tsiaj nrog papillomas ntawm qhov chaw kho mob. Tsis muaj qhov tseem ceeb ntawm kev nce tus naj npawb ntawm cov tsiaj nrog papillomas ntawm qhov chaw kho mob tau pom hauv txiv neej Tg.AC tsiaj tom qab thov ib hnub ib zaug. Tom qab ua ntawv thov ob zaug ib hnub, Azelaic Acid Gel thiab lub tsheb gel ua rau muaj cov ntaub ntawv tseem ceeb hauv cov txiv neej cov tsiaj nrog papillomas ntawm qhov chaw kho mob thaum piv rau cov txiv neej tsis kho. Qhov no qhia tias qhov ua tau zoo tuaj yeem cuam tshuam nrog daim ntawv thov tsheb. Qhov tseeb hauv chaw kho mob ntawm kev tshawb pom hauv tsiaj rau tib neeg tsis meej.

Azelaic acid tsis yog mutagenic lossis clastogenic hauv lub roj teeb ntawmhauv vitro[Ames kuaj, HGPRT hauv V79 hlwb (Suav hamster ntsws hlwb), thiab chromosomal aberration assay hauv tib neeg lymphocytes] thiabhauv vivo(qhov tseem ceeb ua rau muaj kev phom sij hauv nas thiab nas micronucleus assay) kev tshuaj ntsuam genotoxicity.

Kev tswj hwm qhov ncauj ntawm azelaic acid ntawm qib ntau txog 2500 mg/kg/hnub (162 zaug MRHD raws li BSA) tsis cuam tshuam rau kev muaj menyuam lossis kev ua me nyuam hauv cov txiv neej lossis poj niam nas.

Kev Kho Mob

Azelaic Acid Gel tau tshuaj xyuas rau kev kho mob me me mus rau nruab nrab papulopustular rosacea hauv ob lub multicenter, randomized, ob-dig muag, tswj lub tsheb, 12-lub lim tiam kev sim tshuaj uas muaj cov txheej txheem zoo ib yam thiab koom nrog tag nrho ntawm 664 (nquag: 333; tsheb: 331) ) cov ntsiab lus hnub nyoog 21 txog 86 xyoo (hnub nyoog nruab nrab = 49). Zuag qhia tag nrho, 92.5% ntawm cov ncauj lus yog Caucasian thiab 73% ntawm cov ncauj lus yog poj niam. Cov npe kawm muaj cov me me mus rau nruab nrab rosacea nrog qhov nruab nrab qhov txhab ntawm 18 (thaj tsam 8 txog 60) mob papules thiab pustules. Cov ntsiab lus hauv qab no tsis suav nrog: a) cov uas tsis muaj papules thiab pustules; b) cov uas muaj nodules, rhinophyma, lossis kev koom tes nrog lub qhov muag thiab c) cov uas muaj keeb kwm ntawm kev ua tsis tau zoo rau propylene glycol lossis rau lwm yam khoom xyaw ntawm txoj kev tshawb fawb tshuaj. Azelaic Acid Gel lossis nws lub tsheb yuav tsum tau siv ob zaug ib hnub rau 12 lub lis piam; tsis muaj lwm yam tshuaj pleev lossis txheej txheem tshuaj cuam tshuam rau chav kawm rosacea thiab/lossis tshuaj xyuas qhov muaj peev xwm yuav tsum tau siv thaum kawm. Cov ncauj lus tau qhia kom tsis txhob noj zaub mov ntsim, zaub mov kub/dej sov thiab haus cawv thaum lub sijhawm kawm. Cov ncauj lus tseem tau qhia kom siv tsuas yog xab npum me me los yog xab npum tsis siv tshuaj ntxhua khaub ncaws rau kev ntxuav lub ntsej muag.

Thawj qhov ua tau zoo kawg cov ntsiab lus suav nrog ob qho 1) hloov pauv los ntawm cov kab mob suav suav nrog rau 2) kev ua tiav tau txhais raws li tus qhab nia ntawm 'meej' lossis 'tsawg' nrog tsawg kawg 2-theem txo los ntawm lub hauv paus ntawm Kev Tshawb Fawb Kev Ntsuam Xyuas Ntiaj Teb (IGA) ), txhais raws li hauv qab no:

HLOOV:
Tsis muaj papules thiab/lossis pustules; tsis muaj los yog erythema seem; tsis muaj los yog me ntsis mus rau nruab nrab telangiectasia
Yam tsawg kawg nkaus:
Tsis tshua muaj papules thiab/lossis pustules; seem rau erythema me ntsis; me me mus rau nruab nrab telangiectasia
MILD:
Ob peb papules thiab/lossis pustules; erythema me ntsis; me me mus rau nruab nrab telangiectasia
QHOV TSEEB QHOV TSEEB:
Cov naj npawb txawv ntawm papules thiab/lossis pustules; me me mus rau nruab nrab erythema; me me mus rau nruab nrab telangiectasia
QAUV:
Tshaj tawm tus naj npawb ntawm papules thiab/lossis pustules; erythema nruab nrab; me me mus rau nruab nrab telangiectasia
QHOV TSEEB ZOO TSHAJ PLAWS:
Ntau papules thiab/lossis pustules, qee zaum nrog qhov txhab loj; erythema nruab nrab; theem nrab ntawm telangiectasia
SEVERE:
Ntau cov papules thiab/lossis pustules, qee zaum nrog cov chaw sib txuam ntawm qhov txhab ua mob; erythema nruab nrab lossis hnyav; nruab nrab lossis hnyav telangiectasia

Kev ntsuas kev ua tau zoo thawj zaug tau ua raws 'kev mob siab rau kho' (ITT) cov pej xeem nrog 'kev soj ntsuam zaum kawg' (LOCF).

Ob qhov kev sim pom pom qhov sib txawv tseem ceeb hauv kev nyiam ntawm Azelaic Acid Gel hla nws lub tsheb hauv ob qho tib si txo tus naj npawb ntawm cov mob papules thiab pustules cuam tshuam nrog rosacea (Cov Lus 2) ntxiv rau kev ua tiav ntawm IGA hauv ITT-LOCF cov pej xeem thaum kawg ntawm kev kho mob.

Rooj 2: Cov mob Papules thiab Pustules (Cov neeg ITT) *
Kawm Ib
Azelaic Acid Gel, 15%
NPV = 164
Kawm Ib
VEHICLE
N = 165 hli
Kawm Ob
Azelaic Acid Gel, 15%
N = 167 ib
Kawm Ob
VEHICLE
N = 166 ib
*
Cov neeg ITT nrog kev soj ntsuam zaum kawg tau nqa mus tom ntej (LOCF)
Mean Lesion Count Baseline 17.5 17.6 17.9 18.5
Kawg Kev Kho Mob * 6.8 10.5 9.0 12.1
Txo Cov Pej Xeem Txo Qhov Kawg Kev Kho Mob * 57.9% 39.9% 50.0% 38.2%

Txawm hais tias qee qhov txo qis ntawm erythema uas tau muaj nyob hauv cov ncauj lus nrog papules thiab pustules ntawm rosacea tau tshwm sim hauv kev sim tshuaj, ua tau zoo rau kev kho mob ntawm erythema hauv rosacea thaum tsis muaj papules thiab pustules tsis tau tshuaj xyuas.

pem hauv ntej qhov chaw rau saum miv

Azelaic Acid Gel tau zoo dua rau lub tsheb uas hais txog kev ua tiav raws li IGA ntawm rosacea ntawm 7-tus qhab nia zoo li qub thaum kawg ntawm kev kho (ITT cov pej xeem; Rooj 3).

Rooj 3: Tus Kws Tshawb Fawb Txoj Kev Ntsuam Xyuas Thoob Ntiaj Teb Thaum Kawg Kev Kho Mob *
Kawm Ib
Azelaic Acid Gel, 15%
NPV = 164
Kawm Ib
VEHICLE
N = 165 hli
Kawm Ob
Azelaic Acid Gel, 15%
N = 167 ib
Kawm Ob
VEHICLE
N = 166 ib
*
Cov neeg ITT nrog kev soj ntsuam zaum kawg tau nqa mus tom ntej (LOCF)
Ntshiab, Tsawg lossis tsawg me ntsis thaum Kawg Kev Kho Mob
(% Cov Ntsiab Lus)
61% 40% 61% 48%

Kev Muab/Cia thiab Ua Li Cas

Yuav Muab Li Cas

Azelaic Acid Gel, 15% yog xim dawb rau xim daj dawb opaque gel muab rau hauv qab no:

  • 50 g raj NDC 51672-1389-3

Cia thiab Ua Haujlwm

Khaws ntawm 20 ° txog 25 ° C (68 ° txog 77 ° F)[saib USP Tswj Chav Kub].

Cov Lus Qhia Txog Tus Neeg Mob

Qhia cov neeg mob siv Azelaic Acid Gel ntawm cov ntaub ntawv hauv qab no thiab cov lus qhia:

  • Rau sab nrauv siv xwb.
  • Ua ntej thov Azelaic Acid Gel, ntxuav cov cheeb tsam cuam tshuam nrog xab npum me me los yog xab npum tsis tu ncua thiab so qhuav nrog phuam mos muag.
  • Tsis txhob siv cov tshuaj ntxhua khaub ncaws, tinctures thiab astringents, abrasives thiab peeling cov neeg ua haujlwm.
  • Zam kev sib cuag nrog lub qhov muag, qhov ncauj thiab lwm yam hnoos qeev. Yog tias Azelaic Acid Gel tau kov lub qhov muag, ntxuav lub qhov muag nrog dej ntau thiab sab laj nrog lawv cov kws kho mob yog tias qhov muag ua rau tsis pom kev.
  • Ntxuav tes tam sim tom qab thov Azelaic Acid Gel.
  • Cov tshuaj pleev ib ce tuaj yeem siv tom qab thov Azelaic Acid Gel tau qhuav lawm.
  • Zam kev siv cov khaub ncaws hnav lossis qhwv.
  • Cov tawv nqaij ua xua (piv txwv li, khaus, hlawv, lossis ua xua) yuav tshwm sim thaum siv Azelaic Acid Gel, feem ntau yog thawj ob peb lub lis piam ntawm kev kho mob. Yog tias qhov khaus ntau dhau los lossis tseem nyob, lossis muaj kev tsis haum tshwm sim, tsis siv thiab tham nrog koj tus kws kho mob.
  • Yog tias muaj kev fab tshuaj tsis haum, tsum tsis txhob siv thiab sab laj nrog lawv tus kws kho mob.
  • Qhia cov neeg mob kom tshaj tawm txog kev mob hawb pob tsis zoo rau lawv cov kws kho mob.
  • Qhia qhov txawv txav ntawm cov tawv nqaij hloov pauv rau lawv cov kws kho mob.
  • Txhawm rau pab tswj rosacea, zam qhov ua rau muaj qhov ua rau erythema, yaug, thiab ua ntsej muag. Cov teeb meem no tuaj yeem suav nrog cov zaub mov ntsim thiab sov sov xws li kas fes kub, tshuaj yej, lossis dej cawv.
  • Azelaic Acid Gel los hauv lub raj:
    • Cov lus qhia raj: Tshem lub hau ua ntej siv. Nyem lub raj kom faib me me ntawm Azelaic Acid Gel.

Tsim los ntawm: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Faib los ntawm:Taro Pharmaceuticals Tebchaws Asmeskas, Inc.,Hawthorne, NY 10532, Tebchaws Asmeskas

Tshaj tawm: Lub Kaum Hli, 2017
PK-8425-0 11

PRINCIPAL DISPLAY PANEL - 50 g Tube Carton

NDC 51672-1389-3

50g ua

Azelaic kua qaub

Cov neeg
kaum tsib%

Rau Kev Siv Tshuaj Xwb
Tsis yog rau qhov ncauj, qhov muag lossis siv sab hauv

Rx xwb

Khaws qhov no thiab txhua yam tshuaj kom tsis txhob ncav cuag cov menyuam.

lub hauv paus daj zoo li cas

TARO

ZOO TSHAJ PLAWS
Azelaic Acid Gel
Khoom Qhia
Yam Khoom HLOOV KEV POV THAWJ DRUG LABEL Yam Khoom (Qhov Chaw) NDC: 51672-1389
Txoj Kev Tswj XEEB Teem caij DEA
Cov khoom xyaw nquag/nquag muaj nuj nqis
Lub Npe Lub Npe Lub hauv paus ntawm Kev Muaj Zog Lub zog
Azelaic kua qaub (Azelaic Acid) Azelaic kua qaub 0.15g hauv 1g
Cov khoom xyaw tsis haum
Lub Npe Lub Npe Lub zog
benzoic kua qaub
CARBOMER HOMOPOLYMER HOM C (ALLYL PENTAERYTHRITOL CROSSLINKED)
tshem tawm disodium
LECITHIN, SOYBEAN
nruab nrab cov saw triglycerides
polysorbate 80 - cov
propylene glycol hmoov
dej
sodium hydroxide
Yam Khoom
Xim WHITE (dawb rau daj daj) Cov qhab nia
Zoo Loj
Tsw Tsab Cai Luam Tawm
Muaj
Ntim
# Khoom Code Cov lus piav qhia pob
1 NDC: 51672-1389-3 1 TUBE hauv 1 CARTON
1 50g hauv 1 TUBE
Cov Lus Qhia Txog Kev Lag Luam
Qeb Qeb Naj Npawb Daim Ntawv Thov lossis Monograph Citation Hnub Pib Ua Lag Luam Hnub Kawg Ua Lag Luam
Koj TIAB SA 210549 08/23/2019
Daim ntawv loTaro Pharmaceuticals Tebchaws Asmeskas, Inc. (145186370)
Tsim
Lub Npe Chaw nyob ID/FEI Kev ua haujlwm
Taro Tshuaj Inc. 206263295 TUS KHEEJ (51672-1389)
Taro Pharmaceuticals Tebchaws Asmeskas, Inc.

Kev Tsis Pom Zoo Kho Mob