Clobetasol Shampoo

Lub npe dav: Clobetasol propionate
Dosage form: tshuaj zawv plaub hau
Chav kawm tshuaj: Cov tshuaj steroids

Ntawm nplooj ntawv no

• Indications thiab siv
• Dosage thiab Administration
• Daim ntawv siv tshuaj thiab muaj zog
• Contraindications
• Ceeb toom thiab ceev faj
• Cov Kev Phem Tsis Zoo/Sib Phem
• Siv nyob rau hauv cov neeg tshwj xeeb
• Kev noj ntau dhau
• Kev piav qhia
• Clinical Pharmacology
• Nonclinical Toxicology
• Kev tshawb fawb soj ntsuam
• Yuav Ua Li Cas Muab / Cia thiab tuav
• Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Cov lus qhia thiab kev siv rau Clobetasol Shampoo

Qhov taw qhia

Clobetasol propionate tsuaj zawv plaub hau, 0.05%, yog super-siab muaj peev xwm tshuaj pleev xim corticosteroid formulation qhia rau kev kho mob ntawm cov tawv taub hau psoriasis rau cov neeg muaj hnub nyoog 18 xyoo thiab laus dua. Kev kho mob yuav tsum txwv rau 4 lub lis piam sib law liag. Tag nrho cov koob tshuaj yuav tsum tsis pub tshaj 50 g (50 mL lossis 1.75 fl. oz.) ib lub lis piam.

ortho tri-ncig

Cov neeg mob yuav tsum tau qhia kom siv clobetasol propionate tsuaj zawv plaub hau, 0.05%, rau lub sijhawm tsawg kawg nkaus tsim nyog kom ua tiav cov txiaj ntsig xav tau.[saib Dosage thiab Administration (2) ].

Kev siv rau cov neeg mob hnub nyoog qis dua 18 xyoo tsis pom zoo vim muaj tus lej siab ntawm hypothalamic-pituitary-adrenal (HPA) axis suppression[saib Ceeb toom thiab ceev faj (5.1) thiab Siv hauv Cov Pej Xeem Tshwj Xeeb (8.4) ].

Kev txwv kev siv

Clobetasol propionate tsuaj zawv plaub hau, 0.05%, yuav tsum tsis txhob siv rau ntawm lub ntsej muag, puab tais lossis axillae. Tsis txhob sib cuag ntawm cov khoom siv tshuaj nrog lub qhov muag thiab daim di ncauj. Nyob rau hauv rooj plaub ntawm kev sib cuag, yaug kom huv si nrog dej txhua qhov chaw ntawm lub cev uas tau ntsib nrog tshuaj zawv plaub hau.

Clobetasol Shampoo Dosage thiab Administration

Clobetasol propionate tsuaj zawv plaub hau, 0.05% yog siv rau tshuaj pleev ib ce, thiab tsis yog siv rau qhov muag, qhov ncauj los yog intravaginal.

Clobetasol propionate tsuaj zawv plaub hau, 0.05%, yuav tsum tau siv rau ntawm tawv taub hau qhuav (tsis ntub) ib hnub ib zaug hauv ib zaj duab xis nyias mus rau qhov chaw cuam tshuam nkaus xwb, thiab tawm hauv qhov chaw rau 15 feeb ua ntej lathering thiab yaug.

Tag nrho cov koob tshuaj yuav tsum tsis pub tshaj 50 g (50 mL lossis 1.75 fl. oz.) ib lub lis piam.

Tshem cov plaub hau kom deb ntawm cov tawv taub hau kom ib qho ntawm cov chaw raug cuam tshuam. Muab lub raj mis tso rau ntawm qhov txhab. Siv ib qho me me ntawm cov tshuaj zawv plaub hau ncaj qha rau ntawm qhov txhab, cia cov khoom ntws los ntawm lub raj mis ( maj mam nyem lub raj mis), zam kev sib cuag ntawm cov khoom nrog lub ntsej muag ntawm daim tawv nqaij, qhov muag lossis daim di ncauj. Thaum muaj kev sib cuag, yaug kom huv si nrog dej. Tshaj tawm cov khoom kom tag nrho cov kab mob yog them nrog ib daim duab nyias nyias. Nqus maj mam rau hauv qhov txhab thiab rov ua dua rau qhov mob ntxiv. Ntxuav koj ob txhais tes tom qab siv tshuaj zawv plaub hau clobetasol propionate, 0.05%.

Muab cov tshuaj zawv plaub hau tso rau hauv qhov chaw rau 15 feeb, tom qab ntawd ntxiv dej, tawv nqaij thiab yaug kom huv si txhua qhov chaw ntawm tawv taub hau thiab lub cev uas tuaj yeem sib cuag nrog cov tshuaj zawv plaub hau (xws li tes, ntsej muag, caj dab thiab lub xub pwg nyom). Tsis txhob kov qhov muag thiab daim di ncauj. Txo kev sib cuag mus rau qhov chaw tsis muaj kev cuam tshuam ntawm lub cev. Txawm hais tias tsis muaj tshuaj zawv plaub hau ntxiv los ntxuav koj cov plaub hau, koj tuaj yeem siv tshuaj zawv plaub hau yog tias xav tau.

Kev kho mob yuav tsum txwv rau 4 lub lis piam sib law liag. Raws li nrog rau lwm cov tshuaj corticosteroids, kev kho yuav tsum tau txiav tawm thaum tswj tau tiav. Yog tias kev tswj hwm tus kab mob tsis tiav tom qab 4 lub lis piam ntawm kev kho mob nrog clobetasol propionate tsuaj zawv plaub hau, 0.05%, kev kho mob nrog cov tshuaj steroid tsawg dua tuaj yeem hloov tau. Yog tias tsis pom kev txhim kho nyob rau hauv 4 lub lis piam, kev ntsuam xyuas qhov kev kuaj mob yuav tsum yog qhov tsim nyog.

Clobetasol propionate tsuaj zawv plaub hau, 0.05%, yuav tsum tsis txhob siv nrog occlusive hnav khaub ncaws (da dej hau lossis da dej hau) tshwj tsis yog kws kho mob qhia.

Daim ntawv siv tshuaj thiab muaj zog

Shampoo, 0.05%, w/w. Txhua gram ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05%, muaj 0.5 mg ntawm clobetasol propionate nyob rau hauv lub translucent, tsis muaj xim mus rau daj ntseg daj kua.

Contraindications

Tsis muaj

Ceeb toom thiab ceev faj

Kev cuam tshuam rau endocrine System

Clobetasol propionate yog cov tshuaj corticosteroid uas muaj zog heev uas tau pom tias txhawm rau txhawm rau HPA axis ntawm cov koob tshuaj qis tshaj plaws.

Kev nqus ntawm cov tshuaj pleev xim corticosteroids tuaj yeem tsim kev thim rov qab hypothalamic-pituitary-adrenal (HPA) axis axis nrog lub peev xwm rau kev kho mob glucocorticosteroid insufficiency. Qhov no yuav tshwm sim thaum kho lossis thaum tshem tawm cov tshuaj pleev corticosteroid.

Cov nyhuv ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05% ntawm HPA axis suppression tau soj ntsuam hauv ib qho kev sim hauv cov tub ntxhais hluas hnub nyoog 12 txog 17 xyoo. Hauv qhov kev sim no, 5 ntawm 12 tus neeg soj ntsuam tau tsim kev tawm tsam ntawm lawv HPA axis tom qab 4 lub lis piam ntawm kev kho mob nrog clobetasol propionate tsuaj zawv plaub hau, 0.05% thov ib hnub ib zaug rau 15 feeb rau tawv taub hau qhuav ua ntej lathering thiab yaug.

Vim tias muaj peev xwm ua rau lub cev nqus tau, kev siv tshuaj pleev xim corticosteroids yuav xav kom cov neeg mob raug soj ntsuam ib ntus rau HPA axis suppression. Cov yam ntxwv uas ua rau tus neeg mob siv cov tshuaj pleev xim corticosteroid rau HPA axis suppression suav nrog kev siv cov tshuaj steroids ntau dua, siv ntau qhov chaw saum npoo av, siv lub sijhawm ntev, siv nyob rau hauv occlusion, siv rau ntawm daim tawv nqaij hloov, thiab siv rau cov neeg mob siab tsis ua hauj lwm. .

Ib qho kev sim tshuaj adrenocorticotropic hormone (ACTH) yuav pab tau rau hauv kev ntsuam xyuas cov neeg mob rau HPA axis suppression. Yog tias HPA axis suppression tau sau tseg, yuav tsum tau sim kom maj mam tshem cov tshuaj, txo qhov zaus ntawm daim ntawv thov, lossis hloov cov tshuaj steroid tsawg dua. Kev tshwm sim ntawm adrenal tsis txaus yuav xav tau cov tshuaj corticosteroids ntxiv. Kev rov qab los ntawm HPA axis muaj nuj nqi feem ntau yog sai thiab ua tiav thaum txiav cov tshuaj pleev corticosteroids.

Cushing's syndrome, hyperglycemia, thiab unmasking ntawm latent ntshav qab zib mellitus tuaj yeem tshwm sim los ntawm kev nqus ntawm cov tshuaj pleev corticosteroids.

Kev siv ntau dua ib yam khoom uas muaj corticosteroid nyob rau tib lub sijhawm tuaj yeem ua rau muaj kev cuam tshuam tag nrho.

Cov neeg mob menyuam yaus tuaj yeem raug cuam tshuam rau cov kab mob toxicity los ntawm cov koob tshuaj sib npaug vim lawv cov tawv nqaij loj dua rau lub cev qhov sib piv.[saib Siv hauv Cov Pej Xeem Tshwj Xeeb (8.4) ].

Allergic Contact Dermatitis

Yog tias khaus khaus tshwm sim, clobetasol propionate tsuaj zawv plaub hau, 0.05%, yuav tsum tau txiav thiab kho kom tsim nyog. Allergic contact dermatitis nrog corticosteroids feem ntau yog kuaj tau los ntawm kev soj ntsuam qhov ua tsis tau zoo es tsis ceeb toom qhov kev kho mob hnyav. Kev kuaj mob ntawm kev tsis haum tshuaj dermatitis tuaj yeem lees paub nrog kev kuaj kab mob.

Concomitant tawv nqaij kab mob

Nyob rau hauv lub xub ntiag ntawm dermatological kab mob, yuav tsum tau siv ib tug tsim nyog antifungal los yog antibacterial neeg sawv cev. Yog tias cov lus teb zoo tsis tshwm sim tam sim ntawd, kev siv cov tshuaj zawv plaub hau clobetasol propionate, 0.05%, yuav tsum tau txiav kom txog thaum tus kab mob tau tswj tau zoo.

Cov tshuaj tiv thaiv tsis zoo hauv zos nrog cov tshuaj corticosteroids

Cov kev phiv hauv zos tuaj yeem tshwm sim nrog kev siv occlusive, siv ntev lossis siv cov tshuaj corticosteroids ntau dua. Cov tshuaj tiv thaiv muaj xws li atrophy, striae, telangiectasias, kub hnyiab, khaus, khaus, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, Secondary infection, thiab miliaria. Qee qhov kev tsis zoo hauv zos tuaj yeem hloov tsis tau. Clobetasol propionate tsis pom zoo rau cov neeg mob pob txuv vulgaris, rosacea lossis perioral dermatitis.

Kev Phem Tsis Zoo

Kev sim tshuaj ntsuam xyuas

Vim tias qhov kev sim tshuaj ntsuam xyuas tau ua nyob rau hauv cov xwm txheej sib txawv, qhov tshwm sim tsis zoo tshwm sim hauv kev sim tshuaj ntawm cov tshuaj tsis tuaj yeem ncaj qha piv rau cov nqi hauv kev sim tshuaj ntawm lwm cov tshuaj thiab tej zaum yuav tsis cuam tshuam cov nqi kev coj ua.

Hauv kev sim tshuaj nrog clobetasol propionate tsuaj zawv plaub hau, 0.05%, cov tshuaj tiv thaiv hauv qab no tau tshaj tawm: mob taub hau, kub hnyiab / stinging, pruritus, edema, folliculitis, pob txuv, tawv nqaij qhuav, khaus khaus, alopecia, urticaria, tawv nqaij atrophy thiab telangiectasia.

Table 1 piav qhia txog cov kev tsis zoo uas tau tshwm sim hauvyam tsawg kawg1% ntawm cov kev kawm nyob rau theem 2 thiab 3 kev tshawb fawb rau tawv taub hau psoriasis.

tshuaj dawb rau 250

Kev nqus ntawm cov tshuaj pleev xim corticosteroids tau ua rau rov qab HPA axis suppression, tshwm sim ntawm Cushing's syndrome, hyperglycemia, thiab glucosuria hauv qee cov neeg mob.

Postmarketing Experience

Vim tias cov tshuaj tiv thaiv no tau lees paub los ntawm cov pej xeem tsis paub meej qhov loj, nws tsis yog ib txwm ua tau kom ntseeg tau tias lawv cov zaus los yog tsim kom muaj kev sib raug zoo rau kev siv tshuaj. Cov kev tsis zoo hauv qab no tau raug txheeb xyuas thaum siv cov tshuaj zawv plaub hau clobetasol propionate tom qab pom zoo, 0.05%.

• Cov kab mob endocrine:Cushing's Syndrome, kev tawm tsam ntawm adrenal
• Qhov muag:Mob qhov muag, Pom tsis pom kev, qhov muag khaus
• CNS:kiv taub hau
• GI:Ntshai
• Daim tawv nqaij:Erythema, daim tawv nqaij exfoliation, pob khaus, tawv nqaij khaus, plaub hau hloov xim, ua xua tiv tauj dermatitis, mob ntawm daim tawv nqaij, tawv nqaij nruj
• Lwm yam:Psoriasis (ua rau mob hnyav)

Siv rau hauv cov neeg tshwj xeeb

Kev xeeb tub

Cov teebmeem teratogenic:

Tsis muaj kev tshawb fawb txaus thiab tswj tau zoo hauv cov poj niam cev xeeb tub. Yog li ntawd, clobetasol propionate tsuaj zawv plaub hau, 0.05% yuav tsum tau siv thaum cev xeeb tub nkaus xwb yog tias cov txiaj ntsig muaj peev xwm ua rau muaj kev pheej hmoo rau tus menyuam hauv plab.

Corticosteroids tau pom tias yog teratogenic nyob rau hauv cov tsiaj txhu hauv chaw soj nstuam thaum siv cov txheej txheem ntawm cov qib qis. Qee cov corticosteroids tau pom tias yog teratogenic tom qab daim ntawv thov dermal rau cov tsiaj kuaj.

Clobetasol propionate yog absorbed percutaneously, thiab thaum noj subcutaneously nws yog ib qho tseem ceeb teratogen nyob rau hauv ob lub luav thiab nas.

Clobetasol propionate muaj peev xwm teratogenic ntau dua li cov tshuaj steroids uas tsis muaj zog.

Cov txiaj ntsig ntawm clobetasol propionate ntawm kev xeeb tub thiab kev loj hlob ntawm cov xeeb ntxwv tau kawm hauv nas. Clobetasol propionate tau muab tshuaj subcutaneously rau poj niam nas ob zaug ib hnub (0, 12.5, 25, thiab 50 Μg / kg / hnub) txij hnub 7 ntawm kev xeeb tub mus txog hnub 25 ntawm lactation lossis hnub 24 presumed gestation rau cov nas uas tsis xa ib lub litter. . Cov niam txiv tsis pom zoo-qib-qib (NOEL) rau clobetasol propionate tsawg dua 12.5 µg / kg / hnub vim txo qis lub cev hnyav thiab noj zaub mov thaum lub sijhawm xeeb tub. Kev ua me nyuam NOEL hauv cov dams yog 25 µg / kg / hnub (qhov piv ntawm cov koob tshuaj tsiaj rau tib neeg cov koob tshuaj ntawm 0.07 ntawm ib mg / mob/ hnub hauv paus) raws li kev xa khoom ntev ntawm qib siab dua. Qhov tsis pom zoo-tsis pom zoo-tshuaj-qib (NOAEL) rau kev vam meej thiab kev loj hlob ntawm cov xeeb ntxwv yog 12.5 µg µg / kg / hnub (qhov piv ntawm cov koob tshuaj tsiaj rau tib neeg cov koob tshuaj ntawm 0.03 ntawm ib mg / mob/ hnub hauv paus) raws li qhov tshwm sim ntawm kev yug menyuam, kev txo qis hauv tus menyuam lub cev hnyav rau hnub 1 thiab 7 ntawm lactation, nce tus menyuam tuag, nce qhov tshwm sim ntawm umbilical hernia, thiab nce qhov tshwm sim ntawm cov menyuam mos uas muaj hlwv ntawm lub raum ntawm koob tshuaj ntau dua. theem thaum lub sij hawm preweaning. Qhov hnyav ntawm cov epididymides thiab cov qog ntshav tau txo qis ntawm ntau npaum li cas. Txawm hais tias cov kev hloov no, tsis muaj kev cuam tshuam rau mating thiab fertility ntawm cov xeeb ntxwv.

Niam laus

Kev tswj hwm cov tshuaj corticosteroids tshwm sim hauv tib neeg cov kua mis thiab tuaj yeem cuam tshuam kev loj hlob, cuam tshuam nrog endogenous corticosteroid ntau lawm, lossis ua rau lwm yam tsis zoo. Nws tsis paub meej tias kev tswj hwm cov tshuaj corticosteroids puas tuaj yeem ua rau muaj kev nqus txaus los tsim cov kua mis hauv tib neeg. Vim tias ntau cov tshuaj tau tawm hauv tib neeg cov kua mis, yuav tsum tau ceev faj thaum siv tshuaj zawv plaub hau clobetasol propionate, 0.05%, yog muab rau tus poj niam laus.

Kev siv menyuam yaus

Kev siv cov tshuaj zawv plaub hau clobetasol propionate, 0.05%, hauv cov neeg mob hnub nyoog qis dua 18 xyoo tsis pom zoo vim muaj peev xwm ua rau HPA axis suppression[saib Ceeb toom thiab ceev faj (5.1) ].

Cov nyhuv ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05%, ntawm HPA axis suppression tau soj ntsuam nyob rau hauv ib qho kev sim rau cov tub ntxhais hluas hnub nyoog 12 txog 17 xyoo nrog rau nruab nrab rau tawv taub hau psoriasis nrog kev koom tes ntawm tsawg kawg yog 25% ntawm cov tawv taub hau. Hauv qhov kev sim no, 5 ntawm 12 tus neeg soj ntsuam tau tsim kev tawm tsam ntawm lawv HPA axis tom qab 4 lub lis piam ntawm kev kho mob nrog clobetasol propionate tsuaj zawv plaub hau, 0.05%, thov ib hnub ib hnub rau 15 feeb rau tawv taub hau ua ntej lathering thiab yaug. Tsuas yog 1 ntawm 5 yam kev kawm uas muaj kev thab plaub raug kuaj kom rov qab los ntawm HPA axis, thiab cov ncauj lus no tau zoo tom qab 2 lub lis piam.

Tsis muaj kev tshawb fawb tau ua nyob rau hauv cov neeg mob hnub nyoog qis dua 12 xyoos. Vim tias qhov sib piv ntau dua ntawm thaj chaw ntawm daim tawv nqaij mus rau lub cev loj, cov neeg mob hauv cov menyuam yaus muaj kev pheej hmoo ntau dua li cov neeg laus ntawm HPA axis suppression thiab Cushing's syndrome thaum lawv kho nrog tshuaj pleev corticosteroids. Yog li ntawd, lawv kuj tseem muaj kev pheej hmoo ntau dua ntawm adrenal tsis txaus thaum lub sijhawm thiab / lossis tom qab tshem tawm kev kho mob. Cov teebmeem tsis zoo suav nrog striae tau raug tshaj tawm nrog kev siv tsis tsim nyog ntawm cov tshuaj corticosteroids hauv cov menyuam mos thiab menyuam yaus. Yog li, tsis pom zoo siv rau cov neeg mob hnub nyoog qis dua 18 xyoo.

HPA axis suppression, Cushing's syndrome, linear growth retardation, ncua qhov hnyav nce, thiab intracranial kub siab tau raug tshaj tawm nyob rau hauv cov menyuam yaus uas tau txais tshuaj corticosteroids. Kev tshwm sim ntawm adrenal tsub zuj zuj nyob rau hauv cov me nyuam muaj xws li cov plasma cortisol qis thiab tsis muaj lus teb rau ACTH stimulation. Kev tshwm sim ntawm intracranial siab muaj xws li bulging fontanelles, mob taub hau, thiab ob sab papilledema.

Kev siv Geriatric

Kev tshawb fawb soj ntsuam ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05%, tsis suav nrog cov naj npawb txaus ntawm cov neeg muaj hnub nyoog 65 xyoo thiab tshaj los txiav txim seb lawv teb txawv li cas ntawm cov hluas. Feem ntau, kev xaiv koob tshuaj rau tus neeg mob laus yuav tsum tau ceev faj, feem ntau pib ntawm qhov qis kawg ntawm qhov koob tshuaj, qhia txog qhov ntau dua ntawm kev txo qis hauv siab, lub raum lossis lub plawv ua haujlwm, thiab cov kab mob sib kis lossis lwm yam tshuaj kho.

Kev noj ntau dhau

Topically thov, clobetasol propionate tsuaj zawv plaub hau, 0.05%, tuaj yeem nqus tau rau hauv cov nyiaj txaus los tsim cov teebmeem hauv lub cev.[saib Ceeb toom thiab ceev faj (5.1) ].

Clobetasol Shampoo Description

Clobetasol Propionate Shampoo, 0.05%, muaj clobetasol propionate, hluavtaws fluorinated corticosteroid, rau kev siv tshuaj pleev. Cov tshuaj corticosteroids yog ib chav kawm ntawm feem ntau hluavtaws steroids siv topically raws li cov tshuaj tiv thaiv thiab antipruritic.

Lub npe tshuaj clobetasol propionate yog 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1, 4-diene-3, 20-dione 17-propionate.

Nws muaj cov qauv hauv qab no:

Clobetasol propionate muaj qhov hnyav molecular ntawm 466.97 (CAS Registry Number 25122-46-7). Cov mis mos molecular yog C25H32CIFO5. Clobetasol propionate yog ib qho dawb rau siv dawb crystalline, tsw ntxhiab hmoov insoluble hauv dej.

Txhua gram ntawm Clobetasol Propionate Shampoo, 0.05%, muaj 0.5 mg ntawm clobetasol propionate nyob rau hauv ib tug translucent, tsis muaj xim rau daj ntseg daj viscous kua tshuaj zawv plaub hau puag muaj cawv (95% v / v), citric acid monohydrate, coco-betaine, polyquaternium-10 , dej huv, sodium citrate dihydrate, thiab sodium laureth-2 sulfate.

Clobetasol Shampoo - Clinical Pharmacology

Mechanism ntawm Action

Zoo li lwm cov tshuaj corticosteroids, clobetasol propionate tsuaj zawv plaub hau, 0.05%, muaj cov tshuaj tiv thaiv kab mob, tshuaj tua kab mob, thiab vasoconstrictive zog. Cov txheej txheem ntawm kev tiv thaiv kev ua haujlwm ntawm cov tshuaj steroids, feem ntau, tsis meej. Txawm li cas los xij, corticosteroids tau xav tias ua los ntawm induction ntawm phospholipase Aobinhibitory proteins, collectively hu ua lipocortins. Nws yog postulated tias cov proteins no tswj cov biosynthesis ntawm lub zog nruab nrab ntawm cov mob xws li prostaglandins thiab leukotrienes los ntawm inhibiting kev tso tawm ntawm lawv cov precursor, arachidonic acid. Arachidonic acid yog tso tawm los ntawm daim nyias nyias phospholipids los ntawm phospholipase Aob.

Pharmacodynamics

Kev ntsuam xyuas vasoconstrictor

Clobetasol propionate tsuaj zawv plaub hau, 0.05%, yog nyob rau hauv super-siab ntau ntawm potency raws li pom nyob rau hauv vasoconstrictor kev tshawb fawb nyob rau hauv noj qab haus huv kev kawm thaum piv nrog rau lwm yam tshuaj pleev corticosteroids. Txawm li cas los xij, cov qhab nia zoo sib xws tsis tas yuav hais txog kev kho mob sib npaug.

Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression

Hauv kev tshawb fawb soj ntsuam lub peev xwm rau hypothalamic-pituitary-adrenal (HPA) axis suppression, siv clobetasol propionate tsuaj zawv plaub hau, 0.05%, ua rau pom HPA axis suppression hauv 5 tawm ntawm 12 (42%) cov tub ntxhais hluas cov kev kawm.[saib Ceeb toom thiab ceev faj (5.1) thiab Siv hauv Cov Pej Xeem Tshwj Xeeb (8.4) ].

Pharmacokinetics

Qhov cuam tshuam ntawm percutaneous absorption ntawm tshuaj pleev corticosteroids yog txiav txim los ntawm ntau yam, nrog rau lub tsheb, kev ncaj ncees ntawm epidermal barrier thiab occlusion.

Cov tshuaj pleev corticosteroids tuaj yeem nqus tau los ntawm cov tawv nqaij tsis zoo. Kev mob thiab lwm yam kab mob hauv daim tawv nqaij yuav ua rau kom percutaneous nqus.

Tsis muaj tib neeg cov ntaub ntawv hais txog kev faib cov corticosteroids rau hauv lub cev tom qab siv tshuaj pleev. Txawm li cas los xij, ib zaug absorbed los ntawm daim tawv nqaij, tshuaj pleev corticosteroids raug tswj los ntawm cov txheej txheem metabolic zoo ib yam li kev tswj hwm corticosteroids. Lawv yog metabolized, feem ntau nyob rau hauv daim siab, thiab ces excreted los ntawm lub raum. Tsis tas li ntawd, qee cov corticosteroids thiab lawv cov metabolites kuj tau tawm hauv cov kua tsib.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Clobetasol propionate tsis yog carcinogenic rau nas thaum siv tshuaj pleev xim rau 2 xyoos ntawm qhov siab txog 0.005% uas sib raug rau cov koob tshuaj txog li 11 Μg / kg / hnub (qhov piv ntawm tsiaj koob tshuaj rau tib neeg cov koob tshuaj ntawm 0.03 ntawm ib mg / m.ob/ hnub hauv paus).

Clobetasol propionate ntawm qhov siab txog li 0.001% tsis tau nce tus nqi ntawm kev tsim ntawm ultraviolet lub teeb-induced tawv nqaij hlav thaum pleev xim rau cov nas tsis muaj plaub hau 5 hnub hauv ib lub lis piam rau 40 lub lis piam.

Clobetasol propionate yog qhov tsis zoo nyob rau hauvhauv vitromammalian chromosomal aberration test thiab hauvnyobmammalian erythrocyte micronucleus kuaj.

Cov txiaj ntsig ntawm subcutaneously muab clobetasol propionate rau fertility thiab kev loj hlob toxicity tau kawm nyob rau hauv nas ntawm koob 0, 12.5, 25, thiab 50 Μg / kg / hnub. Cov txiv neej raug kho pib 70 hnub ua ntej mating thiab poj niam pib 15 hnub ua ntej mating txog hnub 7 ntawm cev xeeb tub. Kev noj tshuaj tsawg dua 12.5 Μg / kg / hnub clobetasol propionate tau suav tias yog qhov tsis pom qhov cuam tshuam-theem (NOEL) rau leej txiv thiab leej niam cov tshuaj toxicity raws li qhov hnyav nce thiab rau txiv neej kev ua me nyuam toxicity raws li qhov hnyav ntxiv ntawm cov hlab ntsha. Tus poj niam yug me nyuam NOEL yog 12.5 Μg / kg / hnub (qhov piv ntawm cov koob tshuaj tsiaj rau tib neeg cov koob tshuaj ntawm 0.03 ntawm ib mg / mob/ hnub hauv paus) raws li kev txo qis ntawm cov estrous cycles thaum lub sij hawm ua ntej kev sib koom ua ke thiab kev nce ntawm cov embryos uas tsis tuaj yeem ntawm cov koob tshuaj ntau dua.

Kev tshawb fawb soj ntsuam

Kev nyab xeeb thiab kev ua tau zoo ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05%, tau raug tshuaj xyuas hauv ob qhov kev sim tshuaj uas suav nrog 290 tus neeg mob uas muaj qhov nruab nrab mus rau tawv taub hau psoriasis. Hauv ob qhov kev sim, cov neeg mob tau kho nrog cov tshuaj zawv plaub hau clobetasol propionate los yog cov tsheb sib txuas siv ib zaug ib hnub rau 15 feeb ua ntej lathering thiab yaug rau lub sijhawm 4 lub lis piam. Cov txiaj ntsig tau txais txiaj ntsig tau nthuav tawm hauv Table 2 hauv qab no.

Cov kev tshawb fawb soj ntsuam ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05%, tsis suav nrog cov naj npawb txaus ntawm cov neeg tsis yog neeg Caucasian los txiav txim seb lawv teb txawv li cas rau cov neeg Caucasian hais txog kev ua tau zoo thiab kev nyab xeeb.

Yuav Ua Li Cas Muab / Cia thiab tuav

Clobetasol Propionate Shampoo, 0.05%, yog ib qho ntshiab rau translucent, tsis muaj xim rau daj ntseg daj kua muag, nkag rau hauv 4 fl. ib oz. (118 mL) fwj.

NDC51672-1347-8

Cia:Khaws kaw kom nruj. Khaws 20 ° txog 25 ° C (68 ° txog 77 ° F) [saib USP Controlled Room Temperature].

Cov Ntaub Ntawv Qhia Txog Tus Neeg Mob

Saib FDA-pom zoo tus neeg mob daim ntawv lo ( Cov Ntaub Ntawv Tus Neeg Mob )

Cov ntaub ntawv rau cov neeg mob

Qhia rau tus neeg mob siv tshuaj pleev corticosteroids kom ua raws li cov lus qhia hauv qab no:

• Cov tshuaj no yog siv raws li tus kws kho mob qhia thiab yuav tsum tsis txhob siv ntev tshaj li lub sijhawm teem tseg.
• Clobetasol propionate tsuaj zawv plaub hau, 0.05%, yog rau kev siv sab nraud nkaus xwb. Nws yuav tsum tsis txhob siv rau ntawm lub ntsej muag, underarms los yog puab tais. Tsis txhob kov lub qhov muag thiab daim di ncauj.
• Cov tshuaj no yuav tsum tsis txhob siv rau ib qho teeb meem uas tsis yog qhov uas nws tau sau tseg.
• Qhov chaw ntawm tawv taub hau yuav tsum tsis txhob npog thaum cov tshuaj nyob rau ntawm tawv taub hau (piv txwv li, da dej hau, da dej hau) thiaj li yuav occlusive tshwj tsis yog tus kws kho mob qhia.
• Cov neeg mob yuav tsum tau tshaj tawm tej yam tshwm sim ntawm lub zos los yog lub cev tsis zoo rau lawv tus kws kho mob.
• Raws li nrog rau lwm cov tshuaj corticosteroids, kev kho yuav tsum tau txiav tawm thaum tswj tau tiav. Yog tias tsis pom kev txhim kho hauv 4 lub lis piam, hu rau tus kws kho mob.
• Cov neeg mob yuav tsum ntxuav tes tom qab siv tshuaj.
• Cov neeg mob yuav tsum qhia rau lawv tus kws kho mob tias lawv siv clobetasol propionate tsuaj zawv plaub hau, 0.05%, yog tias kev phais yog xav txog.
• Tsis txhob siv lwm yam khoom uas muaj corticosteroid thaum siv clobetasol propionate tsuaj zawv plaub hau, 0.05%.
• Cov neeg mob yuav tsum tsis txhob siv ntau tshaj 50 g (50 mL los yog 1.75 fl. oz.) ib lub lim tiam ntawm clobetasol propionate tsuaj zawv plaub hau, 0.05%.

Mfd. los ntawm: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Dist. los ntawm:Taro Pharmaceuticals U.S.A., Inc.Hawthorne, NY 10532

Tshaj tawm: Tsib Hlis 2020

PRINCIPAL DISPLAY PANEL - 118 mL Lub raj mis Carton

4 ooj (118 mL)

NDC 51672-1347-8

Clobetasol
Propionate
Tshuaj zawv plaub hau
0.05%

SIV SIV SIB THAM xwb.
Tsis siv tshuaj kho qhov muag.

Khaws qhov no thiab tag nrho
tshuaj tawm ntawm
ncav cuag cov me nyuam.

Rx xwb
MASS