Ikrimrimazole Cream

Ikrimrimazole Cream

Ifomu yesisindo: cream
Udidi lweziyobisi: Izihloko zokubulala iintlungu , Iintsholongwane ezichasayo

By Uhlaziyo lweMedia; Ukuhlaziywa ngu-Varixcare.cz. Igqityelwe ukuvuselelwa ngo-Novemba 23, 2020.

Kweli Phepha
Yandisa

Ukusetyenziswa kwangaphandle kuphela
Ayisetyenziselwa iOphthalmic Use

I-promethazine codeine ixabiso lesiraphu

Rx kuphela

INKCAZELO

I-Clotrimazole Cream USP, i-1% iqulethe i-clotrimazole, into ebambekayo ene-arhente yokubulala enegama lemichiza {1- (o-Chloro-α, α-diphenylbenzyl) imidazole}; ubume beemolekyuli C22H17Isikhephe2; Ubunzima beemolekyuli ezingama-344.84; kunye nefomula yolwakhiwo:

I-Clotrimazole USP yinto engenabumba, emhlophe yekristalline. Ayinyibiliki emanzini, inyibilika kancinci kwi-ether kwaye inyibilike kakhulu kwi-polyethylene glycol 400, ethanol kunye ne-chloroform.

Igram nganye yeClotrimazole Cream USP iqulethe i-10 mg ye-clotrimazole USP, isasazeke kwisiseko se-cream esilahlekileyo se-sorbitan monostearate, i-polysorbate 60, i-cetyl esters wax, i-cetostearyl utywala, i-octyldodecanol, amanzi acociweyo, kunye ne-benzyl alcohol (1%) njengendawo yokulondoloza.

IKHEMIKHALI YEKHAYA

I-Clotrimazole yi-arhente yokubola ebanzi esetyenziselwa unyango lwezifo zesikhumba ezibangelwa ziintlobo ezahlukeneyo ze-pathogenic dermatophytes, igwele kunyeMalassezia furfur. Isenzo esiphambili se-clotrimazole sichasene nokwahlula kunye nokukhula kwezinto eziphilayo.

I-In vitro,I-clotrimazole ibonakalisa ukungunda kunye nomsebenzi wokungunda ngokuchasene nokubekwa ecaleni kweTrichophyton rubrum, Trichophyton mentagrophytes,Epidermophyton floccosum, Microsporum caniskwayeUCandidaiintlobo kubandakanyaICandida albicans. Ngokubanzi,i-In vitroUmsebenzi we-clotrimazole uhambelana ne-tolnaftate kunye ne-griseofulvin ngokuchasene ne-mycelia ye-dermatophytes (Trichophyton, iMicrosporum,kwayeEpidermophyton), Kunye neepolyenes (i-amphotericin B kunye ne-nystatin) ngokuchasene nefungi ekhulayo (UCandida). Sebenzisa ikwi vivo(imouse) kunyei-In vitro(mouse kid homogenate) inkqubo yovavanyo, i-clotrimazole kunye ne-micronazole zazisebenza ngokulinganayo ekuthinteleni ukukhula kwe-pseudomycelia kunye ne-myceliaICandida albicans.

Iintlobo zeefungi ezinobunzima bendalo kwi-clotrimazole zinqabile. Kukodwa kuphela ukwahlulwa kweCandida guilliermondiKuxelwe ukuba inokuchasana okuyintloko ne-clotrimazole.

Akukho nyathelo-nye okanye inyathelo elininzi lokumelana ne-clotrimazole ephuhlileyo ngexesha lokuhamba ngokulandelelanaICandida albicanskwayeI-Trichophyton mentagrophytes. Akukho lutshintsho luxabisekileyo kubuntununtunu oluchongiweyo emva kokudlulela ngokulandelelana kokuzahlulaC. albicans, C krusei, okanyePseudotropicaliskwimithombo yeendaba engamanzi okanye eqinileyo equkethe i-clotrimazole. Kwakhona, ukunganyangeki akunakwenziwa kwimichiza eguqukayo ye-polyene-resistant resistantC. iialbicans. Kancinci, ukuxhathisa okubuyiswayo kwaqatshelwa kathathuC. iialbicanskuvavanywa umphandi omnye. Kukho ingxelo enye erekhoda ukuvela kweklinikhiC. iialbicansuxinzelelo ngokuxhathisa okubonakalayo kwi-flucytosine kunye ne-micronazole, kunye nokumelana ne-clotrimazole, ubunzima buhlala buthathaka kwi-nystatin kunye ne-amphotericin B.

Kwizifundo zendlela yokusebenza, ubuncinci be-fungicide ye-clotrimazole ibangele ukuvuza kwe-intracellular phosphorus compounds kwi-ambient medium kunye nokuqhekeka okuhambelana neeseli ze-nucleic acid kunye ne-potassium efflux ekhawulezayo. Zombini ezi ziganeko zaqala ngokukhawuleza kwaye ngokubanzi emva kokongezwa kwesiyobisi.

I-Clotrimazole ibonakala ngathi ifakwe kakuhle ebantwini emva kolawulo lomlomo kwaye isuswe ikakhulu njengeemetabolites ezingasebenziyo. Ukulandela umxholo kunye nolawulo lobufazi, nangona kunjalo, i-clotrimazole ibonakala ngathi incinci.

Emva kweeyure ezintandathu kusetyenziswe i-clotrimazole ene-radioactive 1% cream kunye nesisombululo se-1% kwisikhumba esiqinileyo nesidumbileyo, uxinzelelo lwe-clotrimazole lwahluka ukusuka kwi-100 mcg / cm3kumqolo wecorneum ukuya kwi-0.5 ukuya kwi-1 mcg / cm3kwi-stratum reticulare, kunye ne-0.1 mcg / cm3kwi-subcutis. Akukho sixa sinokulinganiswa somsakazo (≦ 0.001 mcg / mL) wafunyanwa kwiseramu ngaphakathi kweeyure ezingama-48 emva kokufakwa kwesicelo phantsi kokunxitywa kwe-0.5 mL yesisombululo okanye i-0.8 g yekhilimu. Kuphela yi-0.5% okanye ngaphantsi kwe-radioactivity esetyenzisiweyo eyachithwa kumchamo.

Ukulandela ulawulo lwe-intravaginal lwe-100 mg14Iipilisi ze-C-clotrimazole zelungu lobufazi kubantu basetyhini abadala, inqanaba eliphakathi le-serum, elihambelana kuphela ne-0.03 Μg elinganayo / ml ye-clotrimazole, yafikelelwa kwintsuku ezimbini ukuya kwesibini emva kokufakwa kwesicelo. Emva kolawulo lwangaphakathi kwi-5 g ye-1%14I-C-clotrimazole ukhilimu welungu lobufazi oqukethe i-50 mg yechiza elisebenzayo, ukuya kwizifundo ezihlanu (enye ine-colpitis ye-candidal), amanqanaba e-serum ahambelana ne-0.01 Μg elinganayo / mL afikelelwa phakathi kwe-8 kunye neeyure ezingama-24 emva kokufaka isicelo.

IZALATHISO NOSETYENZISO

I-Clotrimazole Cream USP ibonakalisiwe kunyango lwe-candidiasis ngenxaICandida albicanskunye ne-tinea versicolor ngenxaMalassezia furfur.

I-Clotrimazole ikwafumaneka njengeyona nto ingabhaliswanga eboniswe kunyango lwezihloko zezi zifo zilandelayo: i-tinea pedis, i-tinea cruris kunye ne-tinea corporis ngenxaTrichophyton rubrum, Trichophyton mentagrophytes,Epidermophyton floccosum, kunyeMicrosporum canis.

ULAWULO

I-Clotrimazole Cream iyaphikiswa kubantu abanovakalelo kumalungu ayo.

ipilisi ene-ip 465

IZILUMKISO

I-Clotrimazole Cream ayenzelwanga ukusetyenziswa kwamehlo.

UKULUMKELA

Ngokubanzi:

Ukuba ukucaphuka okanye ubuntununtunu bukhula ngokusetyenziswa kweClotrimazole Cream, unyango kufuneka lupheliswe kwaye kunyangwe unyango olufanelekileyo.

Ulwazi kubaguli:

Isigulana kufuneka sicetyiswe ukuba:

Sebenzisa iyeza ixesha elipheleleyo lonyango nangona iimpawu zinokuphucuka. Yazisa ugqirha ukuba akukho phuculo emva kweeveki ezine zonyango.
Yazisa ugqirha ukuba ngaba indawo yesicelo ibonisa iimpawu zokonyuka (ukuba bomvu, ukurhawuzelela, ukutshisa, ukudumba, ukudumba, ukurhawuzelela) okubonisa uvakalelo olunokwenzeka.
Kulumkele ukusetyenziswa kwento esongelayo okanye yokunxiba.
Gwema imithombo yosulelo okanye ukuphinda usulele.

Uvavanyo lweLebhu

Ukuba kukho ukungabikho kwempendulo kwiClotrimazole Cream, izifundo ezifanelekileyo ze-microbiological kufuneka ziphindwe ukuqinisekisa isifo kunye nokulawula ezinye izifo ngaphambi kokuqalisa enye ikhosi yonyango lwe-antimycotic.

Ukusebenzisana kweziyobisi

I-synergism okanye inkcaso phakathi kwe-clotrimazole kunye ne-nystatin, okanye i-amphotericin B, okanye i-flucytosine ngokuchasene neentlobo zeC. iialbicanskhange kuxelwe.

ICarcinogenesis, iMutagenesis, ukungasebenzi kakuhle kokuchuma

Isifundo se-dosing somlomo seenyanga ezili-18 nge-clotrimazole kwiigundane asibonisanga siphumo se-carcinogenic.

Kwiimvavanyo ze-mutagenesis, ii-chromosomes ze-spermatophores ze-hamsters zase-China ezazivezwe kwi-clotrimazole zavavanywa kutshintsho lolwakhiwo ngexesha le-metaphase. Phambi kovavanyo, iihamsters zazifumene iidosi ezintlanu zomlomo ze-clotrimazole ye-100 mg / kg yomzimba. Iziphumo zolu phononongo zibonise ukuba i-clotrimazole ayinampembelelo mutagenic.

Ukusetyenziswa kokuKhulelwa: Udidi lokukhulelwa B

Isimo se14I-C-clotrimazole ifundwe ebantwini nakwizilwanyana. I-Clotrimazole ayifakwanga kakuhle emva kwesicelo sedermal okanye ulawulo lwangaphakathi lomzimba ebantwini. (Jonga IKHEMIKHALI YEKHAYA )

Kuvavanyo lweklinikhi, ukusetyenziswa kwe-clotrimazole efakwe kwilungu lobufazi kubafazi abakhulelweyo kwisibini nakwisithathu sesithathu akuzange kunxulunyaniswe neziphumo ezibi. Kukho, nangona kunjalo, akukho zifundo zaneleyo nezilawulwa kakuhle kwabasetyhini abakhulelweyo ngexesha lekota yokuqala yokukhulelwa.

Izifundo kwiigundane ezikhulelweyo ezinengaphakathiIidosi ukuya kuthi ga kwi-100 mg / kg azivezi bungqina bokwenzakala kwimveku engekazalwa ngenxa ye-clotrimazole.

Phezulungomlomoiidosi ze-clotrimazole kwiigundane kunye neempuku ezisusela kwi-50 ukuya kwi-120 mg / kg zikhokelele kwi-embroyotoxicity (enokwenzeka kwisibini ukuya kwityhefu yoomama), ukonakala komtshato, ukuncipha kwenkunkuma kunye nenani labaselula kunye nokuncitshiswa kokusinda komntwana ekulunyulweni. Nangona kunjalo, i-clotrimazole yayihayiteratogenic kwiimpuku, imivundla kunye neempuku kwiidosi zomlomo ukuya kuthi ga kwi-200, 180 kunye ne-100 mg / kg, ngokwahlukeneyo. Ukufunxwa ngomlomo kumyinge we-rat kufikelela kwi-90% yedosi elawulwayo.

Ngenxa yokuba izifundo zokuvelisa izilwanyana azisoloko ziqikelela ukuphendula kwabantu, eli chiza kufuneka lisetyenziswe kuphela xa kubonisiwe ngokucacileyo ngexesha lekota yokuqala yokukhulelwa.

Oomama Abongikazi

Ayaziwa nokuba eli chiza likhutshiwe kubisi lomntu, isilumkiso kufuneka sisetyenziswe xa i-clotrimazole isetyenziswa ngumfazi ongumongikazi.

Ukusetyenziswa kwabantwana

Ukhuseleko kunye nokusebenza kwabantwana kwenzelwe i-clotrimazole xa isetyenzisiwe njengoko kubonisiwe kunye nakwidosi ekucetyiswa kuyo.

Iziphumo ezingalunganga

Oku kuchazwe gwenxa kulandelayo ngokunxulumene nokusetyenziswa kwale mveliso: i-erythema, i-stinging, blistering, peeling, edema, pruritis, urticaria, ukutsha, kunye nokucaphuka ngokubanzi kolusu.

UTHUTHO

Ukugqithisa okugqithisileyo kunye nokusetyenziswa kwesihloko se-clotrimazole akunakulindeleka kwaye akunakulindeleka ukuba kukhokelele kwimeko esongela ubomi.

IDOSI NOLAWULO

Thambisa ngobunono i-Clotrimazole Cream eyoneleyo kwiindawo ezichaphazelekayo nezingqonge ulusu kabini ngemini, kusasa nangokuhlwa.

Ukuphuculwa kweklinikhi, kunye nokukhululeka kwepritis, kuhlala kwenzeka kwiveki yokuqala yonyango ngeClotrimazole Cream. Ukuba isigulana asibonisi kuphuculwa kweklinikhi emva kweeveki ezine zonyango kunye neClotrimazole Cream, isifo kufuneka siqwalaselwe kwakhona.

INDLELA YOKUXHASA

I-Clotrimazole Cream USP, i-1% ibonelelwa ngeetyhubhu eziyi-15, 30, 45 kunye (2 x 45).

I-NDC 68462-181-17 (15 g)
I-NDC 68462-181-35 (30 g)
I-NDC 68462-181-47 (45 g)
I-NDC 68462-181-48 (2 x 45 g)

Gcina phakathi kwe-2okanye- 30okanyeC (36okanye-86okanyeF).

Yenziwe ngu:

IGlenmark Pharmaceuticals Ltd.
IColvale-Bardez, iGoa 403 513, eIndiya

iziphumo ebezingalindelekanga ze mucinex d

Yenzelwe:

IGlenmark Pharmaceuticals Inc., eUSA
Mahwah, NJ 07430

Imibuzo? 1 (888)721-7115
www.glenmarkpharma.com/usa

NgoSeptemba 2014

INqununu yePhaneli yokuBonisa

I-NDC 68462-181-35
I-Clotrimazole Cream USP, 1%
Ukusetyenziswa kwangaphandle kuphela. Ayisetyenziselwa ukusetyenziswa kwamehlo.

CLOTRIMAZOLE
Ikrimrimazole Cream
Ulwazi lweMveliso
Uhlobo lweMveliso INKCAZELO YABANTU ILELAYIBHILE YEZIYOBISI Ikhowudi yento (Umthombo) I-NDC: 68462-181
Umgaqo woLawulo UMXHOLO Ishedyuli ye-DEA
Isithako esisebenzayo / Umoya oSebenzayo
Igama lezithako Isiseko soMandla Amandla
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg kwi-1 g
Izithako ezingasebenziyo
Igama lezithako Amandla
UBENZYL UTYWALA
AMANZI
UTYWALA CETOSTEARYL
IOCTYLDODECANOL
IPOLITIKI 60
SORBITAN
Ukupakisha
# Ikhowudi yento Inkcazo yephakheji
1 I-NDC: 68462-181-17 I-15 g kwi-1 TUBE
2 I-NDC: 68462-181-35 I-30 g kwi-1 TUBE
3 I-NDC: 68462-181-47 I-45 g kwi-1 TUBE
4 I-NDC: 68462-181-48 2 SAMABHODI 1 ibhokisi
4 I-45 g kwi-1 TUBE
Ulwazi lweNtengiso
Udidi lokuThengisa Inombolo yesicelo okanye iMonograph Citation Umhla wokuQalisa ukuThengisa Umhla Wokuphela Wentengiso
Nina ANDA090219 04/08/2010
Umlebheli -IGlenmark Pharmaceuticals Inc., i-USA (130597813)
Ukusekwa
Igama Idilesi I-ID / FEI Imisebenzi
Inkampani Glenmark Pharmaceuticals Limited 677318665 UHLAHLELO (68462-181), UKWENZIWA (68462-181)
IGlenmark Pharmaceuticals Inc., eUSA

Ukuzihlangula kwezonyango