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Roflumilast: Perbedaan antara revisi

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←Membuat halaman berisi '{{Infobox drug | Verifiedfields = changed | Watchedfields = changed | verifiedrevid = 464383196 | image = Roflumilast structure.svg | width = 240 | alt = | image2 = Roflumilast ball-and-stick model.png | width2 = 240 | alt2 = | caption = <!-- Clinical data --> | pronounce = | tradename = Daxas, Daliresp, Zoryve, others | Drugs.com = {{drugs.com|monograph|roflumilast}} | MedlinePlus = a611034 | DailyMedID = Roflumilast | pregnancy_AU = B3 | pregnancy_AU_comme...'
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(7 revisi perantara oleh satu pengguna lainnya tidak ditampilkan)
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<!-- Clinical data -->
| pronounce =
| tradename = Daxas, Daliresp, Zoryve, othersdll
| Drugs.com = {{drugs.com|monograph|roflumilast}}
| MedlinePlus = a611034
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| pregnancy_AU_comment =
| pregnancy_category =
| routes_of_administration = [[Oral administration|By mouth]], [[Topical administration|topicaltopikal]]
| class = [[Phosphodiesterase-4 inhibitor|PDE4 inhibitor]]
| ATC_prefix = R03
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| bioavailability = 79%<ref name="Daliresp FDA label"/><ref name="Daxas SmPC"/><ref name=EMA/><ref name=MSR/>
| protein_bound = 99%<ref name="Daliresp FDA label"/><ref name="Daxas SmPC"/><ref name=EMA/><ref name=MSR/>
| metabolism = [[Hepatic]]Hati viamelalui [[CYP1A2]] & [[CYP3A4]]<ref name="Daliresp FDA label"/><ref name="Daxas SmPC"/><ref name=EMA/><ref name=MSR/>
| metabolites =
| onset =
| elimination_half-life = 17 hoursjam (30 hoursjam [activemetabolit metaboliteaktif])<ref name="Daliresp FDA label"/><ref name="Daxas SmPC"/><ref name=EMA/><ref name=MSR/>
| duration_of_action =
| excretion = UrineUrin (70%)<ref name="Daliresp FDA label"/><ref name="Daxas SmPC"/><ref name=EMA/><ref name=MSR/>
 
<!-- Identifiers -->
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<!-- Chemical and physical data -->
| IUPAC_name = 3-(CyclopropylmethoxySiklopropilmetoksi)-''N''-(3,5-dichloropyridindikloropiridin-4-ylil)-4-(difluoromethoxydifluorometoksi)benzamidebenzamida
| C=17 | H=14 | Cl=2 | F=2 | N=2 | O=3
| SMILES = C1CC1COC2=C(C=CC(=C2)C(=O)NC3=C(C=NC=C3Cl)Cl)OC(F)F
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}}
 
'''Roflumilast''' adalah obat yang digunakan untuk mengobati [[penyakit paru obstruktif kronik]],<ref name="Daliresp FDA label" /> [[psoriasis]] plak,<ref name="Zoryve cream FDA label" /> [[dermatitis seboroik]],<ref name="Zoryve foam FDA label" /> dan [[dermatitis atopik]].<ref name="Zoryve cream FDA label" /> Obat ini bekerja sebagai penghambat enzim fosfodiesterase-4 (PDE-4) yang selektif dan bekerja lama. Obat ini memiliki efek [[antiinflamasi]].<ref name="pmid18044684">{{cite journal | vauthors = Boswell-Smith V, Spina D | title = PDE4 inhibitors as potential therapeutic agents in the treatment of COPD-focus on roflumilast | journal = International Journal of Chronic Obstructive Pulmonary Disease | volume = 2 | issue = 2 | pages = 121–9 | year = 2007 | pmid = 18044684 | pmc = 2695611 | url = }}</ref><ref name="pmid18307529">{{cite journal | vauthors = Herbert C, Hettiaratchi A, Webb DC, Thomas PS, Foster PS, Kumar RK | title = Suppression of cytokine expression by roflumilast and dexamethasone in a model of chronic asthma | journal = Clinical and Experimental Allergy | volume = 38 | issue = 5 | pages = 847–56 | date = May 2008 | pmid = 18307529 | doi = 10.1111/j.1365-2222.2008.02950.x | s2cid = 19050454 }}</ref><ref name="pmid18447606">{{cite journal | vauthors = Field SK | title = Roflumilast: an oral, once-daily selective PDE-4 inhibitor for the management of COPD and asthma | journal = Expert Opinion on Investigational Drugs | volume = 17 | issue = 5 | pages = 811–8 | date = May 2008 | pmid = 18447606 | doi = 10.1517/13543784.17.5.811 | s2cid = 73241684 }}</ref>
'''Roflumilast''' adalah obat yang digunakan untuk mengobati penyakit paru obstruktif kronik,[4] psoriasis plak,[5] dermatitis seboroik,[6] dan dermatitis atopik.[5] Obat ini bekerja sebagai penghambat enzim fosfodiesterase-4 (PDE-4) yang selektif dan bekerja lama.[10] Obat ini memiliki efek antiinflamasi.[10][11][12]
 
Obat ini disetujui untuk penggunaan medis di [[Uni Eropa]] pada tahun 2010,<ref name="Daxas EPAR">{{cite web | title=Daxas EPAR | website=[[European Medicines Agency]] | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/daxas | access-date=28 September 2020 | archive-date=12 August 2020 | archive-url=https://web.archive.org/web/20200812193907/https://www.ema.europa.eu/en/medicines/human/EPAR/daxas | url-status=live }}</ref> di Amerika Serikat pada tahun 2011,<ref name="Daliresp FDA label">{{cite web | title=Daliresp- roflumilast tablet | website=DailyMed | date=12 March 2020 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9a1d0a8-581f-4f91-a2b8-f419192d0ebf | access-date=28 September 2020 | archive-date=25 March 2021 | archive-url=https://web.archive.org/web/20210325081719/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9a1d0a8-581f-4f91-a2b8-f419192d0ebf | url-status=live }}</ref> dan di Kanada pada tahun 2017.<ref name="Daxas CA PI">{{cite web | title=Daxas Product information | website=[[Health Canada]] | date=20 July 2017 | url=https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84447 | access-date=13 July 2024}}</ref> Obat ini tersedia sebagai [[obat generik]].<ref>{{cite web | title=2022 First Generic Drug Approvals | website=U.S. [[Food and Drug Administration]] (FDA) | date=3 March 2023 | url=https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/2022-first-generic-drug-approvals | archive-url=https://web.archive.org/web/20230630003602/https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/2022-first-generic-drug-approvals | archive-date=30 June 2023 | url-status=live | access-date=30 June 2023}}</ref>
 
Obat ini disetujui untuk penggunaan medis di Uni Eropa pada tahun 2010,[7] di Amerika Serikat pada tahun 2011,[4] dan di Kanada pada tahun 2017.[1] Obat ini tersedia sebagai obat generik.[13]
==Kegunaan dalam medis==
Roflumilast diindikasikan untuk pengobatan penyakit paru obstruktif kronik (PPOK) yang parah,<ref name="Daliresp FDA label" /> [[psoriasis]] plak,<ref name="Zoryve cream FDA label">{{cite web | title=Zoryve- roflumilast cream | website=DailyMed | date=16 August 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec1bb0d1-f38a-4080-831a-68791d1d1fdb | access-date=21 January 2023 | archive-date=21 January 2023 | archive-url=https://web.archive.org/web/20230121062229/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ec1bb0d1-f38a-4080-831a-68791d1d1fdb | url-status=live }}</ref><ref>{{cite press release | title=FDA Approves Arcutis' Zoryve (Roflumilast) Cream 0.3% For the Treatment of Plaque Psoriasis in Individuals Age 12 and Older | publisher=Arcutis Biotherapeutics | via=GlobeNewswire | date=29 July 2022 | url=https://www.globenewswire.com/news-release/2022/07/29/2488966/0/en/FDA-Approves-Arcutis-ZORYVE-Roflumilast-Cream-0-3-For-the-Treatment-of-Plaque-Psoriasis-in-Individuals-Age-12-and-Older.html | access-date=1 August 2022 | archive-date=1 August 2022 | archive-url=https://web.archive.org/web/20220801114445/https://www.globenewswire.com/news-release/2022/07/29/2488966/0/en/FDA-Approves-Arcutis-ZORYVE-Roflumilast-Cream-0-3-For-the-Treatment-of-Plaque-Psoriasis-in-Individuals-Age-12-and-Older.html | url-status=live }}</ref> dermatitis seboroik,<ref name="Zoryve foam FDA label">{{cite web | title=Zoryve- roflumilast aerosol, foam | website=DailyMed | date=20 December 2023 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f9e0b4a9-a227-4947-b00c-41fb18d16589 | access-date=13 July 2024}}</ref> dan dermatitis atopik.<ref name="Zoryve cream FDA label" /><ref>{{cite web |title=FDA Approves Atopic Dermatitis Label Expansion for Arcutis' Zoryve Cream |url=https://www.biospace.com/article/fda-approves-atopic-dermatitis-label-expansion-for-arcutis-zoryve-topical-cream-/ |access-date=13 July 2024 |website=BioSpace }}</ref>
 
Obat ini digunakan untuk mencegah eksaserbasi (serangan paru-paru) pada penyakit paru obstruktif kronik (PPOK) yang parah.<ref name="Daxas SmPC">{{cite web | title=Daxas 250 micrograms tablets - Summary of Product Characteristics (SmPC) | website=(emc) | date=11 June 2020 | url=https://www.medicines.org.uk/emc/product/9162/smpc | access-date=28 September 2020 | archive-date=19 September 2020 | archive-url=https://web.archive.org/web/20200919164902/https://www.medicines.org.uk/emc/product/9162/smpc | url-status=live }}</ref><ref name="Daliresp FDA label" /><ref name="Daxas EPAR" /><ref name=EMA>{{cite web|title=Daliresp : EPAR - Product Information|work=European Medicines Agency|publisher=Takeda GmbH|date=26 September 2013|access-date=18 November 2013|url=http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002398/WC500103078.pdf|archive-date=26 June 2016|archive-url=https://web.archive.org/web/20160626155812/http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002398/WC500103078.pdf|url-status=live}}</ref><ref name=MSR>{{cite web|title=roflumilast (Rx) - Daliresp|work=Medscape Reference|publisher=WebMD|access-date=18 November 2013|url=http://reference.medscape.com/drug/daliresp-roflumilast-999626|archive-date=12 September 2017|archive-url=https://web.archive.org/web/20170912145935/http://reference.medscape.com/drug/daliresp-roflumilast-999626|url-status=live}}</ref>
 
==Efek samping==
Efek samping yang umum (insiden 1–10%) meliputi diare, penurunan berat badan, mual, sakit kepala, insomnia, nafsu makan menurun, nyeri perut, rinitis, sinusitis, infeksi saluran kemih, dan depresi.<ref name="Daliresp FDA label"/><ref name="Daxas SmPC"/><ref name=EMA/><ref name=MSR/><ref name="pmid18660825">{{cite journal | vauthors = Spina D | title = PDE4 inhibitors: current status | journal = British Journal of Pharmacology | volume = 155 | issue = 3 | pages = 308–15 | date = October 2008 | pmid = 18660825 | pmc = 2567892 | doi = 10.1038/bjp.2008.307 }}</ref>
 
==Dalam budaya masyarakat==
===Status hukum===
Pada bulan Juni 2010, obat ini disetujui di Uni Eropa untuk PPOK parah yang berhubungan dengan [[bronkitis]] kronis.<ref name="Daxas EPAR" /><ref>{{Cite web |url=http://www.genengnews.com/gen-news-highlights/nycomed-s-anti-inflammatory-gains-approval-in-eu-for-copd/81243622/ |title="Nycomed's Anti-Inflammatory Gains Approval in EU for COPD" |access-date=10 July 2010 |archive-date=24 August 2017 |archive-url=https://web.archive.org/web/20170824222207/http://www.genengnews.com/gen-news-highlights/nycomed-s-anti-inflammatory-gains-approval-in-eu-for-copd/81243622 |url-status=live }}</ref> Pada bulan Februari 2011, obat ini memperoleh persetujuan FDA di Amerika Serikat untuk mengurangi eksaserbasi PPOK.<ref>{{cite web | title=Drug Approval Package: Daliresp Tablets (roflumilast) NDA #022522 | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 December 1999 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000TOC.cfm | access-date=28 September 2020 | archive-date=27 October 2020 | archive-url=https://web.archive.org/web/20201027013611/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022522Orig1s000TOC.cfm | url-status=live }}</ref><ref>{{cite press release | url = https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm244989.htm | title = FDA approves new drug to treat chronic obstructive pulmonary disease | date = 1 March 2011 | publisher = U.S. [[Food and Drug Administration]] (FDA) | access-date = 16 December 2019 | archive-date = 18 January 2017 | archive-url = https://web.archive.org/web/20170118091136/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm244989.htm | url-status = dead }}</ref>
 
==Referensi==
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