Pantap Dərmanı Nə Üçün İstifadə Olunur?
Pantap dərmanının tərkibindəki Pantoprazol benzimidazolun əvəzolunmuş törəməsi olub, mədədə parietal hüceyrələrin proton nasosuna təsir etməklə xlorid turşusunun ifrazını tormozlayır və beləliklə, mədə xorası olan insanlara kömək edir.
12 yaşlı və daha böyük uşaqlar və yeniyetmələr və böyüklər
- Reflüks ezofaqit
Böyüklər - H. Pylori ilə əlaqəli xorası olan xəstələrdə uyğun antibiotiklərlə müalicə ilə kombinasiyada
Helicobacter pylori (H. pylori)-nin eradikasiyası - Mədə və onikibarmaq bağırsağın xorası
- Zollinger-Ellison sindromu və digər patoloji hipersekresiya halları.
Pantap Dərmanının Tərkibi
Təsiredici maddə: 1 tabletin tərkibində 40 mq pantoprazola ekvivalent miqdarda (45,1 mq)
pantoprazol natrium seskvihidrat vardır.
Köməkçi maddələr: susuz natrium fosfat, IsoMAlt LM-PF, karboksimetilsellüloza-natrium-
7MXF, köndələn-rabitəli polivinilpirolidon (Krospovidon), natrium-stearilfumarat, hipromelloza 2910 (Farmakoat 603), PVP K 25 (Povidon).
Pantap Dərmanının Farmakoloji xüsusiyyətləri
Pantoprazol benzimidazolun əvəzolunmuş törəməsi olub, mədədə parietal hüceyrələrin proton nasosuna təsir etməklə xlorid turşusunun ifrazını tormozlayır.
Pantoprazol parietal hüceyrələrin turş mühitində öz aktiv formasına çevrilməklə mədədə xlorid turşusunun sekresiyasının son mərhələsi olan H+K+-ATF-aza fermentini blokadaya alır. Dozadan asılı olaraq həm bazal, həm də stimulyasiya olunan turşu sekresiyasına təsir edir. Xəstələrin əksəriyyətində 2 həftə ərzində effekt əldə olunur. Proton nasosunun və H2- reseptorların digər blokatorları ilə müalicə zamanı olduğu kimi pantoprazolla müalicə də mədədə turşuluğun azalmasına və buna müvafiq qastrinin artmasına səbəb olur. Qastrinin artması geri dönən prosesdir. Pantoprazol fermentlə hüceyrə reseptorunun distal səviyyəsində birləşdiyi üçün xlorid turşusu sekresiyasına digər substansiyaların (asetilxolin, histamin, qastrin) stimuləedici təsirindən asılı olmayaraq effekt göstərə bilir. Peroral və venadaxili
istifadə zamanı effekti eynidir.
Pantoprazolun təsiri altında acqarına qastrinin səviyyəsi artır. Qısamüddətli istifadə zamanı bir çox hallarda o, normanın yuxarı sərhədini keçmir. Uzunmüddətli istifadə zamanı isə bir çox hallarda qastrinin səviyyəsi iki dəfə artır. Lakin, artıq dərəcədə artım nadir hallarda baş verir. Nəticədə, bəzi hallarda, uzunmüddətli müalicə zamanı, mədənin spesifik endokrin hüceyrələrinin (ECL) sayının orta və zəif artması (adenomatoid hiperplaziyaya qədər) nadir hallarda müşahidə olunmuşdur. Lakin, bu günə qədər aparılmış tədqiqatlarda karsinoid prekursorunun (atipik hiperplaziya) yaxud mədə karsinoidin heyvanlarda yaranmasının aşkar
olunmasına baxmayaraq, insanlarda müşahidə olunmamışdır.
Heyvanlar üzərində aparılan tədqiqatlara əsasən, pantoprazol ilə bir ildən artıq uzunmüddətli müalicənin, qalxanvarı vəzinin endokrin parametrlərinə təsiri tam olaraq istisna edilmir.
Pantap Dərmanının İstifadə Qaydası
Tabletlər əzilmədən və çeynənmədən yeməkdən bir saat əvvəl su ilə bütöv olaraq udulur.
Tövsiyə olunan doza:
12 yaşdan yuxarı yeniyetmələr və böyüklər
Reflüks ezofaqit
Pantap® bir tablet gündə bir dəfə. Fərdi hallarda doza iki dəfə artırıla bilər (gündə iki tabletə qədər) xüsusən digər müalicəyə cavab olmadıqda. Adətən reflüks ezofaqitin müalicəsi üçün 4 həftə tələb olunur.
Bu müddət kifayət etmədikdə, sağalma növbəti 4 həftə ərzində baş verir.
Böyüklər
H. Pylori-nin iki uyğun antibiotiklə kombinasiyada eradikasiyası Helicobacter pylori bakteriyası ilə müşaiyət olunan mədə və onikibarmaq bağırsaq xorası olan xəstələrdə kompleks müalicə ilə mikrobun məhv edilməsinə nail olunur. Bakterial rezistentlik və uyğun antibiotiklərlə müalicə və antibakterial preparatların təyinatına görə lokal rəsmi protokollara baxılmalıdır (milli tövsiyələr). Rezistentlik müxtəlifliyindən asılı olaraq, aşağıdakı kombinasiyalar H. Pylori-nin eradikasiyası üçün tövsiyə oluna bilər.
a) gündə iki dəfə bir tablet Pantap®
- gündə iki dəfə 1000 mq amoksisillin
- gündə iki dəfə 500 mq klaritromisin
b) gündə iki dəfə bir tablet Pantap® - gündə iki dəfə 400 – 500 mq metronidazol (yaxud 500 mq tinidazol)
- gündə iki dəfə 250 – 500 mq klaritromisin
c) gündə iki dəfə bir tablet Pantap® - gündə iki dəfə 1000 mq amoksisillin
- gündə iki dəfə 400 – 500 mq metronidazol (yaxud 500 mq tinidazol)
H. Pylori infeksiyası eradikasiyasının kombinə olunmuş müalicəsində ikinci Pantap® tablet axşam yeməyindən bir saat əvvəl qəbul olunmalıdır. Kombinə olunmuş müalicə ümumiyyətlə 7 gün aparılmalıdır və növbəti 7 günə qədər uzadıla bilər, ümumi müddət iki həftə olmaqla.
Xoranın sağalmasından əmin olmaq üçün daha sonra pantoprazolla müalicə mədə və 12- barmaq bağırsaq xorasında verilən dozada təyin edilir.
Kompleks müalicə istifadə olunmadığı halda, yaxud xəstənin H. pylori bakteriyasına test nəticəsi mənfidirsə, Pantoprazol monoterapiya şəkilində aşağıdakı dozalarda təyin edilir:
Mədə xorasının müalicəsində:
1 tablet gündə bir dəfə. Bəzi hallarda, xüsusən də, başqa müalicələr effekt göstərməyibsə, doza 2 dəfə artırıla bilər (gündəlik 2 tablet). Adətən, mədə yarasının müalicəsi üçün 4 həftə tələb olunur. Bu müddət kifayət etmədikdə adətən sonrakı 4 həftədə sağalmaya nail olunur.
Onikibarmaq bağırsaq xorasının müalicəsində:
1 tablet gündə bir dəfə. Bəzi hallarda, xüsusən də, başqa müalicələr effekt göstərməyibsə, doza 2 dəfə artırıla bilər (gündəlik 2 tablet). Adətən, onikibarmaq bağırsaq yarası müalicəsi üçün 2 həftə tələb olunur. Bu müddət kifayət etmədikdə sonrakı 2 həftədə demək olar ki bütün hallarda sağalmaya nail olunur.
Zollinger-Ellison sindromu və digər patoloji hipersekretor hallar:
Zollinger-Ellison sindromu və digər patoloji hipersekretor hallarda uzunmüddətli müalicə gündəlik 80 mq doza ilə başlamalıdır (2 tablet Pantoprazol 40 mq). Sonradan doza mədə turşusu sekresiyasının intensivliyindən asılı olaraq müvafiq şəkildə artırıla və ya azaldıla bilər. Gündəlik doza 80 mq-dan artıq olduqda iki yerə bölünərək gündə 2 dəfə verilməlidir.
Dozanın müvəqqəti 160 mq-a çatdırılması mümkündür, lakin bu müvafiq turşu nəzarəti üçün tələb olunan müddətdən artıq tətbiq edilməməlidir.
Zollinger-Ellison sindromu və digər patoloji hipersekretor halların müalicə müddətinə limit qoyulmur və klinik ehtiyacdan asılı olaraq uyğunlaşdırıla bilər.
Xüsusi qrup əhali:
12 yaşdan aşağı uşaqlar
12 yaşdan aşağı yaş qrupuna təsiri haqda əldə olan məlumatlar məhdud olduğu üçün bu yaşda
uşaqlara təyin edilməsi məsləhət görülmür.
Qaraciyər pozuntuları
Gündə 20 mq pantoprazol (1 tablet 20 mq pantoprazol) ağır qaraciyər pozuntuları ilə xəstələrdə artırılmamalıdır. Pantoprazol orta və ağır qaraciyər disfunksiyası olan xəstələrdə H. Pylori-nin eradikasiyası üçün kombinə olunmuş müalicədə istifadə olunmamalıdır, çünki belə xəstələrdə pantoprazolun kombinə olunmuş müalicədə effektivliyi və təhlükəsizliyi haqda məlumatlar yoxdur.
Böyrək pozuntuları
Böyrək pozuntuları olan xəstələrdə dozalanmaya düzəlişlər etmək vacib deyil.
Pantoprazol böyrək funksiyasının pozuntusu olan xəstələrdə H. Pylori-nin eradikasiyası üçün kombinə olunmuş müalicədə istifadə olunmamalıdır, çünki belə xəstələrdə pantoprazolun kombinə olunmuş müalicədə effektivliyi və təhlükəsizliyi haqda məlumatlar yoxdur.
Yaşlılar
Yaşlı insanlarda dozalanmaya düzəlişlər etmək vacib deyil.
Hamiləlik və laktasiya dövründə istifadəsi
Hamiləlik
Pantoprazolun hamilə qadınlarda istifadəsinə dair adekvat məlumatlar yoxdur. Heyvanlar üzərində aparılan tədqiqatlarda reproduktiv toksiklik aşkar edilmişdir. İnsanlarda potensial riski məlum deyil. Pantap® hamiləlik zamanı yalnız çox vacib hallar istisna olunmaqla, istifadə olunmamalıdır
Laktasiya
Heyvanlar üzərində aparılan tədqiqatlarda pantoprazolun südə keçməsi müəyyən edilmişdir.
İnsanlarda ana südünə keçməsi qeyd olunmuşdur. Buna görə ana südü ilə qidalandırmanı davam etdirmək/yaxud dayandırmaq, yaxud Pantap® ilə müalicəni davam etdirmək/yaxud dayandırmaq haqqında qərar uşağa ana südü ilə qidalandırmanın faydası və Pantap® ilə müalicənin qadına faydası nəzərə alınaraq verilməlidir.
Əlavələr
Buraxılış forması
Pantap® 40 mq enterik örtüklü tabletlər. 14 tablet, blisterdə. 1 (14 tablet) və ya 2 blister (28
tablet) içlik vərəqə ilə birlikdə karton qutuya qablaşdırılır.
Saxlanma şəraiti
25 °C-dən aşağı temperaturda, öz qutusunda və uşaqların əli çatmayan yerdə saxlamaq
lazımdır.
Yararlılıq müddəti
3 il.
Yararlılıq müddəti bitdikdən sonra istifadə etmək olmaz.
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