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შემადგენლობა
ნახევრად გამჭვირვალე, ღია-ნაცრისფერიდან თითქმის თეთრ ელფერამდე, რბილი, ცხიმოვანი მალამო

შემადგენლობა:
1 გრამი მალამო შეიცავს:
აქტიური ნივთიერება: ჰიდროკორტიზონ-17-ბუტირატი 1.0 მგ;
დამხმარე ნივთიერებები: პოლიეთილენის მალამოს საფუძველი (ვაზელინის ზეთი 95%, პოლიეთილენი 5%)- 1 გ-მდე.
ფარმაკოლოგიური თვისებები
ლოკოიდი წარმოადგენს გარეგანი გამოყენების სინთეზირებულ, არაჰალოგენიზირებულ გლუკოკორტიკოიდულ პრეპარატს. ავლენს სწრაფად მიღწევად ანთების საწინააღმდეგო, შეშუპების საწინააღმდეგო, ქავილის საწინააღმდეგო მოქმედებას.
ლოკოიდის გამოყენება რეკომენდებული დოზებით არ იწვევს ჰიპოთალამო-ჰიპოფიზარულ-ადრენალური სისტემის დათრგუნვას. მიუხედავად იმისა, რომ პრეპარატის დიდი დოზების გამოყენებამ ხანგრძლივად, განსაკუთრებით ოკლუზიური ნახვევის გამოყენების შემთხვევაში, შეიძლება გამოიწვიოს სისხლის პლაზმაში კორტიზოლის შემცველობის მომატება, რასაც არ ახლავს თან ჰიპოფიზურ-თირკმელზედა ჯირკვლის სისტემის ფუნქციის დაქვეითება. პრეპარატის მოხსნა იწვევს კორტიზოლის პროდუქციის სწრაფ ნორმალიზაციას.
ფარმაკოკინეტიკა
შეწოვა
აპლიკაციის შემდეგ ადგილი აქვს აქტიური ნივთიერების ეპიდერმისში დაგროვებას, ძირითადათ მარცვლოვან შრეში.
მეტაბოლიზმი
კანის გზით აბსორბირებული ჰიდროკორტიზონ-17-ბუტირატი მეტაბოლიზდება ჰიდროკორტიზონამდე და სხვა მეტაბოლიტებამდე უშუალოდ ეპიდერმისში და შემდგომ ღვიძლში.
გამოყოფა.
მეტაბოლიტები და შეუცვლელი ჰიდროკორტოზონ-17-ბუტირატის უმნიშვნელო ნაწილი გამოიყოფა შარდით ან განავლით.
ჩვენებები
ზედაპირული, არაინფიცირებული, ადგილობრივი გლუკოკორტიკოიდებისადმი მგრძნობიარე კანის დაავადება:
• ეკზემა
• დერმატიტები
• ფსორიაზი
მიღების წესები და დოზები
პრეპარატის მცირე რაოდენობას უსვამენ დაზიანებულ კანზე დღეში 1-3-ჯერ. დადებითი დინამიკის გამოვლენისას პრეპარატს იყენებენ 1-3-ჯერ კვირაში. შეღწევის გასაუმჯობესებლად პრეპარატის აპლიკაცია წარმოებს მასირების მეშვეობით. დაავადების რეზისტენტული მიმდინარეობისას, მაგალითად იდაყვის მიდამოში, მუხლებზე მკვრივი ფსორიაზული ფოლაქების ლოკალიზაციის დროს აუცილებელია პრეპარატის გამოყენება ოკლუზიური ნახვევის ქვეშ. კვირის განმავლობაში გამოყენებული პრეპარატის დოზა არ უნდა აჭარბებდეს 30-60 გრამს.
გვერდითი მოვლენები
ადგილობრივი რეაქციები: იშვაითად – კანის გაღიზიანება.
დიდ ზედაპირზე ხანგრძლივი გამოყენებისას და/ან წასმისას შესაძლებელია სისტემური გვერდითი ეფექტების განვითარება, რომელიც დამახასიათებელია გკს-სთვის.
გვერდითი ეფექტების გამოვლენის რისკი ლოკოიდის გამოყენებისას უფრო მცირეა ვიდრე ჰალოგენიზირებული სტეროიდების გამოყენების დროს. ადგილობრივი და სისტემური გვერდითი ეფექტების რისკი იზრდება პრეპარატის ხანგრძლივი გამოყენებისას დაზიანებული კანის დიდ ზედაპირებზე ოკლუზიური ნახევევების გამოყენებისას.
უკუჩვენება
• სახეზე ლოკალიზებული ვარდისფერი ფერისმჭამელები
• ვულგარული აკნე (acne vulgaris)
• პირის ღრუში ლოკალიზებული დერმატიტი
• პერიანალური, გენიტალური ქავილი
• ბაქტერიული (მაგალითად იმპეტიგო), ვირუსული (მაგალითად herpes simplex), სოკოვანი (მაგალითად კანდიდებით ან დერმატოფიტებით) ინფექციებით გართულებული დერმატიტები.
ორსულობა და ლაქტაცია
გლუკოკორტიკოიდები აღწევენ პლაცენტაში. ნაყოფზე ზემოქმედება შეიძლება განსაკუთრებულად იყოს გამოხატული პრეპარატის დიდ ფართობზე წასმისას. არ არსებობს მონაცემები დედის რძით გამოყოფილი ჰიდროკორტიზონის რაოდენობის შესახებ. განსაკუთრებული სიფრთხილის გამოჩენაა რეკომენდირებული პრეპარატის ლაქტაციის პერიოდში დანიშვნისას.
განსაკუთრებული მითითებები
პრეპარატის გამოყენება ბავშვთა ასაკში
ბავშვებში პრეპარატი გამოიყენება 6 თვის ასაკიდან. სახის მიდამოში მისი გამოყენების შემთხვევაში ან ოკლუზიური ნახვევის ქვეშ ხმარებისას აუცილებლია მკურნალობის კურსის ხანგრძლივობის შემცირება.
ბავშვთა ასაკში თირკმელზედა ჯირკვლის ქერქის ფუნქციის დათრგუნვა შეიძლება განვითარდეს უფრო სწრაფად. გარდა ამისა, შეიძლება აღინიშნოს ზრდის ჰორმონის ექსკრეციის შემცირება. პრეპარატის გამოყენებისას ხანგრძლივი დროის მანძილზე აუცილებელია სხეულის მასის, ზრდის, პლაზმის კორტიზოლის დონის კონტროლი. საკონტროლო გამოკველევის მიხედვით ბავშვებში, რომლებიც ყოველდღიურად იყენებდნენ 30-60 გ ლოკოიდს ან 1% ჰიდროკორტიზონის მალამოს, არ გამოვლინდა თირკმელზედა ჯირკვლის ქერქის ფუნქციის დარღვევა.
ჭარბი დოზირება
არ არსებობს მონაცემები ლოკოიდის დოზის გადაჭარბების შესახებ. დიდი დოზებით პრეპარატის ხანგრძლივი გამოყენებისას შესაძლებლია ჰიპერკორტიციზმის სიმპტომების გამოვლენა.
სხვა წამლებთან ურთიერთქმედება
ლოკოიდის სხვა სამკურნალო საშუალებებთან ურთიერთქმედების შესახებ მონაცემები არ მოიპოვება.
შენახვის პირობები და ვადები
ინახება არაუმეტეს 25oC
ინახება ბავშვებისთვის მიუწვდომელ ადგილას.
შენახვის ვადა 5 წელი. არ შეიძლება პრეპარატის გამოყენება შეფუთვაზე მითითებული შენახვის ვადის გასვლის შემდეგ.
აფთიაქში გაცემის წესი
გაიცემა ექიმის რეცეპტის გარეშე.
რეგისტრაციის # და თარიღი
რეგისტრაციის მოქმედების ვადა: 02.12.2014

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