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იხილეთ აფთიაქების ჩამონათვალი

სომნოგამა / SOMNOGAMA
შემადგენლობა

სომნოგამას 1 ტაბლეტი შეიცავს 7.5 მგ ზოპიკლონს
არაქტიური ნივთიერებების სახით სომნოგამა შეიცავს:
ლაქტოზა 0.063 გ
სახამებელი 0.0225 გ
პოლივინილპიროლიდონი 0.006 გ
მაგნიუმის სტეარატი 0.001 გ

ფარმაკოლოგიური თვისებები
ზოპიკლონი მიეკუთვნება ციკლოპიროლანის ჯგუფის საძილე საშუალებას, რომელიც თავისი სტრუქტურით განსხვავდება ბენზოდიაზეპინებისა და ბარბიტურატებისაგან. იგი წარმოადგენს ბენზოდიაზეპინური რეცეპტორების ”არაბენზოდიაზეპინურ” აგონისტს. გააჩნია სედატიური, ანქსიოლიზური, ცენტრალური მიორელაქსაციური და ანტიკონვულსიური ეფექტები. ბენზოდიაზპინების მსგავსად, პრეპარატი აძლიერებს გაემ-ერგულ (გამაამინოერბომჟავას) პროცესებს ცნს-ში. იგი ურთიერთქმედებს ბენზოდიაზეპინურ რეცეპტორებთან, რის შედეგადაც იზრდება რეცეპტორების მგრძნობელობა მედიატორის მიმართ. უნდა აღინიშნოს, რომ ზოპიკლონი სავარაუდოდ მოქმედებს ბენზოდიაზეპინური რეცეპტორების სხვა უბნებზე, განსხვავებით ბენზოდიაზეპინებისაგან. საძილე ეფექტი აღინიშნება პრეპარატის მიღებიდან ნახევარი საათის შემდეგ. იგი არ ამცირებს «სწრაფი» ძილის ფაზას, ახანგრძლივებს “ნელ” ძილს და უზრუნველყოფს ნორმალური ფიზიოლოგიური ძილის ინიცირებას, რომელიც გრძელდება 6-8 საათი. პრეპარატის ხანგრძლივი მიღება არ იწვევს დაღლილობის შეგრძნებას დილისათვის, რაც დამახასიათებელია ბენზოდიაზეპინებისა და ბარბიტურატების ჯგუფის საძილე საშუალებებისათვის. არ ხასიათდება კუმულაციური თვისებებით.

ფარმაკოკინეტიკა
პრეპარატი პერორალურად მიღებისას სწრაფად შეიწოვება. მისი ელიმინაციის ნახევარპერიოდი შეადგენს 3-6 საათს. პრეპარატის დაახლოებით 45% უკავშირდება პლაზმის ცილებს. იგი განიცდის მეტაბოლიზმს, რის შედეგადაც წარმოიქმნება 2 ძირითადი მეტაბოლიტი- N- დესმეთილზოპიკლონი (არა აქტიური) და შ-ოქსიდი (ნაწილობრივ აქტიური). ორგანიზმიდან ძირითადად გამოიყოფა შარდთან ერთად. პირის ღრუში მწარე გემოს არსებობა შეიძლება აიხსნას ზოპიკლონის გამოყოფით ნერწყვთან ერთად.

ჩვენებები
ძილის დარღვევის ხანმოკლე მკურნალობა: უძილობა, დაძინების პროცესების გაჭიანურება.

მიღების წესები და დოზები
ინიშნება პერორალურად. მოზრდილების დოზა შეადგენს 7.5 მგ-ს (1 აბი) ძილის წინ. ხანგრძლივი უძილობისას დოზა შეიძლება გაიზარდოს 15 მგ-მდე (2 აბი). ხანდაზმულ პაციენტებში ნიშნავენ განახევრებული დოზით - 3.75 მგ (1/2 აბი), შეძლებისდაგვარად შეარჩევენ მცირე დოზას, რომელიც დამოკიდებულია მის ეფექტურობასა და შეწოვაზე. შემდგომში დოზა შესაძლოა გაიზარდოს.
მიუხედავად იმისა, რომ თირკმელების ფუნქციის დარღვევისას სისხლში პრეპარატის კონცეტრაციის მომატება არ აღინიშნება, საწყისი დოზა უმჯობესია განახევრდეს. მკურნალობის კურსი არ აღემატება 4 კვირაზე მეტ ხანს. პრეპარატის გახანგრძლივებული მიღება არ არის სასურველი წამლისადმი დამოკიდებულების განვითარების რისკის გამო.

გვერდითი მოვლენები
ხშირად ადგილი აქვს პირში მწარე ან ლითონის გემოს, იშვიათად კუჭ-ნაწლავის ტრაქტის მხრივ დარღვევებს (ღებინება, გულისრევა).იშვიათად ვითარდება ალერგია (ჭინჭრის ციება, გამონაყარი), ცალკეულ შემთხვევაში შესაძლოა განვითარდეს ავადმყოფური ძილიანობა, იშვიათად- თავბრუსხვევა და მოძრაობის კოორდინაციის დარღვევა.

უკუჩვენება
სუნთქვის გამოხატული უკმარისობა, თირკმელების უკმარისობა, ორსულობა და ლაქტაციის პერიოდი. პრეპარატი არ ინიშნება 15 წლამდე ასაკის ბავშვებში და პაციენტებში, რომელთაც გააჩნიათ ზოპიკლონის მიმართ მომატებული მგრძნობელობა.

განსაკუთრებული მითითებები
მკურნალობისას საჭიროა ალკოჰოლისა და ცნს-ზე დამთრგუნველად მოქმედ საშუალებების მიღებისაგან თავის შეკავება. პაციენტებს, რომლებსაც დარღვეული აქვთ თირკმელების ფუნქცია პრეპარატი რეკომენდებულია 3.75 მგ დოზით. პრეპარატისადმი დამოკიდებულების რისკი იზრდება პაციენტებში, რომელთაც გააჩნიათ წამლისა და ალკოჰოლის მიმართ მიდრეკილება. რისკი შედარებით მცირეა, თუ მკურნალობის ხანგრძლივობა არ აჭარბებს 4 კვირას. 
სატრანსპორტო საშუალებების მართვის უნარზე ზემოქმედება: მიუხედავად იმისა, რომ გვერდითი მოვლენები ზოპიკლონის მიღებისას იშვიათად ვითარდება, პრეპარატის მიღებიდან მომდევნო დღეს პაციენტს დიდი სიფრთხილე მართებს სატრანსპორტო საშუალების მართვისას და დანადგარების მომსახურეობისას, რომლებიც მოითხოვენ ყურადღების მაღალ კონცენტრაციას.

ჭარბი დოზირება
პრეპარატი არ იწვევს მწვავე რეაქციებს, დარღვევები ძირითადათ გარდამავალი ხასიათისაა. მაღალი დოზების მიღებისას შესაძლოა ადგილი ჰქონდეს ანტეროგრადულ ამნეზიას, რაც ნიველირდება ბენზოდიაზეპინების ანტაგონისტის ფლუმაზელინის ინტრავენური შეყვანით.

სხვა წამლებთან ურთიერთქმედება
ზოპიკლონი აქვეითებს იმიპრამინის კონცენტრაციას, რაც მნიშვნელოვანია მისი ერთდროული მიღებისას ტრიციკლურ ანტიდეპრესანტებთან. ერითრომიცინი აჩქარებს ზოპიკლონის შეწოვას და ახანგრძლივებს მის გამოყოფას. ცნს-ზე პრეპარატის დამთრგუნველ მოქმედებას აძლიერებენ ცნს-ის სხვა მადეპრიმირებელი - საძილე საშუალებები, ალკოჰოლი, ტრანკვილიზატორები, ნეიროლეფსიური საშუალებები, ანტიდეპრესანტები, სანარკოზე საშუალებები, ანალგეტიკები, ეპილეფსიის საწინააღმდეგო საშუალებები და ანტიჰისტამინური საშუალებები. ზოპიკლონის აქტივობა შეიძლება გააძლიერონ პრეპარატებმა, რომლებიც თრგუნავენ ღვიძლის ენზიმების აქტივობას.

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შენახვის პირობები: პრეპარატი ინახება ბავშვებისთვის მიუწვდომელ ადგილას ოთახის ტემპერატურაზე

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