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1 ამპულა (1 მლ) შეიცავს:

მომქმედი ნივთიერება: ჰიოსცინის ბუთილბრომიდი – 20 მგ

დამხმარე ნივთიერებები: ნატრიუმის ქლორიდი, საინიექციო წყალი

აღწერილობა: გამჭვირვალე, უფერული ან თითქმის უფერული ხსნარი, პრაქტიკულად სუნის გარეშე, თავისუფალი ხილული ნაწილაკებისგან.

ფარმაკოლოგიური ჯგუფი: M-ქოლინობლოკატორი.

ფარმაკოლოგიური თვისებები

ფარმაკოდინამიკა: ბუსკოპანი სპაზმალიტიკურ მოქმედებას ახდენს კუჭ-ნაწლავის, ნაღვლისა და შარდ-სასქესო ტრაქტის გლუვ მუსკულატურაზე. ბუტილბრომიდის გიოსცინი, წარმოადგენს რა ამონიუმის მეოთხედოვან ნაწარმს, არ აღწევს ჰემატოენცეფალურ ბარიერში, ამიტომ გამორიცხულია ანტიქოლინერგიული გავლენა ცნს-ზე. პერიფერიული ანტიქოლინერგიული რეაქციები განპირობებულია შიდაორგანული პარასიმპათიკური განგლიების ბლოკადით, ასევე პრეპარატის ანტიმუსკარინული მოქმედებით.

ფარმაკოკინეტიკა: ი/ვ შეყვანისას, გიოსცინის ბუთილბრომიდი სწრაფად ნაწილდება ქსოვილებს შორის (ტ1/2ა = 4 წუთი, ტ1/2β = 29 წუთი ). განაწილების მოცულობა (VSS) უდრის 1281. ნახევრად გამოყოფის ტერმინალური პერიოდი (ტ1/2γ) შეადგენს დაახლოებით 5 საათს. საერთო კლირენსი უდრის 1.2 ლ/წუთში, ნახევარს შეადგენს თირკმლის კლირენსი. ძირითადი მეტაბოლიტები, რომლებიც შარდში განისაზ¬ღვრება, ცუდად უკავშირდება მუსკარინულ რეცეპტორებს. გიოსცინის ბუთილბრომიდი არ აღწევს ჰემატოენცეფალურ ბარიერში. პლაზმის ცილებთან დაკავშირება დაბალია.

ჩვენება

კუჭ-ნაწლავის, ნაღვლისა და შარდ-სასქესო ტრაქტის მწვავე სპასტიკური მდგომარეობა (მათ შორის ნაღველისა და თირკმლის ჭვალი). დიაგნოსტიკური და სამკურნალო პროცედურების ჩატარება, რომელთა განხორციელება გართულებუილია სპაზმების არსებობის დროს (გასტროდუოდენოსკოპია, რენტგენოლოგიური გამოკვლევა და სხვა).

უკუჩვენება

• ჰიპერმგრძნობელობა გიოსცინის ბუთილბრომიდის ან პრეპარატის სხვა კომპონენტების მიმართ;

• ვიწროკუთხოვანი გლაუკომა (არანამკურნალები);

• წინამდებარე ჯირკვლის ჰიპერტროფია შარდის შეკავებით;

• მექანიკური კუჭ-ნაწლავის გაუვალობა;

• ტაქიკარდია;

• მეგაკოლონი;

• მიასთენია გრავისი.

ფეხმძიმობა და ლაქტაცია: მოცემული არ არის რაიმე მონაცემი პრეპარატის ფეხმძიმობის დროს მიღების შესახებ. თუმცა, სხვა პრეპარატების გამოყენების მსგავსად, ფეხმძიმობის დროს სასურველია პრეპარატის დანიშვნა განსაკუთრებული სიფრთხილით, განსაკუთრებით პირველი ტრიმესტრის მანძილზე. დამტკიცებული არ არის პრეპარატის უსაფრთხოება ლაქტაციის პერიოდში. თუმცა, არ მოიპოვება მონაცემები ჩვილ ბავშვებზე წამლის არასასურველი ზეგავლენის შესა¬ხებ.

გამოყენების წესი და დოზირება

უფროსები და ბავშვები 12 წლის ზევით:

1-2 ამპულა (20-40 მგ) ი/ვ ნელა, ი/კ ან კანქვეშ რამდენიმეჯერ დღეში. მაქსიმალური დღე-ღამის დოზაა 100 მგ.

12 წლამდე ასაკის ბავშვები:

მძიმე შემთხვევებში: 0,3-0,6 მგ/კგ ი/ვ ნელა, ი/კ ან კანქვეშ რამდენიმეჯერ დღეში. მაქსიმალური დოზაა 1,5 მგ/კგ.

გვერდითი ეფექტები

შესაძლოა წარმოიქმას ანტიქოლინერგიული გვერდითი ეფექტები: სიმშრალე პირის ღრუში, დისჰიდროზი, ტაქიკარდია, შესაძლოა შარდის შეკავება, რომელიც, როგორც წესი, გამოხატული არ არის და თავისით გვარდება. იშვიათ შემთხვევებში შეიმჩნევა თავბრუს ხვევა, არტერიული წნევის დაცემა და სისხლის მოდინება სახისკენ. ძალზე იშვიათად ყოფილა ჰიპერმგრძნობელობის შემთხვევები, მათ შორის კანის რეაქცია, გართულებული სუნთქვა, ანაფილაქსიური რეაქციები და ანაფილაქსიური შოკი.

ჭარბი დოზა

სიმპტომები:

შესაძლო ანტიქოლინერგიული სიმპტომები.

თერაპია:

საჭიროებისამებრ იყენებენ პარასიმპატომიმეტიურ საშუალებებს. გლაუკომით დაავადებულმა პაციენტებმა დაუყოვნებლივ ოფთალ¬მოლოგს უნდა მიმართონ. გულ-სისხლძარღვთა გართულებას კურნავენ ჩვეულებრივი თერაპიული წესების მიხედვით. სასუნთქი მუსკულატურის დამბლის დროს ნაჩვენებია ინტუბაცია, ხელოვნური ვენტილაცია. შარდის შეკავების შემთხვევაში კეთდება შარდის ბუშტის კათეტერიზირება. ტარდება დამხმარე თერაპია.

წამლების ურთიერთმოქმედება: ბუსკოპანი აძლიერებს ტრიციკლური ანტიდეპრესანტების, ანტიჰისტამინური პრეპარატების, ქინიდინის, ამანტადინისა და დიზოპირამიდის ანტიქოლინერგიულ მოქმედებას. ბუსკოპანის ერთდროული დანიშვნა დოპამინის ანტაგონისტებთან, მაგალითად, მეტოკლოპრამიდთან, იწვევს ორივე პრეპარატის მოქმედების შესუსტებას კუჭ-ნაწლავის ტრაქტზე.

ბუსკოპანი აძლიერებს ბეტა-ადრენერგიული საშუალებებით გამოწვეულ ტაქიკარდიას.

განსაკუთრებული მითითება: პრეპარატის პარენტარული შეყვანის შემდეგ სასურველი არ არის ავტომობილის ან სამანქანო მოწყობილობების მართვა მხედველობის ნორმალიზაციამდე, რადგან ბუსკოპანმა შესაძლოა გამოიწვიოს დროებითი აკომოდაციის დარღვევა. არადიაგნოსტირებული დახურულკუთხოვანი გალუკომის მქონე პაციენტთათვის ანტიქოლინერგიული საშუალებების, მათ შორის, ბუსკოპანის დანიშვნისას, შესაძლოა თვალისშიდა წნევის მომატება. ინიექციის შემდეგ თვალის ტკივილის, სიწითლის ან მხედველობის მოშლის შემთხვევაში, დაუყოვნებლივ ექიმ-ოფთალმოლოგს მიმართეთ. პრეპარატის პარენტერალური შეყვანის დროს დაფიქსირებულია ანაფილაქსიური რეაქციები (მათ შორის შოკი). ამასთან დაკავშირებით, პრეპარატის მიღებისას, პაციენტი ექიმის მუდმივი კონტროლის ქვეშ უნდა იმყოფებოდეს.

გამოშვების ფორმა: საინიექციო ხსნარი 20 მგ/მლ. 1 მლ უფერული შუშის ამპულაში, მწვანე ფერის რკალით ამპულის თავში ან მუქი ფერის შუშის ამპულაში (ევროპული ფარმაკოპეა). 5 ამპულა პლასმასის ქვეშ, გამოყენების ინსტრუქციასთან ერთად, მოთავ-სებულია მუყაოს კოლოფში.

შენახვის პირობები და ვადები

15-დან 20°-მდე ტემპერა¬ტურაში, ბავშვები¬სათვის მიუწვდომელ ადგილას. დაუშვებელია პრეპარატის გაყინვა.

ვარგისიანობის ვადა: 5 წელი.

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