今天剛好跟同事討論到這個藥,其實像這類型非美係藥,會存在著一些很麻煩的地方,就是資料不齊全。 以Diamicron為例,法國原廠的資料很難造一般藥典及美系的文獻中取得,所以只好靠自己整理了。
原廠網站再這邊:
www.servier.com/Pro/Diabetes/DiamicronMR/DiamicronMR.aspx
他有附問答集:www.servier.com/Pro/Diabetes/DiamicronMR/DiamicronMR.aspx
先說明一點,舊款的 Diamicron為80mg的劑型,而新款的Diamicron MR為30mg的劑型,使用上是可以1:1轉換的,簡單的說,就是之前使用80mg的病患,直接吃30mg的MR就可以了。
另外,因為是長效型,所以飯前或是飯後吃就不是這樣重要了,不過如果患者可以接受的話,盡量選在飯前服用。
首先,了解一下MR結構的特色
所謂的MR,也就是Modulate release,其實是利用結構上面的特色,產生一天一次的效果。
簡單的說,就是由許多含Gliclazide控釋顆粒以纖維包覆達到緩慢釋放的目的
那Diamicron到底可以不可剝半或是磨粉呢?
原廠介紹如下:
Can DIAMICRON MR tablets be divided?
No, and in any case it is not necessary, as the results obtained in a pharmacokinetic and pharmacodynamic study in type 2 diabetic patients demonstrated that the dose of 30 mg is the first effective dose of DIAMICRON MR. The clinical efficacy and acceptability of starting DIAMICRON MR at this 1 tablet dose in newly diagnosed or even fragile patients has been demonstrated. The maintenance dose is usually 2 to 4 tablets. This dosage scheme was well demonstrated in the course of large scale clinical studies during the development of the product. Breaking the tablet, and hence the hydrophilic matrix of DIAMICRON MR, could change the unique characteristics of the release profile of the active ingredient (from the tablet as a whole) as well as the absorption of the active ingredient and is therefore not recommended.
簡單翻譯一下:
Diamicron MR可以切開嗎?
不行!而且也沒有必要,在藥效學及藥物動力學中顯示,30mg是首次有效劑量,而切開錠劑後,裡面親水性的網狀結構可能會被改變而導致影響活性成分的吸收。
我有寫信問廠商對於管灌的病患,該如何調整劑量呢?
廠商的回應讓我覺得台灣醫療應該要更進步一點:
住院中的管灌病患建議使用insulin做恆定性血糖控制,Diamicron並不適於此類患者。
而何時吃比較好呢?
簡單翻譯一下:
Diamicron MR可以切開嗎?
不行!而且也沒有必要,在藥效學及藥物動力學中顯示,30mg是首次有效劑量,而切開錠劑後,裡面親水性的網狀結構可能會被改變而導致影響活性成分的吸收。
我有寫信問廠商對於管灌的病患,該如何調整劑量呢?
廠商的回應讓我覺得台灣醫療應該要更進步一點:
住院中的管灌病患建議使用insulin做恆定性血糖控制,Diamicron並不適於此類患者。
而何時吃比較好呢?
Why is DIAMICRON MR given at breakfast time?
DIAMICRON MR, through its innovative hydrophilic matrix formulation, is designed to better match the release of active ingredient to the circadian glycemic levels of type 2 diabetic patients. When given once daily at breakfast, DIAMICRON MR ensures that levels of short-acting active ingredient are highest during the prandial daytime period, and relatively reduced during the fasting nighttime hours.
Clinical trials have demonstrated that this approach ensures 24-hours glycemic control alongside excellent acceptability, the incidence of possible hypoglycemia being very low, including in elderly and renal failure patients, and nocturnal hypoglycemia being avoided.
DIAMICRON MR absorption is highly reproducible and unaffected by food intake, so the tablets can be taken before, during, or after breakfast.
It must be remembered in this context that any effective treatment of diabetes must be given in combination with a good dietary regime, which implies regular meals and therefore breakfast. Like all sulfonylureas, DIAMICRON MR cannot be taken without a meal.
Clinical trials have demonstrated that this approach ensures 24-hours glycemic control alongside excellent acceptability, the incidence of possible hypoglycemia being very low, including in elderly and renal failure patients, and nocturnal hypoglycemia being avoided.
DIAMICRON MR absorption is highly reproducible and unaffected by food intake, so the tablets can be taken before, during, or after breakfast.
It must be remembered in this context that any effective treatment of diabetes must be given in combination with a good dietary regime, which implies regular meals and therefore breakfast. Like all sulfonylureas, DIAMICRON MR cannot be taken without a meal.
全站熱搜
留言列表