SEIBULE（セイブル錠 Miglitol Tablets） - Japan[日本药品]

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SEIBULE（セイブル錠 Miglitol Tablets）(一)

2013-10-21 00:21:53 来源: 作者: 【大中小】浏览:5957次评论:0条

英文药名：SEIBULE（Miglitol Tablets）

中文药名：米格列醇片

生产厂家：大日本住友制药

适用症：糖尿病血糖的改善

包装规格：
セイブル錠 25mg：100錠（PTP10錠×10）、210錠（PTP21錠×10）、500錠（PTP10錠×50）、1050錠（PTP21錠×50）
セイブル錠 50mg：100錠（PTP10錠×10）、210錠（PTP21錠×10）、500錠（PTP10錠×50）、1050錠（PTP21錠×50）
セイブル錠 75mg：100錠（PTP10錠×10）、210錠（PTP21錠×10）、500錠（PTP10錠×50）、1050錠（PTP21錠×50）
原文资料附件：http://www.info.pmda.go.jp/go/pack/3969009F1023_1_10/
药品介绍
米格列醇
Miglitol
中文别名：米格列醇、米格尼醇
英文别名： Glyset SEIBULE
药品类别：胰腺激素及其它影响血糖药
药理药动
Classification: Antidiabetic, oral
Action/Kinetics: Acts by delaying digestion of ingested carbohydrates resulting in smaller rise in blood glucose levels after meals. Effect is due to reversible inhibition of membrane-bound intestinal glucoside hydrolase enzymes which hydrolyze oligosaccharides and disaccharides to glucose and other monosaccharides. Reduces levels of glycosylated hemoglobin in type II diabetes. Does not enhance insulin secretion or increase insulin sensitivity. Does not cause hypoglycemia when given in fasted state. Absorption is saturable at high doses (i.e., only 50% to 70% of 100 mg dose is absorbed while 25 mg dose is 100% absorbed). Peak levels: 2-3 hr. Drug is not metabolized and is eliminated unchanged in urine. Reduce dose in impaired renal function.
适应症
Alone as adjunct to diet to treat non-insulin-dependent diabetes. With sulfonylurea when diet plus either miglitol or a sulfonylurea alone do not result in adequate control (effects of sulfonylurea and miglitol are additive).
用法用量
Tablets Type II diabetes. Individualize dosage. Initial: 25 mg t.i.d. with first bite of each main meal (some may benefit from starting with 25 mg once daily to minimize GI side effects). After 4 to 8 weeks of 25 mg t.i.d. dose, increase dosage to 50 mg t.i.d. for about 3 months. Measure glycosylated hemoglobin; if not satisfactory, increase dose to 100 mg t.i.d. Maintenance: 50 mg t.i.d., up to 100 mg t.i.d. (maximum).
不良反应
GI: Flatulence, diarrhea, abdominal pain, soft stools, abdominal discomfort. Dermatologic: Skin rash (transient).
注意事项
Pregnancy Category: B
Contraindications: Lactation, diabetic ketoacidosis, inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, those predisposed to intestinal obstruction, chronic intestinal diseases associated with marked disorders of digestion or absorption, conditions that may deteriorate due to increased gas formation in the intestine, hypersensitivity to drug.
Special Concerns: When given with sulfonylurea or insulin, miglitol causes further decrease in blood sugar and increased risk of hypoglycemia. Safety and efficacy have not been determined in children.
药物相互作用
Amylase / ↓ Miglitol effect Charcoal / ↓ Miglitol effect Digoxin / May ↓ plasma digoxin levels Pancreatin / ↓Miglitol effect Propranolol / Significant ↓ propranolol bioavailability Ranitidine / Significant ↓ ranitidine bioavailability
セイブル錠25mg／セイブル錠50mg／セイブル錠75mg
作成又は改訂年月