药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201272323063335.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文米格列醇处方资料(仅供参考)
米格列醇 分类名称 一级分类:内分泌系统药物 二级分类:糖尿病及胰岛疾病用药物 药品英文名 Miglitol 药品别名 德赛天、米格尼醇、Glyset 药物剂型 米格列醇片:25mg/片;50mg/片;100mg/片。15~30℃保存。 药理作用 本品为第二代糖苷酶抑制药。本品为小分子化合物,其结构与葡萄糖相似。在食物的消化过程中,α-葡萄糖苷酶(包括麦芽糖酶、异麦芽糖酶、蔗糖酶、葡萄糖淀粉酶等)可以将食物中的多糖及低聚糖水解为单糖(包括葡萄糖)。α-糖苷酶抑制药可延缓葡萄糖的生成及吸收,从而缓解糖尿病患者餐后高血糖及其后血糖的急剧变化。本品主要作用于小肠,对结肠内碳水化合物水解影响较小,由未吸收的糖类发酵继发的胃肠道不良反应较阿卡波糖少见。 药动学 本品较阿卡波糖更易在小肠吸收,口服给药的吸收程度随剂量增加而降低。口服25mg药物的生物利用度为100%,口服100mg药物的生物利用度约50%~70%,在更高剂量时吸收可达饱和。其蛋白结合率低于4%,分布容积为0.18L/kg。较少在体内代谢,超过95%以原形自尿液排泄,剂量超过25mg时,由于吸收不完全,可有少量药物经尿液重吸收。本品半衰期为2h。 适应证 用于治疗成人2型糖尿病。 禁忌证 以下患者禁用。1.对本品过敏者。2.糖尿病酮症酸中毒者。3.消化或吸收不良的慢性肠道疾病患者。4.炎性肠病或其他使肠道产气增加的疾病。5.肠梗阻。6.本品不宜用于儿童。 注意事项 1.本品宜在每次正餐开始时服用。2.发生低血糖时,宜口服葡萄糖,不宜服用蔗糖,因本品可延迟蔗糖吸收。3.在创伤、发热、感染、手术等应激情况下,本品可能对降低血糖无效,必要时应使用胰岛素。4.本品妊娠安全性分级为B级。5.本品排泄至乳汁的浓度很低,对新生儿几乎没有影响的可能,但仍建议哺乳期妇女停止用药。6.用药期间定期监测血糖,在开始治疗时,应监测餐后1h血糖水平。定期监测HbAlc。7.慎用:血清肌酸酐浓度高于2mg/dl患者慎用。 不良反应 1.代谢/内分泌系统:本品可影响糖原代谢,可能抑制肝糖原分解,空腹用药过量可能发生低血糖。根据本品的作用机制,空腹或餐后单独使用时都不应引起低血糖,但与磺酰脲类药物或胰岛素联用,可能导致血糖浓度进一步降低,增加了发生低血糖症的可能。2.消化系统:常见胃肠道反应,腹痛、腹泻、胃肠胀气的发生率可能与剂量正相关,继续治疗时,腹痛、腹泻多可缓解。3.血液:有血清铁浓度降低、贫血的报道。4.皮肤:皮疹多为一过性。 用法用量 口服给药,用于2型糖尿病,可单用或与磺酰脲类降糖药合用。起始剂量为每次25mg,3次/d,个别患者起始时需从1次/d逐渐增加至3次/d。4~8周后可增量至每次50mg,3次/d,服用3个月。在此期间,应测定糖化血红蛋白(HbAlc)以确定是否需加量至每次100mg,3次/d(最大推荐量)。有研究认为,在25~200mg范围内,疗效随剂量相应增加,但胃肠道不良反应也相应增加。单独使用本品的最佳剂量范围为每次50~100mg,3次/d。 药物相应作用 1.与活性炭等肠道吸附剂合用,本品疗效降低,两者应避免合用。2.与含淀粉酶、胰酶等可分解糖类的助消化酶剂合用,本品疗效降低,应避免合用。3.本品可能使地高辛的血药浓度降低,两者合用时应注意监测地高辛血药浓度。4.本品可使格列本脲的血药浓度峰值及药时曲线下面积轻微降低,但该变化无显著临床意义。此外,本品与磺酰脲类降糖药合用,发生低血糖的风险增加,应引起注意。5.本品可使雷尼替丁的生物利用度降低约60%,两者合用时应注意观察雷尼替丁疗效。未见本品与抗酸药、华法林、硝苯地平有明显相互作用。 Glyset Generic Name: Miglitol
What is Glyset? Glyset is used in addition to diet and exercise to improve high blood sugar levels caused by type 2 diabetes (non-insulin-dependent).
What is the most important information I should know about Glyset? It is important to continue to adhere to dietary instructions, a regular exercise program, and regular testing of urine or blood sugar.
Glyset, when administered alone, should not cause very low levels of blood sugar. However, when Glyset is administered with insulin or other diabetes drugs in a class known as sulfonylureas, the combination may cause low blood sugar. Symptoms of low blood sugar include dizziness, hunger, lightheadedness, and shakiness. If you experience signs and symptoms of low blood sugar, eat or drink something with sugar in it right away. If you do not feel better or your blood sugar does not go up, call your doctor immediately or seek emergency medical help.
Gastrointestinal (stomach) side effects may develop in the first few weeks of using Glyset. However, they become less frequent and less intense over time.
Who should not take Glyset? Do not use Glyset if you have diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breast bone, and fruity breath), inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, or chronic (long-term) intestinal disease.
Glyset should not be used by anyone allergic to the drug or any of its components.
What should I tell my doctor before I take the first dose of Glyset? Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Glyset. Also, talk to your doctor about your complete medical history, especially if you are pregnant, plan to become pregnant, or have intestinal or kidney disease.
What is the usual dosage? The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.
Adults: The recommended starting dose is 25 milligrams (mg), given orally three times a day. However, some patients may benefit by starting at 25 mg once a day to minimize side effects, then gradually increase to three times a day.
The usual maintenance dose is 50 mg 3 times a day. Your doctor may increase your dose as appropriate.
How should I take Glyset? Glyset should be taken orally three times a day with the first bite of each main meal.
What should I avoid while taking Glyset? Avoid drinking alcohol while taking this medication because it may increase your risk of developing low blood sugar.
Use caution when engaging in activities that require alertness (such as driving or operating machinery) because you may experience blurred vision, dizziness, or drowsiness from very high or low blood sugar levels.
What are possible food and drug interactions associated with Glyset? If Glyset is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Glyset with the following: amylase, digoxin, glyburide, metformin, propranolol, or ranitidine.
What are the possible side effects of Glyset? Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.
Side effects may include: excess stomach gas, diarrhea, abdominal pain, skin rash, low iron levels
Can I receive Glyset if I am pregnant or breastfeeding? The effects of Glyset during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.
What should I do if I miss a dose of Glyset? If you miss a dose of Glyset and have finished your meal, skip the missed dose. Take the next dose with the next meal. Do not take two doses at once.
How should I store Glyset? Store at room temperature.
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