药品信息:
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201161523152935.pdf、201161523155612.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文格列齐特处方资料(仅供参考)
英文药名: Diamicron MR (Gliclazide Modified Release Tablets)
中文药名: 达美康(格列齐特控释片)
药品名称 通用名: 格列齐特片 英文名: GLICLAZIDE TABLETS 药品类别: 胰岛素及其他影响血糖药 性状: 本品为白色片。
规格 格列齐特片:80mg。 格列齐特控释片:30mg; 60mg。
药理毒理 本品是第二代磺脲类降血糖药,作用较强,其机理是选择性地作用于胰岛β细胞,促进胰岛素分泌,并提高进食葡萄糖后的胰岛素释放,使肝糖生成和输出受到抑制。本品经动物实验和临床使用证明能降低血小板的聚集和粘附力,有助于防治糖尿病微血管病变。
药代动力学 本品口服,在胃肠道迅速吸收,3~4小时可达血浆峰值,血浆蛋白结合率为92%,半衰期为10~12小时,口服后主要在肝脏代谢,经尿排出。
适应症 用于2型糖尿病。
用法用量 口服 开始用量40~80mg,一日1~2次,以后根据血糖水平调整至一日80mg~240mg,分2~3次服用,待血糖控制后,每日改服维持量。老年病人酌减。 任何疑问,请遵医嘱!
不良反应 偶有轻度恶心、呕吐,上腹痛、便秘、腹泻,红斑、荨麻疹,血小板减少,粒性白细胞减少,贫血等,大多数于停药后消失。
禁忌症 1.肝、肾功能不全者禁用。 2.磺脲药过敏者禁用。
注意事项 1.2型糖尿病患者在发生感染、外伤、手术等应激情况及酮症酸中毒和非酮症高渗性糖尿病昏迷时,应改用胰岛素治疗。 2.不适用于1型糖尿病患者。 3.与抗凝药合用时,应定期做凝血检查。 4. 本品剂量过大、进食过少或剧烈运动时,应注意防止低血糖反应。 5.应在医师指导下服用。必须定期检查患者血糖、尿糖。
孕妇及哺乳期妇女用药 动物试验和临床观察证明磺脲类降血糖药可致畸,而且由乳汁排出,故孕妇及乳母不宜使用。
老年患者用药 用药量适当减少。
药物相互作用 与非甾体抗炎药(特别是水杨酸盐)、磺胺类抗菌药、双香豆素类抗凝剂、单胺氧化酶抑制剂、β-受体阻断剂、苯二氮卓 类、四环素、氯霉素、双环己乙哌啶、氯贝丁酯、乙醇等药合用时,用量应减少,以免发生低血糖反应。
Diamicron (gliclazide) Main use:Type 2 diabetes Active ingredient:Gliclazide Manufacturer:Servier How does it work? Diamicron tablets contain the active ingredient gliclazide, which is a type of medicine called a sulphonylurea. (NB. Gliclazide is also available without a brand name, ie as the generic medicine.) Gliclazide is used to help control blood sugar levels in people with type 2 diabetes.
People with type 2 diabetes (non-insulin dependent diabetes) have a deficiency of a hormone called insulin. Insulin is produced by the pancreas and is the main hormone responsible for controlling sugar levels in the blood. It normally makes the cells of the body remove excess sugar from the blood. In type 2 diabetes insulin is produced inefficiently in response to surges of blood sugar, such as following a meal. The cells of the body also become resistant to the action of insulin that is produced, which means that blood sugar levels can become too high.
Gliclazide works mainly by stimulating the cells in the pancreas that produce insulin. These cells are called beta cells. Gliclazide causes the beta cells to produce more insulin. This helps to decrease the amount of sugar in the blood of people with type 2 diabetes.
Gliclazide improves insulin production immediately after eating. This is called early or first phase insulin secretion. The enhanced insulin production results in a blood sugar lowering effect in response to meals or glucose, as occurs naturally in people without diabetes.
Gliclazide is used when dietary measures, weight loss and physical exercise are not enough to control blood sugar levels in people with type 2 diabetes.
Gliclazide also has effects in the blood vessels. It has been shown to prevent blood cells called platelets from clumping together in the blood. It also increases the breakdown of blood clots that form within the blood vessels. This may help prevent the long-term complications of diabetes, which may be partly due to changes in the blood vessels caused by these mechanisms.
What is it used for? Type 2 (non-insulin dependent) diabetes, when diet, exercise and weight loss have failed to fully control blood sugar.
Warning! Your doctor may want you to check your blood sugar level from time to time while you are taking this medicine. Make sure you discuss how to do this and how often with your GP, pharmacist or diabetes specialist. On rare occasions, low blood sugar (hypoglycaemia) can occur as a side effect of this medicine. This is more likely to happen if you suddenly do more exercise than normal, have your meals at irregular times, eat less than usual, or miss meals altogether. For this reason, it is important that you follow any dietary or exercise advice given to you by your doctor. You should also make sure you are aware of the symptoms of hypoglycaemia (these may include cold sweats, cool pale skin, tremor, anxious feeling, unusual tiredness or weakness, confusion, difficulty in concentration, excessive hunger, temporary vision changes, headache or nausea) and what to do if you experience these symptoms. Discuss this with your GP, pharmacist or diabetes specialist. People who are taking antidiabetic tablets should only drink alcohol in moderation and accompanied by food. This is because alcohol can make your warning signs of low blood sugar less clear, and can cause delayed low blood sugar, even several hours after drinking. If you get an infection or illness, or have an accident while taking this medicine you should let your doctor know, because when the body is put under stress this medicine may become less effective at controlling your blood sugar. In these cases your doctor may need to temporarily replace your treatment with insulin. You should also consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic, or if you get pregnant. In these situations blood sugar is normally controlled by insulin. This type of medicine can cause liver problems on rare occasions. For this reason, you should let your doctor know if you develop any of the following symptoms while taking this medicine, as they may indicate a problem with your liver: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the skin or whites of the eyes (jaundice).
Use with caution in Elderly people. Decreased kidney function. Decreased liver function. Underactive thyroid gland (hypothyroidism). Insufficient production of hormones by the pituitary gland (pituitary insufficiency). Insufficient production of natural steroid hormones by the adrenal glands (adrenal insufficiency). Malnutrition. Severe vascular disease, eg severe coronary heart disease.
Not to be used in Children under 12 years of age. Allergy to medicines from the sulphonamide group, eg the antibiotic sulfamethoxazole. Allergy to other sulphonylureas, eg glibenclamide, tolbutamide. Type 1 (insulin dependent) diabetes. Diabetic ketoacidosis. Coma due to ketoacidosis in severe and inadequately treated diabetes (diabetic coma or pre-coma). Severely decreased kidney function. Severely decreased liver function. Hereditary blood disorders called porphyrias. Pregnancy. Breastfeeding.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
This medicine should not be used during pregnancy. Diabetes is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor. It is not known if this medicine passes into breast milk. It should not be used by breastfeeding women, because it could potentially cause low blood sugar in a nursing infant. Seek medical advice from your doctor.
Side effects Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Disturbances of the gut such as diarrhoea, constipation, indigestion, nausea, vomiting or abdominal pain. Temporary visual disturbances at start of treatment. Low blood glucose level (hypoglycaemia). Skin reactions such as rash and itch. Disturbances in the normal levels of blood cells in the blood. Yellowing of the skin and eyes (jaundice). Disturbance in liver function. Inflammation of the liver (hepatitis).
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines? Many medicines can affect blood sugar levels. It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
The following medicines may enhance the blood sugar lowering effect of this medicine and therefore increase the chance of low blood sugar (hypoglycaemia). If you start treatment with any of these your dose of this medicine may therefore need decreasing: anticoagulants, eg warfarin (anticoagulant effect may also be altered - if you are taking an anticoagulant with this medicine your doctor may want to perform extra monitoring of your blood clotting time or blood sugar) ACE inhibitors, eg captopril, enalapril (these can cause unpredictable drops in blood sugar) cimetidine disopyramide fibrates, eg clofibrate fluconazole insulin MAOI antidepressants, eg phenelzine miconazole (should not be taken with gliclazide) other antidiabetic tablets phenylbutazone large doses of salicylates, eg aspirin (small pain relieving doses do not normally have this effect) sulphonamide antibiotics, eg sulfamethoxazole, co-trimoxazole.
Beta-blockers, eg propranolol (including eye drops containing beta-blockers) can mask some of the signs of low blood sugar, such as increased heart rate and tremor. They also prolong episodes of low blood sugar and impair recovery back to normal glucose levels.
The following medicines may increase blood glucose levels. If you start treatment with any of these your dose of this medicine may therefore need increasing: some antipsychotic medicines, eg chlorpromazine, olanzapine corticosteroids, eg hydrocortisone, prednisolone danazol diuretics, especially thiazide diuretics, eg bendroflumethiazide oestrogens and progesterones, such as those contained in oral contraceptives.
Other medicines containing the same active ingredient Diamicron MR Vivazide
Gliclazide tablets are also available without a brand name, ie as the generic medicine.
--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201161523152935.pdf、201161523155612.PDF)的“原文Priscribing Information”为准 --------------------------------------------------------------- |