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马来酸罗格列酮＋格列美脲的复方制剂（rosiglitazone maleate＋glimepiride，Avandaryl）治疗2型糖尿病。本品是FDA批准的首个且唯一的噻唑烷二酮类药物罗格列酮（rosiglitazone ，文迪雅，Avandia）和磺酰脲类药物格列美脲（glimepiride，Amaryl）组成的固定剂量的复方制剂。本品适用于接受罗格列酮＋格列美脲联合疗法的患者或单用2种药物而未能充分控制血糖水平的患者。
罗格列酮通过直接改善胰岛素耐受性，提高组织对天然胰岛素的敏感性，而格列美脲则主要通过促进机体释放更多天然胰岛素而发挥作用。数据显示罗格列酮（4或8mg）＋磺酰脲类药物联用与磺酰脲类药物单用相比，可显著提高糖化血红蛋白（A1c）和空腹血糖水平。1项2年期的双盲对照的临床研究显示，罗格列酮与磺酰脲类药物联用在改善A1C和空腹血糖水平方面耐受性良好。
本品为2种药物联用提供了更方便的使用途径，本品共3种剂量，分别为罗格列酮＋格列美脲4/1、4/2和4/4mg。本品可能导致低血糖，而头昏、眩晕、颤抖或饥饿感可能是血糖过低的体征。部分患者服用本品后可能出现疲劳、体重增加或浮肿。此外，本品未获准与胰岛素联用。
英文药名: Avandaryl (Rosiglitazone/Glimepiride Tablets)
中文药名: 罗格列酮格列美脲片
生产厂家: Glaxo Smith Kline
Avandaryl / Rosiglitazone - Diabetes Prescription Medication
Why is Avandaryl / Rosiglitazone prescribed?
Avandaryl / Rosiglitazone is an Online Pharmacy Medicine used along with a diet and exercise program and sometimes with one or more other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and, therefore, cannot control the amount of sugar in the blood). Avandaryl / Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Avandaryl / Rosiglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated).
How should Avandaryl / Rosiglitazone be used?
Avandaryl / Rosiglitazone comes as a tablet to take by mouth. It is usually taken once or twice daily with or without meals. Take Avandaryl / Rosiglitazone at about the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Avandaryl / Rosiglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may increase your dose of Avandaryl / Rosiglitazone after 8-12 weeks, based on your body's response to Avandaryl / Rosiglitazone.
Avandaryl / Rosiglitazone helps control type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease, and 2-3 months or longer for you to feel the full benefit of Avandaryl / Rosiglitazone. Continue to take Avandaryl / Rosiglitazone even if you feel well. Do not stop taking Avandaryl / Rosiglitazone without talking to your doctor.
Other uses for Avandaryl / Rosiglitazone:
Avandaryl / Rosiglitazone may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow while using Avandaryl / Rosiglitazone?
Before taking Avandaryl / Rosiglitazone:
tell your doctor and pharmacist if you are allergic to Avandaryl / Rosiglitazone or any other medications.
tell your doctor if you are taking insulin or nitrates such as isosorbide dinitrate (Isordril, Sorbitrate), isosorbide mononitrate (Imdur, ISMO), or nitroglycerin (Nitro-BID, Nitro-Dur, Nitroquick, Nitrostat, others). Nitrates come as tablets, sublingual (under the tongue) tablets, sprays, patches, pastes, and ointments. Ask your doctor if you are not sure if any of your medications contain nitrates. Your doctor will probably tell you not to take Avandaryl / Rosiglitazone if you are taking these medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: gemfibrozil (Lopid), other medications for diabetes, montelukast (Singulair), and rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or diabetic eye disease such as macular edema (swelling of the back of the eye); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.
tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking Avandaryl / Rosiglitazone, call your doctor. Do not breastfeed while you are taking Avandaryl / Rosiglitazone.
if you have not yet experienced menopause (change of life; end of monthly menstrual periods) you should know that Avandaryl / Rosiglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.
if you will be having surgery, including dental surgery, tell the doctor or dentist that you are taking Avandaryl / Rosiglitazone.
ask your doctor what to do if you get sick, develop an infection or fever, experience unusual stress, or are injured. These conditions can affect your blood sugar and the amount of Avandaryl / Rosiglitazone you may need.
What special dietary instructions should I follow while using Avandaryl / Rosiglitazone?
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help Avandaryl / Rosiglitazone work more effectively.
What should I do if I forget a dose of Avandaryl / Rosiglitazone?
Take the missed dose as soon as you remember it. However, if it is time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can Avandaryl / Rosiglitazone cause?
Avandaryl / Rosiglitazone may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.
You may experience hypoglycemia (low blood sugar) if you are taking Avandaryl / Rosiglitazone in combination with other medications used to treat diabetes. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
shakiness
dizziness or lightheadedness
sweating
nervousness or irritability
sudden changes in behavior or mood
headache
numbness or tingling around the mouth
weakness
pale skin
hunger
clumsy or jerky movements
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
confusion
seizures
loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
extreme thirst
frequent urination
extreme hunger
weakness
blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Call your doctor immediately if you have any of these symptoms:
dry mouth
upset stomach and vomiting
shortness of breath
breath that smells fruity
decreased consciousness
Avandaryl / Rosiglitazone may cause side effects.
Tell your doctor if any of these symptoms are severe or do not go away:
headache
runny nose and other cold symptoms
sore throat
back pain
painful or irregular menstrual periods
Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:
loss of appetite
nausea
vomiting
dark urine
yellowing of the skin or eyes
blurred vision
vision loss
difficulty seeing colors
difficulty seeing in the dark
pale skin
dizziness
swelling of the eyes, face, lips, tongue, or throat
hoarseness
difficulty swallowing or breathing
hives
itching
fever
blisters
Avandaryl / Rosiglitazone may cause other side effects. Call your doctor if you experience any unusual problems while you are taking Avandaryl / Rosiglitazone.
In clinical studies, more women who took Avandaryl / Rosiglitazone experienced fractures, especially of the hands, arms, feet, ankles, and lower legs than women who did not take Avandaryl / Rosiglitazone. Men who took Avandaryl / Rosiglitazone did not have a greater risk of experiencing fractures than men who did not take the medication. If you are a woman, talk to your doctor about the risk of taking Avandaryl / Rosiglitazone.
What storage conditions are needed for Avandaryl / Rosiglitazone?
Keep Avandaryl / Rosiglitazone in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat, and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What other information should I know about Avandaryl / Rosiglitazone?
Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to Avandaryl / Rosiglitazone. Your blood sugar and glycosylated hemoglobin should be checked regularly to determine your response to Avandaryl / Rosiglitazone. Your doctor may also tell you how to check your response to Avandaryl / Rosiglitazone by measuring your blood or urine sugar levels at home. Follow these directions carefully.
You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
GSK已推出由Glitazone和Sulfonylurea组成的固定剂量复方药Avandaryl，这两种成分在美国是最常用的糖尿病口服治疗药。
Avandaryl联合了GSK的Avandia和赛诺菲-安万特产品——Amaryl的活性成分，它现已在美国上市。此前，GSK已销售由Rosiglitazone和Metformin组成的糖尿病复方药Avandamet。
Avandaryl已通过批准用于曾联用Rosiglitazone 和Sulfonylurea进行治疗但分开用药的2型糖尿病患者，也可用于曾单独使用Sulfonylurea或Rosiglitazone进行治疗并需要外加控制血糖的患者。
GSK称，近2/3的2型糖尿病采用原来的疗法之后，对血糖的控制效果差强人意，而这会继续引发他们出现如神经损伤、心血管疾病以及眼疾等糖尿病并发症的危险。
近期，FDA 对GSK所有含Rosiglitazone的药物标签进行了变更，以警示该药可导致一种罕见的副作用——眼部黄斑点水肿。欧洲药监局也对Rosiglitazone及其同类产品（如武田的Actos）有可能导致的这个副作用加以注意，但这将不会对这种产品的销售情况带来重大的负面影响。 |
