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美国默克制药公司每日用药一次的糖尿病治疗新药Januvia(sitagliptin)通过欧洲批准。该药是第一种通过欧洲批准的二肽酰肽酶4(DPP-4)抑制剂类糖尿病复方治疗药。
Januvia用于治疗2型糖尿病，它通过提高人体降糖素系统的机能而降低血糖水平。当人体血糖水平升高时，降糖素通过两种方式控制血糖水平：其一是促使胰腺释放胰岛素；其二是向肝脏发送信号以降低葡萄糖的生成。DPP-4抑制剂可以通过增加人体降糖素的活性而帮助2型糖尿病患者控制血糖水平特别值得指出的是，当单独使用Januvia效果不理想时，该药可与metformin联用，再结合饮食和运动而达到更好的疗效。同时，它还获准与thiazolidinedione联用。
默克公司生产的Januvia（Sitagli Ptin Phosphate monohydrate，磷酸西他列汀）获得加拿大健康署的批准，成为加拿大市场首个用于治疗2型糖尿病的二肽基肽酶-4（DPP-4）抑制剂类药物。根据审批结果，Januvia与另一种常用口服降糖药——二甲双胍联用，用于当2型糖尿病成年患者控制饮食或锻炼不能达到效果，以及单用二甲双胍无效时，更好地控制患者体内的血糖水平。
About JANUVIA
JANUVIA is a once-daily pill that, along with diet and exercise, helps lower blood sugar levels in people with type 2 diabetes. It's a type of prescription diabetes medicine called a DPP-4 inhibitor (blocker). DPP-4 blockers enhance the body's own ability to control blood sugar levels.
A doctor may prescribe JANUVIA alone or together with certain other diabetes medicines to help control blood sugar.
JANUVIA (jah-NEW-vee-ah) is a once-daily prescription pill that, along with diet and exercise, helps lower blood sugar levels in people with type 2 diabetes.
Important Information About JANUVIA
JANUVIA has not been studied with insulin and should not be used to treat patients with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine) or used if you are allergic to JANUVIA. Your doctor may perform blood tests from time to time to measure how well your kidneys are working. If you have kidney problems, your doctor may prescribe lower doses of JANUVIA.
When JANUVIA is used with a sulfonylurea, low blood sugar (hypoglycemia) can occur. To avoid this risk, your doctor may prescribe lower doses of the sulfonylurea.
Allergic reactions, which may be serious, including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing, can occur. If you have an allergic reaction, stop taking JANUVIA and call your doctor right away. The most common side effects include upper respiratory tract infection, stuffy or runny nose and sore throat, and headache.
Chemical Name: SITAGLIPTIN (si-ta-GLIP-tin)
Common uses
This medicine is a dipeptidyl peptidase-4 (DPP-4) inhibitor used to treat type 2 diabetes in patients who cannot control blood sugar levels by diet and exercise. It is used along with diet and exercise. This medicine may be taken alone or in combination with certain other antidiabetic medicines.
Before using
INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking digoxin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including kidney problems, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have type 1 diabetes or high blood ketone levels (diabetic ketoacidosis). Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
Directions
Follow the directions for using this medicine provided by your doctor. An additional patient information leaflet is available with this medicine. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. CONTINUE TO TAKE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.
Cautions
DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. Laboratory and/or medical tests, including blood glucose, hemoglobin A1C, and kidney function, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. It may be harder for you to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. CHECK BLOOD SUGAR LEVELS closely and ask your doctor before adjusting the dose of your diabetes medicine. MONITOR BLOOD GLUCOSE on a regular basis, as directed by your doctor.
Possible side effects
SIDE EFFECTS that may occur while taking this medicine include headache, nausea, nasal congestion, runny nose, sore throat, or upper respiratory infection. If they continue or are bothersome, check with your doctor. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.
Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions
If you take too much
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
Additional information
If your symptoms do not improve or if they become worse, check with your doctor. FOLLOW THE DIETARY PLAN provided by your doctor. Carry an identification card at all times that says you are diabetic. Monitor your blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher or lower than it should be and you are taking this medicine according to directions, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children.
JANUVIA Rx
Generic Name and Formulations:
Sitagliptin (as phosphate) 25mg, 50mg, 100mg; tabs.
Company:
Merck & Co., Inc.
Indications for JANUVIA:
Adjunct to diet and exercise in type 2 diabetes, as monotherapy or combination therapy (see literature).
Adult Dose for JANUVIA:
100mg once daily. Renal insufficiency: CrCl ≥30–50mL/min: 50mg once daily; CrCl<30mL/min or on dialysis: 25mg once daily.
Children's Dose for JANUVIA:
<18yrs: not recommended.
Pharmacological Class:
Dipeptidyl peptidase-4 inhibitor.
Warnings/Precautions:
Not for the treatment of type 1 diabetes or diabetic ketoacidosis. Monitor renal function before starting therapy, then periodically. Monitor for pancreatitis; discontinue if it occurs. Severe hepatic insufficiency. Pregnancy (Cat.B). Nursing mothers.
Interactions:
Concomitant sulfonylurea or insulin: may need lower dose of sulfonylurea or insulin to reduce risk of hypoglycemia. Monitor digoxin.
Adverse Reactions:
Nasopharyngitis, upper respiratory tract infection, headache; hypersensitivity reactions (eg, anaphylaxis, angioedema, Stevens-Johnson syndrome), discontinue if occur.
How Supplied:
Tabs 25mg, 50mg—30, 90; 100mg—30, 90, 1000
美国FDA批准治疗2型糖尿病的新药
美国FDA于2006年10月17日批准了治疗2型糖尿病的新药——Januvia，该药以一种全新的机制增强患者自身控制血糖的能力。Januvia的临床评估试验显示其单用或联合其他口服降糖药均能有效控制血糖，且不增加患者体重。
Januvia的临床效果
Januvia的临床评价试验总共采用了2719名2型糖尿病患者，持续时间长达12周至一年以上。这些研究显示单独使用Januvia即能有效控制血糖，且对二甲双胍或噻唑烷二酮类治疗效果不好的患者，也能改善其血糖的控制。
美国糖尿病协会的专家称糖尿病患者需要把糖化血红蛋白的水平控制在7％以下，这样才能减少许多并发症，如肾功能衰竭和糖尿病足的发生。在6月份的糖尿病会议上，默克公司称Januvia在一年内能使血糖水平降低0.67％，与格列吡嗪的作用相当。大约2/3的患者能将血红蛋白控制在7％以下。
Januvia全新的作用机制
Januvia的作用机制不同于以往任何口服降糖药。Januvia通过提高糖尿病患者自身胰岛β细胞产生胰岛素的能力，在血糖升高时增加胰岛素的分泌。
当血糖升高时，如进食后，会刺激胃肠内分泌细胞分泌肠促胰岛素，胰高血糖素样肽-1即是肠促胰岛素的一种，它能促进胰岛β细胞分泌胰岛素。二肽基酶IV能降解胰高血糖素样肽-1，而Januvia为二肽基酶IV的抑制剂。因此，使用Januvia能减少胰高血糖素样肽-1的降解，从而延长其活性，使得胰岛素分泌增加，使其能够在血糖升高时控制糖尿病患者的血糖水平。
Januvia可单用，亦可联用
FDA批准在饮食控制和增强锻炼的基础上应用Januvia来提高对2型糖尿病患者血糖的控制。Januvia可单独，也可与其他口服降糖药联合使用。当Januvia，以及其他两个常用口服将糖药二甲双胍、噻唑烷二酮类单用或结合饮食和锻炼而血糖控制不佳时，可将Januvia与二甲双胍或噻唑烷二酮类联合使用。Januvia和噻唑烷二酮类联用可增加机体对胰岛素的敏感性，对以胰岛素抵抗为主的2型糖尿病患者效果更佳。
美国路透社在对60位曾经对Januvia的使用有所顾忌的内分泌专家、全科医师和内科医师的调查中了解到，约90％的全科医师和95％的内分泌专家表示他们打算使用Januvia。
Januvia的优越性，降糖而不增加体重
肥胖是多种疾病的危险因素，体重控制不佳会增加心血管疾病的风险。许多口服降糖药的一个严重副作用即是在降糖的同时会增加患者的体重。而Januvia在试验中显示其不会增加患者的体重，这给2型糖尿病患者带来了福音。
Januvia低血糖反应少见
低血糖反应是大多数口服降糖药的常见副作用。而Januvia与其它降糖药不一样的是它仅在血糖升高时增加胰岛素分泌，从而减少了低血糖反应的发生。这使得患者对Januvia的依从性得到提高。在临床试验中发现，Januvia的主要副反应包括咽喉痛、上呼吸道感染和腹泻。
进一步评价
据美国FDA新陈代谢及内分泌药物科主任玛丽•帕克斯博士介绍，FDA将要求默克公司在Januvia上市后继续进行临床试验，评价Januvia与其他糖尿病常用药物，如磺酰脲类和胰岛素联用的临床效果。FDA也将继续关注这些研究的可靠数据，并不断更新Januvia的适应症。
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注：以下产品不同国家上市，价格以咨询为准！
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产地国家: 美国
原产地英文商品名:
JANUVIA 25mg/tab 30tabs/btl
原产地英文药品名:
SITAGLIPTIN PHOSPHATE
中文参考商品译名:
JANUVIA 25毫克/片 30片/瓶
中文参考药品译名:
磷酸西他列汀
生产厂家中文参考译名:
默克
生产厂家英文名:
Merck
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产地国家: 美国
原产地英文商品名:
JANUVIA 50mg/tab 30tabs/btl
原产地英文药品名:
SITAGLIPTIN PHOSPHATE
中文参考商品译名:
JANUVIA 50毫克/片 30片/瓶
中文参考药品译名:
磷酸西他列汀
生产厂家中文参考译名:
默克
生产厂家英文名:
Merck
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产地国家: 美国
原产地英文商品名:
JANUVIA 10mg/tab 30tabs/btl
原产地英文药品名:
SITAGLIPTIN PHOSPHATE
中文参考商品译名:
JANUVIA 100毫克/片 30片/瓶
中文参考药品译名:
磷酸西他列汀
生产厂家中文参考译名:
默克
生产厂家英文名:
Merck
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产地国家: 西班牙
原产地英文商品名:
JANUVIA 25mg/tab 28tabs/btl
原产地英文药品名:
SITAGLIPTIN
中文参考商品译名:
JANUVIA 25毫克/片 28片/瓶
中文参考药品译名:
西他列汀
生产厂家中文参考译名:
MSD
生产厂家英文名:
MSD
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产地国家: 西班牙
原产地英文商品名:
JANUVIA 50mg/tab 28tabs/btl
原产地英文药品名:
SITAGLIPTIN
中文参考商品译名:
JANUVIA 50毫克/片 28片/瓶
中文参考药品译名:
西他列汀
生产厂家中文参考译名:
MSD
生产厂家英文名:
MSD
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产地国家: 西班牙
原产地英文商品名:
JANUVIA 50mg/tab 28tabs/btl
原产地英文药品名:
SITAGLIPTIN
中文参考商品译名:
JANUVIA 50毫克/片 28片/瓶
中文参考药品译名:
西他列汀
生产厂家中文参考译名:
MSD
生产厂家英文名:
MSD
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