复方降压药Azor获批准上市
日本第一三共制药公司近日宣布，美国FDA已批准其治疗高血压药物AZOR（氨氯地平／奥美沙坦酯复方制剂）上市。AZOR是每日仅需服用一次的氨氯地平和奥美沙坦酯的复方片剂，其中的氨氯地平为全球最畅销的钙离子通道阻断剂，而奥美沙坦酯则是血管紧张素受体阻断剂，这是当前销售增长速度最快的高血压药物。由此，这两种药物的复方制剂既使得医生有了一种高血压治疗的新选择，也为病人提供了一种服用方便的新药物。在临床试验中，AZOR显著降低高血压病人的收缩压和舒张压。AZOR用于治疗高血压时，可单独使用，也可与其它抗高血压药联用，但目前并没有被批准用于高血压的初始治疗。而用于那些使用一定降压药物不能控制血压的患者。
美国FDA同意把AZOR用于高血压的一线治疗，以此补充当前美国推出的联合用药指导方针，这个指导方针认为高血压初治病人常需要一种以上的药物才能达到治疗目标。根据美国新高血压指南（JNC7）指出，约2／3的患者使用一种药物难以控制血压，需联合应用2种或2种以上不同的药物才能达到降压目标。
该药的批准对于那些使用其它方法不能控制血压的患者提供了种重要的治疗选择。
在临床试验中Azor（剂量为 10/40 mg）平均降低30.1 mm Hg的收缩压，平均降低19.0 mm Hg的舒张压。与此对比单用10mg氨氯地平对应的数值为19.7 mm Hg 与12.7 mm Hg（安慰剂为4.8 mm Hg/3.1 mm Hg）。 Azor比单用氨氯地平可多降低53%的收缩压。
作用强的钙通道阻滞剂氨氯地平抑制钙离子进入血管壁，奥美沙坦酯阻断血管紧张素Ⅱ受体，两药联用有协同作用。本品通过两药的协同作用松弛血管，使血液畅通。
在美国，罹患高血压者约占成人的1/3；全球约有10亿例高血压患者，预测至2025年全世界将达16亿例。

Azor Oral Warnings
This drug can cause serious (possibly fatal) harm to an unborn baby if used during pregnancy.
Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control while taking this medication. If you are planning pregnancy, become pregnant, or think you may be pregnant, contact your doctor immediately.
Azor Oral Uses
This product is used alone or with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
This product contains 2 medications, amlodipine and olmesartan.
Amlodipine is a calcium channel blocker, and olmesartan is an angiotensin receptor blocker.
They both work differently to relax the blood vessels so that blood can flow through the body more easily.
These medications are used together when one drug is not controlling your blood pressure. Your doctor may direct you to start taking the individual medications first, and then switch you to this combination product if it is the best dose combination for you.
How to use Azor Oral
Take this medication by mouth with or without food, usually once daily or as directed by your doctor.
The dosage is based on your medical condition and response to treatment. Do not take more than 10 milligrams of amlodipine or 40 milligrams of olmesartan each day.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. It may take up to 2 weeks before you get the full benefit of this drug.
Do not stop taking this medication without first consulting your doctor.
Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.
Tell your doctor if your condition worsens (e.g., your routine blood pressure readings increase).
Azor Oral Side Effects
Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet or flushing may also occur.
If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, muscle weakness, fast/pounding heartbeat.
Tell your doctor immediately if any of these rare but very serious side effects occur: unusual change in the amount of urine, unusual muscle pain/tenderness, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is rare.
However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling(especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects.
If you notice other effects not listed above, contact your doctor or pharmacist.
Azor Oral Precautions
Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or olmesartan; or to other calcium channel blockers (e.g., nifedipine); or to other angiotensin receptor blockers (e.g., losartan); or to ACE inhibitors (e.g., lisinopril); or if you have any other allergies. This product may
contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (e.g., renal artery stenosis), liver disease, heart/blood vessel disease (e.g., heart attack, heart failure, aortic stenosis), high levels of potassium in the blood (hyperkalemia), loss of too much body water (dehydration).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.
Before having surgery, tell your doctor or dentist that you are taking this medication.
This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.
Older adults may be more sensitive to the effects of this product, especially dizziness.
This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Azor Oral Interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: conivaptan, cyclosporine, drugs that may increase your potassium level (e.g., potassium supplements, salt substitutes, potassium-sparing diuretics such as spironolactone, birth control products that contain drospirenone), lithium.
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure(e.g.,pseudoephedrine, phenylephrine) or reduce the effect of this medication (e.g., ibuprofen, naproxen). Ask your pharmacist about using those products safely.
If your doctor has prescribed low doses of aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue to take the aspirin. Consult your doctor or pharmacist for more details.
This document does not contain all possible interactions.
Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
Azor Oral Overdose
NOTES:
Do not share this medication with others.
Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine.
Talk to your doctor or pharmacist about lifestyle changes that might benefit you.
Laboratory and/or medical tests (e.g., potassium levels, kidney function) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
Check your blood pressure regularly while taking this medication, especially when you first start this drug or when your dose is changed. Learn how to monitor your own blood pressure at home, and share the results with your doctor.
MISSED DOSE:
If you miss a dose, take it as soon as you remember.
If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE:
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
附件

201183019361824.PDF

---------------------------------------------------------------
注：以下产品不同规格和不同价格，购买以咨询为准！
---------------------------------------------------------------
产品国家：日本
原产地英文商品名:
AZOR (5-40)MG/TAB 100TABS/BOTTLE
原产地英文药品名:
AMLODIPINE BESYLATE/OLMESARTAN MEDOXOMIL
中文参考商品译名:
AZOR (5-40)毫克/片 100片/瓶
中文参考药品译名:
苯磺酸氨氯地平/奥美沙坦酯
生产厂家中文参考译名:
第一三共
生产厂家英文名:
DAIICHI SANKYO

---------------------------------------------------------------
产品国家：日本
原产地英文商品名:
AZOR (5-20)MG/TAB 100TABS/BOTTLE
原产地英文药品名:
AMLODIPINE BESYLATE/OLMESARTAN MEDOXOMIL
中文参考商品译名:
AZOR (5-20)毫克/片 100片/瓶
中文参考药品译名:
苯磺酸氨氯地平/奥美沙坦酯
生产厂家中文参考译名:
第一三共
生产厂家英文名:
DAIICHI SANKYO
---------------------------------------------------------------
产品国家：日本
原产地英文商品名:
AZOR (10-40)MG/TAB 100TABS/BOTTLE
原产地英文药品名:
AMLODIPINE BESYLATE/OLMESARTAN MEDOXOMIL
中文参考商品译名:
AZOR (10-40)毫克/片 100片/瓶
中文参考药品译名:
苯磺酸氨氯地平/奥美沙坦酯
生产厂家中文参考译名:
第一三共
生产厂家英文名:
DAIICHI SANKYO
---------------------------------------------------------------
产品国家：日本
原产地英文商品名:
AZOR (10-20)MG/TAB 100TABS/BOTTLE
原产地英文药品名:
AMLODIPINE BESYLATE/OLMESARTAN MEDOXOMIL
中文参考商品译名:
AZOR (10-20)毫克/片 100片/瓶
中文参考药品译名:
苯磺酸氨氯地平/奥美沙坦酯
生产厂家中文参考译名:
第一三共
生产厂家英文名:
DAIICHI SANKYO