阿齐沙坦酯衍生物片Edarbi(azilsartan medoxomil）
2011年2月25日，日本武田制药公司宣布，美国食品药品管理局(FDA)已经批准血管紧张素Ⅱ受体阻滞剂Edarbi(阿齐沙坦酯)用于治疗成人高血压。该药为口服用药，每日服药1次，既可单用，亦可与其他降压药联用。
该药的商品名为“Edarbi”，是血管紧张素Ⅱ受体阻滞剂（ARB）阿齐沙坦酯（azilsartan medoxomil）的一个衍生物。
Edarbi可阻滞血管紧张素II引起的血管收缩，从而使血压下降。
武田制药北美公司首席执行官Shinji Honda表示对该药获批感到非常高兴，他说，“通过该新药的发现、开发和商业化，武田致力于将Edarbi等新药推向市场。Edarbi对高血压患者以及为其提供治疗的医护人员是一个重要的新治疗选择。”
Edarbi将以80mg和40mg两种剂型上市，推荐剂量是80mg、每日1次。对于肾素-血管紧张素系统已激活的患者，比如伴有低血容量和(或)低钠血症的患者(如使用大剂量利尿剂治疗的患者)，在使用Edarbi后可发生症状性低血压，故在对这类患者使用Edarbi之前应该先纠正低血容量或低钠血症，而且应以40mg/d作为起始剂量。
EDARBI Rx
Generic Name and Formulations:
Azilsartan medoxomil 40mg, 80mg; tabs.
Company:
Takeda Pharmaceuticals North America, Inc.
Indications for EDARBI:
Hypertension. May be used alone or in combination with other antihypertensive agents.
Adult Dose for EDARBI:
≥18yrs: Monotherapy, not volume-depleted: 80mg once daily. Volume-depleted (eg, concomitant high-dose diuretics): initially 40mg once daily.
Children's Dose for EDARBI:
<18yrs: not established.
Pharmacological Class:
Angiotensin II receptor blocker.
Contraindications:
Concomitant aliskiren in patients with diabetes.
Warnings/Precautions:
Fetal toxicity may develop; discontinue if pregnancy is detected. Correct salt/volume depletion before starting therapy, or reduce initial dose; monitor for hypotension. Severe CHF. Renal artery stenosis. Renal impairment: monitor for worsening renal function. Neonates. Pregnancy (Cat. D); monitor. Nursing mothers: not recommended.
Interactions:
See Contraindications. Dual inhibition of the renin-angiotensin system with ARBs, ACEIs, or aliskiren may increase risk of hypotension, hyperkalemia, renal function changes; monitor closely. Concomitant aliskiren in renal impairment (CrCl <60mL/min): not recommended. May be antagonized by, and renal toxicity potentiated by NSAIDs, including selective COX-2 inhibitors (monitor renal function periodically in elderly and/or volume-depleted).
Adverse Reactions:
Diarrhea; rare: orthostatic hypotension, dizziness, nausea, asthenia, fatigue, muscle spasm, cough.
How Supplied:
Tabs—30, 90
Common name: azilsartan ester Indications: Edarbi angiotensin Ⅱ receptor blocker is the treatment of hypertension, either with other individual ř combination of antihypertensive drugs.
Pregnancy: C level (first semester) and D (second and third period) Manufacturer: Takeda Pharmaceuticals America Formula: 40,80 mg tablets Side effects: diarrhea, hypotension / postural hypotension. Other side effects include nausea, weakness, fatigue, muscle cramps, dizziness, postural dizziness, cough.
Note:
When pregnancy is detected as soon as possible to stop Edarbi.
Those drugs on the renin-angiotensin system can cause direct damage and fetal death.
Avoid contact with the fetus or the newborn.
* The correct volume or salt depletion before, Edarbi management.
* Monitor renal dysfunction in patients with renal function deterioration.
Deerfield: Takeda Pharmaceutical Company Limited (Takeda) and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc.
today announced that the U.S. Food and Drug Administration (FDA) approved for the treatment of hypertension Edarbi (azilsartan medoxomil), or high blood pressure, adults.
Edarbi is the angiotensin Ⅱ receptor blocker (ARB) to reduce by blocking the vasoconstrictor angiotensin Ⅱ and other hormones, contraction of blood pressure in rats. When angiotensin Ⅱ receptor blocker, blood vessels stay relaxed and open, can lower blood pressure.
Edarbi was approved as a once-daily alone and with other antihypertensive drugs in combination with oral therapy.
Takeda Global R & D center in April 2010 the U.S. proposed a new drug Edarbi application (NDA). Confidentiality agreement is to support the seven involved in over 5900 cases of controlled phase 3 clinical trials in patients with hypertension.
The key phase III studies show that the Edarbi (80 mg / day) was statistically
superior to placebo and the highest approved two drugs commonly used ARB, olmesartan medoxomil (40mg/day) and valsartan (320mg/day), dose reduction, outpatient and 24-hour mean blood pressure measurements.
"We are pleased to build on the cardiovascular and Edarbi treatment in the United States ratified the global expertise, said:" Honda President and CEO Shinji Takeda Pharmaceuticals North America.
"Through the discovery, development and commercialization of new medicines, Takeda is committed to the market as Edarbi therapy.
Edarbi is an important hypertension and health care workers who put their new treatment option."
The safety and efficacy were studied Edarbi once daily oral treatment, as well as chlorthalidone and amlodipine combination.
The results from the Phase III clinical trials that successfully met Edarbi lower blood pressure than the statistical significance of the primary endpoint of 24-hour mean systolic blood pressure (SBP)measurement of changes in ambulatory blood pressure monitoring, placebo and active head to head comparison.
Specifically, results from a study in the 80mg/day and40mg/day to 24 hours average 14.3 mm Hg and 13.2 mm Hg baseline, respectively, systolic blood pressure Edarbi. On Edarbi(80mg/day) reduced blood pressure was statistically more active than
valsartan 320 mg / day (-10.0 mm Hg), and olmesartan medoxomil 40 mg/ day (-11.7 mm Hg). Similar results were compared in all three studies. In adults the most common adverse reactions were diarrhea(2%).
附件:
20125200110524.PDF
20125200110013.PDF
20125200105616.PDF
20125200105227.pdf
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注：以下产品不同规格和不同价格，购买以咨询为准！
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产地国家: 美国
原产地英文商品名:
EDARBI 80mg/tab 30tabs/bottle
原产地英文药品名:
AZILSARTAN MEDOXOMIL
中文参考商品译名:
EDARBI 80毫克/片 30片/瓶
中文参考药品译名:
阿齐沙坦酯
生产厂家中文参考译名:
武田
生产厂家英文名:
TAKEDA
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产地国家: 美国
原产地英文商品名:
EDARBI 40mg/tab 30tabs/bottle
原产地英文药品名:
AZILSARTAN MEDOXOMIL
中文参考商品译名:
EDARBI 40毫克/片 30片/瓶
中文参考药品译名:
阿齐沙坦酯
生产厂家中文参考译名:
武田
生产厂家英文名:
TAKEDA
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产地国家:德国
原产地英文商品名:
EDARBI 20mg/tab 98tabs/bottle
原产地英文药品名:
AZILSARTAN MEDOXOMIL
中文参考商品译名:
EDARBI 20毫克/片 98片/瓶
中文参考药品译名:
阿齐沙坦酯
生产厂家中文参考译名:
武田
生产厂家英文名:
TAKEDA
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产地国家:德国
原产地英文商品名:
EDARBI 40mg/tab 98tabs/bottle
原产地英文药品名:
AZILSARTAN MEDOXOMIL
中文参考商品译名:
EDARBI 40毫克/片 98片/瓶
中文参考药品译名:
阿齐沙坦酯
生产厂家中文参考译名:
武田
生产厂家英文名:
TAKEDA
该药品相关信息网址1:
www.edarbi.com/
该药品相关信息网址2:
www.drugs.com/edarbi.html
该药品相关信息网址3:
www.rxlist.com/edarbi-drug.htm