英文药名: Exforge HCT(Amlodipine besylate/Valsartan/Hydrochlorothiazide Tablets)

中文药名: 复合苯磺酸氨氯地平/缬沙坦/氢氯噻嗪片

生产厂家: Novartis

药品介绍

美国FDA批准了诺华公司的Exforge HCT（缬沙坦/苯磺酸氨氯地平/氢氯噻嗪，valsartan/amlodipine besylate/hydrochlorothiazide）

本品是惟一联合钙通道阻滞剂氨氯地平、血管收缩素受体阻滞剂缬沙坦和利尿剂氢氯噻嗪的单片剂。在上述3类药物中的任何2类药物不足以控制患者的血压，患者可以转为服用此三合一的单片剂。

Exforge HCT（氨氯地平，缬沙坦片，氢氯噻嗪）片剂，薄膜包衣

美国首次批准：2009   公司：美国诺华制药公司

适应症与USAGEExforge HCT，二氢吡啶类钙通道阻滞剂（DHP CCB），血管紧张素II受体阻滞剂（ARB），缬沙坦和氢氯噻嗪，噻嗪类利尿药氨氯地平片的组合。 Exforge HCT被用于治疗高血压，降低血压。降低血压，降低致死性和非致死性心血管事件的发生，主要是中风和心肌梗死的风险。 （1）

未标明的初始治疗

【用法用量】，每日一次ADMINISTRATIONDose。滴定到最大的10/320/25毫克剂量

Exforge HCT可作为add-on/switch没有得到充分控制上任何两个以下的抗高血压类：钙通道阻滞剂，血管紧张素受体阻滞剂，利尿剂治疗的患者。

Exforge HCT可被取代的为其个别滴定的部件

剂型和STRENGTHSTablets：（氨氯地平/缬沙坦/氢氯噻嗪毫克）5/160/12.5，10/160/12.5，5/160/25，10/160/25，10/320/25

CONTRAINDICATIONSAnuria过敏的磺胺类药物

正确的血容量不足警告和PRECAUTIONSHypotension：

开始之前

增加心绞痛和/或心肌梗死

监测肾功能的易感例

观察的迹象体液或电解质不平衡

加重或激活系统性红斑狼疮

急性闭角型青光眼

不利REACTIONSMost常见的不良反应（发生率≥2％），头晕，血管神经性水肿，头痛，消化不良，乏力，肌肉痉挛，背部疼痛，恶心和鼻咽炎。

共同管理的药品INTERACTIONSIf辛伐他汀与氨氯地平，不超过剂量超过20毫克，每天的辛伐他汀

降糖药：降糖可能需要调整剂量

消胆胺和考来替泊噻嗪类药物的吸收减少

锂电池：锂毒性的利尿剂增加的风险。监测血清锂浓度在同时使用。

非甾体抗炎药可能增加肾损害的风险可降低利尿，利钠和利尿剂的降压效果。
 
在特定POPULATIONSNursing母亲：避免使用护理 - 停止或者护理或药物

更新日期：02/2012

相关说明附件：http://www.pdr.net/drugpages/productlabeling.aspx?mpcode=57300723

FDA approves Exforge HCT® - the only high blood pressure treatment to combine three medications in a single pill

• Exforge HCT combines in one pill a calcium channel blocker, angiotensin receptor blocker and diuretic (amlodipine, valsartan, hydrochlorothiazide)
• In a clinical trial, Exforge HCT demonstrated significantly greater reductions in systolic and diastolic BP, compared to all dual combinations of its components1
• Up to 85% of patients may need multiple medications to help control their blood pressure2 and many need three or more1
• Exforge HCT can help appropriate patients reach BP goals; offers convenienceand potential cost savings by reducing up to three co-payments to one

Basel, 30 April, 2009 — The US Food and Drug Administration (FDA) has approved Exforge HCT, the only single pill to combine the three most prescribed high blood pressure treatments in their classes in the US3: the calcium channel blocker amlodipine, the angiotensin receptor blocker valsartan, and the diuretic hydrochlorothiazide. Exforge HCT is an important new option for patients who have tried taking dual combinations of these classes of blood pressure medications without success.

“The majority of people with hypertension will require more than one medication to control their blood pressure and it’s not uncommon for patients with severe hypertension and/or patients requiring stricter blood pressure control to need three or more medications,” said David A. Calhoun, MD, Professor of Medicine, Vascular Biology and Hypertension Program, University of Alabama at Birmingham. “With a triple combination option, appropriate patients may experience a simpler routine of a convenient, once-daily pill to help them control their high blood pressure.”

Exforge HCT provides proven efficacy in patients with moderate to severe hypertension (MSDBP 100 mmHg and <120 mmHg, MSSBP 145 mmHg and <200 mmHg)1. In a clinical trial, the maximum dose of Exforge HCT (amlodipine/valsartan/hydrochlorothiazide 10 mg/320 mg/25 mg) demonstrated additional reductions of 18-29% in systolic blood pressure and 19-32% in diastolic blood pressure when compared to all dual combinations of its components at the same doses1,4. The reductions in systolic/diastolic blood pressure with Exforge HCT were 7.6/5.0 mmHg greater than with valsartan/hydrochlorothiazide 320mg/25 mg; 6.2/3.3 mmHg greater than with amlodipine/valsartan 10mg/320 mg; and 8.2/5.3 mmHg greater than with amlodipine/hydrochlorothiazide 10 mg/25 mg4. These results also include a placebo effect of unknown size. Ambulatory blood pressure monitoring showed that the blood pressure lowering effect of Exforge HCT was maintained throughout the 24-hour period4.

High blood pressure affects approximately 74 million adults in the US and one in four adults worldwide5. If high blood pressure is not treated, it can lead to heart attack and stroke. Exforge HCT is not indicated for the treatment or prevention of heart attack or stroke.2/3 Research suggests that up to 85% of patients may need multiple medications2 and many need three or more1 to help control their blood pressure. Patients may find treatment more convenient with one single pill rather than separate pills.

Exforge HCT contains three effective medicines that work in three different ways1. A patient may be switched to the single pill combination Exforge HCT if blood pressure is not adequately controlled on any two of the following anti-hypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics4. The full blood pressure lowering effect was achieved two weeks after being on the maximal dose of Exforge HCT.

“This approval of Exforge HCT as the only single blood pressure pill combining the efficacy of three of the most-prescribed treatments in their classes represents a significant milestone toward reducing the burden of unmet need in hypertension,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “Novartis remains confident in the important role of single pill combination medications to help appropriate patients achieve their blood pressure targets, while providing physicians with a range of powerful yet flexible combinations of doses to effectively manage high blood pressure in different patients.”

Exforge and Exforge HCT will be offered at the same price in the US on a doseequivalent basis, essentially providing the added diuretic in Exforge HCT at no additionalcost. Since Exforge HCT combines three medications in a single pill, patients may benefit from reduced insurance co-payments.

近日,美国食品和药品管理局(FDA)批准了Exforge HCT治疗高血压,这种药物包含了三种最常用的抗高血压药物:钙离子通道阻滞剂氨氯地平,血管紧张素受体抑制剂缬沙坦和利尿剂氢氯噻嗪。Exforge HCT为那些尝试联合使用多种抗高血压药物无效的患者带来了福音。

高血压复方制剂—Exforge HCT美国上市

美国FDA批准诺华公司氨氯地平+缬沙坦+氢氯噻嗪片复方制剂(Exforge HCT)上市，用于治疗高血压。本品结合了3种最常处方用药的高血压治疗药：钙通道阻滞剂氨氯地平、血管紧张素受体阻滞剂缬沙坦和利尿药氢氯噻嗪。本品对曾联合使用过这些降压药中的两者但未获得满意疗效的患者来说是一重要的治疗新观点。
临床研究显示本品治疗中度至严重高血压[平均坐位舒张压（MSDBP）100mmHg而<120mmHg，平均坐位收缩压（MSSBP）145mmHg而<200mmHg]患者有效。在临床研究中，ExforgeHCT最大剂量（氨氯地平/缬沙坦/氢氯噻嗪10mg/320mg/25mg）显示较所有2种相同剂量药物联合使用多降低收缩压18％～29％和舒张压19％～32％。对不卧床患者的血压监测显示，ExforgeHCT降压疗效可持续24小时。
大多数高血压患者需要一种以上的抗高血压药来控制血压，少数严重高血压患者需3种或更多的药物来严格控制血压。3种药物结合在1片一日1次的ExforgeHCT服用更为方便，有助于更好地控制患者的血压。

两个固定复方制剂，复代文®和Exforge®，在美国被批准为高血压治疗一线用药

●获批一线用药体现了目前美国治疗指南的精神，即对适合的病人初始治疗就采用联合用药
●近80％的病人需要多药联合治疗，以帮助血压达标
●固定复方制剂不仅疗效显著，而且服用方便，可帮助病人更快实现治疗目标
●心血管疾病是世界首要致死原因，高血压是心血管疾病最重要的，且可治疗的危险因素之一。
美国食品药品监督管理局（FDA）7月23日批准两个固定复方制剂，复代文®（缬沙坦和氢氯噻嗪）和Exforge®（氨氯地平和缬沙坦），作为一线用药，用于需要多种药物治疗以令血压达标的病人。 
FDA批准复代文和Exforge为一线用药的决定与目前美国治疗指南的推荐意见一致，即对适合的病人初始治疗就应采用联合用药。研究指出，近80％的病人需要多药联合治疗，以帮助血压达标。
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产地国家: 美国
原产地英文商品名:
EXFORGE HCT 10-160-25 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 10MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 25MG
中文参考商品译名:
EXFORGE HCT 10-160-25毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平10毫克 / 缬沙坦160毫克 / 氢氯噻嗪 25毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
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产地国家: 美国
原产地英文商品名:
EXFORGE HCT 10-160-12.5 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 10MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 12.5MG
中文参考商品译名:
EXFORGE HCT 10-160-12.5毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平10毫克 / 缬沙坦160毫克 / 氢氯噻嗪 12.5毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
---------------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
EXFORGE HCT 5-160-25 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 5MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 25MG
中文参考商品译名:
EXFORGE HCT 5-160-25毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平5毫克 / 缬沙坦160毫克 / 氢氯噻嗪 25毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS
-------------------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
EXFORGE HCT 5-160-12.5 MG/ TAB 30tablets/bottle
原产地英文药品名:
AMLODIPINE BESYLATE 5MG / VALSARTAN 160MG / HYDROCHLOROTHIAZIDE 12.5MG
中文参考商品译名:
EXFORGE HCT 5-160-12.5毫克/片 30片/瓶
中文参考药品译名:
苯磺酸氨氯地平5毫克 / 缬沙坦160毫克 / 氢氯噻嗪 12.5毫克
生产厂家中文参考译名:
诺华
生产厂家英文名:
NOVARTIS