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Amturnide（阿利吉仑，氨氯地平，氢氯噻嗪片 TEKTURNA HCT TAB）

2011-04-10 16:37:04 作者：新特药房来源：中国新特药网天津分站浏览次数：529 文字大小：【大】【中】【小】

简介： 制造商：诺华制药公司药理分类：肾素抑制剂+二氢吡啶类钙通道阻滞剂（CCB）的+噻嗪类利尿剂。活性成分（补）：阿利吉仑hemifumarate /氨氯地平/氢氯噻嗪（氢氯噻嗪）; 150/5/12.5mg; 300/5/12.5mg ...

关键字：Amturnide（阿利吉仑氨氯地平氢氯噻嗪片 TEKTURNA HCT TAB）

制造商：
诺华制药公司

药理分类：
肾素抑制剂+二氢吡啶类钙通道阻滞剂（CCB）的+噻嗪类利尿剂。

活性成分（补）：
阿利吉仑hemifumarate /氨氯地平/氢氯噻嗪（氢氯噻嗪）; 150/5/12.5mg; 300/5/12.5mg; 300/5/25mg; 300/10/12.5mg; 300/10/25mg;片。

指示（补）：
高血压。不适用于初步治疗。

药理作用：
阿利吉仑降低血浆肾素活性，抑制血管紧张素一氨氯地平的形成是一个外周动脉血管扩张剂能降低血压，减少外周阻力。氢氯噻嗪增加了钠和氯的排泄。

临床试验：
涉及1181年的一项研究治疗高血压患者进行评估Amturnide疗效。患者谁被分配到双结合疗法收到阿利吉仑/氨氯地平150/5mg，阿利吉仑/氢氯噻嗪150/12.5mg，或氨氯地平/氢氯噻嗪5/12.5mg。患者分配到Amturnide收到阿利吉仑/氢氯噻嗪150/12.5mg。经过3天，Amturnide患者调整到阿利吉仑/氨氯地平/氢氯噻嗪150/5/12.5mg，而其他患者原来的剂量仍在继续。 4周后，所有患者均调整到阿利吉仑/氨氯地平/氢氯噻嗪300/10/25mg，阿利吉仑/氨氯地平300/10mg，阿利吉仑/氢氯噻嗪300/25mg，或氨氯地平/氢氯噻嗪10/25mg。患者给予Amturnide比任何三双组合处理更大的血压降低等。在408谁被列为严重高血压患者在基线，Amturnide生产比三双的组合方案的任何较大幅度的削减。在这组，Amturnide在收缩压/舒张压降低了16.3/8.2mmHg比阿利吉仑更大/氢氯噻嗪，氨氯地平9.6/4.8mmHg比/氢氯噻嗪更大，11.4/4.9mmHg比阿利吉仑/氨氯地平更大。

法律分类：
接收

成人：
以每天一次。滴定在2个星期的时间间隔（在肾或肝功能不全慢），最大一300/10/25mg片剂每日。替换：可以取代单独滴定组件。 Add-on/switch：阿利吉仑，二氢建设银行，噻嗪类利尿剂：如果没有充分的任何两个以下控制。可开关的任何组件，导致剂量限制性不良反应低剂量。 ≥75岁或重度肝功能不全：最初氨氯地平2.5mg/day（不可用）。

儿童：
不推荐。

禁忌（补）：
无尿。磺胺类药物过敏。

警告/注意事项：
妊娠（Cat.D，避免）。严重肾功能不全（肌酐清除率<30mL/min）：不推荐。正确盐/容衰竭开始之前，或开始密切监督。系统性红斑狼疮。重度阻塞性冠状动脉疾病：心绞痛或心肌梗塞与建设银行剂量变化的风险增加。心力衰竭。肾动脉狭窄。监测电解质。哺乳母亲：不推荐。

互动（补）：
阿利吉仑：伴随环孢素，伊曲康唑：不推荐;由厄贝沙坦拮抗; potentiated阿托伐他汀，酮康唑;可能对抗速尿。 ACE抑制剂，钾补充剂，钾利尿剂，钾离子增加含盐高钾血症的危险。氢氯噻嗪：体位性低血压与酒精，镇静剂等中枢神经系统，可能需要调整抗糖尿病药物，促肾上腺皮质激素，皮质类固醇增加低钾血症的风险;锂毒性;由NSAIDs的拮抗。

不良反应（补）：
周围水肿，头晕，头痛，鼻咽炎;罕见：血管性水肿（如果发生中断，不重新启动）;急性近视，继发闭角型青光眼（如停止发生）。

如何提供：
制表- 30，90，100

最后更新：
2011年3月10日

Amturnide approved for treatment of hypertension

Novartis announced that the FDA has approved Amturnide (aliskiren, amlodipine, hydrochlorothiazide tablets), a fixed-dose combination therapy for the treatment of hypertension in patients who are not adequately controlled on any two of the following antihypertensive drug classes: direct renin inhibitor, calcium channel blockers, and diuretics. This approval was based on data from a double-blind, active controlled study conducted on 1,181 patients with moderately elevated blood pressure (mean systolic blood pressure [mSBP] 160—179mmHg) or severely elevated blood pressure (mSBP≥ 180mmgHg) that showed Armturnide produced significantly greater reductions in systolic and diastolic blood pressure in both patient populations compared to three dual combination therapies. Armturnide yielded a further mean reduction in systolic blood pressure/diastolic blood pressure of 9.9/6.3mmHg, 7.2/3.6mmgHg, and 6.6/2.6mmHg, respectively, compared to each of the following dual combination therapies: alikskiren/hydrochlorothiazide, amlodipine/hydrochlorothiazide, and aliskiren/amlodipine.

AMTURNIDE

Manufacturer:

Novartis Pharmaceuticals Corp

Pharmacological Class:

Renin inhibitor + dihydropyridine calcium channel blocker (CCB) + thiazide diuretic.

Active Ingredient(s):

Aliskiren hemifumarate/amlodipine besylate/hydrochlorothiazide (HCTZ); 150/5/12.5mg; 300/5/12.5mg; 300/5/25mg; 300/10/12.5mg; 300/10/25mg; tablets.

Indication(s):

Hypertension. Not for initial therapy.

Pharmacology:

Aliskiren decreases plasma renin activity and inhibits the formation of angiotensin I. Amlodipine is a peripheral arterial vasodilator that lowers BP by reducing peripheral resistance. HCTZ increases the excretion of sodium and chloride.

Clinical Trials:

A study involving 1181 treated hypertensive patients was conducted to evaluate the efficacy of Amturnide. Patients who were assigned to dual-combination therapy received aliskiren/amlodipine 150/5mg, aliskiren/HCTZ 150/12.5mg, or amlodipine/HCTZ 5/12.5mg. Patients assigned to Amturnide received aliskiren/HCTZ 150/12.5mg. After 3 days, Amturnide patients were titrated to aliskiren/amlodipine/HCTZ 150/5/12.5mg, while other patients continued on their original doses. After 4 weeks, all patients were titrated to aliskiren/amlodipine/HCTZ 300/10/25mg, aliskiren/amlodipine 300/10mg, aliskiren/HCTZ 300/25mg, or amlodipine/HCTZ 10/25mg. Patients given Amturnide had greater reductions in BP than any other of the three dual-combination treatments. In the 408 patients who were classified as severely hypertensive at baseline, Amturnide produced greater reductions than any of the three dual-combination regimens. In this group, the reductions in SBP/DBP with Amturnide were 16.3/8.2mmHg greater than with aliskiren/HCTZ, 9.6/4.8mmHg greater than with amlodipine/HCTZ, and 11.4/4.9mmHg greater than with aliskiren/amlodipine.

Legal Classification:

Adults:

Take once daily. Titrate at 2-week intervals (slower in renal or hepatic impairment); max one 300/10/25mg tablet daily. Replacement: may substitute for individually titrated components. Add-on/switch: if not adequately controlled on any two of the following: aliskiren, dihydropyridine CCB, thiazide diuretics. May switch with a lower dose of any component that causes dose-limiting ADRs. ≥75 years or severe hepatic impairment: initially amlodipine 2.5mg/day (not available).

Children:

Not recommended.

Contraindication(s):

Anuria. Sulfonamide allergy.

Warnings/Precautions:

Pregnancy (Cat.D; avoid). Severe renal dysfunction (CrCl <30mL/min): not recommended. Correct salt/volume depletion before starting, or start under close supervision. SLE. Severe obstructive coronary disease: increased risk of angina or MI with CCB dose change. Heart failure. Renal artery stenosis. Monitor electrolytes. Nursing mothers: not recommended.

Interaction(s):

Aliskiren: concomitant cyclosporine, itraconazole: not recommended; antagonized by irbesartan; potentiated by atorvastatin, ketoconazole; may antagonize furosemide. ACE inhibitors, K⁺ supplements, K⁺ sparing diuretics, K⁺ containing salts increase hyperkalemia risk. HCTZ: orthostatic hypotension with alcohol, other CNS depressants; may need to adjust antidiabetic agents; ACTH, corticosteroids increase hypokalemia risk; lithium toxicity; antagonized by NSAIDs.

Adverse Reaction(s):

Peripheral edema, dizziness, headache, nasopharyngitis; rare: angioedema (discontinue if occurs, do not restart); acute myopia, secondary angle closure glaucoma (discontinue if occurs).