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:

Rx

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).

How Supplied:

Tabs—30, 90, 100

AMTURNIDE
制造商：
诺华制药公司

类药物：
肾素抑制剂+二氢吡啶类钙通道阻滞剂（CCB）+噻嗪类利尿剂。

活性成分（S）：
阿利吉仑hemifumarate /氨氯地平/氢氯噻（氢氯噻嗪）; 150/5/12.5mg; 300/5/12.5mg;; 300/10/25mg 300/5/25mg; 300/10/12.5mg的;片。
指示（S）：
高血压。不为初始治疗。

药理作用：
阿利吉仑降低血浆肾素活性和抑制血管紧张素一氨氯地平的形成是周边动脉血管扩张，降低血压，降低外周阻力。氢氯噻嗪增加钠和氯的排泄。

临床试验：
涉及1181治疗的高血压患者进行的一项研究，以评估疗效Amturnide。谁被分配到双组合治疗的患者接受：阿利吉仑/地平150/5mg的，的阿利吉仑/ HCTZ 150/12.5mg的，或氨氯地平/ HCTZ 5/12.5mg的。分配到Amturnide患者接受阿利吉仑/ HCTZ 150/12.5mg的。经过3天，Amturnide患者进行滴定阿利吉仑/氨氯地平/ HCTZ 150/5/12.5mg的，而其他患者继续其原来的剂量。 4周后，所有患者均滴定阿利吉仑/氨氯地平/ HCTZ 300/10/25mg的阿利吉仑/地平300/10mg的，阿利吉仑/ HCTZ 300/25mg的，或氨氯地平/氢氯噻嗪10/25mg。给予Amturnide患者降低血压比任何其他的三个双结合治疗。 Amturnide在408人归类为严重高血压基线的患者，产生更大的削减比任何三双组合方案。收缩压/舒张压与Amturnide在这一组中，减少了16.3/8.2mmHg大于阿利吉仑/ HCTZ，9.6/4.8mmHg大于氨氯地平/ HCTZ，和11.4/4.9mmHg大于阿利吉仑/氨氯地平。

法律分类：
RX

成人：
采取每日一次。滴定在2周的时间间隔（慢肾或肝功能不全）;最大一个300/10/25mg片剂每日。更换：可替代滴定个别组件。 add-on/switch：建设银行，阿利吉仑，二氢噻嗪类利尿剂：如果没有充分控制任何两个以下。可以切换与低剂量导致不良反应，剂量限制的任何组件。 ≥75岁或严重肝功能不全：最初2.5mg/day氨氯地平（不可用）。

儿童：
不推荐使用。

禁忌症（S）：
无尿。磺胺类药物过敏。

警告/注意事项：
怀孕（Cat.D;避免）。严重肾功能不全（肌酐清除率<30ml/min者）：不建议。正确的盐/体积枯竭开始之前，或开始密切监督下。 SLE。严重的阻塞性冠状动脉疾病：与建设银行剂量变化的心绞痛或心肌梗塞的危险性增加。心脏衰竭。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;阿托伐他汀，酮康唑potentiated;可对抗速尿。 ACE抑制剂，钾离子补充剂，钾利尿剂，钾离子含盐增加高钾血症的危险。氢氯噻嗪：酒精，其他中枢神经系统抑制剂的体位性低血压，可能需要调整降糖药，促肾上腺皮质激素，糖皮质激素增加低血钾症的风险;锂毒性，非甾体抗炎药拮抗。

不良反应（S）：
周围水肿，头晕，头痛，鼻咽炎;罕见：血管神经性水肿（停止，如果发生，不重新启动）;急性近视，继发闭角型青光眼（停止，如果发生）。

如何提供：
标签-30，90，100

最后更新：
2011年6月16日