PRESTALIA片剂是首个获美国FDA批准用于高血压初始治疗的固定复方制 Prestalia是培哚普利和氨氯地平的混合片剂，前者是血管紧张素转换酶抑制剂，后者为二氢吡啶类钙通道阻滞剂，用于治疗降压不理想或初始治疗需要多种药物的高血压患者。Prestalia为口服片剂，推荐起始剂量为3.5/2.5mg，每日1次。剂量可根据需要调节至目标血压，待1~2周后逐步调整，最大推荐剂量为14/10mg，每日1次。 美国首次批准：2015年  公司：symplmedTM PRESTALIA（AMLODIPINE BESYLATE; PERINDOPRIL ARGININE）TABLET;ORAL PRESTALIA Rx Pharmacological Class: ACE inhibitor + calcium channel blocker (dihydropyridine). Active Ingredient(s): Perindopril arginine, amlodipine; 3.5mg/2.5mg, 7mg/5mg, 14mg/10mg; tablets. Company Symplmed Indication(s): Hypertension. Pharmacology: Perindopril is a prodrug of perindoprilat, which inhibits angiotensin converting enzyme (ACE) in humans and animals. Inhibition of ACE results in decreased plasma angiotensin II, leading to decreased vasoconstriction, increased plasma renin activity and decreased aldosterone secretion. Amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. It is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure. Clinical Trials: The efficacy of Prestalia was evaluated in two randomized controlled trials. The highest strength of Prestalia (14mg/10mg) was studied in a double-blind, active controlled study in a total of 837 hypertensive patients randomized to receive Prestalia 14mg/10mg, perindopril erbumine 16mg, or amlodipine 10mg once daily for 6 weeks. At Week 6, Prestalia 14mg/10mg demonstrated statistically significantly greater reductions in blood pressure than the other treatment groups. Treatment with Prestalia reduced 10.1/6.3mmHg more than the perindopril erbumine 16mg group and 3.9/2.5mmHg more than the amlodipine 10mg group. In a second study, the lowest strength of Prestalia (3.5mg/2.5mg) was assessed in a total of 1,581 hypertensive patients randomized to receive Prestalia 3.5mg/2.5mg, perindopril arginine 3.5mg, perindopril arginine 5mg, amlodipine 2.5mg, amlodipine 5mg, or placebo. At Week 8, Prestalia 3.5mg/2.5mg demonstrated statistically significantly greater reductions in blood pressure than the perindopril arginine 3.5mg and amlodipine 2.5mg treatment groups. Treatment with Prestalia 3.5mg/2.5mg reduced 7.2/4.1mmHg more than the placebo group. For more clinical trial data, see full labeling. Legal Classification: Rx Adults: Initially 3.5mg/2.5mg once daily. Adjust at 7–14 day intervals; max 14mg/10mg once daily. Children: Not established. Contraindication(s): History of ACEI-associated or other angioedema. Concomitant aliskiren in patients with diabetes. Warnings/Precautions: Fetal toxicity may develop; discontinue if pregnancy is detected. Discontinue if angioedema, laryngeal edema occurs. Severe obstructive coronary artery disease. Salt/volume depletion. Severe aortic stenosis. Surgery. Monitor for hyperkalemia. Diabetes. Renal artery stenosis. Severe CHF. Post-MI. Monitor renal function periodically during treatment; consider withholding or discontinuing if significant renal dysfunction occurs. Dialysis. Heart failure, hepatic or renal (CrCl <60mL/min) impairment, elderly (>65yrs): not recommended. Pregnancy (Cat.D). Nursing mothers: not recommended. Interaction(s) See Contraindications. Potentiated by diuretics. Risk of hyperkalemia with K+ supplements, K+ sparing diuretics, or other drugs (eg, indomethacin, heparin, cyclosporine). May increase lithium levels; monitor. Nitritoid reactions with concomitant injectable gold (eg, sodium aurothiomalate); rare. 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). 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. Potentiates simvastatin; limit simvastatin dose to 20mg daily. Monitor cyclosporine levels. May be potentiated by moderate or strong CYP3A inhibitors (eg, diltiazem, itraconazole). Monitor BP if coadministered with CYP3A4 inducers. Adverse Reaction(s) Edema, cough, headache, dizziness; angioedema, hypotension, hyperkalemia. How Supplied: Tabs—90 LAST UPDATED: 8/7/2015 IMPORTANT SAFETY INFORMATION WARNING: FETAL TOXICITY •When pregnancy is detected, discontinue PRESTALIA as soon as possible •Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus PRESTALIA is contraindicated in patients with hereditary or idiopathic angioedema, with or without previous angiotensin converting enzyme (ACE) inhibitor treatment, and in patients who are hypersensitive to perindopril, to ACE inhibitors, or to amlodipine. Rare cases of angioedema, including intestinal angioedema, have been reported in patients treated with ACE inhibitors. Do not co-administer aliskiren with ACE inhibitors, including PRESTALIA, in patients with diabetes. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of PRESTALIA, particularly in patients with severe obstructive coronary artery disease. In patients at risk of excessive hypotension, start PRESTALIA therapy under close medical supervision. Follow patients closely for the first 2 weeks of treatment and whenever the dose of PRESTALIA is increased or a diuretic is added or its dose increased. Monitor renal function periodically in patients treated with PRESTALIA. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function. The most common adverse events associated with PRESTALIA include peripheral edema, cough, headache, and dizziness. HOW SUPPLIED/STORAGE AND HANDLING Prestalia®Tablets 3.5/2.5  perindopril arginine and amlodipine NDC 61894-010-02 Prestalia®Tablets   7/5    perindopril arginine and amlodipine NDC 61894-011-02 Prestalia®Tablets 14/10    perindopril arginine and amlodipine NDC 61894-012-02 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Tell female patients of childbearing age that use of drugs like perindopril that act on the renin-angiotensin system can cause serious problems in the fetus and infant, including low blood pressure, poor development of skull bones, kidney failure, and death. Discuss other treatment options with female patients planning to become pregnant. Tell women using PRESTALIA who become pregnant to notify their physician as soon as possible. In case of a missed dose, have patients resume the usual dose at the next scheduled time. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?audience=professional&setid=98cc3e47-3463-4162-96ac-bf97d77eb041