英文药名：ACEON（perindopril erbumine  Tablets）

中文药名：培哚普利片

生产厂家：Symplmed制药
药品介绍
ACEON（培哚普利 perindopril erbumine）2，4和8毫克片剂 供口服使用
最初美国批准：1993年
警告：
胚胎毒性请参阅完整的黑框警告完整的处方信息。
当检测妊娠，尽快停止ACEON。
药品做了肾素-血管紧张素系统的直接行为可能导致伤害和死亡发育中的胎儿。
作用机理
ACEON®（培哚普利）是perindoprilat前体药物，它在人体和动物抑制ACE。通过perindoprilat降低血压，相信该机制是抑制主要ACE活性的。 ACE为肽基二肽酶没有催化非活性十肽的转换，血管紧张素I，对血管收缩剂，血管紧张肽Ⅱ。血管紧张素II是一种强效外周血血管收缩剂，其中由肾上腺皮质刺激醛固酮分泌，并提供关于肾素分泌的负反馈。在降低血浆血管紧张素ⅡACE的抑制导致，导致血管收缩下降，增加血浆肾素活性和醛固酮分泌减少。在利尿排钠和后期的效果，并且与血钾的小幅增加有关。
ACE是相同的激肽酶II，以酶降解做缓激肽。是否缓激肽的水平升高，一个强效肽血管减压，起到ACEON的治疗效果的作用仍有待阐明。
而血压减少培哚普利的主要机制被认为是通过肾素 - 血管紧张素 - 醛固酮系统，ACE抑制剂甚至在明显低肾素高血压一定效果。普利一直是相对较少黑人患者研究底栖，通常是一低肾素人口和舒张压以普利平均响应其中大约一半的反应见于非黑人患者中，发现与其他ACE抑制剂的先前经验一致。
适应症和用法
ACEON的适应症为治疗原发性高血压患者
ACEON的适应症为患者的治疗稳定型冠心病，降低心血管死亡率或非致死性心肌梗死的危险
用法用量
高血压
推荐的初始剂量是4毫克，每天一次。该剂量可以向上滴定直到血压，当刚刚下一剂量之前测量，控制或至最多每天16毫克
稳定性冠状动脉疾病
ACEON shoulderstand在上的4毫克起始剂量每日一次给予2周，然后每天一次增加耐受，至8毫克的维持剂量
剂型和规格
片剂：2，4和8毫克
禁忌症
血管性水肿涉及与ACE抑制剂既往治疗，或遗传性或特发性血管神经性水肿史
不要用阿利吉仑ACEON糖尿病患者共施用
警告和注意事项
当心过敏性反应，血管神经性水肿包括
监控治疗过程中肾功能
评估低血压和高钾血症
不良反应
高血压：最常见的不良事件（发生率大于或等于5％）是咳嗽，头晕和背痛
稳定性冠状动脉疾病：最常见的不良反应导致停药为咳嗽，药物不耐受，低血压
药物相互作用
利尿剂：血压过度下降
保钾利尿剂/补钾：高钾血症
锂：提高血清锂浓度，锂中毒症状
注射金：Nitritoid反应（面部潮红，恶心，呕吐，低血压等）
使用NSAID可导致肾功能损害及降压作用损失的风险增加
肾素 - 血管紧张素系统的双重抑制：肾功能损害，低血压和高钾血症的风险增加。
在使用特定人群
老年医学：开始在低日剂量（4毫克或更少），并根据需要缓慢滴定。与剂量超过8毫克经验有限
剂量调整可能是肾功能受损的患者必要
包装规格
2毫克×100片/瓶
4毫克×100片/瓶
8毫克×100片/瓶
生产厂家：Symplmed，LLC
完整资料附件：
1）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=340846a3-896e-40bf-a4d0-419922df71a1
2）：https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=10240
3）：http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm239914.htm#
PERINDOPRIL ERBUMINE
Aceon
Classifications: cardiovascular agent; angiotensin-converting enzyme inhibitor; antihypertensive
Prototype: Captopril
Pregnancy Category: C (first trimester); D (second and third trimesters)
Availability
2 mg, 4 mg, 8 mg tablets
Actions
Angiotensin-converting enzyme (ACE) inhibitor. ACE catalyzes the conversion of angiotensin I to angiotensin II, a vasoconstrictor substance. Therefore, angiotensin II levels are decreased by perindopril, thus decreasing vasopressor activity and aldosterone secretion.
Therapeutic Effects
Lowers BP by inhibition of ACE. Reduced aldosterone is associated with potassium-sparing effect. In addition, decreases systemic vascular resistance (afterload) and pulmonary capillary wedge pressure (PCWP), a measure of preload, and improves cardiac output as well as activity tolerance.
Uses
Hypertension, CHF
Contraindications
Hypersensitivity to perindopril or any other ACE inhibitor; history of angioedema induced by an ACE inhibitor, pregnancy [category C (first trimester), category D (second and third trimester)]; patients with hypertrophic cardiomyopathy, renal artery stenosis.
Cautious Use
Renal insufficiency, volume-depleted patients, severe liver dysfunction; autoimmune diseases, immunosuppressant drug therapy; hyperkalemia or potassium-sparing diuretics; older adult; surgery; neutropenia; lactation; febrile illness.
Route & Dosage
Hypertension, CHF
Adult: PO 4 mg once daily, may be increased to 8 mg daily in 1 or 2 divided doses (max:16 mg/d)
Renal Impairment
Clcr May need to use lower doses in patients with mild to moderate impairment
Administration
Oral
Manufacturer recommends an initial dose of 2–4 mg in 1 or 2 divided doses if concurrently ordered diuretic cannot be discontinued 2–3 d before beginning perinodopril. Consult physician.
Give on an empty stomach 1 h before meals.
Dosage adjustments are generally made at intervals of at least 1 wk.
Store at 20°–25° C (68°–77° F) and protect from moisture.
Adverse Effects (1%)
CNS: Dizziness, light-headedness (in the absence of postural hypotension), headache, mood and sleep disorders, fatigue. CV: Palpitations. Endocrine: Hyperkalemia. GI: Nausea, vomiting, epigastric pain, diarrhea, taste disturbances, dyspepsia. Urogenital: Proteinuria, impotence, sexual dysfunction. Special Senses: Dry eyes, blurred vision. Body as a Whole: Cough, angioedema, pruritus, muscle cramps, sinusitis, hypertonia, fever. Skin: Rash.
Interactions
Drug: potassium-sparing diuretics (amiloride, spironolactone, triamterene) may increase the risk of hyperkalemia. potassium supplements increase the risk of hyperkalemia. Food: Food can decrease drug absorption 35%.
Pharmacokinetics
Absorption: Readily absorbed from GI tract, absorption significantly decreased when taken with food. Peak: Perindopril: 1 h; perindoprilat: 3–7 h. Duration: 24 h. Metabolism: Hydrolyzed in the liver to its active form, perindoprilat. Elimination: Primarily excreted in urine. Half-Life: Perindopril: 0.8–1 h, perindoprilat: 30–120 h.
Nursing Implications
Assessment & Drug Effects
Monitor BR and HR carefully following initial dose for several hours until stable, especially in patients using concurrent diuretics, on salt restriction, or volume depleted.
Place patient immediately in a supine position if excess hypotension develops.
Lab tests: Monitor serum potassium, serum sodium, BUN and creatinine, ALT, blood glucose, lipid profile, and WBC with differential periodically.
Monitor kidney function in patients with CHF closely.
Monitor serum lithium levels and assess for S&S of lithium toxicity frequently when used concurrently; increased caution is needed when diuretic therapy is also used.
Patient & Family Education
Discontinue drug and immediately report S&S of angioedema (i.e., swelling) of face or extremities to physician. Seek emergency help for swelling of the tongue or any other signs of potential airway obstruction.
Be aware that light-headedness can occur, especially during early therapy; excess fluid loss of any kind (e.g., vomiting, diarrhea) will increase risk of hypotension and syncope.
Avoid using potassium supplements unless specifically directed to do so by physician.
Report S&S of infection (e.g., sore throat, fever) promptly to physician.
Do not breast feed while taking this drug without consulting physician.
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