英文药名: Nootropil(Piracetam Tablets and Syrup)

中文药名: 吡拉西坦片

品牌药生产厂家: UCB Pharma Inc.
药品说明

【药品名称】
通用名：吡拉西坦, 吡乙酰胺、脑复康、酰胺吡咯烷酮，酰胺吡酮，酰胺吡，咯烷酮，吡烷酮醋胺, Piracetam, Euvifor, Nootropil
英文名：Piracetam Tablets
本品主要成份为：吡拉西坦。其化学名称为：2-氧化-1-吡咯烷基乙酰胺。
分子式：C6H10N2O2
分子量：142.16

【药理毒理】
本品为脑代谢改善药，属于g-氨基丁酸的环形衍生物。有抗物理因素、化学因素所致的脑功能损伤似的作用。能促进脑内ATP，可促进乙酰胆碱合成并正增强神经兴奋的传导，具有促进脑内代谢作用。可以对抗由物理因素、化学因素所致的脑功能损伤。对缺氧所致的逆行性健忘有改进作用。可以增强记忆，提高学习能力。
动物实验的急性毒理试验表明，小鼠灌胃剂量大于10g/kg，未见死亡。静脉给药的半数致死量LD50为9.2g/kg。亚急性和慢性毒理实验均未发现对大鼠、狗的生长发育有任何不良影响。对血液、心、肝、肾、脑等重要内脏器官和功能均无影响。

【药代动力学】
口服本品后很快从消化道吸收，进入血液，并透过血脑屏障到达脑和脑脊液，大脑皮层和嗅球的浓度较脑干中浓度更高。易通过胎盘屏障。口服后，30～45分钟血药浓度达到峰值，血浆蛋白结合率30％，半衰期t1/2为5～6小时。表观分布容积（Vd）为0.6L/kg。吡拉西坦口服后不能由肝脏分解，以原形形式从尿和粪便中排泄。肾脏清除速度为86ml/分钟。大便排出量约为1%～2%。

【适应症】
适用于急、慢性脑血管病、脑外伤、各种中毒性脑病等多种原因所致的记忆减退及轻、中度脑功能障碍。也可用于儿童智能发育迟缓。

【用法用量】
口服。每次0.8～1.6g( 2～4片)，每日3次，4～8周为一疗程。儿童每次给予40mg／kg。一般3～6周为1疗程。服完一疗程后，维持剂量减半，或遵医嘱。

【不良反应】
消化道不良反应常见有恶心、口干、纳差、失眠、荨麻疹、腹部不适、腹胀、腹痛等，症状的轻重与服药剂量直接相关。中枢神经系统不良反应包括兴奋、易激动、头晕、头痛和失眠等，但症状轻微，且与服用剂量大小无关。停药后以上症状消失。偶见轻度肝功能损害，表现为轻度转氨酶升高，但与药物剂量无关。

【禁忌】
锥体外系疾病，Huntington舞蹈症者禁用本品，以免加重症状。

【注意事项】
肝肾功能障碍者慎用并应适当减少剂量。

【孕妇及哺乳期妇女用药】
本品易通过胎盘屏障，故孕妇禁用；哺乳期妇女用药指征尚不明确。

【儿童用药】 新生儿禁用。

【药物相互作用】
本品与华法林联合应用时，可延长凝血酶原时间，可诱导血小板聚集的抑制。在接受抗凝治疗的患者中，同时应用吡拉西坦时应特别注意凝血时间，防止出血危险，并调整抗凝治疗的药物剂量和用法。

规格：
·1200mg *30 片
·800mg *30 片
·400mg *120 胶囊

Drug name: Brand Nootropil

Active substance: piracetam

Pharmacological effects: Nootropil is a nootropic preparation that contains piracetam. Piracetam is a cyclic derivate of gamma-amino-butyric acid. Nootropil acts direclty on brain, improves cognitive processes, improves memory, attention and learning capability, mental capacity. Nootropil does not possess sedative and psychogogic effects.
Therapeutic effect of the medication is associated with different action mechanisms. Nootropil improves metabolic processing in the brain cells, microcirculaton is improved as well.

Nootropil improves the cooperation between cerebral hemispheres and synaptic conductibility.

Nootropils inhibits platelets aggregation and restores the elasticity of the red blood cells. Nootropil exerts protective and restorative action in the brain's dysfunction caused by hypoxia, intoxication and trauma.

Indications: Nootropil is approved for the treatment of the following conditions:

Symptomatic treatment of psychoorganic syndrome in elderly patients manifested in decreased memory, dizziness, reduced attention concentration, mood changes, attention disorders.
Conditions after ischemic stroke(dysphasia, emotional disorders, decreased motional and psychotic activity.
Chronic alcoholism
Dizziness of the vascular or psychotic origin
Complex treatment of the psychoorganic syndrome in chidlren
Complex treatment of the cortical myoclonia
Complex treatment of sickle cell disease
Warnings and Precautions: The drugs should not be used in the following conditions:

Hypersensitivity to any components of the preparations.
Psychomotor agitation
Acute disorders of the brain circulation(bloodstroke)
Acute kidney failure
Huntington's chorea
Children under 3 years of age
Severe bleedings

Surgical interventions
Hemostasis disorders
Pregnancy and breastfeeding
Nootropil side effects: Drugs may cause side effects which in specific patients may manifest differently. In the following paragraph we want to underline the most serious and frequent side effect of Nootropil that were identified by the drug manufacturers. The possibility of the adverse effect manifestation depends only on the individual and his specific traits. Nootropil side effects include:

CNS: agitation, drowsiness, depression, asthenia, dizziness, headache, ataxia, epilepsy, tremor, increased libido.
Cardiovascular system: drop in blood pressure
Other: weight gain, dermatitis, itching, rash, Quinke's edema
For full information on any risks and adverse effects associated with Nootropil, please consult your doctor, read the included leaflet or contact our customer support service.

Interactions: Before using Nootropil please tell your doctor which drugs or supplements you are already taking including those bought without a prescription. Also check if any additional medicine which you will take during the course of Nootropil therapy are safe in combination. Especially mention if you are taking the following groups of drugs:

Thyroid medicines
Antipsychotics
CNS stimulants
Blood thinners
Patients information: Nootropil is not to be shared with healthy individuals. It is strictly FORBIDDEN to use the drugs in treatment of any conditions unrelated to their indications. The product as well as utilized vials, syringes, needles if used during the course of treatment should be kept out of reach of children and never reused.