英文药名：DEPAKOTE ER（DIVALPROEX SODIUM TAB）

中文药名：双丙戊酸钠缓释片

生产厂家：雅培（ABBOTT）
药品介绍
FDA批准了缓释片剂Depakote（双丙戊酸钠divalproex sodium）的通用名药，该药已获准用于治疗癫痫、双向情感障碍和偏头痛。 　　
有FDA官员就此表示，对通用名类药物的审批程序及其严格、科学，以保证药物在质量、安全性和疗效等各方面达到其专利药的水平。此次Depakote通用名的获准给患者又增加了一种可选的治疗药。
DEPAKOTE ER Rx
Generic Name and Formulations:
Divalproex sodium 250mg, 500mg; ext-rel tabs.

Company:
AbbVie
Indications for DEPAKOTE ER:
Prophylaxis of migraine headaches.

Adult Dose for DEPAKOTE ER:
Swallow whole. 500mg once daily for 1 week, then 1g once daily. Elderly: reduce initial dose and titrate slowly; monitor.

Children's Dose for DEPAKOTE ER:
Use other forms.

See Also:
DEPAKOTE

Contraindications:
Hepatic disease or significant hepatic dysfunction. Known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG). Suspected POLG-related disorder in children <2years of age. Urea cycle disorders. Migraine prophylaxis in pregnant women.

Warnings/Precautions:
Increased risk of hepatotoxicity in patients with congenital metabolic disorders, multiple AEDs, severe seizure disorders with mental retardation, organic brain disorders, esp. in children <2 years of age. Increased risk of major congenital malformations (eg, spina bifida) and decreased IQ scores. Discontinue if hepatic dysfunction, pancreatitis, thrombocytopenia, hyperammonemia, or multi-organ hypersensitivity reactions occur. History of liver disease; monitor liver function and clinical symptoms prior to therapy and at frequent intervals (esp. for 1st 6 months). Follow-up if symptoms of hyperammonemia occur. Suicidal tendencies (monitor). Depakote ER is not bioequivalent to delayed-release tabs on mg/mg basis. Avoid abrupt cessation. Monitor platelets, bleeding time (at baseline, before surgery, and in pregnancy); reevaluate periodically. May affect HIV or CMV viral load (in vitro). Monitor motor and cognitive functions routinely. Elderly (monitor fluid and nutritional intake, and for somnolence). Pregnancy (Cat.X): apprise females of childbearing potential of risks to fetus. Nursing mothers: not recommended.

Interactions:
Monitor levels of valproate, ethosuximide, other anticonvulsants, and whenever an enzyme inducer is added or withdrawn. Potentiates carbamazepine, diazepam, ethosuximide, lamotrigine, phenobarbital, phenytoin, tolbutamide, warfarin, zidovudine, amitriptyline, nortriptyline. Potentiated by aspirin, felbamate. Levels reduced by rifampin, phenytoin, carbamazepine, phenobarbital, carbapenem antibiotics. CNS depression with alcohol, other CNS depressants. Clonazepam may induce absence status in patients with history of absence seizures. May interfere with urine ketone and thyroid tests. Others: see full labeling.

Adverse Reactions:
Abdominal pain, accidental injury, alopecia, ambylopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, abnormal thinking, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss; hepatotoxicity, acute pancreatitis, hyperammonemia.

How Supplied:
Tabs 125mg—100; Tabs 250mg, 500mg—100, 500; ER 250mg—60; ER 250mg, 500mg—100, 500

包装规格：
DEPAKOTE ER TAB 250MG 100 (DIVALPROEX SODIUM)                 
DEPAKOTE ER TAB 500MG 100 (DIVALPROEX SODIUM)             
DEPAKOTE ER TAB 250MG HUD 100 (DIVALPROEX SODIUM)
DEPAKOTE ER TAB 500MG 500 (DIVALPROEX SODIUM)

双丙戊酸钠（Divalproex Sodium，商品名Depakote）由美国第三大制药企业雅培公司（Abbott）研制。双丙戊酸钠最早获准用于治疗癫痫是在1983年，随后在1995年和1996年分别获准用于治疗双相情感障碍症和预防偏头痛。癫痫是人类最古老的疾病之一，世界卫生组织(WHO)的癫痫定义强调：癫痫是慢性脑部疾病，本质是异常放电，并具有反复发作性。按照WHO统计，全球有5000万癫痫患者。中国癫痫患者大约在800万以上，终身患病率为0.7%，每年新发病例达40万例左右。
丙戊酸盐比锂盐具有更好的安全性，无须监测血药浓度，副作用与患者耐受性更好，近10年来已成为心境稳定剂中的主要用药，双丙戊酸钠国内外医生接受程度均较高。2003年，赛诺非-安万特的双丙戊酸钠缓释片“德巴金”进入中国市场当年即领跑市场；在目前国内丙戊酸钠用药市场中，销售金额90%的份额被“德巴金”占有。国外使用最普遍的丙戊酸盐并不是丙戊酸钠，而是双丙戊酸钠。与丙戊酸钠相比，双丙戊酸钠由于胃肠道副反应更轻、药物相互作用较少，已取代了传统丙戊酸钠的市场地位。雅培与赛诺非-安万特（分别负责美国市场及美国以外市场的销售）旗下的双丙戊酸钠均属于“重磅”级药物。
临床试验
为评价评价双丙戊酸钠缓释片(心境稳定剂)与碳酸锂治疗双相障碍I型躁狂发作的疗效及安全性，方法采用用随机双盲多中心对照研究方法，对157例患者分别进行双丙戊酸钠缓释片(双丙戊酸钠缓释片组)和碳酸锂(碳酸锂组)治疗，其中丙戊酸钠缓释片组78例，碳酸锂组79例；观察疗程均为 4周。以Young躁狂评定量表作为主要疗效评价指标。结果双丙戊酸钠缓释片组患者的有效率为68.8%, 碳酸锂组的有效率为68.4%。Young躁狂评定量表减分值的比较显示,丙戊酸钠缓释片治疗急性躁狂的疗效与碳酸锂相近。药物不良反应发生率2组均为 22%,因不良事件导致脱落的发生率丙戊酸钠缓释片组(2.5%)低于碳酸锂组(7.6%)。结论双丙戊酸钠缓释片治疗双相障碍I型躁狂发作的疗效与碳酸锂相当, 耐受性较好。