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Simcor(烟酸辛伐他汀缓释片)

2011-12-21 18:32:02  作者:新特药房  来源:中国新特药网天津分站  浏览次数:210  文字大小:【】【】【
简介:制造商:雅培公司 类药物:烟酸微分。 + HMG - CoA还原酶抑制剂 活性成分(S):烟酸EXT - REL 500毫克,辛伐他汀20毫克;选项卡。 另外:SIMCOR二十〇分之七百五十○烟酸EXT - REL 750mg,辛伐他汀20毫克;选 ...

制造商:
雅培公司

类药物:
烟酸微分。 + HMG - CoA还原酶抑制剂

活性成分(S):
烟酸EXT - REL 500毫克,辛伐他汀20毫克;选项卡。

另外:
SIMCOR二十〇分之七百五十○
烟酸EXT - REL 750mg,辛伐他汀20毫克;选项卡。

SIMCOR 1000年至1020年
烟酸EXT - REL 1000毫克,辛伐他汀20毫克;选项卡。

指示(S):
兼任原发性高胆固醇血症,混合血脂异常,高甘油三酯血症的饮食,如果单药治疗是不够的。

药理学:
Simcor结合的HMG - CoA还原酶抑制剂,辛伐他汀和烟酸衍生物,缓释烟酸(Niaspan也从雅培,)。

临床试验:
Simcor比较辛伐他汀20毫克和80毫克641 II型高脂血症或混合血脂异常在24周的研究患者。 A组包括高架非高密度脂蛋白水平,一直服用辛伐他汀20毫克,这些患者被随机要么Simcor二十分之千,Simcor 2000/20,或20毫克的辛伐他汀。非HDL - C与Simcor第2000/20号和1000年至1020年降低了显著辛伐他汀20毫克取得更大。

成人:
Adults:
Take once daily at bedtime with low-fat snack. Swallow whole. Naive to or switching from immediate-release niacin: initially one 500/20 tab. May increase at 4-wk intervals by up to 500mg/day (ext-rel niacin component); maintenance: 1000/20 to 2000/40 once daily. May substitute for previously-titrated ext-rel niacin at equivalent doses. Retitrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID.

儿童:
不推荐。

禁忌(S):
活动性肝病或消化性溃疡病。原因不明的持续性转氨酶升高。动脉出血。怀孕(Cat.X)。哺乳的母亲。


警告/注意事项:
不要代替等效剂量立即释放烟酸。大量的酒精消费。肝脏疾病的历史。监视器转氨酶(在基线,每头奖6 MOS 12wks,然后定期);停止水平≥3xULN坚持或肝脏疾病的症状/体征发生。停止肌病的诊断或怀疑。暂停手术治疗前,如果主要的医疗事件发生。肾功能不全。痛风。监测血糖,PT,血小板。

相互作用(S):
避免其他烟酸,强效CYP3A4抑制剂(如,唑类抗真菌药,大环内酯类,艾滋病毒蛋白酶抑制剂,奈法唑酮,葡萄柚汁> 1qt/day),吉非罗齐,非诺贝特,环孢素,达那唑。 Potentiated由胺碘酮和维拉帕米(限制辛伐他汀20mg/day)。胆汁酸螯合剂4 - 6小时的单独给药。体位性低血压,神经节阻滞剂,血管活性药物。监视器华法林,地高辛,抗糖尿病药物。

不良反应(S):
潮红,头痛,皮肤瘙痒,胃肠不适,背痛;升高的ALT / AST,肌病,横纹肌溶解症肾功能衰竭。

一瓶90片SIMCOR 500/20

 
April 4, 2008
  Drug
SIMCOR 500/20
Niacin ext-rel 500mg, simvastatin 20mg; tabs.

Cardiovascular System > Hyperlipoproteinemias
  Drug
SIMCOR 750/20
Niacin ext-rel 750mg, simvastatin 20mg; tabs.

Cardiovascular System > Hyperlipoproteinemias
  Drug
SIMCOR 1000/20
Niacin ext-rel 1000mg, simvastatin 20mg; tabs.

Cardiovascular System > Hyperlipoproteinemias
  Drug
SIMCOR 500/40
Niacin ext-rel 500mg, simvastatin 40mg; tabs.

Cardiovascular System > Hyperlipoproteinemias
  Drug
SIMCOR 1000/40
Niacin ext-rel 1000mg, simvastatin 40mg; tabs.

雅培公司降醇新药Simcor即将在美国上市

FDA近日批准了雅培公司降醇新药Simcor,Simcor含有Niaspan(缓释烟酸)和辛伐他汀两种成分,前者属雅培公司产品,后者为默克公司药物Zocor的活性成分,其专利保护已于去年失效。Simcor可以同时作用于“好胆固醇”、“坏胆固醇”和甘油三酸酯。
 
实验结果显示,总体上Simcor耐受性良好,但受试者中有6%的人因出现面部潮红的情况而终止用药,这是含烟酸药物最常见的副作用。

雅培公司提示,在睡前服药时提前30分钟服用阿司匹林或非甾体类抗炎药物可以把上述不良反应降到最低。

Manufacturer:
Abbott Laboratories

Pharmacological Class:
Nicotinic acid deriv. + HMG-CoA reductase inhibitor

Active Ingredient(s):
Niacin ext-rel 500mg, simvastatin 20mg; tabs.

Also:
SIMCOR
750/20
Niacin ext-rel 750mg, simvastatin 20mg; tabs.

SIMCOR 1000/20
Niacin ext-rel 1000mg, simvastatin 20mg; tabs.

Indication(s):
Adjunct to diet in primary hypercholesterolemia, mixed dyslipidemia, and hypertriglyceridemia if monotherapy is inadequate.

Pharmacology:
Simcor combines the HMG-CoA reductase inhibitor, simvastatin, and the nicotinic acid derivative, extended-release niacin (Niaspan, also from Abbott).

Clinical Trials:
Simcor was compared to simvastatin 20mg and 80mg in 641 patients with type II hyperlipidemia or mixed dyslipidemia in a 24-week study. Group A included those with elevated non-HDL levels who had been taking simvastatin 20mg; these patients were randomized to either Simcor 1000/20, Simcor 2000/20, or simvastatin 20mg. The non-HDL-C lowering with Simcor 2000/20 and 1000/20 was significantly greater than that achieved with simvastatin 20mg.

Legal Classification:
Rx

Adults:
Take once daily at bedtime with low-fat snack. Swallow whole. Naive to or switching from immediate-release niacin: initially one 500/20 tab. May increase at 4-wk intervals by up to 500mg/day (ext-rel niacin component); maintenance: 1000/20 to 2000/40 once daily. May substitute for previously-titrated ext-rel niacin at equivalent doses. Retitrate if therapy interrupted ≥7 days. To reduce flushing, pretreat with aspirin or an NSAID.

Children:
Not recommended.

Contraindication(s):
Active liver or peptic ulcer disease. Unexplained persistent elevated transaminases. Arterial bleeding. Pregnancy (Cat.X). Nursing mothers.


Warnings/Precautions:
Do not substitute for equivalent doses of immediate-release niacin. Substantial alcohol consumption. History of liver disease. Monitor transaminases (at baseline, every 12wks for 1st 6 mos, then periodically); discontinue if levels ≥3xULN persist or if signs/symptoms of liver disease occur. Discontinue if myopathy is diagnosed or suspected. Suspend therapy before surgery and if major medical event occurs. Renal dysfunction. Gout. Monitor blood glucose, PT, platelets.

Interaction(s):
Avoid other niacin, potent CYP3A4 inhibitors (eg, azole antifungals, macrolides, HIV PIs, nefazodone, grapefruit juice >1qt/day), gemfibrozil, fenofibrate, cyclosporine, danazol. Potentiated by amiodarone and verapamil (limit simvastatin to 20mg/day). Separate dosing of bile acid sequestrants by 4–6hrs. Postural hypotension with ganglionic blockers, vasoactive drugs. Monitor warfarin, digoxin, antidiabetics.

Adverse Reaction(s):
Flushing, headache, pruritus, GI upset, back pain; elevated ALT/AST, myopathy, rhabdomyolysis with renal failure.

How Supplied:
Tabs—90

Last Updated:
1/15/2009

责任编辑:admin


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