部分中文匹伐他汀钙处方资料(仅供参考) 【通用名】匹伐他汀钙片 【英文名】LIVALO 【主要成分】匹伐他汀钙 【药理毒理】匹伐他汀通过竞争性抑制羟甲戊二酰辅A(HMG-CoA)还原酶,减少胆固醇的生物合成。血管内胆固醇浓度的降低可使肝脏内低密度脂蛋白一胆固醇(LDL—C)受体下调,使LDL—C从血中的清除加快。 【适应症】主要用于高胆固醇血症和家族性高胆固醇血症 【用法用量】成人晚餐后口服本品一日1~2mg,根据年龄和症状调整剂量,若降LDL-C的疗效不理想,可增加剂量,最大日剂量为4mg。 【不良反应】主要不良反应有腹痛、皮疹、抑郁、搔痒以及r-谷氧酰胺转肽酶、肌酸激酶(CK1、谷丙转氯酶和谷草转氨酶升高。严重不良反应有横纹肌溶解和肌病。 【禁忌】对本品过敏者禁用,孕妇禁用 【注意事项】本品慎用于过度饮酒及有肝病史者若有不明原因肌痛、肌无力发生时,特别是伴有发热者应立即向医生报告,这些患者应检测CK水平,若CK水平高于正常或临床怀疑有肌病时应立即停用本品。 【FDA妊娠分级】X级:对动物和人类的药物研究或人类用药的经验表明,药物对胎儿有危害,而且孕妇应用这类药物无益,因此禁用于妊娠或可能怀孕的患者。 【贮藏】密封避光保存 【生产厂家】第一三共株式会社 【产品包装规格】 リバロ錠1mg PTP:100錠、140錠(14錠×10)、500錠、700錠(14錠×50) リバロ錠1mg 瓶:500錠 リバロ錠2mg PTP:100錠、140錠(14錠×10)、500錠、700錠(14錠×50)、1000錠 リバロ錠2mg 瓶:500錠 リバロ錠4mg PTP:100錠
生产厂家:第一三共株式会社
完整资料附件:http://www.info.pmda.go.jp/go/pack/2189016F1028_1_21/ General Information Livalo is a HMG-CoA reductase inhibitor. It differs from other statins in that it has a unique cyclopropyl group on the base structure. This cyclopropyl group contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol. Livalo is specifically indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia. Livalo is supplied as a tablet (1, 2 and 4 mg) for oral administration. The recommended initial dose of the drug is 2 mg and the maximum dose is 4 mg. After initiation or upon titration of Livalo, lipid levels should be analyzed after 4 weeks and the dosage adjusted accordingly. Considerations: Renal Impairment: Patients with moderate renal impairment and end stage renal disease receiving hemodialysis should receive a starting dose of Livalo 1 mg once daily and a maximum dose of Livalo 2 mg once daily. Those with severe renal impairment should not use Livalo. Use with Erythromycin: a dose of Livalo 1 mg once daily should not be exceeded. Use with Rifampin: a dose of Livalo 2 mg once daily should not be exceeded. What is LIVALO? LIVALO is a prescription medicine that, along with diet, has been approved for the treatment of high cholesterol. Important Safety Information for LIVALO Who should NOT take LIVALO? LIVALO is not right for everyone, including: Those who have had an allergic reaction to LIVALO Anyone with liver disease Patients with severe kidney disease not on hemodialysis Women who are nursing, pregnant, or who may become pregnant Anyone currently taking cyclosporine What should I talk to my doctor about? If you take LIVALO, tell your doctor right away if you experience any unexplained muscle pain, tenderness, or weakness, particularly if accompanied by fever or a general feeling of discomfort. This could be a sign of a rare but serious side effect. Your doctor should do blood tests to monitor your liver function before starting LIVALO, and then at 12 weeks following the start of LIVALO, after any increase in dose, and periodically (e.g., every 6 months) thereafter. Please talk to your doctor about your alcohol use. Tell your doctor about all the medications you take including nonprescription medicines, vitamins, or herbal supplements. What are the most common side effects of LIVALO? The most common side effects of LIVALO in clinical studies were: Back pain Constipation Diarrhea Muscle pain Pain in the legs or arms This is not a complete list of side effects. Other Important Information about LIVALO LIVALO has not been studied to evaluate its effect on reducing heart-related disease or death.
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