英文药名: Altoprev(Lovastatin Extended Release Tablets)
中文药名: 洛伐他汀缓释片
生产厂家: Andrx Pharmaceuticals Inc.
【药物名称】
中文药名: 洛伐他汀缓释片
英文名：Lovastatin Extended Release Tablets
主要成分：本品主要成分为洛伐他汀
性状：本品为白色片。
【生产厂家】
Andrx Pharmaceuticals Inc. 安德克斯制药公司
【药理作用】
本品为甲基羟戊二酰辅酶A(HMG－CoA)还原酶抑制剂，抑制内源性胆固醇合成，为血脂调节剂。动物实验表明洛伐他汀能降低TritonWR－1339所引起的高脂血症大鼠的血清胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白(LDL)及肝脏TC浓度，升高高密度脂蛋白(HDL)水平。能降低由高脂饲料引起的高脂血症家兔血清及肝脏的TC浓度。
【药代动力学】
文献资料表明：口服洛伐他汀后2～4小时血浆中的浓度达峰值。洛伐他汀有高度的肝脏选择性。在肝脏的浓度明显高于其他组织。洛伐他汀的作用主要是在肝脏发挥，大部分的药物经过肝脏组织被吸收，随后从胆汁中排泄。
【适应症】
高胆固醇血症。饮食疗法和其他非药物治疗反应欠佳时，降低原发性高胆固醇血症患者的总胆固醇(TC)和低密度脂蛋白胆固醇(LDL-C)。
【用法用量】
病人在接受本品治疗前及治疗过程中应使用标准降胆固醇饮食。
一般起始剂量为每日20mg，晚餐时一次顿服，至少应在服药4周后方可按疗效调整剂量。最大剂量可至每日80mg，一次顿服或分早、晚餐分次服用。
轻、中度高胆固醇血症患者起始剂量为10mg。当LDL－C降至75mg/100ml (1.94mmol/L)以下或TC降至140mg/100ml(3.6mmol/L)以下时，洛伐他汀应减量。
任何疑问，请遵医嘱！
【不良反应】
常见不良反应为恶心、消化不良、腹痛、胃肠胀气、腹泻、便秘、视力障碍、眩晕、头痛、肌痛、肌痉挛、皮疹等，其它不良反应为肝炎、过敏反应综合症、多形性红斑。
实验室检查，可见血清转氨酶或磷酸肌酸激酶轻、中度升高、罕见显著升高。也有报导碱性磷酸酶、胆红素水平升高。
【禁忌症】
1．对本品任何成分过敏者禁用。
2．肝脏活动性病变或血清转氨酶持续升高而无法解释者禁用。
3．孕妇及哺乳妇女禁用。
【注意事项】
1．使用本品前及用药期间应定期检查血清转氨酶。若血清转氨酶持续增高并上升至正常值上限三倍以上时，应停药。
2．用药期间出现弥漫性肌痛、肌肉压痛或软弱等疑为肌病症状和/或磷酸肌酸激酶显著升高，应停止用药。
3．本品仅有中度降低甘油三酯作用，故不适用于以高甘油三酯异常为主(即高脂血症I、IV和V型)的患者。
4．患有罕见的纯合子家族性高胆固醇血症者，可能由于患者缺乏功能性LDL受体，服用本品似更易出现血清转氨酶的升高。
5．若病人有急性或严重情况，特别是易发生继发于横纹肌溶解的肾脏衰竭者，包括严重急性感染、低血压、大手术、外伤、严重代谢、内分泌或电解质平衡紊乱和不能控制的抽搐，均应暂停或终止使用洛伐他汀治疗。
6．接受免疫抑制治疗的病人，正在服用吉非罗齐或烟酸并同时服用本品曾有导致肌病的报导，故应权衡利弊。
【规格】
10, 20, 40, 60mg/片。
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ALTOPREV®
(lovastatin) Extended-Release Tablets
DRUG DESCRIPTION
ALTOPREV® lovastatin extended-release tablets contain a cholesterol-lowering agent isolated from a strain of Aspergillus terreus. After oral ingestion, lovastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol.
Lovastatin is [1 S -[1α(R*),3α,7β,8β(2 S*,4 S*),8aβ]]-1,2,3,7,8,8a-hexa-hydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. The empirical formula of lovas-tatin is C24H36O5 and its molecular weight is 404.55. Its structural formula is:
Lovastatin is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile.
ALTOPREV® (lovastatin extended-release tablets) extended-release tablets are designed for once-a-day oral administration and deliver 20 mg, 40 mg, or 60 mg of lovastatin. In addition to the active ingredient lovastatin, each tablet contains the following inactive ingredients: acetyltributyl citrate; butylated hydroxyanisole; candellila wax; cellulose acetate; confectioner's sugar (contains corn starch); F D & C yellow # 6; glyceryl monostearate; hypromellose; hypromellose phthalate; lactose; methacrylic acid copolymer, type B; polyethylene glycols (PEG 400, PEG 8000); polyethylene oxides; polysorbate 80; propylene glycol; silicon dioxide; sodium chloride; sodium lau-ryl sulfate; synthetic black iron oxide; red iron oxide; talc; titanium dioxide and triacetin.
What are the possible side effects of lovastatin (Altoprev, Mevacor)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using lovastatin and call your doctor at once if you have any of these serious side effects:
muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine.
Less serious side effects may include:
mild stomach pain, gas, bloating, stomach upset, heartburn;
nausea; ...
Read All Potential Side Effects and See Pictures of Altoprev »
What are the precautions when taking lovastatin extended-release tablets (Altoprev)?
Before taking lovastatin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, alcohol use.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Limit alcoholic beverages. Daily use of alcohol may increase your risk for liver problems, especially when combined with lovastatin.