部分中文维生素K1处方资料(仅供参考) MEPHYTON®是一种口服处方维生素K TABLET在美国MEPHYTON(植物甲萘醌)在由故障形成的因素II,VII,IX和X的下列因素造成凝血功能障碍是由于维生素K缺乏症或干扰维生素指示ķ活动1: •由香豆素或茚满二酮衍生物抗凝血剂引起的凝血酶原不足 •低凝血酶原血症继发于抗菌治疗 •低凝血酶原血症继发于水杨酸的管理 •低凝血酶原血症继发梗阻性黄疸或胆汁瘘但只有当胆盐同时给予;否则,口服维生素K不会absorbed1 MEPHYTON就像天然存在的维生素K,需要胆盐为从胃肠道的吸收,并且通常施加6至10小时1内其效果。 成人初始剂量 抗凝诱导凝血酶原不足(由香豆素或indianedione衍生物)2.5毫克-10毫克或25毫克(很少50毫克) 低凝血酶原血症,由于其他原因(抗生素;水杨酸盐,或其它药物;限制吸收或合成因子)2.5毫克-25毫克或更多(很少高达50毫克) 产品MEPHYTON®标签 强度5毫克 每瓶装置/包100粒进球 迹象 MEPHYTON(植物甲萘醌)表示通过维生素K缺乏或维生素K活性干扰引起的,当这是由于错误的形成因素二,七,九和十以下凝血功能障碍: •由香豆素或茚满二酮衍生物抗凝血剂引起的凝血酶原不足; •低凝血酶原血症继发于抗菌治疗; •低凝血酶原血症继发于水杨酸盐的管理; •低凝血酶原血症继发梗阻性黄疸或胆汁瘘但只有当胆盐同时给予,否则口服维生素K会不会被吸收。 重要安全信息 •MEPHYTON禁用于个体过敏这种药物的任何成分。 •一个直接效果混凝剂不应植物甲萘醌给药后可以预期的。 •植物甲萘醌不会抵消肝素的抗凝血作用。 •当维生素K1来校正过度抗凝血诱发低凝血酶原血症,抗凝治疗仍被指示,患者再次面临开始抗凝治疗之前存在的凝血的危险。 •植物甲萘醌不是凝血剂,但与维生素K1过分热心的治疗可能恢复原先允许的血栓栓塞现象的条件。 用法用量 应保持尽可能低的水平,并作为临床情况表明凝血酶原时间应定期检查。 •反复大剂量的维生素K是不是肝病保证,如果初次使用维生素的反应并不理想。未能对维生素K响应可以指示先天性凝血缺陷或所治疗的病症是响应于维生素K •维生素K1是相当迅速由轻度退化;因此,时刻保护MEPHYTON由轻。直到内容已被应用于封闭的原包装箱存放MEPHYTON。 •在儿童患者中安全性和有效性已建立与MEPHYTON。 •严重过敏反应,包括过敏性反应和死亡报告如下胃肠外给药。短暂的“冲洗感觉”和味“奇特”的感觉已经观察到肠道植物甲萘醌,以及眩晕的极少数情况下,脉搏快而弱,大量出汗,短暂的低血压,呼吸困难,紫绀。 高胆红素血症已在以下肠外植物甲萘醌的行政新生儿被观察到。这与剂量高于推荐的很少,主要发生。
The only prescription vitamin K tablet available in the US MEPHYTON is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. MEPHYTON tablets are indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; hypoprothrombinemia secondary to antibacterial therapy; hypoprothrombinemia secondary to administration of salicylates; hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed1 MEPHYTON acts just like naturally occurring vitamin K, requires bile salts for absorption from the gastrointestinal tract, and generally exerts its effect within 6 to 10 hours.1 AdultsInitial Dosage Anticoagulant-induced prothrombin deficiency (caused by coumarin or indianedione derivatives)2.5 mg-10 mg or up to 25 mg (rarely 50 mg) Hypoprothrombinemia due to other causes (Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) Indications MEPHYTON(PHYTONADIONE) is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX, and X when caused by vitamin K deficiency or interference with vitamin K activity. MEPHYTON tablets are indicated in: anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; hypoprothrombinemia secondary to antibacterial therapy; hypoprothrombinemia secondary to administration of salicylates; hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently, since otherwise the oral vitamin K will not be absorbed. Important Safety Information MEPHYTON (PHYTONADIONE) is contraindicated in patients with hypersensitivity to any component of this medication. An immediate coagulation effect should not be expected after administration. MEPHYTON will not counteract the anticoagulant action of heparin. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. Dosage should be kept as low as possible, and prothrombin time should be checked regularly. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K. You are encouraged to report negative side effects of prescription drugs to the FDA. MEPHYTON Rx Vitamins/minerals/supplements Only 4 drugs may be compared at once Generic Name and Formulations: Phytonadione (Vit. K1) 5mg; scored tabs. Company: Valeant Pharmaceuticals, Inc Select therapeutic use: Vitamins/minerals/supplements Indications for MEPHYTON: Secondary hypoprothrombinemia. Adult: Initially 2.5–25mg as a single dose depending on severity and response; max 50mg. Children: Not recommended. Warnings/Precautions: Does not counteract effects of heparin. Thromboembolism. Hepatic disease. Absorption requires endogenous bile supply. Neonates. Pregnancy (Cat.C). Nursing mothers. Interactions: Reduced absorption with mineral oil, cholestyramine. Antagonizes coumarin or indanedione derivative anticoagulants. Adverse Reactions: Gastric disturbances, rash. How Supplied: Tabs—100 完整资料附件:https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a85200b6-0514-44bf-8acc-bac359993340 --------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: MEPHYTON 5MG/TAB 100TABS/BOTTLE 原产地英文药品名: PHYTONADIONE 中文参考商品译名: MEPHYTON 5毫克/片 100片/瓶 中文参考药品译名: 维生素K1 生产厂家中文参考译名: BIOVAIL TECHNOLOGIES 生产厂家英文名: BIOVAIL TECHNOLOGIES
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