英文药名: Rebetol(Ribavirin) 中文药名: 利巴韦林胶囊 此药品需要处方 生产厂家: Schering 药品简介 慢性丙型病毒性肝炎干扰素治疗的主要开发商先灵-葆雅公司近日开始上市利巴韦林 (ribavirin USP, REBETOL) 口服液，该产品可与重组干扰素α-2b（interferon alfa- 2b, recombinant，INTRON A）注射剂联合治疗小儿慢性丙型病毒性肝炎。在此之前，还没有获准用于儿童慢性丙型病毒性肝炎的治疗药物。 据统计，在美国大约有400万人感染丙型肝炎病毒，其中近16万为儿童。由未经治疗的儿童患者参与的临床试验显示，INTRON A与REBETOL的联合治疗使全部患者中的46%产生持续病毒学应答(SVR)，基因型1型丙肝病毒感染患者的SVR率是36%，基因型2型或3型的SVR率是81%。 在儿科患者中，INTRON A与REBETOL的联合治疗适于3岁慢性丙型病毒性肝炎的患儿以及先前未经干扰素治疗的3岁以上代偿性肝病患儿。对于这部分患者，要进行个体化治疗，REBETOL的剂量要根据体重来计算，而INTRON A要根据体表面积来计算。建议基因型2型或3型丙肝病毒感染儿患的治疗时间应持续24周，基因型1型要48周。经24周治疗仍未产生病毒学应答的患者应考虑停药。 REBETOL口服液是利巴韦林的新剂型，满足了儿科患者的需要。而且还添加了泡泡糖味。REBETOL胶囊目前已获准与INTRON A联合治疗儿童慢性丙型病毒性肝炎。 通用名称：利巴韦林胶囊 英文名称：Ribavirin Capsules 【药理毒理】 药理学 广谱抗病毒药。体外具有抑制呼吸道合胞病毒、流感病毒、甲肝病毒、腺病毒等多种病毒生长的作用，其机制不全清楚。本品并不改变病毒吸附、侵入和脱壳，也不诱导干扰素的产生。药物进入被病毒感染的细胞后迅速磷酸化，其产物作为病毒合成酶的竞争性抑制剂，抑制肌苷单磷酸脱氢酶、流感病毒RNA多聚酶和mRNA鸟苷转移酶，从而引起细胞内鸟苷三磷酸的减少，损害病毒RNA和蛋白合成，使病毒的复制与传播受抑。对呼吸道合胞病毒也可能具免疫作用及中和抗体作用。 毒理学 动物实验发现本品可诱发乳房、胰腺、垂体和肾上腺良性肿瘤，但对人体的致癌性并未肯定。药物对仓鼠等动物可引起头颅、腭、眼、颌、骨骼和胃肠道的畸形，子代成活减少，但灵长类动物实验并未发现药物对胎仔的影响。 给予小鼠、大鼠和猴口服利巴韦林，剂量分别为30、36和120mg/kg或持续4周以上(相当于人用剂量：给予体重为5kg的儿童4.8、12.3和111.4mg/kg，或者体重为60kg成人2.5、5.1和40mg/kg。以上均按体表面积折算)，出现心脏损伤。 【药代动力学】 口服吸收迅速，生物利用度(F)约45%，少量可经气溶吸入。口服后1.5小时血药浓度达峰值，血药峰浓度(Cmax)约1～2mg/L。小儿每日以面罩吸药2.5小时共3天，平均血药峰浓度(Cmax)为0.2mg/L；每日吸药20小时共5天，平均血药峰浓度(Cmax)为1.7mg/L，与血浆蛋白几乎不结合。药物在呼吸道分泌物中的浓度大多高于血药浓度。药物能进入红细胞内，且蓄积量大。长期用药后脑脊液内药物浓度可达同时期血药浓度的67%。本品可透过胎盘，也能进入乳汁。在肝内代谢。血药消除半衰期(t1/2β)约为0.5～2小时。本品主要经肾排泄。72～80小时尿排泄率为30%～55%。72小时粪便排泄率约15%。药物在红细胞内可蓄积数周。 【适应症】 适用于呼吸道合胞病毒引起的病毒性肺炎与支气管炎，皮肤疱疹病毒感染。 【用法用量】 口服给药： 成人 （1）病毒性呼吸道感染：一次0.15g，一日3次，疗程7天。 （2）皮肤疱疹病毒感染：一次0.3g，一日3次，疗程7天。 儿童 小儿每日按体重10mg/kg ，分4次服用，疗程7天。6岁以下小儿口服剂量未定。 【不良反应】 常见的不良反应有贫血、乏力等，停药后即消失。较少见的不良反应有疲倦、头痛、失眠、食欲减退、恶心、呕吐、轻度腹泻、便秘等，并可致红细胞、白细胞及血红蛋白下降。 【禁忌】 对本品过敏者、孕妇禁用。 【注意事项】 1．有严重贫血、肝功能异常者慎用。 2．对诊断的干扰：口服本品后引起血胆红素增高者可高达25%。大剂量可引起血红蛋白含量下降。 3．尽早用药。呼吸道合胞病毒性肺炎病初3日内给药一般有效。本品不宜用于未经实验室确诊为呼吸道合胞病毒感染的患者。 4．长期或大剂量服用对肝功能、血象有不良反应。 【孕妇及哺乳期妇女用药】 1．本品有较强的致畸作用，家兔日剂量1mg/kg即引起胚胎损害，故禁用于孕妇和有可能怀孕的妇女(本品在体内消除很慢，停药后4周尚不能完全自体内清除)。 2．少量药物由乳汁排泄，且对母子二代动物均具毒性，因此哺乳期妇女在用药期间需暂停哺乳，乳汁也应丢弃。由于哺乳期妇女呼吸道合胞病毒感染具自限性，故本品不用于此种病例。 【药物相互作用】 本品与齐多夫定同用时有拮抗作用，因本品可抑制齐多夫定转变成活性型的磷酸齐多夫定。 【药物过量】 大剂量应用可致心脏损害，对有呼吸道疾患者(慢性阻塞性肺病或哮喘者)可致呼吸困难、胸痛等。 【包装规格】 ·200mg *84 胶囊(Schering-Plough 生产) ·200mg *40 胶囊 rebetol (Ribavirin)  capsule  rebetol (Ribavirin)  solution  [Schering Corporation] Rebetol can be generically prescribed as ribavirin, and is commonly used to treat hepatitis C in conjunction with an interferon alpha medication. Rebetol is a strong antiviral medication but can not treat hepatitis C without the assistance of an interferon alpha medication. Rebetol is not appropriate for all patients and a thorough medical history is necessary to prevent complications. Patients with anemia can not take this medication as it may cause anemia. Patients with heart disease, circulation problems, a hemoglobin disorder, or autoimmune hepatitis can not take Rebetol. Patients with a medical history which includes heart disease, heart attacks, high blood pressure, cancer, diabetes, sarcoidosis, lung disease, breathing problems, kidney disease, liver disease, drug or alcohol addiction, depression, suicide attempts, thyroid disorder, organ transplantation, hepatitis B, or HIV or AIDS may not be able to take Rebetol or may require extra monitoring while undergoing drug therapy with this medication, depending on the condition and the severity of the condition. Rebetol presents a very serious risk to unborn babies. Women who are pregnant, may become pregnant, or have a high likelihood of pregnancy should not take Rebetol, as this medication has been proven to cause serious harm, death, or birth defects in unborn babies. Men who have pregnant sexual partners can not take Rebetol or must refrain from sexual activity. Women who are nursing should not take Rebetol. The risk of serious birth defects or infant death is present for both men and women for at least six months after treatment ends. There is a risk of side effects associated with Rebetol, some of which are liely to be severe. An allergic reaction is likely to present with hives, difficulty breathing and swelling of the lips, mouth, tongue, or throat, and requires immediate medical attention. Other serious side effects include symptoms such as chest pain or heaviness that incorporates the arm or other symptoms of heart attack, severe pain in the abdomen which spreads to the back accompanied by nausea, vomiting, and fast heart rate, trouble breathing, fever, chills, body aches, flu symptoms, pale skin, dark urine, jaundice, confusion, easy bleeding, unusual weakness, and easy bruising, or severe depression or thoughts or actions of self harm. Less serious side effects are much more common and may include symptoms such as stuffy nose, dry mouth, joint pain, muscle pain, insomnia, sleep problems, fatigue, trouble concentrating, feeling irritable, skin rash, itching, headaches, dizziness, nausea, vomiting, weight loss, and loss of appetite. These side effects should be reported to the prescribing physician and may be able to be relieved through reducing the dosage of Rebetol. It is vital that patients take Rebetol only as it has been prescribed to avoid overdosing. Taking too much Rebetol can result in an overdose. If a dose is missed it can be taken when it is remembered unless it is close to the next scheduled dose, in which case the missed dose should be skipped. In the event of an overdose the patient should seek immediate medical attention, which will present with symptoms which include the symptoms of a heart attack including chest pain or heaviness that travels down the arm, a serious decrease in urination or the inability to urinate at all, easy bruising, easy bleeding, and a generally ill feeling. Other medications may react negatively with Rebetol and patients should be encouraged to ask the prescribing physician before taking any new medications, including over the counter medications and herbal remedies. Medications with known interactions with Rebetol include stavudine, didanosine, and zidovudine.