英文药名: Rebetol(Ribavirin)

中文药名: 利巴韦林口服液

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。
【规格】 40mg/ml 1 x 100ml  口服液(Schering-Plough 生产)

Rebetol
Generic Name: ribavirin (oral) (rye ba VYE rin)
Brand Names: Copegus, Rebetol, RibaPak, Ribasphere, RibaTab
What is Rebetol?
Rebetol is an antiviral medication.
Rebetol must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.
Rebetol may also be used for other purposes not listed in this medication guide.
--------------------------------------------------------
Important information about Rebetol
Rebetol is not effective when used alone to treathepatitis C.
Rebetol must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.
This medication can cause birth defects or death in an unborn baby.
If you are a woman, do not take Rebetol if you are pregnant.
If you are a man, do not take Rebetol if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking Rebetol.
Use at least two effective forms of birth control while either sexual partner is taking this medication, and for at least 6 months after treatment ends.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking Rebetol.
Rebetol may decrease the number of red blood cells in your
body.
This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.
Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.
--------------------------------------------------------
Before taking Rebetol
You should not take Rebetol if you are allergic to ribavirin,
or if you have:
severe liver disease;
autoimmune hepatitis;
a hemoglobin disorder such as anemia, thalassemia
(Mediterranean anemia), or sickle-cell anemia; or
if you are pregnant woman, or a man whose female sexual
partner is pregnant.
If you have certain conditions, you may need a dose adjustment or special tests to safely take Rebetol. Before using this medication, tell your doctor if you have:
kidney or liver disease;
hepatitis B infection;
a blood cell disorder;
cancer;
psoriasis;
diabetes;
sarcoidosis;
a thyroid disorder;
hepatitis B virus or human immunodeficiency virus (HIV or
AIDS);
a history of heart disease, high blood pressure, or a heart attack;
a history of depression or suicide attempt;
a history of drug or alcohol addiction; or
a history of a liver or other organ transplant.
Tell your doctor if you have been treated with interferon in the past and it did not work well in treating your hepatitis C.
This medication can cause birth defects or death in an unborn baby.
If you are a woman, do not take Rebetol if you are pregnant.
You will need frequent pregnancy tests to make sure you are not pregnant while taking this medicine.
If you are a man, do not take Rebetol if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking this medicine. Your sexual partner will need frequent pregnancy tests to make sure she is not pregnant while you are taking Rebetol.
Use at least two effective forms of birth control while either sexual partner is taking Rebetol, and for at least 6 months after treatment ends.
Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking this medicine.
Your name may need to be listed on a Rebetol pregnancy
registry if you become pregnant while you or your male sexual partner are taking this medication or during the 6 months after treatment ends.
The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether Rebetol had any effect on the baby.
It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
--------------------------------------------------------
How should I take Rebetol?
Take Rebetol exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Rebetol is not effective when used alone to treat hepatitis C.
It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.
Take this medicine with food.
Measure the liquid form of Rebetol with a special dose-measuring spoon or cup, not a regular table spoon. If you
do not have a dose-measuring device, ask your pharmacist for one.
Rebetol may decrease the number of red blood cells in your
body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver and thyroid function may also need to be checked. Do not miss any scheduled visits to your doctor.
Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.
It is important to use Rebetol regularly to get the most
benefit. Get your prescription refilled before you run out of medicine completely. You may need to take this medication for many months.
Drink extra fluids while you are taking Rebetol to keep from getting dehydrated, especially during exercise or in hot weather.
Rebetol can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking Rebetol, rinse your mouth out with water to prevent damage to your teeth or gums.
Be sure to have regular dental exams while you are taking this medication.
Store ribavirin tablets and capsules at room temperature away from moisture, heat, and light. Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.
--------------------------------------------------------
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. If you have not taken the medication for longer than 24 hours, call your doctor for instructions. Do not take extra medicine to make up the missed dose.
--------------------------------------------------------
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling.
--------------------------------------------------------
What should I avoid while taking Rebetol?
Treatment with Rebetol does not prevent spread of the
hepatitis C virus to other people. Follow your doctor's
instructions about how to prevent passing the disease to
another person.
Do not drink alcohol while taking Rebetol. Alcohol can
increase the risk of damage to your liver.
Rebetol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
-------------------------------------------------------
Rebetol side effects
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 Rebetol and call your doctor at once if you have any of these serious side effects:
pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;
severe depression, hallucinations, thoughts of suicide or
hurting yourself;
fever, chills, body aches, flu symptoms, trouble breathing;
severe blistering, peeling, and red skin rash;
blood diarrhea, or black tarry stools;
chest pain or heavy feeling, pain spreading to the arm or
shoulder, nausea, sweating, general ill feeling; orsevere pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.
Less serious Rebetol side effects may include:
feeling tired or irritable;
dry mouth, cough;
headache, dizziness;
hearing or vision problems;
hair loss, dry skin, rash, itching;
joint or muscle pain; orsleep problems (insomnia).
This is not a complete list of side effects and others may
occur. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
--------------------------------------------------------
What other drugs will affect Rebetol?
Before taking Rebetol, tell your doctor if you are using any of the following drugs:
abacavir (Ziagen);
didanosine (Videx);
lamivudine (Combivir, Epivir, Epzicom, Trizivir);
stavudine (Zerit);
tenofovir (Viread);
zalcitabine (Hivid); or
zidovudine (Retrovir, AZT).
This list is not complete and there may be other drugs that can interact with Rebetol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
--------------------------------------------------------
Where can I get more information?
Your pharmacist can provide more information about Rebetol.
--------------------------------------------------------
What does my medication look like?
Ribavirin is available with a prescription under the brand
names Rebetol and Copegus. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Rebetol 200 mg - white, opaque capsules
Rebetol Oral Solution 40 mg-mL - clear, colorless to light
yellow, bubblegum-flavored solutionCopegus 200 mg - pink, oval-shaped, film-coated tabletsRemember, keep this and all other medicines out of the reach of children, never share your medicines with other, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information
provided by Cerner Multum, Inc. ('Multum') is accurate,
up-to-date, and complete, but no guarantee is made to that
effect.
Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the
United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a
warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum
provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
---------------------------------------------------------------
原产地英文商品名:
REBETOL SOLUTION 40mg/ml 100mls/bottle
原产地英文药品名:
RIBAVIRIN
原产地英文化合物名称:
1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide
中文参考商品译名:
REBETOL混悬剂 40毫克/毫升 100毫升/瓶
中文参考药品译名:
利巴韦林
生产厂家中文参考译名:
先灵葆雅
生产厂家英文名:
SCHERING PLOUGH RES