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利巴韦林胶囊REBETOL(Ribavirin Capsules)

2013-04-15 14:22:37  作者:新特药房  来源:互联网  浏览次数:158  文字大小:【】【】【
简介: 通用名 利巴韦林 英文名 RIBAVIRIN TABLETS 拼音名 LIBAWEILIN PIAN 药品类别 抗病毒类 性状 本品为白色。 药理毒理 1.药理广谱抗病毒药。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 ...

通用名 利巴韦林  
英文名 RIBAVIRIN TABLETS
拼音名 LIBAWEILIN PIAN
药品类别 抗病毒类
性状 本品为白色。
药理毒理
1.药理广谱抗病毒药。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。
2.毒理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),出现心脏损伤。
药代动力学
口服吸收迅速,生物利用度约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。血消除半衰期(t1/2?)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
1. 病毒性呼吸道感染:成人一次0.15g,一日3次,疗程7天。
2. 皮肤疱疹病毒感染:成人一次0.3g,一日3次,疗程7天。
3.小儿每日按体重10mg/kg ,分4次服用,疗程7天。 
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。
禁忌症
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。
儿童用药 6岁以下小儿口服剂量未定。
老年患者用药 老年人不推荐应用。
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。
药物过量  
贮藏 遮光,密封保存。
包装
(1)20mg
(2)50 mg
(3)100mg
Rebetol Side Effects – For Healthcare Professionals:
Generic name: ribavirin
Applies to ribavirin: compounding powder, inhalation powder for reconstitution, oral capsule, oral solution, oral tablet
General
The most common serious or life-threatening side effects induced or aggravated by ribavirin (the active ingredient contained in Rebetol) tablets in combination with peginterferon alfa-2a have included depression, suicide, relapse of drug abuse/overdose, and bacterial infections in less than 1% of patients and hepatic decompensation in 2% of chronic hepatitis C (CHC)-HIV coinfected patients. The most common serious side effect in CHC monoinfected (3%) and CHC-HIV coinfected (5%) patients receiving peginterferon alfa-2a alone or in combination with ribavirin tablets was bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Common side effects reported in CHC-HIV coinfected patients receiving ribavirin tablets in combination with peginterferon alfa-2a have included neutropenia, anemia, thrombocytopenia, weight decrease, and mood alteration.
The most common side effects reported in patients receiving ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b were injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability. The most common serious side effects associated with peginterferon alfa-2b in combination with ribavirin capsules/oral solution were depression and suicidal ideation in less than 1% of patients. The most common fatal side effects reported in patients receiving peginterferon alfa-2b in combination with ribavirin capsules/oral solution were cardiac arrest, suicidal ideation, and suicide attempt in less than 1% of patients.
Respiratory
Mechanically ventilated patients may be predisposed to respiratory deterioration.
Severe hypoxia was described in a case report of a previously healthy infant who experienced a dramatic drop in transcutaneous oxygen within 1 minute of receiving ribavirin (the active ingredient contained in Rebetol) Oxygen levels returned to normal promptly following discontinuation of therapy. However, the infant later died, and postmortem examination revealed a high pulmonary arterial pressure and a patent ductus arteriosus. A definitive causal relationship was not established, and equipment failure was not specifically ruled out by the authors.
Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.
Respiratory side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included dyspnea (up to 26%), cough (up to 23%), and exertional dyspnea (up to 7%). Pharyngitis (up to 13%), rhinitis (up to 8%), and sinusitis (up to 12%) have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Pulmonary symptoms (including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, pneumonia, and fatal pneumonia), sarcoidosis, and exacerbation of sarcoidosis have been reported with oral ribavirin in combination with alpha interferon. Pulmonary hypertension has been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b. Significant deterioration of pulmonary function in patients with chronic obstructive pulmonary disease or asthma and minor pulmonary function abnormalities in healthy volunteers have been reported with aerosolized ribavirin. Asthmatic patients have also reported dyspnea and chest soreness with aerosolized ribavirin. Worsening of respiratory status, bronchospasm, hypoventilation, cyanosis, dyspnea, bronchoconstriction, bacterial pneumonia, cough, pneumothorax, pulmonary edema, apnea, atelectasis, hypoxia, and ventilator dependence have been reported with aerosolized ribavirin. Rhinitis and pharyngitis, as well as several cases of bronchospasm and/or chest pain (usually in individuals with underlying reactive airway disease), have been reported in health care workers exposed to aerosolized ribavirin.
Hypersensitivity
Hypersensitivity side effects have included reactions such as urticaria, angioedema, bronchoconstriction, and anaphylaxis in patients treated with alfa interferon and ribavirin (the active ingredient contained in Rebetol) Severe skin reactions (including vesiculobullous eruptions, Stevens-Johnson syndrome, erythema multiforme, and exfoliative dermatitis/erythroderma) have been reported in patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Serious skin reactions have been reported during postmarketing experience in patients treated with peginterferon alfa-2a.
Dermatologic
Dermatologic side effects have included rash and skin irritation from prolonged drug contact. Alopecia (up to 36%), pruritus (up to 29%), dermatitis (up to 16%), dry skin (up to 24%), increased sweating (up to 11%), rash (up to 34%), and eczema (up to 5%) have been associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Grover’s disease has been reported in a 55-year-old man 2 weeks after the start of ribavirin therapy. A photoallergic skin reaction was reported to occur 4 months after initiation of ribavirin treatment, and recurred approximately 24 hours after reexposure to ribavirin. Skin disorders associated with ribavirin tablets in combination with peginterferon alfa-2a have included lichenoid eruptions and maculopapular rashes. Rash has been reported in patients treated with and health care workers exposed to aerosolized ribavirin. Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a.
Grover’s disease (suprabasal transient acantholytic dermatosis) secondary to ribavirin use was confirmed upon drug rechallenge in a 55-year-old man with chronic active hepatitis C.
Rash associated with aerosolized ribavirin usually resolved within hours of stopping treatment in patients and within minutes to hours of stopping close exposure in health care workers.
Cardiovascular
Cardiovascular side effects have included angina, arrhythmia, and pulmonary embolism in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin (the active ingredient contained in Rebetol) tablets. Fatal and nonfatal myocardial infarctions have been reported in patients with anemia due to ribavirin capsules/oral solution. Cardiac arrest, hypotension, bradycardia, bigeminy, tachycardia, hypertension (usually slight increases in blood pressure), and digitalis toxicity have been reported with aerosolized ribavirin.
Bigeminy, bradycardia, and tachycardia have been reported in patients with underlying congenital heart disease.
Hematologic
Hemolytic anemia is the primary toxicity of ribavirin (the active ingredient contained in Rebetol) therapy. Hemoglobin levels generally declined within the first 1 to 2 weeks of oral therapy. Cardiac and pulmonary adverse effects associated with anemia have been reported in 10% of patients.
Hemoglobin less than 10 g/dL was reported in 13% of patients receiving ribavirin tablets in combination with peginterferon alfa-2a. Additional laboratory abnormalities during treatment with ribavirin tablets in combination with peginterferon alfa-2a or interferon alfa-2b have included decreased neutrophils (1000 to less than 1500 cells/mm3: up to 38%; 500 to less than 1000 cells/mm3: up to 49%; less than 500 cells/mm3: up to 5%), platelets (50,000 to less than 75,000 cells/mm3: up to 11%; 20,000 to less than 50,000 cells/mm3: up to 5%), and hemoglobin (8.5 to 9.9 g/dL: 11%; less than 8.5 g/dL: up to 2%).
Changes in laboratory values during treatment with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b have included decreased hemoglobin (9.5 to 10.9 g/dL: up to 32%; 8 to 9.4 g/dL: up to 5%; 6.5 to 7.9 g/dL: up to 0.2%), leukocytes [2 to 2.9 x 10(9)/L: up to 46%; 1.5 to 1.9 x 10(9)/L: up to 24%; 1 to 1.4 x 10(9)/L: up to 5%], neutrophils [1 to 1.49 x 10(9)/L: up to 42%; 0.75 to 0.99 x 10(9)/L: up to 25%; 0.5 to 0.74 x 10(9)/L: up to 18%; less than 0.5 x 10(9)/L: up to 11%], and platelets [70 to 99 x 10(9)/L: up to 15%; 50 to 69 x 10(9)/L: up to 3%; 30 to 49 x 10(9)/L: up to 0.2%; less than 30 x 10(9)/L: up to 1%].
Hematologic side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included anemia (up to 35%), lymphopenia (up to 14%), neutropenia (up to 40%), thrombocytopenia (up to 8%), and leukopenia (up to 10%). Hemolytic anemia is the most significant toxicity of ribavirin. Aplastic anemia and thrombotic thrombocytopenic purpura have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Pancytopenia (marked decreases in red blood cells, neutrophils, and platelets) and bone marrow suppression have been reported following concomitant administration of pegylated interferon plus oral ribavirin and azathioprine. Aplastic anemia has been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b. Pure red cell aplasia has been reported during postmarketing experience with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Cases of anemia (type unspecified), reticulocytosis, and hemolytic anemia associated with aerosolized ribavirin have been reported during postmarketing experience and have been reversible with drug discontinuation.
Ocular
Ocular side effects associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included blurred vision (up to 6%). Corneal ulcer has been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Conjunctivitis (up to 5%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Serous retinal detachment has been reported during postmarketing experience with oral ribavirin in combination with peginterferon alfa-2a, interferon alfa-2b, or peginterferon alfa-2b. Eye irritation and conjunctivitis have been reported in patients treated with and health care workers exposed to aerosolized ribavirin. Lacrimation has been reported in health care workers exposed to aerosolized ribavirin. Damage to contact lenses after prolonged close exposure to aerosolized ribavirin has also been reported.
Conjunctivitis associated with aerosolized ribavirin usually resolved within hours of stopping treatment in patients. Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.
Eye and conjunctival irritation resolved spontaneously when the caregivers left the hospital. In five of six cases, the caregivers were wearing contact lenses. After the staff stopped wearing contact lenses while caring for patients receiving aerosolized ribavirin, the reactions did not occur.
Gastrointestinal
Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin (the active ingredient contained in Rebetol)
Gastrointestinal side effects associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included nausea (up to 47%), nausea and vomiting (up to 29%), diarrhea (up to 22%), vomiting (up to 14%), abdominal pain (up to 13%), dry mouth (up to 12%), dyspepsia (up to 16%), and constipation (5%). Peptic ulcer, gastrointestinal bleeding, pancreatitis, and colitis have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Nausea has been reported in health care workers exposed to aerosolized ribavirin.
Musculoskeletal
Musculoskeletal side effects associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included myalgia (up to 64%), arthralgia (up to 34%), musculoskeletal pain (up to 28%), and back pain (5%). Myositis has been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. At least 6 cases of mild to moderate gout have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.
Nervous system
Nervous system side effects associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included headache (up to 66%), dizziness (excluding vertigo; 26%), and memory impairment (up to 6%). Peripheral neuropathy, coma, and cerebral hemorrhage have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Taste perversion (up to 9%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Hearing impairment and hearing loss have been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a. Vertigo and hearing disorder have been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b. Headache and dizziness have been reported in health care workers exposed to aerosolized ribavirin. Seizures have been reported with experimental intravenous ribavirin.
Most signs and symptoms reported in exposed health care workers resolved within minutes to hours of stopping close exposure to aerosolized ribavirin.
Metabolic
Metabolic side effects associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included anorexia (up to 32%) and weight decrease (up to 29%). Diabetes mellitus has been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Falsely low hemoglobin A1c levels have been reported. Dehydration has been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a. Diabetes has been reported during postmarketing experience with ribavirin capsules/oral solution in combination with interferon alfa-2b or peginterferon alfa-2b.
Falsely low hemoglobin A1c levels may be due to ribavirin-induced hemolysis decreasing the number of circulating glycosylated hemoglobin molecules.
Psychiatric
Psychiatric side effects associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included irritability/anxiety/nervousness/emotional lability (up to 47%), insomnia (up to 41%), depression (up to 36%), concentration impairment (up to 21%), mood alteration (up to 9%), and agitation (up to 8%). Suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse/overdose, psychotic disorder, and hallucination have been reported in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin tablets. Impairment of desire and the potential to affect sexual satisfaction have been reported with ribavirin tablets in combination with peginterferon alfa-2a in male patients.
Endocrine
Endocrine side effects associated with oral ribavirin (the active ingredient contained in Rebetol) in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b have included hypothyroidism (up to 5%).
Other
Other side effects frequently associated with ribavirin (the active ingredient contained in Rebetol) tablets in combination with peginterferon alfa-2a have included influenza-like symptoms (such as fatigue, pyrexia, myalgia, headache, and rigors). Fatigue/asthenia (up to 70%), pyrexia (up to 55%), rigors (up to 48%), chills (up to 39%), influenza-like illness (up to 18%), unspecified pain (up to 13%), right upper quadrant pain (up to 12%), pain (up to 10%), chest pain (up to 9%), and malaise (up to 6%) have been associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Hyperuricemia (in association with hemolysis; up to 38%) and flushing (up to 4%) have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Asthenia has been reported with experimental intravenous ribavirin.
Hepatic
Hepatic side effects have included hepatic dysfunction, fatty liver, and cholangitis in less than 1% of patients treated with peginterferon alfa-2a alone or in combination with ribavirin (the active ingredient contained in Rebetol) tablets. Hepatic decompensation has been reported in 2% of CHC-HIV coinfected patients receiving peginterferon alfa-2a in combination with ribavirin tablets. Hyperbilirubinemia (in association with hemolysis; up to 14%), hepatomegaly (4%), and increased ALT have been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.

Changes in laboratory values during treatment with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b have included increased total bilirubin (1.5 to 3 mg/dL: up to 32%; 3.1 to 6 mg/dL: up to 3%; 6.1 to 12 mg/dL: up to 0.4%) and ALT (2 x baseline: up to 0.6%; 2.1 to 5 x baseline: up to 3%).
Immunologic
Immunologic side effects associated with peginterferon alfa-2a alone or in combination with ribavirin (the active ingredient contained in Rebetol) tablets have included bacterial infection (e.g., sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia) in 3% of CHC and 5% of CHC-HIV patients and autoimmune phenomena (such as hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis) in less than 1% of patients. Resistance mechanism disorders (overall: up to 12%), including viral infection (12%) and fungal infection (up to 6%), have been associated with oral ribavirin in combination with peginterferon alfa-2a, peginterferon alfa-2b, or interferon alfa-2b. Liver and renal graft rejections have been reported during postmarketing experience with ribavirin tablets in combination with peginterferon alfa-2a.
Genitourinary
Genitourinary side effects associated with ribavirin (the active ingredient contained in Rebetol) tablets in combination with peginterferon alfa-2a have included sexual dysfunction in male patients. Menstrual disorder has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b.
Local
Local side effects have included injection site reactions (up to 58%) in patients treated with oral ribavirin (the active ingredient contained in Rebetol) in combination with interferon alfa-2b, peginterferon alfa-2b, or peginterferon alfa-2a. Injection site inflammation (up to 25%) has been reported with ribavirin capsules/oral solution in combination with peginterferon alfa-2b or interferon alfa-2b. Skin disorders associated with ribavirin tablets in combination with peginterferon alfa-2a have included cutaneous necrosis at peginterferon alfa-2a injection sites. Hyperpigmentation around/over peginterferon alfa-2a injection sites has been reported.

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原方处方资料附件:http://www.info.pmda.go.jp/go/pack/6250022M1021_1_29/
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レベトールカプセル200mg

有効成分に関する理化学的知見
商標名
REBETOL Capsules 200mg
一般名
リバビリン(JAN)、Ribavirin(JAN)
化学名
1-β-D-Ribofuranosyl-1H-1,2,4-triazole-3-carboxamide
構造式

分子式
C8H12N4O5
分子量
244.20
性状
白色の結晶性の粉末で、水、ギ酸又はN,N-ジメチルホルムアミドに溶けやすく、メタノール、エタノール(95)又は酢酸(100)に溶けにくく、アセトンに極めて溶けにくく、アセトニトリル、ジエチルエーテル又はヘキサンにほとんど溶けない。
融点
167-171℃
分配係数
(1-オクタノール-水系)
pH2:3.76×10-3 pH8:1.38×10-3
pH4:3.85×10-3 pH10:1.70×10-4
pH6:3.44×10-3 pH12:1.78×10-4
承認条件
インターフェロン アルファ-2b(遺伝子組換え)との併用の場合
インターフェロン アルファ-2b(遺伝子組換え)との併用療法について、体重による用量区切りを変更した際の安全性を確認するための市販後臨床試験を実施し、結果を速やかに報告すること。
ペグインターフェロン アルファ-2b(遺伝子組換え)との併用の場合
ペグインターフェロン アルファ-2b(遺伝子組換え)との併用療法について、体重による用量区切りを変更した際の安全性を確認するための市販後臨床試験を実施し、結果を速やかに報告すること。

包装
レベトールカプセル200mg:140カプセル(PTP14カプセル×10)、28カプセル(PTP14カプセル×2)


製造販売元
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