【中文品名】异丙肌苷
【药效类别】抗病毒药
【通用药名】ISOPRINOSINE
【别　　名】Delimmun, Inosine pranobex, Inosiplex, Imunovir, Isoviral, Np-113, Npt-10381, Meliscoprinol, Pranosina, Pranosine, Virimun, Viruxan
【化学名称】Inosine, compd. with 1-(dimethylamino)-2-propanol 4-(acetylamino)benzoate (saIt) (1:3)
【CA登记号】[36703-88-5]
【结 构 式】
【分 子 式】C52H78N10O17
【分 子 量】1115.30
【收录药典】
【开发单位】Newport Pharm (美国)
【首次上市】1980年，美国
【性　　状】白色粉末，无臭，无味。溶于水。mp81~83℃。
【用　　途】抗病毒药。为新的抗病毒-免疫调节剂。通过增强机体的特异和非特异防卫机能来抵抗病毒的入侵，对人体疱疹、流感及鼻病毒感染均有疗效。本品具有疗效高，毒副作用小等特点。
给药说明；
别名:异丙脂肌苷、Anavir、Inosiplex、Imunovir、Isoviral;
适应症:
1.用于多种病毒感染，包括亚急性硬化性全脑炎、急性病毒性脑膜炎、带状疱疹、皮肤疱疹、流行性感冒及鹅口疮、疱疹病毒角膜炎、葡萄膜炎、获得性免疫缺陷综合征（艾滋病）、免疫缺陷病等。
2.作为治疗剂用于恶性淋巴瘤、骨髓瘤、早期恶性黑素瘤。与手术合用治疗食管癌、胃癌、直肠癌、甲状腺癌术后患者。;异丙肌苷药理学作用:体外实验表明，它能增强PHA(植物血凝素)或抗原的免疫反应，促进T淋巴细胞的分化和增殖，且可激活TH细胞或巨噬细胞而刺激B淋巴细胞分化和产生抗体。在体内具有抗肿瘤活性。它能促进干扰素、淋巴毒素及辅助性因子的产生，并可增强淋巴因子与干扰素的作用。
药物剂型
片剂：0.5g。
药理作用
体外实验表明，它能增强PHA(植物血凝素)或抗原的免疫反应，促进T淋巴细胞的分化和增殖，且可激活TH细胞或巨噬细胞而刺激B淋巴细胞分化和产生抗体。在体内具有抗肿瘤活性。它能促进干扰素、淋巴毒素及辅助性因子的产生，并可增强淋巴因子与干扰素的作用。
药动学
本品口服易吸收，血药浓度迅速下降，t1/2约为50min。90%以上代谢成尿素和尿酸，随尿排出。乙酰氨基苯甲酸和二甲氨基异丙醇分别代谢成葡糖醛酸结合物和氧化物随尿排出。 
禁忌证
尚不明确。
注意事项
1.因该药的肌苷部分最后转变为尿酸，可使血清和尿中尿酸短暂升高。注意适当多饮水。
2.用药前应行细胞免疫功能检查。 不良反应
1.临床应用中未见明显不良反应，仅用大剂量时偶有恶心。对症处理即可。
2.用药未见肝功能、血液学参数、嘌呤代谢等有异常。
用法用量
口服，每次1～1.5g，每天2～3次。 专家点评
1.用于多种病毒感染都有较好疗效。用本品治疗98例亚急性硬化性全脑炎，2年和8年后存活率分别为78%和61%；对急性病毒性脑炎也有效；对带状疱疹可减轻疼痛；治疗皮肤疱疹能加速干化，缩短治愈时间，迅速减轻疼痛和瘙痒，降低复发率。对流感及鹅口疮也有益。该药片剂或滴眼剂可使疱疹病毒角膜炎、葡萄膜炎的症状和体征有较大的改善。也用于艾滋病、免疫缺陷病等，疗效有待于进一步观察。
2.作为肿瘤的辅助治疗剂，用于恶性淋巴瘤、骨髓瘤、早期恶性黑色素瘤有一定疗效。与手术合用治疗食管癌、胃癌、直肠癌、甲状腺癌术后患者，可提高细胞免疫功能，使其恢复到术前健康水平。与放疗、化疗合用，可减轻不良反应，提高疗效。

 
Isoprinosine Tablets 500mg
1. NAME OF THE MEDICINAL PRODUCT Isoprinosine 500mg Tablets
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION Each tablet contains 500mg inosine acedoben dimepranol.
For excipients, see section 6.1
3. PHARMACEUTICAL FORM Tablet A round, white to off-white uncoated tablet with a bisecting scoreline on one side and “NPT” on the obverse. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Isoprinosine tablets are indicated: a) As an immunomodulator for the management of patients with immunodepression suffering from viral infections such as subacute sclerosing panencephalitis, varicella, herpes simplex Type 1 & 2. b) In the management of recurrent herpes simplex Type 1 & 2. c) As an adjunct in the treatment of genital warts.
4.2 Posology and method of administration a) Route of administration: Oral b) Dosing Dosage is determined on the basis of lean body weight of the patient and the severity of the disease.
Daily administration should be divided evenly during waking hours.
The normal duration of acute treatment is 5-14 days. Adults and the Elderly: 50mg/kg of body weight daily, up to a maximum of 4g, (usually, 2 tablets x 3-4 times a day). Children over the age of 1 year: 50mg/kg of body weight daily. (1 tablet per 10 kg up to 20 kgs; thereafter, use adult dose). SSPE Dosage: 100mg/kg of body weight daily, up to a maximum of 3-4g, continuously, with regular monitoring to evaluate patient status and requirement for extended treatment. Genital Warts Dosage: 3g (2 tablets x 3 times a day) for a total of 14-28 days, as an adjunct to conventional topical or surgical procedures, according to the following schedules: a) 14-28 days continuous in “low risk” patients, allowing up to 2 months more with no drug to achieve maximum lesion clearance rate; or b) 5 days per week, 1-2 consecutive weeks a month, for 3 months in “high risk*” patients, allowing until end of 3rd month to achieve maximum clearance rate.
*The latest “high risk” profile composite for recurrences or cervical dysplasia for patients with genital HPV
infections is similar for other conditions and includes: Genital HPV history >2 years or >3 failures of past therapy 
Immunodepression resulting from - history of recurrent or chronic infections or any other STD - cancer chemotherapy - habitual excess alcohol consumption Poorly controlled diabetes Atopy Long-term use of oral contraceptives (2 years or more) Red blood cell (RBC) folate levels at or below 660nmol/L No history of cutaneous childhood warts Multiple vaginal sexual partners or any change in a long-standing partner Frequency of vaginal sex (≥2-6 times per week) Anal sex Age (per additional year after median age of 20 ±3 years) = 1.1 odds ratio p = 0.001 at 95% CI) Current smoker, generally, but was found protective in college women of median age of 20 ± 3 years) To make ingestion easier, the tablets may be crushed and dissolved in a small amount of flavoured liquid at the time of administration.
4.3 Contraindications Isoprinosine should not be used in those cases where there is a known hypersensitivity to product components or in cases where the patient is presently suffering from gout or elevated uric acid blood levels.
4.4 Special warnings and precautions for use a) Isoprinosine may cause a transient elevation of baseline serum and urinary uric acid, usually remaining within the normal range (using 8mg % as the upper limit), particularly in males and in the ageing population of both sexes.
The elevation of uric acid levels is due to the catabolic metabolism of the inosine moiety in this product in humans to uric acid. It is not due to a fundamental drug-induced alteration of enzyme or renal clearance function. Therefore, Isoprinosine may be administered with caution in patients with a history of gout, hyperuricaemia, urolithiasis, or to patients with impaired renal function.
During treatment, uric acid levels in these patients should be monitored closely. b) If administered continuously for 3 months or more, the serum and urine uric acid levels, liver function, blood count and renal functions should be checked on a regular basis in all patients. There is a possibility that ureteric and biliary calculi may occur when patients receive long term treatment.
4.5 Interaction with other medicinal products and other forms of interaction The drug should be used with caution with xanthine oxidase inhibitors or uricosuric agents, including diuretics.
4.6 Pregnancy and lactation
Controlled trials monitoring foetal risk and impairment of fertility in humans are not available. It is not known if Isoprinosine is excreted in human milk. Therefore, Isoprinosine should not be administered during pregnancy or lactation unless the physician decides the benefits outweigh the potential risk.
4.7 Effects on ability to drive and use machines The pharmacodynamic profile of Isoprinosine is unlikely to produce a debilitating effect on the ability to drive or use a machine. (See also undesirable effects.)
4.8 Undesirable effects a) The only consistently observed very common (≥ 1/10) drug-related side effect is a transient elevation(usually remaining within normal range) of urine and serum uric acid levels, which usually return to baseline values a few days after the end of treatment. b) Common ( ≥ 1/100 to <1/10) side effects recorded in >1% of clinical studies of 3 months or longer: Gastrointestinal disorders: Nausea with or without vomiting, epigastric discomfort General disorders and administration site conditions Fatigue or malaise Investigations Elevation of transaminases, alkaline phosphatase or blood urea nitrogen (BUN)level Skin and subcutaneous tissue disorders: Itching, skin rashes Nervous system disorders: Headaches, vertigo, Musculoskeletal and connective tissue disorders: Arthralgia c) Uncommon (≥1/1000 to<1/100) side effects recorded in <1% of clinical studies of 3 months: Gastrointestinal disorders:: Diarrhoea, constipation Nervous system disorders:Drowsiness or insomnia Psychiatric disorders: Nervousness Renal and Urinary disorders: Polyuria (increased urine volume).
4.9 Overdose There has been no experience of overdosage with Isoprinosine. However, serious adverse effects apart from increased levels of uric acid in the body seem unlikely in view of the animal toxicity studies. Treatment should be restricted to symptomatic and supportive measures.
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产地国家: 法国
原产地英文商品名:
Isoprinosine 500mg 40 Tabs/bottle
原产地英文药品名:
Inosine Pranobex
中文参考商品译名:
异丙肌苷 500毫克/片 40片/瓶
生产厂家英文名:
Sanofi-Aventis

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产地国家: 日本
原产地英文商品名:
Isoprinosine 400mg 100 Tabs/bottle
原产地英文药品名:
Inosine Pranobex
中文参考商品译名:
异丙肌苷 400毫克/片 100片/瓶
生产厂家英文名:
Mochida