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  药店国别: 日本药房
产地国家: 日本
所属类别: 抗微生物药物->抗病毒药物
处方药:处方药
包装规格: 25克/瓶
计价单位:
   
生产厂家英文名:
Nippon kayaku
原产地英文商品名:
Astric Dry Syrup 80% 25g bottle
中文参考商品译名:
Astric干糖浆 25克/瓶
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Virus infection
英文适应病症2:
Herpes
临床试验期:
完成
中文适应病症参考翻译1:
病毒感染
中文适应病症参考翻译2:
疱疹
药品信息:
阿昔洛韦片 (ACICLOVIR TABLETS) 【适用症】 1.单纯疱疹病毒感染:用于生殖器疱疹病毒感染初发和复发病例,对反复发作病例口服阿昔洛韦片用作预防。 2.带状疱疹:服用于免疫功能正常者带状疱疹和免疫缺陷者轻症病例的治疗。 3.免疫缺陷者水痘的治疗。 【注意事项】 1.对更昔洛韦过敏者也可能对阿昔洛韦片过敏。 2.脱水或已有肝、肾功能不全者需慎用。 3.严重免疫功能缺陷者长期或多次应用阿昔洛韦片治疗后可能引起单纯疱疹病毒和带状疱疹病毒对阿昔洛韦片耐药。如单纯疱疹患者应用阿昔洛韦后皮损不见改善者应测试单纯疱疹病毒对阿昔洛韦片的敏感性。 4.随访检查:由于生殖器疱疹患者大多易患子宫颈癌,因此患者至少应一年检查一次,以早期发现。 5.一旦疱疹症状与体征出现,应尽早给药。 6.进食对血药浓度影响不明显。但在给药期间应给予患者充足的水,防止阿昔洛韦片在肾小管内沉淀。 7.生殖器复发性疱疹感染以间歇短程疗法给药有效。由于动物实验曾发现阿昔洛韦片对生育的影响及致突变,因此口服剂量与疗程不应超过推荐标准。生殖器复发性疱疹的长程疗法也不应超过6个月。 8.一次血液透析可使血药浓度减低60%,因此血液透析后应补给一次剂量。 9. 阿昔洛韦片对单纯疱疹病毒的潜伏感染和复发无明显效果,不能根除病毒。 【用法与用量】 口服1. 生殖器疱疹初治和免疫缺陷者皮肤粘膜单纯疱疹:成人常用量一次0.2g,一日5次,共10日; 或一次0.4g,一日3次,共5日;复发性感染一次0.2g,一日5次,共5日;复发性感染的慢性抑制疗法,一次0.2g,一日3次,共6个月,必要时剂量可加至一日5次,一次0.2g,共6~12个月。 2.带状疱疹:成人常用量一次0.8g,一日5次,共7~10日。 3.肾功能不全的成人患者应按下表调整剂量;4.水痘:2岁以上儿童按体重一次20mg/kg,一日4次,共5日,出现症状立即开始治疗。40kg以上儿童和成人常用量为一次0.8g,一日4次,共5日。 【禁忌症】 对阿昔洛韦片过敏者禁用。 【儿童用药注意事项】 2岁以下小儿剂量尚未确定。 【孕妇、哺乳期妇女用药注意事项】 药物能通过胎盘,虽动物实验证实对胚胎无影响,但孕妇用药仍需权衡利弊。 药物在乳汁中的浓度为血药浓度的0.6~4.1倍,虽未发现婴儿异常,但哺乳期妇女应慎用。 【老年人用药注意事项】 由于生理性肾功能的衰退,阿昔洛韦片剂量与用药间期需调整。 【不良反应】 偶有头晕、头痛、关节痛、恶心、呕吐、腹泻、胃部不适、食欲减退、口渴、白细胞下降、蛋白尿及尿素氮轻度升高、皮肤瘙痒等,长程给药偶见痤疮、失眠、月经紊乱。 【药物相互作用】 1. 与齐多夫定(Zidovudine)合用可引起肾毒性,表现为深度昏睡和疲劳。 2. 与丙磺舒竞争性抑制有机酸分泌,合并用丙磺舒可使阿昔洛韦片的排泄减慢,半衰期延长,体内药物量蓄积。 【药理】 抗病毒药。体外对单纯性疱疹病毒、水痘带状疱疹病毒、巨细胞病毒等具抑制作用。 阿昔洛韦片进入疱疹病毒感染的细胞后,与脱氧核苷竞争病毒胸苷激酶或细胞激酶,药物被磷酸化成活化型阿昔洛韦三磷酸酯,然后通过二种方式抑制病毒复制:①干扰病毒DNA多聚酶,抑制病毒的复制;②在DNA多聚酶作用下,与增长的DNA链结合,引起DNA链的延伸中断。  阿昔洛韦片对病毒有特殊的亲和力,但对哺乳动物宿主细胞毒性低。体外细胞转化测定有致癌报道,但动物实验未见致癌依据。某些动物实验显示高浓度药物可致突变,但无染色体改变的依据。阿昔洛韦片的致癌与致突变作用尚不明确。大剂量注射可致动物睾丸萎缩和精子数减少,药物能通过胎盘,动物实验证实对胚胎无影响。 【药物代谢动力学】 口服吸收差,约15%~30%由胃肠道吸收。进食对血药浓度影响不明显。能广泛分布至各组织与体液中,包括脑、肾、肺、肝、小肠、肌肉、脾、乳汁、子宫、阴道粘膜与分泌物、脑脊液及疱疹液。在肾、肝和小肠中浓度高,脑脊液中浓度约为血中浓度的一半。药物可通过胎盘。每4小时口服200mg和400mg,5天后的血药峰浓度(Cmax)分别为0.6mg/L和1.2mg/L。阿昔洛韦片蛋白结合率低(9%~33%)。在肝内代谢,主要代谢物占给药量的9%~14%,经尿排泄。血消除半衰期(tl/2β)约为2.5小时。肌酐清除率50~80ml/分钟和15~50ml/分钟时,血消除半衰期(tl/2β)分别为3.0小时和3.5小时。无尿者的血消除半衰期(tl/2β)长达19.5小时,血液透析时降为5.7小时。阿昔洛韦片主要经肾由肾小球滤过和肾小管分泌而排泄,约14%的药物以原形由尿排泄,经粪便排泄率低于2%,呼出气中含微量药物。血液透析6小时约清除血中60%的药物。腹膜透析清除量很少。 【拼音名】: AXILUOWEI PIAN 【性状】: 阿昔洛韦片为白色片。 【贮藏】: 密闭,在阴凉干燥处保存。 [Indications] 1 herpes simplex virus infection: a case early and recurrent genital herpes virus infections, recurrent cases of oral acyclovir tablets used for prevention. 2 herpes zoster: taking in normal immune function shingles and immunocompromised mild cases of treatment. 3 immunocompromised chickenpox treatment. [Note] 1 may also be allergic to ganciclovir allergy to acyclovir tablets. 2 dehydration or existing liver and kidney dysfunction, be used with caution. May cause herpes simplex virus and herpes zoster virus resistant to acyclovir tablets severe immune deficiency after 3 long-term or repeated application of acyclovir tablets therapy. Such as herpes simplex lesions seen in patients after application of acyclovir should be tested to improve the sensitivity of herpes simplex virus acyclovir tablets. 4 follow-up examination: Because most patients with genital herpes susceptibility to cervical cancer, so patients should be checked at least once a year to early detection. 5 Once the herpes symptoms and signs appear, should be administered as soon as possible. 6 eating little effect on the plasma concentrations. However, during the administration should be given to patients with sufficient water to prevent precipitation of acyclovir tablets in the renal tubules. 7 recurrent genital herpes infections with intermittent administration of an effective short-term therapy. Because animal studies have found that the impact on fertility and acyclovir tablets mutagenic, and therefore oral dose and duration should not exceed the recommended standards. Recurrent genital herpes long-term therapy should not be more than six months. 8 hemodialysis can reduce the plasma concentration of 60%, and therefore should recharge after a single dose of hemodialysis. 9 acyclovir tablets latent herpes simplex virus infection and relapse had no significant effect, not eradicate the virus. [Usage and dosage] 1 oral and genital herpes novo immunocompromised mucocutaneous herpes simplex: Adult usual dose once 0.2g, 5 times a day, a total of 10 days; Or a 0.4g, 3 times a day, 5 days; recurrent infections once 0.2g, 5 times a day, 5 days; chronic recurrent infections suppressive therapy, once 0.2g, 3 times a day, a total of six month, if necessary, the dose can be increased to 5 times a day, once 0.2g, 6 to 12 months. 2 herpes zoster: Adult usual dose once 0.8g, 5 times a day, a total of seven to 10 days. 3 adult patients with renal insufficiency the dose should be adjusted under the table; 4 Chickenpox: Children under 2 years of age according to the weight once 20mg / kg, 4 times a day, 5 days, symptoms begin treatment immediately. Children and adults over 40kg usual dose for a 0.8g, 4 times a day, a total of 5 days. Taboos Acyclovir tablets for allergy. Pediatric Precautions Two children under the age dose has not been determined. Pregnant women, lactating women Precautions Drug through the placenta, although animal experiments confirmed no effect on the embryo, but still need to be weighed against the drug in pregnant women. Concentration of the drug in breast milk is the plasma concentration of 0.6 to 4.1 times, although not found abnormal babies, but breast-feeding women should be used with caution. [Note] older drugs Because of the physiological decline in renal function between acyclovir tablets need to adjust the dose of medication. Adverse reactions Occasional dizziness, headache, joint pain, nausea, vomiting, diarrhea, stomach upset, loss of appetite, thirst, leukopenia, proteinuria, and mildly elevated blood urea nitrogen, itchy skin, long-range administration occasional acne, insomnia , menstrual disorders. Drug Interactions 1 with zidovudine (Zidovudine) combination can cause renal toxicity, manifested as deep lethargy and fatigue. 2 and probenecid competitively inhibits the secretion of organic acids combined with probenecid can slow down the excretion of acyclovir tablets, half-life, the amount of drug accumulation in vivo. Pharmacological] Antiviral drugs. In vitro against herpes simplex virus, varicella zoster virus, cytomegalovirus and other tools inhibition. After entering the herpes virus infection acyclovir tablets cells to compete with the deoxynucleoside kinase virus thymidine kinase or a cell, the drug is activated phosphorylated acyclovir triphosphate, and inhibition of viral replication by two ways: ① interfere with viral DNA polymerase, inhibition of viral replication; ② under the action of DNA polymerase, a DNA chain binding and growth, causing the extension of the DNA strand break. Acyclovir tablets have a special affinity for the virus, but a host of low toxicity to mammalian cells. Determination of in vitro cell transformation carcinogenic reported, but no carcinogenic based on animal experiments. Animal experiments have shown high concentrations of some drugs can cause mutations, but no chromosomal changes basis. Acyclovir tablets carcinogenic and mutagenic effects is not clear. Animals injected large doses can cause testicular atrophy and sperm count reduction, drug through the placenta, animal experiments confirmed no effect on the embryo. [Pharmacokinetic] Oral absorption is poor, from about 15% to 30% absorption from the gastrointestinal tract. Eating little effect on the plasma concentrations. Can be widely distributed to all tissues and body fluids, including brain, kidney, lung, liver, small intestine, muscle, spleen, milk, uterus, vaginal mucosa and secretions, cerebrospinal fluid and herpes. In the kidney, liver and small intestine in high concentrations in cerebrospinal fluid concentration of about half of the blood concentration. Drugs can pass through the placenta. 200mg orally every 4 hours, and peak plasma concentrations of 400mg, 5 days after the (Cmax) was 0.6mg / L and 1.2mg / L. Acyclovir tablets low protein binding (9% ~ 33%). Metabolism in the liver, the major metabolite accounted for 9% to 14% of the administered dose, the urinary excretion. Serum elimination half-life (tl / 2β) is approximately 2.5 hours. Creatinine clearance 50 ~ 80ml / min, and 15 ~ 50ml / min, blood elimination half-life (tl / 2β) was 3.0 hours and 3.5 hours. No blood in urine elimination half-life (tl / 2β) for up to 19.5 hours, down to 5.7 hours during hemodialysis. Acyclovir tablets primarily by the kidneys by glomerular filtration and tubular secretion and excretion, about 14% of the drug to the prototype by urinary excretion, fecal excretion rate of less than 2%, exhaled gas containing trace drugs. Clear hemodialysis the blood of about 6 hours 60% of the drug. Peritoneal dialysis removals rarely. [Pinyin]: AXILUOWEI PIAN [Character]: Acyclovir tablets are white film. [Storage]: sealed in a cool dry place.
调控比例: 100%
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