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【药品名称】

  通用名称：阿昔洛韦片

  商品名称：阿昔洛韦片

  英文名称：AciclovirTablets

 

【主要成份】 本品主要成份为阿昔洛韦。

 

【成 份】

  化学名：9-（2-羟乙氧甲基）鸟嘌呤

   分子量：C8H11N5O3

 

【性 状】 本品为白色至类白色片。

 

【适应症/功能主治】 1.单纯疱疹病毒感染：用于生殖器疱疹病毒感染的初发和复发病例，对反复发作的病例口服本品用作预防。 2.带状疱疹：口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。

 

 

【用法用量】 口服： 1.生殖器疱疹初治和免疫缺陷者皮肤黏膜单纯疱疹：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 人患者应按说明书中标注的剂量服用。 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。

 

【不良反应】 1.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、蛋白质及尿素氮轻度升高、皮肤瘙痒等； 2.长程给药偶见痤疮、失眠、月经紊乱。

 

【禁 忌】 对本品过敏者禁用。

 

【注意事项】 1.对更昔洛韦过敏者也可能对本品过敏； 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本品治疗后可能引起单纯性疱疹病毒和带状疱疹病毒对本品耐药。如单纯疱疹患者应用阿昔洛韦后皮肤不见改善者应测试单纯疱疹病毒对本品的敏感性； 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，防止本品在肾小管内沉淀； 7.生殖器复发性疱疹感染以间歇短疗程序法给药有效。由于动物实验曾发现本品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.本品对单纯性疱疹病毒的潜伏感染和复发无明显效果，不能根除病毒。
请仔细阅读说明书并遵医嘱使用。

 

【儿童用药】 2岁以下小儿剂量尚未确定。

 

【老年患者用药】 由于生理性肾功能的衰退，本品剂量与用药间需调整。

 

【孕妇及哺乳期妇女用药】 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。

 

【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，合并用丙磺舒可使本品的排泄减慢，半衰期延长，体内药物量蓄积。

 

【药物过量】 尚不明确。

 

【药理毒理】 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。本品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。本品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。本品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。

 

【药代动力学】 本品口服吸收不完全，约15-30%由胃肠道吸收。食物对血药浓度影响不明显。多剂量给药平均1-2天达稳态。每4小时口服200mg-400mg，5天后的血药峰浓度为0.6μg/ml和1.2μg/ml。本品可广泛分布至全身组织与体液中，包括脑、肾、肺、肝、小肠、肌肉、脾、乳汁、子宫、阴道黏膜与分泌物、脑脊液及疱疹液，以肾、肝、小肠等组织浓度为高，脑脊液浓度约为血浆浓度的1/2倍。本品可通过胎盘屏障。中央室表观分部容积1L/1.73m2，与血浆蛋白结合率低（9-33%）。 本品在肝内代谢，仅有少量转化为9-羧甲氧甲基鸟嘌呤，主要代谢物占给药量的9%-14%。血浆消除半衰期2-3小时，肾功能明显不良者半衰期延长。无尿患者的血消除半衰期可长达19.5小时。血液透析时可降为5.7小时。主要经肾小球滤过和肾小管分泌而排泄，口服给药约14%的药物以原形由尿排泄。经粪便排泄率低于2%，呼气中含微量药物。血液透析时约清除血中60%的药物，腹膜透析清除量很少。

 

【贮 藏】 密闭，置阴凉干燥处。

 

Description

This medicine suppresses the proliferation of herpes simplex and varicella/herpes zoster viruses.
It is usually used to suppress the onset of herpes simplex, herpes simplex virus infection (herpes simplex) associated with hematopoietic stem cell transplantation, or to suppress the recurrence of herpes zoster or genital herpes.

Presentation

Feature

white tablet with split line, diameter: 8.6 mm, thickness: 4.0 mm

Active Ingredients

Aciclovir 400mg

Effect/Efficacy

This medicine suppresses the proliferation of herpes simplex and varicella/herpes zoster viruses.
It is usually used to suppress the onset of herpes simplex, herpes simplex virus infection (herpes simplex) associated with hematopoietic stem cell transplantation, or to suppress the recurrence of herpes zoster or genital herpes.

Usage/Dosage

For herpes simplex: In general, for adults, take 1 tablet (200 mg of the active ingredient) at a time, 5 times a day. For children, take 20 mg per kilogram of the body weight at a time, 4 times a day. However, the maximum single dose is 1 tablet (200 mg).
For suppression of onset of herpes simplex virus infection (herpes simplex) associated with hematopoietic stem cell transplantation: In general, for adults, take 1 tablet (200 mg of the active ingredient) at a time, 5 times a day from 7 days prior to hematopoietic stem cell transplantation to 35 days after transplantation throughout. For children, take 20 mg per kilogram of the body weight at a time, 4 times a day from 7 days prior to hematopoietic stem cell transplantation to 35 days after transplantation throughout. However, the maximum single dose is 1 tablet (200 mg).
For herpes zoster: In general, for adults, take 4 tablets (800 mg of the active ingredient) at a time, 5 times a day. For children, take 20 mg per kilogram of the body weight at a time, 4 times a day. However, the maximum single dose is 4 tablets (800 mg).
For suppression of recurrence of genital herpes: In general, for children, take 20 mg of the active ingredient per kilogram of the body weight at a time, 4 times a day. However, the maximum single dose is 1 tablet (200 mg).
In any case, the dosage may be adjusted according to the disease, age or symptoms. Strictly follow the instructions.
In general, take the medicine 5 times a day (after breakfast, after lunch, at around 4 pm, after dinner and before bedtime). In general, for children, take the medicine 4 times a day (after breakfast, after lunch, at around 4 pm and after dinner).
If you miss a dose, take the missed dose when you remember. However, if it is almost time for the next dose, skip the missed dose and follow your next dosing schedule. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.

Cautions

If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you have renal or liver disorder.
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

This medicine may cause dehydration. Take an appropriate amount of water while you are on this medicine. However, if you have been instructed to restrict fluid intake, please consult with your doctor or pharmacist.
This medicine may cause consciousness disorder. Pay attention when operating dangerous machinery, such as driving a car. Patients with renal dysfunction are more susceptible to consciousness disorder, so avoid operating dangerous machinery if instructed to do so by your doctor.

Storage conditions and other information
Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.

Contraindication

The most commonly reported adverse reactions include fever, rash, blister, erythema, hives, itch, fixed drug eruption, photosensitivity, abdominal pain, diarrhea, anemia and headache. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
respiratory distress, angioedema, generalized flushing [anaphylaxis shock, anaphylaxis]
fever, general malaise, bleeding tendency [pancytopenia, agranulocytosis, decreased platelets, disseminated intravascular coagulation syndrome, thrombocytopenic purpura]
edema, decreased urine output, headache [acute renal failure]
consciousness disorder (coma), hallucination, convulsion [neuropsychiatric symptom]
fever, erythema, bloodshot eyes [toxic epidermal necrolysis, mucocutaneous ocular syndrome]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.