伐昔洛韦片说明书
盐酸伐昔洛韦胶囊说明书
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盐酸伐昔洛韦胶囊说明书盐酸伐昔洛韦胶囊(南国春)用于治疗水痘带状疱疹及Ⅰ型、Ⅱ型单纯疱疹的感染，包括初发和复发的生殖器疱疹。
本品在医生的指导下，可用于阿昔洛韦的所有适应症。
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盐酸伐昔洛韦胶囊商品介绍通用名：盐酸伐昔洛韦胶囊生产厂家:湖北潜龙药业有限公司批准文号：国药准字Hxx6070药品规格：0.15g*6粒药品价格：￥28元【通用名称】盐酸伐昔洛韦胶囊【商品名称】盐酸伐昔洛韦胶囊(南国春)【英文名称】ValacyclovirHydrochlorideCapsules【拼音全码】YanSuanFaXiLuoWeiJiaoNang(NanGuoChun)【主要成份】盐酸伐昔洛韦。
化学名：L-缬氨酸-2-[(6-氧代-2-氨基-1，6-二氢-9H-嘌呤-9-基)甲氧基]乙基酯盐酸盐分子式：C13H20N6O4·HCL分子量：360.80【性状】盐酸伐昔洛韦胶囊(南国春)内容物为白色或类白色粉末。
【适应症/功能主治】用于治疗水痘带状疱疹及Ⅰ型、Ⅱ型单纯疱疹的感染，包括初发和复发的生殖器疱疹。
盐酸伐昔洛韦胶囊(南国春)在医生的指导下，可用于阿昔洛韦的所有适应症。
【规格型号】0.15g*6s【用法用量】口服：一日2次，一次0.3g，饭前空腹服用。
带状疱疹连续服药10天。
单纯疱疹连续服药7天。
【不良反应】偶有轻度胃部不适、头晕等。
【禁忌】对盐酸伐昔洛韦胶囊(南国春)及阿昔洛韦过敏者禁用。
【注意事项】1.对更昔洛韦过敏者也可能对盐酸伐昔洛韦胶囊(南国春)过敏。
2.脱水或已有肝、肾功能不全者慎用。
肾功能不全者在接受盐酸伐昔洛韦胶囊(南国春)治疗时，需根据肌酐清除率来校正剂量。
维德思说明书
【药品名称】商品名称：维德思通用名称：盐酸伐昔洛韦片英文名称：Valaciclovir Hydrochloride Tablets【成份】盐酸伐昔洛韦化学名称：L-缬氨酸-2-[（6-氧代-2-氨基-1，6-二氢- 9H -嘌呤-9-基）甲氧基]乙基酯盐酸盐。
分子式：C13H20N6O4·HCl分子量：360.80【性状】薄膜衣片，除去薄膜衣后显白色或类白色。
【适应症】1.主要用于带状疱疹。
2.用于治疗单纯疱疹病毒感染及预防复发，包括生殖器疱疹的初发和复发。
【用法用量】成人·常规剂量·口服给药1.单纯疱疹的治疗：一次500mg，一日2次。
对于单纯疱疹的复发，理想的服药时间为前驱期或症状及体征首次出现时。
2.单纯疱疹的预防：(1)免疫功能正常的患者，一日给药总量为500mg，可分为1-2次给药。
(2)免疫缺陷的患者，服用剂量为一次500mg，一日2次。
3.带状疱疹的治疗：一次1000mg，一日3次，共7日，在发病的24小时内服用本药最有效。
【药理作用】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。
【药代动力学】口服后迅速吸收转化为阿昔洛韦，血中阿昔洛韦达峰时间为0.88～1.75小时。
口服生物利用度为67±13%，是阿昔洛韦的3～5倍。
药物进入体内后广泛分布，可分布至多种组织中，其中胃、小肠、肾、肝、淋巴结和皮肤组织中浓度最高，脑组织中的浓度最低。
药物在体内全部转化为阿昔洛韦，代谢物主要从尿中排除，其中阿昔洛韦占46%～59%，8-羟基-9-鸟嘌呤占25%～30%，9-羟基甲氧基鸟嘌呤占11%～12%。
阿昔洛韦原形为单相消除，血消除半衰期（t1/2β）为2.86±0.39小时。
【药理毒理】口服后吸收迅速并在体内很快转化为阿昔洛韦，其抗病毒作用为阿昔洛韦所发挥。
【注意事项】1.交叉过敏对其它鸟嘌呤类抗病毒药(如阿昔洛韦、更昔洛韦、泛昔洛韦)过敏者也可对本药过敏。
盐酸伐昔洛韦分散片
盐酸伐昔洛韦分散片核准日期：2009年02月18日修订日期：2009年06月24日药品名称：【通用名称】盐酸伐昔洛韦分散片【商标名称】新尤可【英文名称】 Valacyclovir Hydrochloride Dispersible Tablets【汉语拼音】 Yan Suan Fa Xi Luo Wei Fen San Pian成份：本品主要成份为盐酸伐昔洛韦。
化学名称：L-缬氨酸-2-[(6-氧代-2-氨基-1，6-二氢-9H-嘌呤-9-基)甲氧基]乙基酯盐酸盐。
化学结构式：分子式：C13H20N6O4HCL分子量：360.80所属类别：化药及生物制品>> 抗微生物药>> 抗病毒药>> 逆转录酶抑制药性状：本品为白色或类白色片；味微甜。
适应症：用于治疗水痘带状疱疹及Ⅰ型、Ⅱ型单纯疱疹病毒感染，包括初发和复发的生殖器疱疹病毒感染。
规格：0.3g(伐昔洛韦计)。
用法用量：本品为分散片，可直接口服/吞服，或将本品投入约100ml水中，振摇分散后口服。
一次0.3g，一日2次，饭前空腹服用。
带状疱疹连续服药10日。
单纯疱疹连续服药7日。
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。
禁忌：对本品及阿昔洛韦过敏者禁用。
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、肾功能不全者慎用。
肾功能不全者在接受本品治疗时，需根据肌酐清除率来校正剂量。
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本品治疗后皮损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、服药期间应给予患者充分的水，防止阿昔洛韦在肾小管内沉淀。
伐昔洛韦(葛兰素史克)说明书
PRESCRIBING INFORMATION ZOVIRAX®(acyclovir)CapsulesZOVIRAX®(acyclovir)TabletsZOVIRAX®(acyclovir)SuspensionDESCRIPTIONZOVIRAX is the brand name for acyclovir, a synthetic nucleoside analogue active against herpesviruses. ZOVIRAX Capsules, Tablets, and Suspension are formulations for oral administration. Each capsule of ZOVIRAX contains 200 mg of acyclovir and the inactive ingredients corn starch, lactose, magnesium stearate, and sodium lauryl sulfate. The capsule shell consists of gelatin, FD&C Blue No. 2, and titanium dioxide. May contain one or more parabens. Printed with edible black ink.Each 800-mg tablet of ZOVIRAX contains 800 mg of acyclovir and the inactive ingredients FD&C Blue No. 2, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.Each 400-mg tablet of ZOVIRAX contains 400 mg of acyclovir and the inactive ingredients magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.Each teaspoonful (5 mL) of ZOVIRAX Suspension contains 200 mg of acyclovir and the inactive ingredients methylparaben 0.1% and propylparaben 0.02% (added as preservatives), carboxymethylcellulose sodium, flavor, glycerin, microcrystalline cellulose, and sorbitol.Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka’s of acyclovir are 2.27 and 9.25.The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula:VIROLOGYMechanism of Antiviral Action: Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV).The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate bycellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA. This is accomplished in 3 ways: 1) competitive inhibition of viral DNA polymerase, 2) incorporation into and termination of the growing viral DNA chain, and 3) inactivation of the viral DNA polymerase. The greater antiviral activity of acyclovir against HSV compared to VZV is due to its more efficient phosphorylation by the viral TK. Antiviral Activities: The quantitative relationship between the in vitro susceptibility of herpesviruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized. Sensitivity testing results, expressed as the concentration of drug required to inhibit by 50% the growth of virus in cell culture (IC 50), vary greatly depending upon a number of factors. Using plaque-reduction assays, the IC 50 against herpes simplex virus isolates ranges from 0.02 to 13.5 mcg/mL for HSV-1 and from 0.01 to 9.9 mcg/mL for HSV-2. The IC 50 for acyclovir against most laboratory strains and clinical isolates of VZV ranges from 0.12 to10.8 mcg/mL. Acyclovir also demonstrates activity against the Oka vaccine strain of VZV with a mean IC 50 of 1.35 mcg/mL.Drug Resistance: Resistance of HSV and VZV to acyclovir can result from qualitative andquantitative changes in the viral TK and/or DNA polymerase. Clinical isolates of HSV and VZV with reduced susceptibility to acyclovir have been recovered from immunocompromised patients, especially with advanced HIV infection. While most of the acyclovir-resistant mutants isolated thus far from immunocompromised patients have been found to be TK-deficient mutants, other mutants involving the viral TK gene (TK partial and TK altered) and DNA polymerase have been isolated. TK-negative mutants may cause severe disease in infants and immunocompromised adults. The possibility of viral resistance to acyclovir should be considered in patients who show poor clinical response during therapy.CLINICAL PHARMACOLOGYPharmacokinetics: The pharmacokinetics of acyclovir after oral administration have been evaluated in healthy volunteers and in immunocompromised patients with herpes simplex or varicella-zoster virus infection. Acyclovir pharmacokinetic parameters are summarized in Table 1.Table 1. Acyclovir Pharmacokinetic Characteristics (Range)Parameter RangePlasma protein binding 9% to 33%Plasma elimination half-life 2.5 to 3.3 hrAverage oral bioavailability 10% to 20%**Bioavailability decreases with increasing dose.In one multiple-dose, crossover study in healthy subjects (n = 23), it was shown that increases in plasma acyclovir concentrations were less than dose proportional with increasing dose, as shown in Table 2. The decrease in bioavailability is a function of the dose and not the dosage form.Table 2. Acyclovir Peak and Trough Concentrations at Steady StateParameter 200 mg 400 mg 800 mgmax SS C 0.83 mcg/mL 1.21 mcg/mL 1.61 mcg/mLtrough SS C 0.46 mcg/mL 0.63 mcg/mL 0.83 mcg/mLThere was no effect of food on the absorption of acyclovir (n = 6); therefore, ZOVIRAX Capsules, Tablets, and Suspension may be administered with or without food.The only known urinary metabolite is 9-[(carboxymethoxy)methyl]guanine.Special Populations: Adults with Impaired Renal Function:The half-life and total body clearance of acyclovir are dependent on renal function. A dosage adjustment is recommended for patients with reduced renal function (see DOSAGE AND ADMINISTRATION).Geriatrics:Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function. Dosage reduction may be required in geriatric patients with underlying renal impairment (see PRECAUTIONS: Geriatric Use).Pediatrics:In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. Mean half-life after oral doses of 300 mg/m2 and 600 mg/m2 in pediatric patients aged7 months to 7 years was 2.6 hours (range 1.59 to 3.74 hours).Drug Interactions: Coadministration of probenecid with intravenous acyclovir has been shown to increase the mean acyclovir half-life and the area under the concentration-time curve. Urinary excretion and renal clearance were correspondingly reduced.Clinical Trials: Initial Genital Herpes: Double-blind, placebo-controlled studies have demonstrated that orally administered ZOVIRAX significantly reduced the duration of acute infection and duration of lesion healing. The duration of pain and new lesion formation was decreased in some patient groups.Recurrent Genital Herpes:Double-blind, placebo-controlled studies in patients with frequent recurrences (6 or more episodes per year) have shown that orally administered ZOVIRAX given daily for 4 months to 10 years prevented or reduced the frequency and/or severity of recurrences in greater than 95% of patients.In a study of patients who received ZOVIRAX400 mg twice daily for 3 years, 45%, 52%, and 63% of patients remained free of recurrences in the first, second, and third years, respectively. Serial analyses of the 3-month recurrence rates for the patients showed that 71% to 87% were recurrence free in each quarter.Herpes Zoster Infections:In a double-blind, placebo-controlled study of immunocompetent patients with localized cutaneous zoster infection, ZOVIRAX (800 mg 5 times daily for 10 days) shortened the times to lesion scabbing, healing, and complete cessation of pain, and reduced the duration of viral shedding and the duration of new lesion formation.In a similar double-blind, placebo-controlled study, ZOVIRAX (800 mg 5 times daily for7 days) shortened the times to complete lesion scabbing, healing, and cessation of pain; reduced the duration of new lesion formation; and reduced the prevalence of localized zoster-associated neurologic symptoms (paresthesia, dysesthesia, or hyperesthesia).Treatment was begun within 72 hours of rash onset and was most effective if started within the first 48 hours.Adults greater than 50 years of age showed greater benefit.Chickenpox:Three randomized, double-blind, placebo-controlled trials were conducted in 993 pediatric patients aged 2 to 18 years with chickenpox. All patients were treated within 24 hours after the onset of rash. In 2 trials, ZOVIRAX was administered at 20 mg/kg 4 times daily (up to3,200 mg per day) for 5 days. In the third trial, doses of 10, 15, or 20 mg/kg were administered 4 times daily for 5 to 7 days. Treatment with ZOVIRAX shortened the time to 50% healing; reduced the maximum number of lesions; reduced the median number of vesicles; decreased the median number of residual lesions on day 28; and decreased the proportion of patients with fever, anorexia, and lethargy by day 2. Treatment with ZOVIRAX did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or 1 year following treatment.INDICATIONS AND USAGEHerpes Zoster Infections:ZOVIRAX is indicated for the acute treatment of herpes zoster (shingles).Genital Herpes:ZOVIRAX is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes.Chickenpox:ZOVIRAX is indicated for the treatment of chickenpox (varicella). CONTRAINDICATIONSZOVIRAX is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.WARNINGSZOVIRAX Capsules, Tablets, and Suspension are intended for oral ingestion only. Renal failure, in some cases resulting in death, has been observed with acyclovir therapy (see ADVERSE REACTIONS: Observed During Clinical Practice and OVERDOSAGE). Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (TTP/HUS), which has resulted in death, has occurred in immunocompromised patients receiving acyclovir therapy.PRECAUTIONSDosage adjustment is recommended when administering ZOVIRAX to patients with renal impairment (see DOSAGE AND ADMINISTRATION). Caution should also be exercised when administering ZOVIRAX to patients receiving potentially nephrotoxic agents since this may increase the risk of renal dysfunction and/or the risk of reversible central nervous system symptoms such as those that have been reported in patients treated with intravenous acyclovir. Adequate hydration should be maintained.Information for Patients: Patients are instructed to consult with their physician if they experience severe or troublesome adverse reactions, they become pregnant or intend to become pregnant, they intend to breastfeed while taking orally administered ZOVIRAX, or they have any other questions.Patients should be advised to maintain adequate hydration.Zoster: There are no data on treatment initiated more than 72 hours after onset of the Herpeszoster rash. Patients should be advised to initiate treatment as soon as possible after a diagnosis of herpes zoster.Genital Herpes Infections: Patients should be informed that ZOVIRAX is not a cure for genital herpes. There are no data evaluating whether ZOVIRAX will prevent transmission of infection to others. Because genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode.Chickenpox: Chickenpox in otherwise healthy children is usually a self-limited disease of mild to moderate severity. Adolescents and adults tend to have more severe disease. Treatment was initiated within 24 hours of the typical chickenpox rash in the controlled studies, and there is no information regarding the effects of treatment begun later in the disease course.Drug Interactions:See CLINICAL PHARMACOLOGY: Pharmacokinetics.Carcinogenesis, Mutagenesis, Impairment of Fertility: The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with800 mg given orally 5 times a day (dosing appropriate for treatment of herpes zoster) or 200 mg given orally 5 times a day (dosing appropriate for treatment of genital herpes). Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir at the higher and lower dosing schedules (see CLINICAL PHARMACOLOGY: Pharmacokinetics).Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to450 mg/kg administered by gavage. There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Maximum plasma concentrations were 3 to 6 times human levels in the mouse bioassay and 1 to 2 times human levels in the rat bioassay.Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the assays.Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, p.o.) or in rats(25 mg/kg/day, s.c.). In the mouse study, plasma levels were 9 to 18 times human levels, while in the rat study, they were 8 to 15 times human levels. At higher doses (50 mg/kg/day, s.c.) in rats and rabbits (11 to 22 and 16 to 31 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In a rat peri- and post-natal study at 50 mg/kg/day, s.c., there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses.No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for 1 month (21 to41 times human levels) or in dogs given 60 mg/kg/day orally for 1 year (6 to 12 times human levels). Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Pregnancy: Teratogenic Effects:Pregnancy Category B. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, p.o.), rabbit (50 mg/kg/day, s.c. and IV), or rat (50 mg/kg/day, s.c.). These exposures resulted in plasma levels 9 and 18, 16 and 106, and 11 and 22 times, respectively, human levels.There are no adequate and well-controlled studies in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy was established in 1984 and completed in April 1999. There were 749 pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximates that found in the general population. However, the small size of the registry is insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. Acyclovir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.Nursing Mothers: Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of ZOVIRAX and ranged from 0.6 to 4.1 times corresponding plasma levels. These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0.3 mg/kg/day. ZOVIRAX should be administered to a nursing mother with caution and only when indicated.Pediatric Use: Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established.Geriatric Use: Of 376 subjects who received ZOVIRAX in a clinical study of herpes zoster treatment in immunocompetent subjects ≥50 years of age, 244 were 65 and over while 111 were 75 and over. No overall differences in effectiveness for time to cessation of new lesion formation or time to healing were reported between geriatric subjects and younger adult subjects. The duration of pain after healing was longer in patients 65 and over. Nausea, vomiting, and dizziness were reported more frequently in elderly subjects. Elderly patients are more likely to have reduced renal function and require dose reduction. Elderly patients are also more likely to have renal or CNS adverse events. With respect to CNS adverse events observed during clinical practice, somnolence, hallucinations, confusion, and coma were reported more frequently in elderly patients (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS: Observed During Clinical Practice, and DOSAGE AND ADMINISTRATION).ADVERSE REACTIONSHerpes Simplex: Short-Term Administration:The most frequent adverse events reported during clinical trials of treatment of genital herpes with ZOVIRAX 200 mg administered orally 5 times daily every 4 hours for 10 days were nausea and/or vomiting in 8 of 298 patient treatments (2.7%). Nausea and/or vomiting occurred in 2 of 287 (0.7%) patients who received placebo.Administration:The most frequent adverse events reported in a clinical trial for Long-Termthe prevention of recurrences with continuous administration of 400 mg (two 200-mg capsules) 2 times daily for 1 year in 586 patients treated with ZOVIRAX were nausea (4.8%) and diarrhea (2.4%). The589 control patients receiving intermittent treatment of recurrences with ZOVIRAX for 1 year reported diarrhea (2.7%), nausea (2.4%), and headache (2.2%).Herpes Zoster: The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster (shingles) with 800 mg of oral ZOVIRAX 5 times daily for 7 to 10 days in 323 patients was malaise (11.5%). The 323 placebo recipients reported malaise (11.1%).Chickenpox: The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral ZOVIRAX at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg4 times daily for5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).Observed During Clinical Practice: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of ZOVIRAX. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, potential causal connection to ZOVIRAX, or a combination of these factors.General:Anaphylaxis, angioedema, fever, headache, pain, peripheral edema.Nervous:Aggressive behavior, agitation, ataxia, coma,confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. These symptoms may be marked, particularly in older adults or in patients with renal impairment (see PRECAUTIONS).Digestive: Diarrhea, gastrointestinal distress, nausea.Hematologic and Lymphatic:Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice.Musculoskeletal:Myalgia.Skin:Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.Senses:SpecialVisual abnormalities.Urogenital: Renal failure, elevated blood urea nitrogen, elevated creatinine, hematuria (see WARNINGS).OVERDOSAGEOverdoses involving ingestion of up to 100 capsules (20 g) have been reported. Adverse events that have been reported in association with overdosage include agitation, coma, seizures, and lethargy. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Overdosage has been reported following bolus injections or inappropriately high doses and in patients whose fluid and electrolyte balance were not properly monitored. This has resulted in elevated BUN and serum creatinine and subsequent renal failure. In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored (see DOSAGE AND ADMINISTRATION).DOSAGE AND ADMINISTRATIONAcute Treatment of Herpes Zoster:800 mg every 4 hours orally, 5 times daily for 7 to 10 days. Genital Herpes: Treatment of Initial Genital Herpes:200 mg every 4 hours, 5 times daily for 10 days.Chronic Suppressive Therapy for Recurrent Disease:400 mg 2 times daily for up to 12 months, followed by re-evaluation. Alternative regimens have included doses ranging from 200 mg 3 times daily to 200 mg 5 times daily.The frequency and severity of episodes of untreated genital herpes may change over time. After 1 year of therapy, the frequency and severity of the patient’s genital herpes infection should be re-evaluated to assess the need for continuation of therapy with ZOVIRAX.IntermittentTherapy:200 mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom (prodrome) of recurrence.Treatment of Chickenpox:Children (2 years of age and older): 20 mg/kg per dose orally4 times daily (80 mg/kg/day) for5 days. Children over 40 kg should receive the adult dose for chickenpox.Adults and Children over 40 kg:800 mg 4 times daily for 5 days.Intravenous ZOVIRAX is indicated for the treatment of varicella-zoster infections in immunocompromised patients.When therapy is indicated, it should be initiated at the earliest sign or symptom of chickenpox. There is no information about the efficacy of therapy initiated more than 24 hours after onset of signs and symptoms.Patients With Acute or Chronic Renal Impairment: In patients with renal impairment, the dose of ZOVIRAX Capsules, Tablets, or Suspension should be modified as shown in Table 3:Table 3. Dosage Modification for Renal ImpairmentCreatinine Adjusted Dosage RegimenNormal Dosage RegimenClearance(mL/min/1.73 m2)Dose(mg) Dosing Interval200 mg every 4 hours >10 200 every 4 hours, 5x daily0-10 200 every 12 hours400 mg every 12 hours >100-10 400200every 12 hoursevery 12 hours800 mg every 4 hours >25 800 every 4 hours, 5x daily10-25 800 every 8 hours0-10 800 every 12 hours Hemodialysis:For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60% decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.Peritoneal Dialysis:No supplemental dose appears to be necessary after adjustment of the dosing interval.Bioequivalence of Dosage Forms: ZOVIRAX Suspension was shown to be bioequivalent to ZOVIRAX Capsules (n = 20) and 1 ZOVIRAX 800-mg tablet was shown to be bioequivalent to 4 ZOVIRAX 200-mg capsules (n = 24).HOW SUPPLIEDZOVIRAX Capsules (blue, opaque cap and body) containing 200 mg acyclovir and printed with “Wellcome ZOVIRAX 200.”Bottle of 100 (NDC 0173-0991-55).Unit dose pack of 100 (NDC 0173-0991-56).Store at 15° to 25°C (59° to 77°F) and protect from moisture.ZOVIRAX Tablets (light blue, oval) containing 800 mg acyclovir and engraved with “ZOVIRAX 800.”Bottle of 100 (NDC 0173-0945-55).Store at 15° to 25°C (59° to 77°F) and protect from moisture.ZOVIRAX Tablets (white, shield-shaped) containing 400 mg acyclovir and engraved with "ZOVIRAX" on one side and a triangle on the other side.Bottle of 100 (NDC 0173-0949-55).Store at 15° to 25°C (59° to 77°F) and protect from moisture.ZOVIRAX Suspension (off-white, banana-flavored) containing 200 mg acyclovir in each teaspoonful (5 mL).Bottle of 1 pint (473 mL) (NDC 0173-0953-96).Store at 15° to 25°C (59° to 77°F).GlaxoSmithKlineResearch Triangle Park, NC 27709©2005, GlaxoSmithKline. All rights reserved.June 2005 RL-2203。
盐酸伐昔洛韦片怎么吃
盐酸伐昔洛韦片怎么吃关于《盐酸伐昔洛韦片怎么吃》，是我们特意为大家整理的，希望对大家有所帮助。
夏日炎炎，气温愈来愈炎热。
恰如其分的轻风有时候会吹走一些躁热，却不知道，这一阵阵轻风也会使一些细菌病毒迅速的复生、生长发育、繁育，最后给我们产生病症。
带状疱疹就这样的一类病症。
带状疱疹的外型与水痘有相近，但病发感却带著疼痛感，即便是风吹过也会将刺疼传到人体各部神经，困惑着许多病人。
盐酸伐昔洛韦片是用于医治带状疱疹的，那麼这种药的药力怎样，盐酸伐昔洛韦片又该怎样吃呢？药物概述：盐酸伐昔洛韦片，本产品适用医治带状疱疹。
本产品适用医治单纯性疱疹病毒感染感染。
本产品适用防止（抑止）单纯性疱疹病毒感染感染的发作。
适用范围：本产品适用医治带状疱疹。
本产品适用医治单纯性疱疹病毒感染感染。
本产品适用防止（抑止）单纯性疱疹病毒感染感染的发作。
使用方法使用量：成人带状疱疹医治：内服本产品500mg ，2 片，每天3次，治疗过程7 天。
单纯疱疹医治：内服本产品500mg，每天2 次。
初次病发者病况可能较重，治疗过程需要增加到10 天。
针对发作的感染，治疗过程应是5天。
建议在前轮驱动病症期或刚出現病症临床症状时即刚开始医治。
单纯性疱疹病毒感染感染医治（抑止）：对免疫功能一切正常的患者，内服本产品500 mg，每天1次。
针对经常发作（每一年≥10 次）的患者，250Mg 每天2次的给药计划方案实际效果更强。
针对免疫缺陷病人，服药计划方案为500 mg，每天2 次。
肾脏功能危害针对肾脏功能显著损伤的患者，本产品的使用量理应按以下方法调节：肾脏功能（肌酐本产品使用量调节清除率ml/min）带状疱疹单纯疱疹医治防止免疫功能一切正常免疫缺陷15-30 1000Mg每天2次不用调节不用调节不用调节。
伐昔洛韦片说明书
伐昔洛韦片说明书【药品名称】通用名称：伐昔洛韦片商品名称：＿____英文名称：Valacyclovir Tablets【成份】本品主要成份为伐昔洛韦。
【性状】本品为薄膜衣片，除去包衣后显白色或类白色。
【适应症】用于治疗水痘带状疱疹及Ⅰ型、Ⅱ型单纯疱疹病毒感染，包括初发和复发的生殖器疱疹病毒感染。
【规格】＿____mg【用法用量】口服，一次_____片，一日_____次，饭前空腹服用。
带状疱疹连续服药 10 日。
单纯性疱疹连续服药 7 日。
【不良反应】1、消化系统：可能会出现恶心、呕吐、腹泻、胃部不适、食欲减退等症状。
2、神经系统：头痛、头晕、失眠等。
3、皮肤及附件：可能会出现皮疹、瘙痒等。
4、血液及淋巴系统：白细胞减少、血小板减少等。
如果出现以上不良反应，且症状严重或持续不缓解，应立即停药并就医。
【禁忌】对本品及阿昔洛韦过敏者禁用。
【注意事项】1、脱水或已有肝、肾功能不全者慎用。
肾功能不全者在接受本品治疗时，需根据肌酐清除率来校正剂量。
2、食物对本品的吸收无明显影响，但为了减少胃肠道不适，建议在饭前空腹服用。
3、服药期间应多饮水，以防止药物在肾小管内沉淀。
4、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。
5、带状疱疹患者在急性发作期时，应尽量卧床休息，避免劳累。
6、单纯疱疹患者应避免接触眼睛，防止感染扩散。
7、孕妇及哺乳期妇女用药：孕妇慎用。
哺乳期妇女用药期间应暂停哺乳。
8、儿童用药：儿童用药的安全性和有效性尚未确定，应在医生指导下使用。
9、老年患者用药：由于生理性肾功能的衰退，老年患者应根据肾功能调整剂量。
【药物相互作用】1、与齐多夫定合用可引起肾毒性，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，合用丙磺舒可使本品的排泄减慢，半衰期延长，体内药物蓄积。
【药理毒理】伐昔洛韦是阿昔洛韦的前体药物，口服后吸收迅速并在体内很快转化为阿昔洛韦，进而发挥抗病毒作用。
【药代动力学】本品口服后迅速吸收转化为阿昔洛韦，血药浓度达峰时间为 088 175 小时。
丽珠威(盐酸伐昔洛韦片)使用说明
丽珠威(盐酸伐昔洛韦片)【用法用量】口服。
一次0.3g，一日2次，饭前空腹服用。
1.带状疱疹连续服药10日。
2.单纯性疱疹连续服药7日。
【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、肾功能不全者慎用。
肾功能不全者在接受本品治疗时,需根据肌酐清除率来校正剂量。
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本品后皮损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.服药期间应给予患者充分的水，防止阿昔洛韦在肾小管内沉淀。
7.一次血液透析可使阿昔洛韦的血药浓度减低60%，因此血液透析后应补给一次剂量。
8.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本品对生育的影响及致突变作用，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。
9.本品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。
【不良反应】1.消化系统少数患者有轻度胃肠道症状，如胃部不适、食欲减退、恶心、呕吐、腹痛、腹泻、便秘等。
2.中枢神经系统可出现头痛、乏力、眩晕。
3.血液可引起贫血、白细胞减少、粒细胞减少、血栓性血小板减少性紫癜(TTP)和溶血性尿毒症综合征。
4.心血管系统可引起心动过速、血管扩张等。
5.其它可见皮肤瘙痒、关节痛、肌痛、畏光、眼痛等。
【禁忌】本品禁用于对伐昔洛韦、阿昔洛韦或本品制剂中任何成分过敏的病人。
【适应症】1.主要用于带状疱疹。
2.用于治疗单纯疱疹病毒感染及预防复发，包括生殖器疱疹的初发和复发。
【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，合用丙磺舒可使阿昔洛韦的排泄减慢，半衰期延长，体内药物蓄积。
伐昔洛韦对频发性生殖器疱疹的抑制疗法
伐昔洛韦对频发性生殖器疱疹的抑制疗法毕建军;杨慧兰;樊建勇;张玲【摘要】目的研究伐昔洛韦抗病毒抑制疗法治疗频发性生殖器疱疹的临床效果.方法将120例频发性生殖器疱疹患者(复发次数＞6次/年)采用数字表法随机分成4组,Ⅰ组:阿昔洛韦400 mg,每d2次6个月；Ⅱ组:伐昔洛韦500 mg,每d1次6个月；Ⅲ组:伐昔洛韦500 mg,每d2次3个月；Ⅳ组:伐昔洛韦500 mg,每d2次3个月,500 mg,每d1次3个月.对患者复发情况进行观察,并检测患者单纯疱疹病毒2型( herpes simplex virus 2,HSV-2) DNA病毒载量的变化.结果与治疗前相比,4种治疗方案均能明显减少患者疱疹的复发次数,其中Ⅳ组减少复发次数与其他3组比较差异均有统计学意义(P均＜0.05).伐昔洛韦500 mg,每d2次能有效抑制病毒复制,后续的减量抑制疗法可以进一步抑制病毒复制.结论伐昔洛韦能有效预防患者频发性生殖器疱疹复发,并且能够有效抑制病毒复制.%Objective To study the clinical effects of valacyclovir administered as suppressive therapy for patients with recurrent genital herpes (GH). Methods A total of 120 patients were randomly divided into four groups: patients in group 1 were treated with 400 mg aciclovir, Bid for 6 months; those in group 2 were treated with 500 mg valaciclovir, qd for 6 months; those in group 3, were treated with 500 mg valaciclovir, Bid for 3 months; and those in group 4, were treated with 500 mg valaciclovir, Bid for 3 months, and then with 500 mg valaciclovir, qd for 3 months. The patients were observed for the recurrence of GH after treatment and were followed up, and the viral load of HSV-2 DNA was monitored. Results Compared with pre-therapy, the recurrence of GH was significantly reduced in all the 4 groups, especially ingroup 4. Administration of 500 mg valaciclovir, Bid, could inhibit the replication of HSV-2 efficiently, and the subsequent reduced dose treatment additionally inhibited the replication of HSV-2. Conclusion Valaciclovir can not only reduce the recurrence of GH, but also efficiently inhibit replication of HSV-2.【期刊名称】《首都医科大学学报》【年(卷),期】2011(032)006【总页数】4页(P834-837)【关键词】生殖器疱疹;伐昔洛韦;病毒抑制疗法【作者】毕建军;杨慧兰;樊建勇;张玲【作者单位】广州军区广州总医院皮肤科,广州510010;广州军区广州总医院皮肤科,广州510010;广州军区广州总医院皮肤科,广州510010;广州军区广州总医院皮肤科,广州510010【正文语种】中文【中图分类】R751.05生殖器疱疹(genital herpes，GH)是一种常见的性传播疾病，主要由单纯疱疹病毒2型(herpes simplex virus 2，HSV-2)引起。
盐酸伐昔洛韦片
注射用阿昔洛韦【药品名称】通用名称：注射用阿昔洛韦英文名称：Aciclovir for Injection【成份】本品主要成分为阿昔洛韦，化学名为：9-[(2-羟基乙氧基)甲基]鸟嘌呤【适应症】本品用于1单纯疱疹病毒感染：用于免疫缺陷者初发和复发性粘膜皮肤感染的治疗以及反复发作病例的预防；也用于单纯疱疹性脑炎治疗。
2带状疱疹：用于免疫缺陷者严重带状疱疹病人或免疫功能正常者弥散型带状疱疹的治疗。
3免疫缺陷者水痘的治疗。
【用法用量】仅供静脉滴注，每次滴注时间在1小时以上。
成人常用量1 重症生殖器疱疹初治，按体重一次5mg/kg（按阿昔洛韦计，下同），一日3次，每隔8小时滴注一次，共5日。
2 免疫缺陷者皮肤粘膜单纯疱疹或严重带状疱疹，按体重一次5～10mg/kg，一日3次，每隔8小时滴注1次，共7～10日。
3 单纯疱疹性脑炎，按体重一次10mg/kg，一日3次，每隔8小时滴注一次，共10日。
成人一日最高剂量按体重为30mg/kg，或按体表面积为1.5g/m【不良反应】1 常见的不良反应：注射部位的炎症或静脉炎、皮肤瘙痒或荨麻疹、皮疹、发烧、轻度头痛、恶心、呕吐、腹泻、蛋白尿、血液尿素氮和血清肌酐值升高、肝功能异常如血清氨基转移酶、碱性磷酸酶、乳酸脱氢酶、总胆红素轻度升高等。
2 少见的不良反应有：急性肾功能不全、白细胞和红细胞下降、血红蛋白减少、中性粒细胞减少、血小板减少性紫癜、胆固醇、甘油三酯升高、血尿、低血压、多汗、心悸、呼吸困难、胸闷。
3 本品上市后临床还观察到的不良反应有：（1）消化系统：包【禁忌】对阿昔洛韦过敏者禁用。
【注意事项】1 对更昔洛韦过敏者也可能对本品过敏。
2 以下情况需考虑用药利弊：(1) 脱水或已有肾功能不全者，本品剂量应减少。
(2) 严重肝功能不全者、对本品不能承受者、精神异常或以往对细胞毒性药物出现精神反应者，静脉用本品易产生精神症状，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疱疹病毒和带状疱疹病毒对本品耐药。
伐昔洛韦
适用于病毒性感染的疾病，如单纯疱疹、水痘、带状疱疹、初发及复发的生殖器疱疹、肝炎、病毒性脑膜炎 等，并可用于防止免疫损伤及免疫抑制治疗的患者如获得性免疫缺陷综合征(AIDS)、器官移植患者的病毒感染。 本品在医生的指导下，可用于阿昔洛韦的所有的适应证(如乙型病毒性肝炎、全身带状疱疹等)原发性生殖器疱疹， 带状疱疹。
药动学
本药水溶性好，口服吸收后在肝内迅速被水解酶水解成阿昔洛韦，血浆中测不出伐昔洛韦，但阿昔洛韦的血 浆浓度很高，可与静脉注射阿昔洛韦相比，且比口服阿昔洛韦要高3～5倍。本药生物利用度为65%，显著高于阿 昔洛韦，进餐后服用不影响其生物利用度。本药和血浆蛋白结合率ห้องสมุดไป่ตู้13.5%～17.9%，可由乳汁分泌。本药的分解 代谢在肝及肠壁内进行。由于快速分解为阿昔洛韦，本药的半衰期小于30min，而阿昔洛韦的半衰期在正常肾功 能时约3h。广泛分布于全身14个组织，可达小肠、肝、肾等组织，尤以淋巴结、皮肤中的浓度为最高，在脑组织 浓度最低。24h后可以从所有组织中清除，48h后全部剂量从尿和粪便中排除。代谢物主要从尿液中排除。其中阿 昔洛韦占46%～59%，8-羟基阿昔洛韦占25%～30%。在口服和静脉注射相同的前体药后，未代谢的前体药分别占 0.5%和6%，说明该药更适合于口服给药。血药浓度接近于静脉滴注ACV，对肾脏的毒性作用亦较轻，可更快地缩 短带状疱疹后遗神经痛的时间。
口服：1.带状疱疹：每次0.3g，每天2次，连续10天，总用量6g(最小用量1.8g，疗程3天)。2.单纯疱疹： 每次0.3g，每天2次，连续7天，总用量4.2g(最小用量1.8g，疗程3天)。3.生殖器疱疹：每次0.3g，每天2次， 连续5～10天。4.尖锐湿疣：每次0.3g，每天2次，连续9～27天 。
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伐昔洛韦片
【药品名称】
通用名称：盐酸伐昔洛韦片
商品名称：盐酸伐昔洛韦片(丽珠威)
英文名称：Valaciclovir Hydrochloride Tablets
拼音全码：YanSuanFaXiLuoWeiPian(LiZhuWei)
【主要成份】该品主要成分为盐酸伐昔洛韦。
【成份】
分子量：C13H20N6O4·HCL
【性状】该品为薄膜衣片，除去薄膜衣后显白色或类白色。
【适应症/功能主治】用于治疗水痘带状疱疹及I型、II型单纯疱疹病毒感染，包括初发和复发的生殖器疱疹病毒感染。
本品可用于阿昔洛韦的所有适应症。
【规格型号】 0.15g*6s
【用法用量】口服，一次0.3g，一日2次，饭前空腹服用。
带状疱疹连续服药10日。
单纯性疱疹连续服药7日。
【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。
【禁忌】对本品及阿昔洛韦过敏者禁用。
【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、肾功能不全者慎用。
肾功能不全者在接受本品治疗时,需根据肌酐清除率来校正剂量。
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本品后皮损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.服药期间应给予患者充分的水，防止阿昔洛韦在肾小管内沉淀。
7.一次血液透析可使阿昔洛韦的血药浓度减低60%，因此血液透析后应补给一次剂量。
8.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本品对生育的影响及致突变作用，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。
9.本品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。
请仔细阅读说明书并遵医嘱使用。
【儿童用药】儿童用药的安全性和有效性尚未确定。
【老年患者用药】由于生理性肾功能的衰退，该品剂量与用药间期需调整。
【孕妇及哺乳期妇女用药】孕妇及哺乳期妇女用药阿昔洛韦能通过胎盘，孕妇用药需权衡利弊。
阿昔洛韦在乳汁中的浓度为血药浓度的0.6～4.1倍，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，合用丙磺舒可使阿昔洛韦的排泄减慢，半衰期延长，体内药物蓄积。
【药物过量】尚不明确。
【药理毒理】品体内的抗病毒活性优于阿昔洛韦，对单纯性疱疹病毒I型和Ⅱ型的治疗指数分别比阿昔洛韦高42.91%和30.13%。
对水痘带状疱疹病毒也有很高的疗效，对哺乳动物宿主细胞的毒性很低。
【药代动力学】该品口服后迅速吸收转化为阿昔洛韦，血中阿昔洛韦达峰时间为0.88～1.75小时。
口服生物利用度为67±13%，是阿昔洛韦的3～5倍。
该品进入体内后广泛分布，可分布至多种组织中，其中胃、小肠、肾、肝、淋巴结和皮肤组织中浓度最高，脑组织中的浓度最低。
该品在体内全部转化为阿昔洛韦，代谢物主要从尿中排除，其中阿昔洛韦占46%～59%，8-羟基-9-鸟嘌呤占25%～30%，9-羟基甲氧基鸟嘌呤占11%～12%。
阿昔洛韦原形为单相消除，血消除半衰期（t1/2β）为2.86±0.39小时。
【贮藏】密封。
【包装】 6片/盒。
【有效期】 24 月
【批准文号】国药准字H10960080。