伐昔洛韦片-维德思
阿迈新(盐酸伐昔洛韦缓释片)使用说明
阿迈新(盐酸伐昔洛韦缓释片)【用法用量】口服，一次0.6g(1片)，一日一次，饭前空腹服用。
带状疱疹一般需连续服药10日。
单纯性疱疹一般需连续服药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.本品对单纯疱疹病毒的潜伏感染无明显效果，不能根除病毒。
9.早期HIV感染者、同种基因骨髓移植者及肾脏移植者用药后可能出现血栓性血小板减少性紫癜/溶血性尿毒性综合征(TTP/HUS)，有些时候可能会导致死亡。
【不良反应】偶有头晕、头痛、关节痛、恶心、呕吐、腹泻、腹痛、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。
【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，包括初发生殖器疱疹病毒感染。
【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。
【药理毒理】1.药理作用:(1)本品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，其抗病毒作用为阿昔洛韦所发挥，阿昔洛韦进入疱疹感染细胞之后，与脱氧核苷竞争病毒胸腺嘧啶激酶或细胞激酶，药物被磷酸化成活化型无环鸟苷三磷酸酯，作为病毒复制的底物与脱氧鸟嘌呤三磷酸酯竞争病毒DNA多聚酶，从而抑制了病毒DNA合成，显示抗病毒作用。
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。
凡乐(泛昔洛韦片)使用说明
凡乐(泛昔洛韦片)【用法用量】口服。
1.成人一次0.25g，每8小时1次。
治疗带状疱疹的疗程为7日，治疗原发性生殖器疱疹的疗程为5天。
2.肾功能不全患者应根据肾功能状况调整剂量。
推荐剂量如下：肌酐清除率剂量≥60ml/分钟成人一次0.25g，每8小时1次40～59ml/分钟成人一次0.25g，每12小时1次20～39ml/分钟成人一次0.25g，每24小时1次【注意事项】1.本品对预防生殖器疱疹的复发，眼部带状疱疹﹑播散性带状疱疹及免疫缺陷患者疱疹的疗效尚未得到确认。
2.肾功能不全者喷昔洛韦的表观血浆清除率﹑肾清除率和血浆清除速率常数均随肾功能的降低而下降，故肾功能不全者应注意调整用法用量。
3.肝功能代偿的肝病患者无需调整剂量，尚未对肝功能失代偿的肝病患者进行药代动力学研究。
4.食物对生物利用度无明显影响，口服本品0.5g，一日3次，连续7天，未见喷昔洛韦的蓄积现象。
5.病毒胸腺嘧啶脱氧核苷激酶或DNA多聚酶的质变可导致HSV或VZV对喷昔洛韦耐药突变株的产生，若病人治疗临床疗效不佳时，应考虑病毒可能对喷昔洛韦耐药。
对阿昔洛韦耐药的突变株对喷昔洛韦也耐药。
6.本品并不能完全治愈生殖器疱疹，是否能够防止疾病传播尚不清楚，但生殖器疱疹可以通过性接触传播，故治疗期间应避免性接触。
7.药物过量，采用对症及支持治疗，血液透析有助于消除本品。
8.药物不要放在孩童可触及的地方。
9.废弃药品包装不应随意丢弃。
【不良反应】常见是头痛和恶心。
此外尚可见下列反应：1.神经系统：头晕﹑失眠﹑嗜睡﹑感觉异常等。
2.消化系统：腹泻﹑腹痛﹑消化不良﹑厌食﹑呕吐﹑便秘﹑胀气等。
3.全身反应：疲劳﹑疼痛﹑发热﹑寒战等4.其他反应：皮疹﹑皮肤瘙痒﹑鼻窦炎﹑咽炎等。
5.实验室异常可有ALT﹑AST增高﹑血中脂酶增高﹑淀粉酶增高﹑胆红素增高﹑白细胞减低﹑中性粒细胞减低﹑偶有血肌酐增高，曾有报道肾功能减退患者应用大剂量本品引起急性肾功能衰竭。
阿昔洛韦片作用与功效
阿昔洛韦片作用与功效阿昔洛韦片(Acyclovir Tablets)是一种用于抗病毒治疗的药物。
它是一种口服药物，常用来治疗由单纯疱疹病毒(herpes simplex virus，简称HSV)引起的感染，如口唇疱疹、生殖器疱疹和脑炎。
阿昔洛韦片被广泛应用于临床上，具有显著的疗效和安全性。
阿昔洛韦片属于核苷类似物抗病毒药物，通过抑制病毒的DNA聚合酶活性，阻断病毒DNA的合成和复制，从而抑制病毒在细胞内的生长和复制。
阿昔洛韦片只对病毒感染的细胞具有选择性抑制作用，对正常细胞无副作用。
阿昔洛韦片主要作用于单纯疱疹病毒(HSV)和带状疱疹病毒(varicella-zoster virus，简称VZV)。
这两种病毒都是一种DNA病毒，具有较高的传染性。
HSV可以感染皮肤和黏膜，引起口唇疱疹、生殖器疱疹等疾病；VZV则引起水痘和带状疱疹。
阿昔洛韦片通过抑制这两种病毒的复制和生长，有效地控制疾病的发展和传播。
阿昔洛韦片的主要功效有以下几点：1.治疗单纯疱疹病毒感染：阿昔洛韦片可用于治疗口唇疱疹和生殖器疱疹等由HSV引起的感染。
口唇疱疹是一种常见的嘴唇周围的疱疹，患者常表现为嘴唇疼痛、瘙痒、发红、疱疹等症状。
生殖器疱疹是一种通过性接触传播的性病，患者常表现为生殖器疼痛、瘙痒、溃疡等症状。
阿昔洛韦片能迅速缓解症状，减轻患者的不适感。
2.治疗带状疱疹病毒感染：阿昔洛韦片也可用于治疗带状疱疹。
带状疱疹是由VZV引起的一种皮肤病，患者常表现为疼痛、瘙痒、发红和水疱等症状。
这种病毒感染通常在免疫力低下的情况下发作，如老年人、患有免疫缺陷病的人等。
阿昔洛韦片能有效地减轻症状和并发症，如神经痛等。
3.预防疱疹病毒感染：阿昔洛韦片还可用于预防疱疹病毒的感染。
在某些特殊情况下，如免疫功能低下的患者接受器官移植、白血病患者接受化疗等，感染病毒的风险较高。
阿昔洛韦片能够降低感染病毒的风险，预防疾病的发生。
4.治疗脑炎症：阿昔洛韦片还被用于治疗脑炎症，尤其是由HSV引起的脑炎。
伐昔洛韦分散片治疗手足口病效果观察
患者症状轻微 ， 以发热和手 、 、 足 口及臀 部等部 位 的皮疹或 疱疹
为 主要特征 。少 数可并 发 无菌 性脑 膜 炎、 炎 、 性迟 缓 性麻 脑 急 痹 、 吸道感染 和心肌炎 等。个别重症患儿病 情进展快 ， 呼 易发生
丝型 型墼 壅堕
对照组
墨塾
查塾
塾
篁 查整皇
采用盐酸伐昔洛 韦分散 片 （ 湖北 科益 药业股 份有 限公 司生 产 ） ｋ ｄ 分 ３次 口服 ， ｇ・ ， 两组均 用 ３～５天。若合并 细菌 感染 ， 则另 给予抗生索治疗 。观察临床症状 、 体征及疗 效。 １３ 疗效评定 ． 治疗 ３天后 连续 观察患 儿症状 、 征 ， 定疗 体 判
１ 资 料 与 方 法
口病暴发流行 ， 发生 重症导致 死亡 的病例 明显增 多。我 国已 且 于 ２０ ０ ８年 ５月将手足 口病列为法定丙类传染病 ， 该病主要 由肠
人是肠道病毒惟一 宿主 ， 患者和隐性感染 者均 １１ 一般资料 选择 ２１ 年 ６月 一 ０ １ １ ． ００ ２１ 年 ２月在我单 位 门 道病毒感染 引起 ， 可在短 期 内造 诊皮肤科治疗 的普 通 型 手足 口病 患儿 ２ ６例 ， 符合 卫生 部 为本病 的传染源 。在发病后 １周 内传 染性 最强 ， ０ 均 ２１ ００年制定的手 足 口病 诊 断标 准。其 中男 １０例 （ ３ ４ ％ ） １ ５ ．０ ， 成局部流行并呈现季节性流行和全年散发趋势。各年龄组均 可 感染发病 ， 以≤３岁年 龄组 发病率 最 高。感染 后大 多数表 现 但
醉、 插管影响支撑喉镜的插入及对声 门的暴露 ， 作中容易 出现 参 考 文 献 操 等并发症 。如改为经鼻麻 醉插 管 ， 在操作 时细致 、 和 ， 柔 可减少
盐酸伐昔洛韦片和阿昔洛韦注射液治疗带状疱疹的效果观察及临床价值
盐酸伐昔洛韦片和阿昔洛韦注射液治疗带状疱疹的效果观察及临床价值摘要目的：对比盐酸伐昔洛韦片和阿昔洛韦注射液联合治疗带状疱疹的临床价值和盐酸伐昔洛韦片、阿昔洛韦注射液治疗带状疱疹的临床疗效。
方法：选取我院2018年2月—2020年1月收治的带状疱疹患者76例，随机分为治疗组和对照组，每组各38例。
治疗组口服盐酸伐昔洛韦片，2片/次，2次/d；对照组静脉滴注阿昔洛韦注射液加入250mL0.9%生理盐水中，5mg/kg，2次/d，治疗8天。
观察并记录两组患者的疗效并记录患者出现的各种不良反应。
结果：治疗后，治疗组和对照组的总有效率分别为97.36%、94.74%，两组比较差异无统计学意义。
分析两组患者皮损停止进展时间、开始结痂时间、一半皮疹结痂时间、所有皮疹脱痂时间和开始出现无疼痛时间，经过对比发现差异没有统计学意义。
治疗组疼痛完全消失时间显著短于对照组，并且后遗神经痛的发生率低于对照组，两组比较差异有统计学意义（P＜0.05）。
结论：盐酸伐昔洛韦片治疗带状疱疹具有较好的临床疗效，可以有效缩短疼痛时间，减少后遗神经痛的发生，值得在今后的临床中推广。
关键词：盐酸伐昔洛韦片；阿昔洛韦注射液；带状疱疹；后遗神经痛效果Observation and clinical value of valaciclovir hydrochloride tablets and aciclovir injection in the treatment of herpes zosterAbstractObjective: To compare the clinical value of valaciclovir hydrochloride tablets and aciclovir injection in the treatment of herpes zoster and the clinical efficacy of valaciclovir hydrochloride tablets and aciclovir injection in the treatment of herpes zoster.Methods: 76 patients with herpes zoster admitted to our hospital from February 2018 to January 2020 were selected and randomly divided into treatment group and control group, 38 patients in each group.In the treatment group, valaciclovir hydrochloride tablets were taken orally, 2 tablets/time and 2 times /d.The control group was intravenously injected with acyclovir injection in 250ml 0.9% normal saline,5mg/kg, twice a day, and treated for 8 days.The efficacy of the two groups of patients was observed and recorded, and various adverse reactions occurred in the patients were recorded.Results: After treatment, the total effective rate of the treatment group and the control group were 97.36% and 94.74%, respectively, and the difference between the two groups was not statistically significant.The time when skin lesions stopped progressing, the time when scabs began to form, the time when half of the skin rashes began to form scabs, the time when all the skin rashes removed from scabs and the time when no pain appeared were analyzed in the two groups, and the differences were not statistically significant after comparison.The total disappearance time of pain in the treatment group was significantly shorter than that in the control group, and the incidence of neuropathic pain after treatment was lower than that inthe control group, with statistically significant difference between the two groups (P < 0.05).Conclusion: Valaciclovir hydrochloride tablets in the treatment of herpes zoster has a good clinical efficacy, can effectively shorten the time of pain, reduce the incidence of neuralgia after, it is worth promoting in the future clinical.Keywords: Valaciclovir hydrochloride tablets;Acyclovir injection;Herpeszoster;Posterior neuralgiaThe effect1资料与方法1.1一般资料选取我院2018年2月—2020年1月经临床上确诊为带状疱疹患者76例，患者的临床症状与相关标准中带状疱疹的诊断标准相符合。
清开灵分散片联合伐昔洛韦治疗带状疱疹89例疗效观察
带状疱疹 是临床 常见皮肤疾 患之一 ， 目前发 病率逐 步上
升， 抗病 毒是该疾 患的治疗原则 ｌ ＿ 】 ］ ， 我们采用抗病 毒药伐 昔洛 韦治疗基础上 ， 应用清开灵分散 片中西药结合治疗 ， 取得 一定
疗效 ， 现 报 道 如下 ： １ 资料 与 方 法
部 分 消退 、 疼痛无减轻 。
１ ． ５ 统计学方法
观察 所 得 数 据 以 ｘ ＋ｓ 表示 ， 采用 Ｓ Ｐ Ｓ Ｓ １ ５ ． ０统 计 软 件 包
进行统计 分析 ， 计量资料采用 Ｔ检验 ， 计数资料 比较应用 检
验。
带状疱疹 由水痘 一带状疱疹病毒感染引起 ， 好发在春 、 秋 两季 。病毒由呼吸道进 入血液后 形成病 毒血 症 ， 发生水 痘或
隐性 感染 后病 毒潜伏 于脊 髓后 神经节 或脑 神经感 觉神 经元
内， 当机体抵抗力下降时 ， 潜伏病毒被激活 ， 沿感觉神经轴索
作者简介 ： 赵敏 （ １ ９ ７ ６ 一 ） ， 女， 籍贯广东三水 ， 主治医师 ， 本科毕业于广州中医药 大学 ， 从事中医内科工作 。
Ｊ ｏ ｕ ｒ ｎ ａ ｌ ｏ ｆ Ｍａ ｔ ｈ ｅ ｍａ ｔ ｉ ｃ ａ ｌ Ｍｅ ｄ ｉ ｃ ｉ ｎ ｅ
文章编 号 ： １ ０ ０ ４ — ４ ３ ３ ７ （ ２ ０ １ ３ ） ０ １ 类号 ： Ｒ７ ５ ２ ． １ ２
文献标识码 ： Ａ
１ ． ３ 治疗方法
注： ＊ 代 表 组 间比 较 ， Ｐ ＜Ｏ ． ０ ５ 。
表 ２ 两 组 患 者 临 床 症 状 改 善 时 间 比较 （ 天）
盐酸伐昔洛韦
盐酸伐昔洛韦
张征
【期刊名称】《中国抗生素杂志》
【年(卷),期】1999(24)2
【摘要】［通用名称］盐酸伐昔洛韦片（ｖａｌａｃｉｃｌｏｖｉｒｈｙｄｒｏｃｈｌｏｒｉｄｅｔａｂｌｅｔｓ），盐酸伐昔洛韦胶囊（ｖａｌａｃｉｃｌｏｖｉｒｈｙ－ｄｒｏｃｈｌｏｒｉｄｅｃａｐｓｕｌｅｓ），四川抗菌素工业研究所制药厂生产，商品名“明竹欣”。
［化学名称］Ｌ...
【总页数】2页(P160,S001)
【作者】张征
【作者单位】四川抗菌素工业研究所制药厂
【正文语种】中文
【中图分类】R978.7
【相关文献】
1.盐酸伐昔洛韦片联合龙胆泻肝汤治疗带状疱疹临床疗效观察 [J], 玉男
2.盐酸伐昔洛韦片联合重组人干扰素α2b凝胶、NUVB治疗成人水痘的疗效观察[J], 唐春翊;唐春蕾;郑义宏;郑雯
3.盐酸伐昔洛韦治疗人巨细胞病毒感染临床疗效及安全性研究 [J], 王凡;黄蓉;张斌;李巧玲;熊洪平;王世恒
4.匹多莫德联合盐酸伐昔洛韦治疗复发性生殖器疱疹的效果 [J], 庞晓霞
5.匹多莫德联合盐酸伐昔洛韦治疗复发性生殖器疱疹的效果 [J], 庞晓霞
因版权原因，仅展示原文概要，查看原文内容请购买。
宁夏回族自治区物价局关于公布部分政府定价药品最高零售价格的通知
宁夏回族自治区物价局关于公布部分政府定价药品最高零售价格的通知文章属性•【制定机关】宁夏回族自治区物价局•【公布日期】2009.11.05•【字号】宁价商发[2009]43号•【施行日期】2009.11.20•【效力等级】地方规范性文件•【时效性】现行有效•【主题分类】药政管理正文宁夏回族自治区物价局关于公布部分政府定价药品最高零售价格的通知（宁价商发[2009]43号）各市、县（区）政府价格主管部门：根据各药品生产经营企业报送的资料，现将个别尚未公布价格的自治区政府定价药品，参考其产地及其他省市价格主管部门核定的价格制定其最高零售价格；对国家发改委和我局已公布价格品种的补充剂型规格品，按照《药品差比价规则（试行）》的有关规定制定其最高零售价格；对个别国家发改委已公布价格和尚未公布价格的中管品种，依据国家发改委办公厅有关文件规定制定其临时最高零售价格；对个别原公布价格有误或因成本上升产地及其他省市价格主管部门已调整价格的自治区政府定价品种，经西北五省（区）片区协商，重新制定其最高零售价格。
现一并印发给你们（详见附表一、二），请遵照执行，并就有关事项通知如下：一、附表一、二备注栏未标注的，其所列价格为药品统一最高零售价格；附表备注栏中标注生产企业的，其所列价格为该企业执行的单独定价或优质优价，其他生产企业不得执行此价格。
二、国家发改委办公厅《关于裹金衣安宫牛黄丸和热淋清颗粒价格问题的复函》（发改办价格[2007]1232号）规定，热淋清颗粒与热淋清胶囊之间不执行差比价，取消发改价格[2007]645号文中公布的热淋清颗粒价格，暂由贵州省物价局制定热淋清颗粒临时零售价格；国家发改委办公厅《关于部分药品差比价政策执行问题的通知》（发改办价格[2009]751号）规定，取消发改价格[2007]312号文附表一中公布的甜梦口服液价格，该药品与甜梦胶囊暂不执行差比价，由各地核定临时价格；国家发改委办公厅《关于醒脑静注射液优质优价问题的通知》（发改办价格[2007]2783号）规定，大理药业有限公司生产的醒脑静注射液执行优质优价，具体价格暂由各地临时核定；国家发改委办公厅《关于部分药品价格执行问题的通知》（发改办价格[2009]1239号）规定，无锡济民可信山禾药业股份有限公司生产的含人工麝香的醒脑静注射液价格，暂按照大理药业有限公司生产的醒脑静注射液价格执行。
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规格图片
0.5 g
维德思薄膜衣片[Valtrex filmtab]相关信息常用缩写符号
制造商葛兰素史克 (GlaxoSmithKline)
成份盐酸伐昔洛韦 Valaciclovir HCl
适应症本品适用于治疗带状疱疹；治疗单纯疱疹病毒感染；预防（抑制）单纯疱疹病毒感染的复发。
用法用量成人带状疱疹治疗：口服本品500 mg，2片，每日3次，疗程7天。
单纯疱疹治疗：口服本品500 mg，每日2次。
首次发病者病
情可能较重，疗程需要延长到10天。
对于复发的感染，疗程应
为5天。
建议在前驱症状期或刚出现症状体征时即开始治疗。
单纯疱疹病毒感染治疗（抑制）：
对免疫功能正常的病人，口服本品500 mg，每日1次。
对于频
繁复发（每年≥10次）的病人，250 mg每日2次的给药方案效
果更好。
对于免疫缺陷病人，用药方案为500 mg，每日2次。
肾功能损害：对于肾功能明显受损的病人，本品的剂量应当按
下列方式调整：
肌酐清除率为15-30 mL/者：
-带状疱疹：1000 mg，每日2次；
-单纯疱疹：无需调整剂量。
肌酐清除率<15 mL/者：
-带状疱疹：1000 mg，每日1次；
-治疗单纯疱疹：500 mg，每日1次；
-免疫功能正常者的预防：250 mg，每日1次；
-免疫缺陷者的预防：500 mg，每日1次。
血液透析的病人，本品的剂量应当按照肌酐清除率<15 mL/min
免疫系统：非常罕见过敏反应。
精神和神经系统：罕见眩晕，意识模糊，幻觉，意识丧失；
非常罕见兴奋，震颤，共济失调，构音困难，精神病症状，抽
搐，脑病，昏迷。
以上不良反应一般是可逆的，通常见于伴有肾功能损害或其他
诱病因素的患者。
在预防CMV而接受高剂量盐酸伐昔洛韦治疗
的器官移植患者中，神经学反应的发生率要高于低剂量组患者。
呼吸系统：不常见呼吸困难。
胃肠道：罕见腹部不适，呕吐，腹泻。
肝脏：非常罕见肝功检测可逆性升高；偶有肝炎描述。
皮肤及结缔组织：不常见皮疹包括光敏反应；罕见瘙痒；非
常罕见风疹，血管性水肿。
肾脏及泌尿系统：罕见肾功能损伤；非常罕见急性肾衰竭，
肾痛。
肾痛可能与肾衰竭有关。
其他：在延长期临床试验中，严重免疫抑制病人尤其是晚期HIV
感染者，服用大剂量（每日8 g）伐昔洛韦，有肾功能不全、毛
细血管溶血性贫血和血小板减少的报道（有时两者同时存在）。
上述情况也见于有相同基础疾病或合并症，但未用伐昔洛韦治
疗的病人。
药物相互作用未发现明显的药物相互作用。
西咪替丁和丙磺舒能通过降低肾脏的清除率使阿昔洛韦的AUC
增加，但由于阿昔洛韦治疗指数较大，故无需调整剂量。
影响
肾脏生理的其他药物也可能会影响阿昔洛韦的血浆水平。
查看维德思[Valtrex]详细药物相互作用信息
FDA妊娠分级
B级: 在动物繁殖研究中（并未进行孕妇的对照研究），未见到
药物对胎儿的不良影响。
或在动物繁殖性研究中发现药物有副
作用，但这些副作用并未在设对照的、妊娠首３个月的妇女中
得到证实（也没有在其后６个月具有危害性的证据）。
病人中的药代动力学：带状疱疹和单纯疱疹对口服本品后的伐
昔洛韦和阿昔洛韦药代动力学特征没有明显影响。
HIV感染的病人单剂或多剂口服伐昔洛韦1000 mg或2000 mg
后，阿昔洛韦的分布和药代动力学特征与健康人相比无明显变
化。
MIMS药物分类抗病毒药 (Antivirals)
ATC编码J05AB11 - 伐昔洛韦
药品监管分级医保药品
制造商: 葛兰素史克(GlaxoSmithKline)
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