Avoid brushing your teeth, chewing gum, or wearing an upper denture while you have a buccal tablet in your mouth. You may rinse your mouth gently. Drink plenty of liquids to prevent dry mouth. Herpes infections are contagious and you can infect other people, even while you are being treated with acyclovir. Avoid letting infected areas come into contact with other people.
Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others. Taking this medicine will not prevent you from passing genital herpes to your sexual partner. Avoid sexual intercourse while you have active lesions or the first symptoms of an outbreak.
Genital herpes may still be contagious through "viral shedding" from your skin, even if you have no symptoms. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. Acyclovir can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis including Advil, Motrin, and Aleve.
Other drugs may affect acyclovir, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
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Zovirax slide 10 of 45, Zovirax,. Zovirax slide 11 of 45, Zovirax,. Acyclovir slide 12 of 45, Acyclovir,. 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.
The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with mg given orally 5 times a day dosing appropriate for treatment of herpes zoster or mg given orally 5 times a day dosing appropriate for treatment of genital herpes. 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. 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.
Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Teratogenic Effects: Pregnancy Category B. These exposures resulted in plasma levels 9 and 18, 16 and , 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 and completed in April There were pregnancies followed in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 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. Acyclovir concentrations have been documented in breast milk in 2 women following oral administration of acyclovir and ranged from 0.
These concentrations would potentially expose the nursing infant to a dose of acyclovir up to 0. Acyclovir should be administered to a nursing mother with caution and only when indicated.
Safety and effectiveness of oral formulations of acyclovir in pediatric patients younger than 2 years of age have not been established. 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. Long-Term Administration: The most frequent adverse events reported in a clinical trial for the prevention of recurrences with continuous administration of mg two mg capsules 2 times daily for 1 year in patients treated with acyclovir were nausea 4.
The control patients receiving intermittent treatment of recurrences with acyclovir for 1 year reported diarrhea 2. The most frequent adverse event reported during 3 clinical trials of treatment of herpes zoster shingles with mg of oral acyclovir 5 times daily for 7 to 10 days in patients was malaise The placebo recipients reported malaise The patients receiving placebo reported diarrhea 2.
In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of acyclovir. 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 acyclovir, or a combination of these factors. Nervous: Aggressive behavior, agitation, ataxia, coma, confusion, decreased consciousness, delirium, dizziness, dysarthria, encephalopathy, hallucinations, paresthesia, psychosis, seizure, somnolence, tremors. Hematologic and Lymphatic: Anemia, leukocytoclastic vasculitis, leukopenia, lymphadenopathy, thrombocytopenia.
Hepatobiliary Tract and Pancreas: Elevated liver function tests, hepatitis, hyperbilirubinemia, jaundice. Skin: Alopecia, erythema multiforme, photosensitive rash, pruritus, rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria. Overdoses involving ingestion of up to 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. 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. Alternative regimens have included doses ranging from mg 3 times daily to 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 acyclovir.
Intermittent Therapy: mg every 4 hours, 5 times daily for 5 days. Therapy should be initiated at the earliest sign or symptom prodrome of recurrence.
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 quantitative relationship between the in vitro susceptibility of herpes viruses to antivirals and the clinical response to therapy has not been established in humans, and virus sensitivity testing has not been standardized.
Using plaque-reduction assays, the IC50 against herpes simplex virus isolates ranges from 0. 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. 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 inTable 1. The decrease in bioavailability is a function of the dose and not the dosage form. The only known urinary metabolite is 9-[ carboxymethoxy -methyl]guanine. Adults with Impaired Renal Function: The half-life and total body clearance of acyclovir are dependent on renal function. Geriatrics: Acyclovir plasma concentrations are higher in geriatric patients compared to younger adults, in part due to age-related changes in renal function.
Pediatrics: In general, the pharmacokinetics of acyclovir in pediatric patients is similar to that of adults. 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. Initial Genital Herpes: Double-blind, placebo-controlled studies have demonstrated that orally administered acyclovir 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.
Herpes Zoster Infections: In a double-blind, placebo-controlled study of immunocompetent patients with localized cutaneous zoster infection, acyclovir 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, acyclovir mg 5 times daily for 7 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. Chickenpox: Three randomized, double-blind, placebo-controlled trials were conducted in pediatric patients aged 2 to 18 years with chickenpox.
All patients were treated within 24 hours after the onset of rash. Treatment with acyclovir did not affect varicella-zoster virus-specific humoral or cellular immune responses at 1 month or 1 year following treatment. Acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir. Acyclovir tablets are intended for oral ingestion only.
Adequate hydration should be maintained. 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 breast feed while taking orally administered acyclovir, or they have any other questions.
Patients should be advised to maintain adequate hydration. Herpes Zoster: There are no data on treatment initiated more than 72 hours after onset of the zoster 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 acyclovir is not a cure for genital herpes. There are no data evaluating whether acyclovir will prevent transmission of infection to others. 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. The data presented below include references to peak steady-state plasma acyclovir concentrations observed in humans treated with mg given orally 5 times a day dosing appropriate for treatment of herpes zoster or mg given orally 5 times a day dosing appropriate for treatment of genital herpes.
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. 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. Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Teratogenic Effects: Pregnancy Category B. These exposures resulted in plasma levels 9 and 18, 16 and , 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 and completed in April
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