The possibility of viral resistance to acyclovir should be considered in patients who fail to respond or experience recurrent viral shedding during therapy. Cross-resistance has been observed among HSV isolates carrying frameshift mutations and resistance-associated substitutions, which confer reduced susceptibility to penciclovir , famciclovir, and foscarnet.
Plasma drug concentrations in animal studies are expressed as multiples of human exposure to acyclovir [see Clinical Pharmacology Valacyclovir was noncarcinogenic in lifetime carcinogenicity bioassays at single daily doses gavage of valacyclovir giving plasma acyclovir concentrations equivalent to human levels in the mouse bioassay and 1.
There was no significant difference in the incidence of tumors between treated and control animals, nor did valacyclovir shorten the latency of tumors. Valacyclovir was tested in 5 genetic toxicity assays.
An Ames assay was negative in the absence or presence of metabolic activation. Also negative were an in vitro cytogenetic study with human lymphocytes and a rat cytogenetic study. In the mouse lymphoma assay, valacyclovir was not mutagenic in the absence of metabolic activation.
Valacyclovir did not impair fertility or reproduction in male or female rats at acyclovir exposures AUC 6 times higher than in humans given the MRHD.
Testicular atrophy occurred in male rats orally dosed for 97 days at 18 times the MRHD and was reversible. The majority of subjects initiated treatment within 2 hours of onset of symptoms. The mean duration of cold sore episodes was about 1 day shorter in treated subjects as compared with placebo.
The 2-day regimen did not offer additional benefit over the 1-day regimen. No significant difference was observed between subjects receiving VALTREX or placebo in the prevention of progression of cold sore lesions beyond the papular stage. For both treatment groups the median time to lesion healing was 9 days, the median time to cessation of pain was 5 days, and the median time to cessation of viral shedding was 3 days.
Three double-blind trials 2 of them placebo-controlled in immunocompetent adults with recurrent genital herpes were conducted. Subjects self-initiated therapy within 24 hours of the first sign or symptom of a recurrent genital herpes episode.
Results supporting efficacy were replicated in a second trial. The median time to cessation of pain was about 3 days in both treatment groups. Two clinical trials were conducted, one in immunocompetent adults and one in HIVinfected adults. Outcomes for the overall trial population are shown in Table 5. The median duration of recurrent genital herpes in enrolled subjects was 8 years, and the median number of recurrences in the year prior to enrollment was 5.
Outcomes for the overall trial population are shown in Table 6. The source partner had a history of 9 or fewer genital herpes episodes per year. Both partners were counseled on safer sex practices and were advised to use condoms throughout the trial period.
The efficacy results are summarized in Table 7. Individual results may vary based on consistency of safer sex practices. VALTREX was compared with placebo in subjects aged less than 50 years and with oral acyclovir in subjects aged greater than 50 years.
All subjects were treated within 72 hours of appearance of zoster rash. In subjects aged less than 50 years, the median time to cessation of new lesion formation was 2 days for those treated with VALTREX compared with 3 days for those treated with placebo.
In subjects aged greater than 50 years, the median time to cessation of new lesions was 3 days in subjects treated with either VALTREX or oral acyclovir. Acyclovir systemic exposures in pediatric subjects following valacyclovir oral suspension were compared with historical acyclovir systemic exposures in immunocompetent adults receiving the solid oral dosage form of valacyclovir or acyclovir for the treatment of herpes zoster.
Because the efficacy and safety of acyclovir for the treatment of chickenpox in children aged less than 2 years have not been established, efficacy data cannot be extrapolated to support valacyclovir treatment in children aged less than 2 years with chickenpox.
Advise patients not to double their next dose or take more than the prescribed dose. Patients should be advised to initiate treatment at the earliest symptom of a cold sore e. There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore e. Patients should be instructed that treatment for cold sores should not exceed 1 day 2 doses and that their doses should be taken about 12 hours apart.
Genital herpes is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Sex partners of infected persons should be advised that they might be infected even if they have no symptoms. 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. There are no data on the effectiveness of treatment initiated more than 72 hours after the onset of signs and symptoms of a first episode of genital herpes or more than 24 hours after the onset of signs and symptoms of a recurrent episode.
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. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Elderly people are more likely to get certain side effects. Talk to your healthcare provider if this is a concern for you.
Call your doctor for medical advice about side effects. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. It may harm them. This Patient Information has been approved by the U. Food and Drug Administration. Patients aged less than 12 years with cold sores herpes labialis.
Patients aged less than 2 years or greater than or equal to 18 years with chickenpox. Patients aged less than 18 years with genital herpes. Patients aged less than 18 years with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus HSV infection. Gradually add approximately 5-mL aliquots of SSV to the mortar and triturate the powder until a paste has been produced. Ensure that the powder has been adequately wetted.
Transfer the mixture to a suitable mL measuring flask. Once dissolved, add to the measuring flask. Rinse the mortar at least 3 times with approximately 5-mL aliquots of SSV, transferring the rinsing to the measuring flask between additions.
Make the suspension to volume mL with SSV and shake thoroughly to mix. Transfer the suspension to an amber glass medicine bottle with a child-resistant closure. Discard after 28 days. Table 1. Caution should be exercised when administering VALTREX to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration 2.
Patients receiving other nephrotoxic drugs. Patients without adequate hydration. Adequate hydration should be maintained for all patients. Acute Renal Failure [see Warnings and Precautions 5. Table 2. General Facial edema, hypertension, tachycardia. Allergic Acute hypersensitivity reactions including anaphylaxis, angioedema, dyspnea, pruritus, rash, and urticaria [see Contraindications 4 ].
Central Nervous System CNS Symptoms Aggressive behavior; agitation; ataxia; coma; confusion; decreased consciousness; dysarthria; encephalopathy; mania; and psychosis, including auditory and visual hallucinations, seizures, tremors [see Warnings and Precautions 5. Eye Visual abnormalities. Gastrointestinal Diarrhea. Hepatobiliary Tract and Pancreas Liver enzyme abnormalities, hepatitis.
Renal Renal failure, renal pain may be associated with renal failure [see Warnings and Precautions 5. In your body, valacyclovir becomes the anti-herpes medicine, acyclovir. Although valacyclovir will not cure shingles or genital herpes, it does help relieve the pain and discomfort and helps the sores heal faster. In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:.
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.
For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of valacyclovir in children below 12 years of age with cold sores, and children below 2 years of age with chickenpox.
Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valacyclovir in the elderly.
However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose of patients receiving valacyclovir. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding.
Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur.
Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:. Always speak with your doctor or pharmacist about dosages that are right for you. Valacyclovir oral tablet is used for short-term treatment of oral herpes, genital herpes, shingles, or chickenpox. You should not stop taking this drug unless your doctor tells you to stop.
If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include more severe side effects, such as:. But if your symptoms are severe, call or go to the nearest emergency room right away. What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once.
This could result in dangerous side effects. How to tell if the drug is working: Your symptoms from the viral infection should improve. A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled.
Your doctor will write the number of refills authorized on your prescription. Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.
You may need to have blood tests during your treatment with this drug. The cost of these tests will depend on your insurance coverage. Many insurance companies require a prior authorization for this drug.
This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.
There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date.
However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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