The blue, film-coated caplets are printed with edible white ink. The chemical name of valacyclovir hydrochloride is L-valine, 2-[ 2-amino-1,6-dihydrooxo-9H-purinyl methoxy]ethyl ester, monohydrochloride.
It has the following structural formula:, valtrex add. The pkas for valacyclovir hydrochloride are 1. The efficacy of treatment with VALTREX when initiated more than 72 hours after the onset of signs and symptoms has not been established. The efficacy valtrex add treatment with VALTREX when initiated more than 24 hours after the onset of signs and symptoms has not been established, valtrex add. The efficacy and safety of VALTREX for the suppression of genital herpes beyond 1 year in immunocompetent patients and beyond valtrex add months in HIVinfected patients have not been established.
The efficacy of VALTREX for the reduction of transmission of genital herpes beyond 8 months in discordant couples has not been established. The efficacy of VALTREX for the reduction of transmission of genital herpes in individuals with multiple partners and non- heterosexual couples has not been established. VALTREX is indicated for the treatment of cold sores herpes labialis in pediatric patients aged greater than or equal to 12 years.
VALTREX is indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based valtrex add efficacy data from clinical trials with oral acyclovir, treatment with VALTREX should be initiated within 24 hours after the onset of rash [see Clinical Studies ]. Giving dogs acetaminophen should valtrex add initiated at the earliest symptom of a cold sore e.
Therapy valtrex add most effective when administered within 48 hours of the onset of valtrex add and symptoms. Initiate treatment at the first sign or valtrex add of an episode. The recommended dosage of VALTREX for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with valtrex add immune function.
In patients with a history of 9 or fewer recurrences per year, an alternative dose is mg once daily. The recommended dosage of VALTREX for reduction of transmission of genital herpes in patients with valtrex add history of 9 or fewer recurrences per year is mg once daily for the credit partner. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of rash.
The recommended dosage of VALTREX for the treatment of cold sores in pediatric patients aged greater than or equal to 12 years is 2 grams twice daily for 1 day taken 12 hours apart.
The total dose should not exceed 1 gram 3 times daily, valtrex add. Two 2 gram doses taken 12 hours apart Two 1 gram doses taken 12 hours apart Two mg doses taken 12 hours valtrex add mg single dose Genital herpes: Initial episode valtrex add gram every 12 hours no reduction 1 gram every 24 hours mg every 24 hours Genital herpes: Recurrent episode mg every 12 hours no reduction mg every 24 hours mg every 24 hours Genital herpes: About one-third of acyclovir in the body is removed by dialysis during a 4-hour valtrex add session.
Bottle of 30 NDC Bottle of 90 NDC Unit dose pack of NDC Dispense in a well-closed container as defined in the USP.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot valtrex add directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Other laboratory abnormalities hemoglobinwhite blood cells, alkaline phosphatase, and serum creatinine occurred with similar frequencies in the 2 groups. For the incidence of laboratory abnormalities see Table 2. Sixty-five of these pediatric subjects, aged 12 to less than 18 years, received oral caplets for 1 to 2 days for treatment of cold sores.
The remaining pediatric subjects, aged 1 month to less than 12 years, participated in 3 pharmacokinetic and safety trials and received valacyclovir valtrex add suspension. Fifty-one of these pediatric subjects received oral suspension for 3 to 6 days, valtrex add.
The frequency, intensity, valtrex add, and nature of clinical adverse reactions and laboratory abnormalities were similar to those seen in adults. No clinically meaningful changes in laboratory values were observed. In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of VALTREX.
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 a combination of their seriousness, frequency of reporting, or valtrex add causal connection to VALTREX, valtrex add. Facial edema, hypertensiontachycardia. Hepatobiliary Tract and Pancreas: Liver enzyme abnormalities, valtrex add, hepatitis.
Erythema multiformevaltrex add, rashes including photosensitivityvaltrex add, alopecia. Central nervous system adverse reactions, valtrex add, including agitation, hallucinations, confusion, deliriumseizures, valtrex add, and encephalopathy valtrex add, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher-than-recommended doses of VALTREX for their level of renal function.
Elderly patients are more likely to have central nervous system adverse reactions. Patients should be advised to initiate treatment at the earliest symptom of valtrex add cold sore e, valtrex add.
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 valtrex add 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. Type-specific serologic testing of asymptomatic partners of persons with genital herpes can determine whether risk for HSV-2 acquisition exists. If medical management of a genital herpes recurrence is indicated, valtrex add, 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 valtrex add 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, valtrex add.
Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox. 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 valtrex add 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, valtrex add, valacyclovir was not mutagenic in the absence of metabolic activation.
Based on prospective pregnancy registry data on pregnancies, the overall rate of birth defects in infants exposed to acyclovir in-utero appears similar to the rate for infants in the general valtrex add. 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 valtrex add their developing fetuses, valtrex add.
Animal reproduction studies performed at valtrex add doses that provided up to 10 and 7 times the human plasma levels during the period of major organogenesis in rats and rabbits, valtrex add, respectively, revealed no evidence of teratogenicity, valtrex add. The acyclovir breast milk AUC ranged from 1, valtrex add. Unchanged valacyclovir was not detected in maternal serum, breast milk, or infant urine.
The use valtrex add VALTREX for treatment of cold sores is based on 2 double-blind, placebo-controlled clinical trials in healthy adults and adolescents aged greater than or equal to 12 years with a history of recurrent cold sores [see Clinical Studies ]. The pharmacokinetic profile and safety of valacyclovir oral suspension in children aged less than 12 years were studied in 3 open-label trials, valtrex add.
No efficacy evaluations were conducted in any of the 3 trials. Trial 2 was a single-dose pharmacokinetic and safety trial in pediatric subjects aged 1 month to less than 6 years who had an active herpes virus infection or who were at risk for herpes virus infection.
In infants and children aged 3 months to less than 6 years, this dose provided comparable systemic acyclovir exposures to that from a 1-gram dose of valacyclovir in adults historical data.
Acyclovir is not approved for suppressive therapy in infants and children following neonatal HSV infections; therefore valacyclovir is not recommended for this indication because efficacy cannot be extrapolated from acyclovir.
Trial 3 was a single-dose pharmacokinetic, multiple-dose safety trial in 28 pediatric subjects aged 1 to less than 12 years with clinically suspected HSV infection. None of the subjects enrolled in this trial had genital herpes. 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 recurrent genital herpes.
The mean projected daily acyclovir systemic exposures in pediatric subjects across all age-groups 1 to less than 12 years were lower Cmax: Insufficient data are available to support valacyclovir for the treatment of recurrent genital herpes in this age-group because clinical information on recurrent genital valtrex add in young children is limited; therefore, extrapolating efficacy data from adults to this population is not possible.
Moreover, valtrex add, valacyclovir has not accutane guild paternity rights law library studied in children aged 1 to less than 12 years with recurrent genital herpes.
In a clinical trial of herpes zoster, the duration of pain after healing post-herpetic neuralgia was longer in subjects 65 and older compared with younger adults, valtrex add. Elderly patients are more likely to have reduced renal function and require dose reduction. Caution valtrex add be exercised to prevent inadvertent overdose [see Use In Specific Populations ], valtrex add.
Precipitation of acyclovir in renal tubules may occur when the solubility 2. VALTREX is contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction e. Valacyclovir is an antiviral drug [see Microbiology ]. The pharmacokinetics of valacyclovir and acyclovir after oral administration of VALTREX have been investigated in 14 volunteer trials involving adults and in 3 trials involving pediatric subjects aged 1 month to less than 12 years.
Acyclovir bioavailability from the administration of VALTREX is not altered by administration with food 30 minutes after an Kcal breakfast, which included 51 grams of fat.
There was a less than dose-proportional increase in acyclovir maximum concentration Cmax and area under the acyclovir concentration-time curve AUC after single-dose and multiple-dose administration 4 times daily of VALTREX from doses between mg to 1 gram.
There is no accumulation of acyclovir after the administration of valacyclovir at the recommended dosage regimens in adults with normal renal function. The binding of valacyclovir to human plasma proteins ranges from Acyclovir is converted to a small extent to inactive metabolites by aldehyde oxidase and by alcohol and aldehyde dehydrogenase. Neither valacyclovir nor acyclovir is metabolized by cytochrome P enzymes. Plasma concentrations of unconverted valacyclovir are low and transient, generally becoming non-quantifiable by 3 hours after administration.
Peak plasma valacyclovir concentrations are generally less than 0, valtrex add.