Two randomized, double-blind clinical trials in immunocompetent adults with localized herpes zoster were conducted. Valacyclovir hydrochloride 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 valacyclovir hydrochloride 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 valacyclovir hydrochloride or oral acyclovir. In subjects aged less than 50 years, no difference was found with respect to the duration of pain after healing (post-herpetic neuralgia) between the recipients of valacyclovir hydrochloride and placebo. In subjects aged greater than 50 years, among the 83% who reported pain after healing (post-herpetic neuralgia), the median duration of pain after healing (95% CI) in days was: 40 (31, 51), 43 (36, 55), and 59 (41, 77) for 7-day valacyclovir hydrochloride, 14-day valacyclovir hydrochloride, and 7-day oral acyclovir, respectively.
The use of valacyclovir hydrochloride for treatment of chickenpox in pediatric subjects aged 2 to less than 18 years is based on single-dose pharmacokinetic and multiple-dose safety data from an open-label trial with valacyclovir and supported by safety and extrapolated efficacy data from 3 randomized, double-blind, placebo-controlled trials evaluating oral acyclovir in pediatric subjects.
The single-dose pharmacokinetic and multiple-dose safety trial enrolled 27 pediatric subjects aged 1 to less than 12 years with clinically suspected VZV infection. Each subject was dosed with valacyclovir oral suspension, 20 mg/kg 3 times daily for 5 days. 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. The mean projected daily acyclovir exposures in pediatric subjects across all age-groups (1 to less than 12 years) were lower (Cmax : ↓13%, AUC: ↓30%) than the mean daily historical exposures in adults receiving valacyclovir 1 gram 3 times daily, but were higher (daily AUC: ↑50%) than the mean daily historical exposures in adults receiving acyclovir 800 mg 5 times daily. The projected daily exposures in pediatric subjects were greater (daily AUC approximately 100% greater) than the exposures seen in immunocompetent pediatric subjects receiving acyclovir 20 mg/kg 4 times daily for the treatment of chickenpox. Based on the pharmacokinetic and safety data from this trial and the safety and extrapolated efficacy data from the acyclovir trials, oral valacyclovir 20 mg/kg 3 times a day for 5 days (not to exceed 1 gram 3 times daily) is recommended for the treatment of chickenpox in pediatric patients aged 2 to less than 18 years. 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. Valacyclovir is also not recommended for the treatment of herpes zoster in children because safety data up to 7 days’ duration are not available [see Use in Specific Populations (8.4)].
Valacyclovir tablets, USP, equivalent to 500 mg of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed “SZ” on one side and 393 on the other side and are supplied as follows:.
NDC 0781-5208-31 in bottles of 30 tablets with child-resistant closure
NDC 0781-5208-92 in bottles of 90 tablets with child-resistant closure
NDC 0781-5208-01 in bottles of 100 tablets with child-resistant closure
NDC 0781-5208-05 in bottles of 500 tablets
NDC 0781-5208-13 carton of 100 tablets (10 x 10 Unit-dose)
Valacyclovir tablets, USP, equivalent to 1 gm of valacyclovir base, are blue, capsule-shaped, film-coated tablets debossed “SZ” on one side and 394 on other side with partial score bar on both sides and are supplied as follows:
NDC 0781-5209-27 in bottles of 21 tablets with child-resistant closure
NDC 0781-5209-31 in bottles of 30 tablets with child-resistant closure
NDC 0781-5209-92 in bottles of 90 tablets with child-resistant closure
NDC 0781-5209-01 in bottles of 100 tablets with child-resistant closure
NDC 0781-5209-05 in bottles of 500 tablets
NDC 0781-5209-13 carton of 100 tablets (10 x 10 Unit-dose)
Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Protect from moisture.
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Importance of Adequate Hydration
Patients should be advised to maintain adequate hydration.
Instruct patients that if they miss a dose of valacyclovir tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose.
Cold Sores (Herpes Labialis)
Patients should be advised to initiate treatment at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer). 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. Patients should be informed that valacyclovir hydrochloride is not a cure for cold sores.
Patients should be informed that valacyclovir hydrochloride is not a cure for genital herpes. 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 is frequently transmitted in the absence of symptoms through asymptomatic viral shedding. Therefore, patients should be counseled to use safer sex practices in combination with suppressive therapy with valacyclovir hydrochloride. 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.
Valacyclovir hydrochloride has not been shown to reduce transmission of sexually transmitted infections other than HSV-2.
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 the safety or effectiveness of chronic suppressive therapy of more than 1 year’s duration in otherwise healthy patients. There are no data on the safety or effectiveness of chronic suppressive therapy of more than 6 months’ duration in HIV-1˗infected patients.
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.
Patients should be advised to initiate treatment at the earliest sign or symptom of chickenpox.
Manufactured in India by Sandoz Private Limited
for Sandoz Inc., Princeton, NJ 08540
Valacyclovir Tablets, USP
(val ay sye’ kloe veer)
What are valacyclovir tablets?
Valacyclovir tablets are a prescription medicine used in adults:
Valacyclovir tablets are used in children to treat:
Valacyclovir tablets do not cure cold sores, chickenpox, shingles or genital herpes.
Do not take valacyclovir tablets if you are allergic to valacyclovir, acyclovir, or any of the ingredients in valacyclovir tablets. See the end of this leaflet for a complete list of ingredients in valacyclovir tablets.
Before you take valacyclovir tablets, tell your healthcare provider about all of your medical conditions, including if you:
How should I take valacyclovir tablets?
What are the possible side effects of valacyclovir tablets?
Valacyclovir tablets can cause serious side effects including:
Elderly people are more likely to get certain side effects. Talk to your healthcare provider if this is a concern for you.
The most common side effects of valacyclovir tablets in adults include:
The most common side effect of valacyclovir tablets in children less than 18 years of age is headache.
These are not all the possible side effects of valacyclovir tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store valacyclovir tablets?
General information about the safe and effective use of valacyclovir tablets
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use valacyclovir tablets for a condition for which it was not prescribed. Do not give valacyclovir tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about valacyclovir tablets that is written for health professionals.
What are the ingredients in valacyclovir tablets?
Active Ingredient: valacyclovir hydrochloride
Manufactured in India by Sandoz Private Limited
for Sandoz Inc., Princeton, NJ 08540
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: January 2020
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.