Two randomized double-blind clinical trials in immunocompetent adults with localized herpes zoster were conducted. Valacyclovir 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 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 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 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, 14-day valacyclovir, and 7-day oral acyclovir, respectively.
The use of valacyclovir 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 (C max : ↓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, 500 mg are blue colored capsule shaped, biconvex, film coated tablets debossed with ‘RDY’ on one side and ‘552’ on the other side containing 556.2 mg of valacyclovir hydrochloride equivalent to 500 mg valacyclovir and are supplied in bottles of 30, 42, 500 and unit dose packages of 100 (10 x 10).
Bottles of 30 NDC 49483-690-03
Bottles of 42 NDC 49483-690-41
Bottles of 500 NDC 49483-690-50
Unit dose packages of 100 (10×10) NDC 49483-690-04
Valacyclovir Tablets USP, 1 gram are blue, film-coated, capsule-shaped, biconvex tablets, with a partial score bar on both sides debossed with “RDY” on one side containing 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir and “553” on the other side and are supplied in bottles of 30, 100, 500 and unit dose packages of 100 (10 x 10).
Bottles of 30 NDC 49483-691-03
Bottles of 100 NDC 49483-691-01
Bottles of 500 NDC 49483-691-50
Unit dose packages of 100 (10×10) NDC 49483-691-04
Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].
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, 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 is not a cure for cold sores.
Patients should be informed that valacyclovir 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. 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 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.
Marksans Pharma Ltd.
Plot No. L-82, L-83, Verna Indl. Estate,
Verna, Goa – 403 722, India
Time-Cap Labs, Inc.
PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
|PATIENT INFORMATION Valacyclovir (val·a·cy·clo·vir ) Tablets, USP|
|What is valacyclovir tablet? Valacyclovir tablet is a prescription medicine used in adults: |
|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: |
| 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 Inactive Ingredients: pregelatinized starch, hypromellose, magnesium stearate, FD&C blue #2 indigo carmine aluminum lake, titanium dioxide, polyethylene glycol, carnauba wax and polysorbate 80. Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa – 403 722, India Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA|
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