Valacyclovir (Valtrex) Indications and Dosage

Bell’s palsy _†

cytomegalovirus (CMV) _†

cytomegalovirus (CMV) infection prophylaxis _†

herpes genitalis

herpes genitalis prophylaxis

herpes labialis

herpes simplex infection prophylaxis _†

herpes simplex virus type 1

herpes simplex virus type 2

herpes zoster

varicella-zoster virus

_† non-FDA-approved indication

Valacyclovir (Valtrex) Indications and Dosage

The following viruses are generally considered susceptible to acyclovir, the active component of valacyclovir, in vitro: Epstein-Barr virus _† ; cytomegalovirus (CMV) _† ; herpes simplex virus type 1; herpes simplex virus type 2; varicella-zoster virus.

For the treatment of localized herpes zoster (shingles) in immunocompetent adults:
NOTE: Valacyclovir is not approved for the treatment of disseminated herpes zoster infections.

Oral dosage:
Adults: 1 g PO three times a day for 7 days starting at the first sign or symptom of herpes zoster (shingles), preferably within 48 hours of onset. Efficacy of treatment started after 72 hours has not been established.
Children: Safe and effective use has not been established.

For the treatment of recurrent infections of herpes labialis:
Oral dosage (one day treatment regimen):
Adults: 2 g PO every 12 hours for 2 doses starting at the first sign or symptom of lesions. There are no data supporting the effectiveness of beginning treatment after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer).

For the treatment of herpes genitalis:

for treatment of the initial episode of herpes genitalis in immunocompetent patients:
Oral dosage:
Adults and adolescents: 1 g PO twice daily for 10 days starting at the first sign or symptom of lesions, preferably within 48 hours of onset. The CDC recommends this same dose for 7 - 10 days; treatment may be extended if healing is not complete after 10 days. There are no data supporting the effectiveness of beginning treatment more than 72 hours after the onset of signs and symptoms.

for the treatment of recurrent herpes genitalis in immunocompetent patients:
Oral dosage:
Adults: 500 mg PO twice daily for 3 days starting at the first sign or symptom of lesions, preferably within 24 hours of onset. The CDC recommends this same dose for 3 - 5 days or 1 g PO once daily for 5 days. There are no data supporting the effectiveness of beginning treatment more than 24 hours after the onset of symptoms.

for the acute treatment of recurrent herpes genitalis in immunocompromised patients _† :
Oral dosage:
Adults: A dose of 1 g PO twice daily for 5 days has been studied. Treatment should be initiated by patients within 12 hours of symptoms. The CDC recommends this same dose for 5 - 10 days.

For herpes genitalis prophylaxis:

for suppressive therapy of recurrent herpes genitalis in immunocompetent patients:
Oral dosage:
Adults and adolescents: 1 g PO once daily. In patients with a history of <= 9 recurrences per year, 500 mg PO once daily may be given. The CDC recommends 500 mg PO once daily or 1 g PO once daily. Safety and efficacy of valacyclovir beyond 1 year have not been established.

for suppressive therapy of recurrent herpes genitalis in patients with human immunodeficiency virus (HIV) infection who have a CD4 cell count >= 100 cells/mm³:
Oral dosage:
Adults: 500 mg PO twice daily. The safety and efficacy of therapy beyond 6 months have not been established. This dose is also recommended by the CDC.

for the reduction of transmission of genital herpes to an immunocompetent uninfected sex partner, in immunocompetent patients with a history of 9 or fewer recurrences per year:
Oral dosage:
Adults: 500 mg PO once daily for the source partner decreases risk of transmission to the uninfected partner in monogamous, heterosexual relationships when combined with safer sex practices. The efficacy of reducing transmission beyond 8 months in discordant couples has not been established.

For primary cytomegalovirus (CMV) infection prophylaxis _† :
NOTE: Thrombotic thrombocytopenia purpura (TTP)/hemolytic uremic syndrome (HUS) as been associated with valacyclovir use in patients with advanced HIV disease and allogeneic bone marrow transplant and renal transplant patients (see Contraindications/Precautions).

for patients with AIDS:
Oral dosage:
Adults: The CDC does not recommend using valacyclovir for the prevention CMV disease in patients with AIDS. In a study that compared valacyclovir 2 g PO four times a day with two acyclovir regimens, valacyclovir-treated patients showed a 29% reduction in CMV end-organ disease at one year and a reduction in the risk of CMV disease; however, the trial was discontinued because of an unexpected trend toward earlier mortality at one year in valacyclovir-treated patients (24.3%) compared to those receiving high-dose or low-dose acyclovir (19.5% and 18.8%, respectively). In addition, toxicity and earlier medication discontinuation were more common in patients treated with valacyclovir.

for patients following kidney transplantation:
Oral dosage:
Adults: In a randomized trial, 2 g PO four times a day for 90 days post transplant significantly reduced the incidence of CMV disease in both CMV-seronegative and -seropositive patients. In this study, treatment with valacyclovir was associated with a decreased rate of CMV viremia and viruria, herpes simplex virus disease, and acute graft rejection.

for patients following bone marrow transplantation:
Oral dosage:
Adults: Valacyclovir 2 g PO four times daily was found to be as effective as IV ganciclovir in preventing CMV disease, when used for 100 days following engraftment, after bone marrow transplantation. Valacyclovir 1.5 - 2 g PO two to four times a day, is under investigation in a randomized, double-blind study in comparison with oral acyclovir. Therapy with valacyclovir or oral acyclovir follows an initial 28 day IV course of acyclovir for all patients, and continues for 14 weeks.

for patients following heart transplantation:
Oral dosage:
Adults: Valacyclovir 2 g PO four times a day, is under investigation in a randomized, double-blind study in comparison with acyclovir PO. Therapy is initiated within 48 hours of allograft and continued to day 90.

For herpes simplex infection prophylaxis _† in HIV-patients for frequent or severe recurrences:
Oral dosage:
Adults: As an alternative, the CDC recommends valacyclovir 500 mg PO twice daily.

For the treatment of Bell’s palsy _† :
Oral dosage:
Adults: 1 g PO twice daily for 7 days, with prednisone , has been recommended.

Maximum Dosage Limits:

Adults: 3 g/day PO.

Elderly: 3 g/day PO.

Adolescents: Maximum dosage information is not available.

Children: Maximum dosage information is not available.

Patients with hepatic impairment:
No dosage adjustment is necessary.

Patients with renal impairment:
CrCl >= 50 ml/min: no dosage adjustment needed.
CrCl 30 - 49 ml/min: For regimens of 1 g PO every 8 hours, change to 1 g PO every 12 hours. For one-day treatment of herpes labialis, give 1 g PO every 12 hours x 2 doses.
CrCl 10 - 29 ml/min: For regimens of 1 g PO every 8 - 12 hours, reduce dose to 1 g PO every 24 hours. For regimens of 1 g PO once daily or 500 mg PO every 12 hours, reduce dose to 500 mg PO once daily. For regimens of 500 mg PO once daily, change dose to 500 mg PO every 48 hours. For one-day treatment of herpes labialis, give 500 mg PO every 12 hours x 2 doses.
CrCl < 10 ml/min: For regimens of 1 g PO every 8 - 24 hours or 500 mg PO every 12 hours, reduce dose to 500 mg PO once daily. For regimens of 500 mg PO once daily, change dose to 500 mg PO every 48 hours. For one-day treatment of herpes labialis, give 500 mg PO x 1 dose.

Intermittent hemodialysis:
Patients should receive the recommended dosage of valacyclovir after dialysis.

_† non-FDA-approved indication

[ Last revised: 12/3/2004 4:44:00 PM ]

References
_{. Centers for Disease Control and Prevention (CDC). The Living Document: USPHS/IDSA Guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. Retrieved November 28, 2001. Available on the World Wide Web at http://www.hivatis.org.}

. Centers for Disease Control and Prevention (CDC). Sexually Transmitted Diseases Treatment Guidelines 2002. MMWR 2002;51(no. RR-06):1 - 80.

. Lowance D, Neumayer HH, Legendre CM, et al. Valacyclovir for the prevention of cytomegalovirus disease after renal transplantation. N Engl J Med 1999;340:1462 - 70.

. Feinberg JE, Hurwitz S, Cooper D, et al. A randomized, double-blind trial of valacyclovir prophylaxis for cytomegalovirus disease in patients with advanced human immunodeficiency virus infection. AIDS Clinical Trial Group Protocol 204/Glaxo Wellcome 123 - 014 International CMV Prophylaxis Study Group. J Infect Dis 1998;177;48 - 56.

. Winston DJ, Yeager AM, Chandrasekar PH, et al. Randomized Comparison of Oral Valacyclovir and Intravenous Ganciclovir for Prevention of Cytomegalovirus Disease after Allogeneic Bone Marrow Transplantation. Clin Infec Dis 2003;36:749 - 58.

Valacyclovir (Valtrex) Indications and Dosage

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