1 INDICATIONS AND USAGE
Valacyclovir hydrochloride is a nucleoside analogue DNA polymerase inhibitor indicated for:
Adult Patients (
1.1)
Cold Sores (Herpes Labialis)
Genital Herpes
Treatment in immunocompetent patients (initial or recurrent episode)
Suppression in immunocompetent or HIV-infected patients
Reduction of transmission
Herpes Zoster
Pediatric Patients (
1.2)
Cold Sores (Herpes Labialis)
Chickenpox
Limitations of Use (
1.3)
The efficacy and safety of valacyclovir hydrochloride have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-infected patients.
1.1 Adult Patients
Cold Sores (Herpes Labialis): Valacyclovir Tablets, USP are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir hydrochloride initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.
Genital Herpes:
Initial Episode: Valacyclovir Tablets, USP are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 72hours after the onset of signs and symptoms has not been established.
Recurrent Episodes:
Valacyclovir Tablets, USP are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir hydrochloride when initiated more than 24hours after the onset of signs and symptoms has not been established.
Suppressive Therapy:
Valacyclovir Tablets, USP are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in immunocompetent and in HIVinfected adults. The efficacy and safety of valacyclovir hydrochloride for the suppression of genital herpes beyond 1year in immunocompetent patients and beyond 6months in HIVinfected patients have not been established.
Reduction of Transmission: Valacyclovir Tablets, USP are indicated for the reduction of transmission of genital herpes in immunocompetent adults. The efficacy of valacyclovir hydrochloride for the reduction of transmission of genital herpes beyond 8months in discordant couples has not been established. The efficacy of valacyclovir hydrochloride for the reduction of transmission of genital herpes in individuals with multiple partners and nonheterosexual couples has not been established. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention [CDC]
Sexually Transmitted Diseases Treatment Guidelines).
Herpes Zoster:
Valacyclovir Tablets, USP are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir hydrochloride when initiated more than 72hours after the onset of rash and the efficacy and safety of valacyclovir hydrochloride for treatment of disseminated herpes zoster have not been established.
1.2 Pediatric Patients
Cold Sores (Herpes Labialis): Valacyclovir Tablets, USP are indicated for the treatment of cold sores (herpes labialis) in pediatric patients 12years of age. The efficacy of valacyclovir hydrochloride initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer) has not been established.
Chickenpox:Valacyclovir Tablets, USPare indicated for the treatment of chickenpox in immunocompetent pediatric patients2 to <18 years of age. Based on efficacy data from clinicalstudies with oral acyclovir, treatment with valacyclovir tablets, USP should be initiated within 24 hours after the onset of rash
[see Clinical Studies (
14.4)]
.
1.3 Limitations of Use
The efficacy and safety of valacyclovirtablets, USPhave not been established in:
Immunocompromised patients other than for the suppression of genital herpes in HIVinfected patients with a CD4+ cell count 100cells/mm
3.
Patients <12years of age with cold sores (herpes labialis).
Patients <2 years of age or 18 years of age with chickenpox.
Patients <18years of age with genital herpes.
Patients <18years of age with herpes zoster.
Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.