Indication: Valacyclovir tablet is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients ( Error! Hyperlink reference not valid. ) Pediatric Patients ( Error! Hyperlink reference not valid. ) Limitations of Use ( Error! Hyperlink reference not valid. ) Cold Sores (Herpes Labialis) Genital Herpes Initial Episode: Recurrent Episodes: Suppressive Therapy: Reduction of Transmission: Sexually Transmitted Diseases Treatment Guidelines Herpes Zoster Cold Sores (Herpes Labialis) Chickenpox [see Clinical Studies ( Error! Hyperlink reference not valid. The efficacy and safety of valacyclovir tablets have not been established in: 3.

Indication: Herpes Zoster Infections: Genital Herpes: Chickenpox:

Indication: INDICATIONS & USAGE
Herpes Zoster Infections: Genital Herpes: Chickenpox:
Herpes Simplex
Short-Term Administration: Long-Term Administration:
Chickenpox
The most frequent adverse event reported during 3 clinical trials of treatment of chickenpox with oral acyclovir tablets at doses of 10 to 20 mg/kg 4 times daily for 5 to 7 days or 800 mg 4 times daily for 5 days in 495 patients was diarrhea (3.2%). The 498 patients receiving placebo reported diarrhea (2.2%).

Indication: Valacyclovir hydrochloride is a deoxynucleoside 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-1-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 tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. Cold Sores (Herpes Labialis) Genital Herpes Recurrent Episodes: Suppressive Therapy: Reduction of Transmission: Sexually Transmitted Diseases Treatment Guidelines Herpes Zoster Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e. , papule, vesicle, or ulcer) has not been established. Chickenpox Valacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based on efficacy data from clinical trials with oral acyclovir, treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash [see Clinical Studies (14. 4) The efficacy and safety of valacyclovir tablets have not been established in: Immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 Patients aged less than 12 years with cold sores (herpes labialis). Patients aged less than 2 years or greater than or equal to 18 years with chickenpox. Patients aged less than 18 years with genital herpes. Patients aged less than 18 years with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.

Indication: Herpes Zoster Infections: Genital Herpes: Chickenpox:

Indication: Valacyclovir tablets are a deoxynucleoside 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-1-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 tablets have not been established in immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients. Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis). The efficacy of valacyclovir tablets initiated after the development of clinical signs of a cold sore (e. , papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode: Recurrent Episodes: Suppressive Therapy: Reduction of Transmission: Sexually Transmitted Diseases Treatment Guidelines). Herpes Zoster Valacyclovir tablets are indicated for the treatment of herpes zoster (shingles) in immunocompetent adults. The efficacy of valacyclovir tablets when initiated more than 72 hours after the onset of rash and the efficacy and safety of valacyclovir tablets for treatment of disseminated herpes zoster have not been established. Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for the treatment of cold sores (herpes labialis) in pediatric patients aged greater than or equal to 12 years. Chickenpox Valacyclovir tablets are indicated for the treatment of chickenpox in immunocompetent pediatric patients aged 2 to less than 18 years. Based on efficacy data from clinical trials with oral acyclovir, treatment with valacyclovir tablets should be initiated within 24 hours after the onset of rash [see Clinical Studies (14. 4) The efficacy and safety of valacyclovir tablets have not been established in: Immunocompromised patients other than for the suppression of genital herpes in HIV-1-infected patients with a CD4+ cell count greater than or equal to 100 cells/mm 3 Patients aged less than 12 years with cold sores (herpes labialis). Patients aged less than 2 years or greater than or equal to 18 years with chickenpox. Patients aged less than 18 years with genital herpes. Patients aged less than 18 years with herpes zoster. Neonates and infants as suppressive therapy following neonatal herpes simplex virus (HSV) infection.