Valacyclovir

4). 4). 4). 1). 4)

APO-VALACYCLOVIR, valacyclovir tablets (as valacyclovir hydrochloride) is indicated: • For the treatment of herpes zoster (shingles) in adult patients. • For the treatment or suppression of genital herpes in immunocompetent adult patients and for the suppression of recurrent genital herpes in HIV infected adult patients.

• To reduce the risk of transmission of genital herpes with the use of suppressive therapy in adult patients. Safer sex practices should be used with suppressive therapy. • For the treatment of cold sores (herpes labialis) in adult patients and adolescent patients ≥ 12 years of age.

1 Pediatrics Pediatrics (< 12 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (> 65 years of age): Use in the geriatric population may be associated with differences in safety due to age-related changes in renal function and a brief discussion can be found in the appropriate sections (see 7 WARNINGS AND PRECAUTIONS, Renal).

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. 1 Adult Patients Cold Sores (Herpes Labialis) Valacyclovir tablets are indicated for treatment of cold sores (herpes labialis).

, papule, vesicle, or ulcer) has not been established. Genital Herpes Initial Episode Valacyclovir tablets are indicated for treatment of the initial episode of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 72 hours after the onset of signs and symptoms has not been established.

Recurrent Episodes Valacyclovir tablets are indicated for treatment of recurrent episodes of genital herpes in immunocompetent adults. The efficacy of treatment with valacyclovir tablets when initiated more than 24 hours after the onset of signs and symptoms has not been established.