Valacyclovir Hydrochloride valacyclovir 1000 MG Oral Tablet
1 INDICATIONS AND USAGE 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. 1.1 Adult 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.g., 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. Suppressive Therapy Valacyclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of Genital Herpes in immunocompetent and in HIV-1–infected adults. The efficacy and safety of valacyclovir tablets for the suppression of Genital Herpes beyond 1 year in immunocompetent patients and beyond 6 months in HIV-1–infected patients have not been established. Reduction of Transmission Valacyclovir tablets are indicated for the reduction of transmission of Genital Herpes in immunocompetent adults. The efficacy of valacyclovir tablets for the reduction of transmission of Genital Herpes beyond 8 months in discordant couples has not been established. The efficacy of valacyclovir tablets for the reduction of transmission of Genital Herpes in individuals with multiple partners and non-heterosexual 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 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. 1.2 Pediatric Patients 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.g., papule, vesicle, or ulcer) has not been established. Chickenpox Valacyclovir is 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 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 valacyclovir 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.
Mylan Pharmaceuticals Inc.
OVAL WHITE M123
M123 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING
VALACYCLOVIR Tablets, USP are available containing 556.2 mg or 1.112 grams of
VALACYCLOVIR hydrochloride, USP (hydrous), which are equivalent to 500 mg or 1 gram of
VALACYCLOVIR, on the anhydrous basis, respectively. The 500 mg tablets are white, film-coated, oval, unscored tablets with M122 imprinted with black ink on one side of the tablet and plain on the other side of the tablet. They are available as follows: NDC 0378-4275-93 bottles of 30 tablets NDC 0378-4275-77 bottles of 90 tablets The 1 gram tablets are white, film-coated, oval tablets with a partial break line on both sides of the tablet and M123 imprinted with black ink on one side of the tablet. They are available as follows: NDC 0378-4276-93 bottles of 30 tablets NDC 0378-4276-77 bottles of 90 tablets Storage: Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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