Herpes Zoster: VALTREX is indicated for the treatment of herpes zoster (shingles).

Genital Herpes: VALTREX is indicated for the treatment or suppression of genital herpes in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals.

When VALTREX is used as suppressive therapy in immunocompetent individuals with genital herpes, the risk of heterosexual transmission to susceptible partners is reduced. Safer sex practices should be used with suppressive therapy (see current Centers for Disease Control and Prevention (CDC) Sexually Transmitted Diseases Treatment Guidelines).

Cold Sores (Herpes Labialis): VALTREX is indicated for the treatment of cold sores (herpes labialis).

VALTREX Caplets may be given without regard to meals.

Herpes Zoster: The recommended dosage of VALTREX for the treatment of herpes zoster is 1 gram orally 3 times daily for 7 days. Therapy should be initiated at the earliest sign or symptom of herpes zoster and is most effective when started within 48 hours of the onset of zoster rash. No data are available on efficacy of treatment started greater than 72 hours after rash onset.

Genital Herpes

Initial Episodes: The recommended dosage of VALTREX for treatment of initial genital herpes is 1 gram twice daily for 10 days.

There are no data on the effectiveness of treatment with VALTREX when initiated more than 72 hours after the onset of signs and symptoms. Therapy was most effective when administered within 48 hours of the onset of signs and symptoms.

Recurrent Episodes: The recommended dosage of VALTREX for the treatment of recurrent genital herpes is 500 mg twice daily for 3 days.

If medical management of a genital herpes recurrence is indicated, patients should be advised to initiate therapy at the first sign or symptom of an episode. There are no data on the effectiveness of treatment with VALTREX when initiated more than 24 hours after the onset of signs or symptoms.

Suppressive Therapy: The recommended dosage of VALTREX for chronic suppressive therapy of recurrent genital herpes is 1 gram once daily in patients with normal immune function. In patients with a history of 9 or fewer recurrences per year, an alternative dose is 500 mg once daily. The safety and efficacy of therapy with VALTREX beyond 1 year have not been established.

In HIV-infected patients with CD4 cell count ≥ 100 cells/mm³, the recommended dosage of VALTREX for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily. The safety and efficacy of therapy with VALTREX beyond 6 months in patients with HIV infection have not been established.

Reduction of Transmission: The recommended dosage of VALTREX for reduction of transmission of genital herpes in patients with a history of 9 or fewer recurrences per year is 500 mg once daily for the source partner. Patients should be counseled to use safer sex practices in combination with suppressive therapy with VALTREX. The efficacy of reducing transmission beyond 8 months in discordant couples has not been established.

Cold Sores (Herpes Labialis): The recommended dosage of VALTREX for the treatment of cold sores is 2 grams twice daily for 1 day taken about 12 hours apart. Therapy should be initiated at the earliest symptom of a cold sore (e.g., tingling, itching, or burning). There are no data on the effectiveness of treatment initiated after the development of clinical signs of a cold sore (e.g., papule, vesicle, or ulcer).

Patients with Acute or Chronic Renal Impairment: In patients with reduced renal function, reduction in dosage is recommended (see Table 7).

Table 7. Dosages for Patients with Renal Impairment

Hemodialysis: During hemodialysis, the half-life of acyclovir after administration of VALTREX is approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session. Patients requiring hemodialysis should receive the recommended dose of VALTREX after hemodialysis.

Peritoneal Dialysis: There is no information specific to administration of VALTREX in patients receiving peritoneal dialysis. The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied. The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis, and the pharmacokinetic parameters closely resemble those observed in patients with ESRD not receiving hemodialysis. Therefore, supplemental doses of VALTREX should not be required following CAPD or CAVHD.

VALTREX Caplets (blue, film-coated, capsule-shaped tablets) containing valacyclovir hydrochloride equivalent to 500 mg valacyclovir and printed with "VALTREX 500 mg."

Bottle of 30 (NDC 0173-0933-08).
Bottle of 90 (NDC 0173-0933-10).
Unit dose pack of 100 (NDC 0173-0933-56).

VALTREX Caplets (blue, film-coated, capsule-shaped tablets, with a partial scorebar on both sides) containing valacyclovir hydrochloride equivalent to 1 gram valacyclovir and printed with "VALTREX 1 gram."

Bottle of 30 (NDC 0173-0565-04).
Bottle of 90 (NDC 0173-0565-10).

Store at 15° to 25°C (59° to 77°F). Dispense in a well-closed container as defined in the USP.

VALTREX and ZOVIRAX are registered trademarks of GlaxoSmithKline. Manufactured by: GlaxoSmithKline, Research Triangle Park, NC 27709 or DSM Pharmaceuticals, Inc. Greenville, NC 27834. October 2007. FDA Rev date: 12/11/2007

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