Valaciclovir instructions for administration

Instructions for administration
Overview Herpes zoster Genital herpes Cold sores (herpes labialis)''' Patients with acute or chronic renal impairment''' Hemodialysis''' Peritoneal dialysis'''
 * Initial episodes
 * Recurrent episodes
 * Suppressive therapy
 * Reduction of transmission

Overview
Valaciclovir Caplets may be given without regard to meals. Return to top

Herpes zoster
The recommended dosage of Valaciclovir 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. Return to top

Initial episodes
The recommended dosage of Valaciclovir for treatment of initial genital herpes is 1 gram twice daily for 10 days. There are no data on the effectiveness of treatment with Valaciclovir 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. Return to top

Recurrent episodes
The recommended dosage of Valaciclovir 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 Valaciclovir when initiated more than 24 hours after the onset of signs or symptoms. Return to top

Suppressive therapy
The recommended dosage of Valaciclovir 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 Valaciclovir beyond 1 year have not been established. In HIV-infected patients with CD4 cell count≥100 cells/mm3, the recommended dosage of Valaciclovir for chronic suppressive therapy of recurrent genital herpes is 500 mg twice daily. The safety and efficacy of therapy with Valaciclovir beyond 6 months in patients with HIV infection have not been established. Return to top

Reduction of transmission
The recommended dosage of Valaciclovir 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 Valaciclovir. The efficacy of reducing transmission beyond 8 months in discordant couples has not been established. Return to top

Cold sores (herpes labialis)
The recommended dosage of Valaciclovir 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). Return to top

Patients with acute or chronic renal impairment
See FDA label. Return to top

Hemodialysis
During hemodialysis, the half-life of acyclovir after administration of Valaciclovir 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 Valaciclovir after hemodialysis. Return to top

Peritoneal dialysis
There is no information specific to administration of Valaciclovir 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 Valaciclovir should not be required following CAPD or CAVHD. Return to top