DOSAGE AND ADMINISTRATION
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 |
Indications
|
Normal Dosage
Regimen
(Creatinine Clearance ≥50)
|
Creatinine Clearance (mL/min)
|
|
30-49
|
10-29
|
<10
|
|
Herpes zoster
|
1 gram every 8 hours
|
1 gram every
12 hours
|
1 gram every
24 hours
|
500 mg every
24 hours
|
|
Genital herpes
Initial treatment
|
1 gram every 12 hours
|
no reduction
|
1 gram every 24 hours
|
500 mg every 24 hours
|
|
Genital herpes
Recurrent episodes
|
500 mg every 12 hours
|
no reduction
|
500 mg every 24 hours
|
500 mg every 24 hours
|
|
Genital herpes
Suppressive therapy
|
1 gram every 24 hours
|
no reduction
|
500 mg every 24 hours
|
500 mg every 24 hours
|
|
500 mg every 24 hours
|
no reduction
|
500 mg every 48 hours
|
500 mg every 48 hours
|
|
Genital herpes
Suppressive therapy in
HIV-infected patients
|
500 mg every 12 hours
|
no reduction
|
500 mg every 24 hours
|
500 mg every 24 hours
|
|
Herpes labialis
(cold sores)
Do not exceed 1 day of treatment.
|
Two 2-gram doses taken about 12 hours apart
|
Two 1-gram doses taken about 12 hours apart
|
Two 500-mg doses taken about 12 hours apart
|
500-mg
single dose
|
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.
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