Famciclovir
Dosing in kidney impairment
Dosing Recommendation in Patients with Renal Impairment Dosage recommendations for adult patients with renal impairment are provided in Table 1 [see Use in Specific Populations, Clinical Pharmacology]. Table 1: Dosage Recommendations for Adult Patients with Renal Impairment [See table below.] Suppression of Recurrent Genital Herpes 250 mg every 12 hours ≥40 250 every 12 hours 20-39 125 every 12 hours <20 125 every 24 hours HD* 125 following each dialysis Recurrent Orolabial or Genital Herpes in HIV-Infected Patients 500 mg every 12 hours ≥40 500 every 12 hours 20-39 500 every 24 hours <20 250 every 24 hours HD* 250 following each dialysis *Hemodialysis
| Indication and Normal Dosage Regimen | Creatinine Clearance (mL/min) | Adjusted Dosage Regimen Dose (mg) | Dosing Interval |
| Single-Day Dosing Regimens Recurrent Genital Herpes 1000 mg every 12 hours for1 day | ≥60 | 1000 | every 12 hours for 1 day |
| 40-59 | 500 | every 12 hours for 1 day | |
| 20-39 | 500 | single dose | |
| <20 | 250 | single dose | |
| HD* | 250 | single dose following dialysis | |
| Recurrent Herpes Labialis 1500 mg single dose | ≥60 | 1500 | single dose |
| 40-59 | 750 | single dose | |
| 20-39 | 500 | single dose | |
| <20 | 250 | single dose | |
| HD* | 250 | single dose following dialysis | |
| Multiple-Day Dosing Regimens | |||
| Herpes Zoster 500 mg every 8 hours | ≥60 | 500 | every 8 hours |
| 40-59 | 500 | every 12 hours | |
| 20-39 | 500 | every 24 hours | |
| <20 | 250 | every 24 hours | |
| HD* | 250 | following each dialysis | |
| Suppression of Recurrent Genital Herpes 250 mg every 12 hours | ≥40 | 250 | every 12 hours |
| 20-39 | 125 | every 12 hours | |
| <20 | 125 | every 24 hours | |
| HD* | 125 | following each dialysis | |
| Recurrent Orolabial or Genital Herpes in HIV-Infected Patients 500 mg every 12 hours | ≥40 | 500 | every 12 hours |
| 20-39 | 500 | every 24 hours | |
| <20 | 250 | every 24 hours | |
| HD* | 250 | following each dialysis |
Dosing in liver impairment
Patients with Hepatic Impairment Mild or moderate hepatic impairment (chronic hepatitis [n=6], chronic ethanol abuse [n=8], or primary biliary cirrhosis [n=1]) had no effect on the extent of availability (AUC) of penciclovir following a single dose of 500 mg famciclovir. However, there was a 44% decrease in penciclovir mean maximum plasma concentration (C max ) and the time to maximum plasma concentration (t max ) was increased by 0.75 hours in patients with hepatic impairment compared to normal volunteers.
No dosage adjustment is recommended for patients with mild or moderate hepatic impairment. The pharmacokinetics of penciclovir has not been evaluated in patients with severe hepatic impairment. Conversion of famciclovir to the active metabolite penciclovir may be impaired in these patients resulting in a lower penciclovir plasma concentrations, and thus possibly a decrease of efficacy of famciclovir [see Clinical Pharmacology].