Famciclovir

2 DOSAGE & ADMINISTRATION Famciclovir tablets may be taken with or without food. 2 ) Recurrent episodes of orolabial or genital herpes 500 mg twice daily for 7 days Patients with renal impairment: Adjust dose based on creatinine clearance.

1 Dosing Recommendation in Immunocompetent Adult Patients Herpes labialis (cold sores): The recommended dosage of famciclovir tablets for the treatment of recurrent herpes labialis is 1500 mg as a single dose. , tingling, itching, burning, pain, or lesion).

Genital herpes:

Recurrent episodes: The recommended dosage of famciclovir tablets for the treatment of recurrent episodes of genital herpes is 1000 mg twice daily for 1 day. , tingling, itching, burning, pain, or lesion).

Suppressive therapy:

The recommended dosage of famciclovir tablets for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes zoster (shingles):

The recommended dosage of famciclovir tablets for the treatment of herpes zoster is 500 mg every 8 hours for 7 days. Therapy should be initiated as soon as herpes zoster is diagnosed. 2 Dosing Recommendation in HIV-Infected Adult Patients Recurrent orolabial or genital herpes: The recommended dosage of famciclovir tablets for the treatment of recurrent orolabial or genital herpes in HIV-infected patients is 500 mg twice daily for 7 days.

, tingling, itching, burning, pain, or lesion). 3 )].

Table 1:

Dosage Recommendations for Adult Patients with Renal Impairment 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 *Hemodialysis

6 ADVERSE REACTIONS Acute renal failure is discussed in greater detail in other sections of the label [see Warnings and Precautions ( 5 )]. The most common adverse events reported in at least 1 indication by greater than 10% of adult patients treated with famciclovir are headache and nausea.

The most common adverse events reported in at least 1 indication by greater than 10% of adult patients are headache and nausea. gov/medwatch . 1 Clinical Trials Experience in Adult Patients Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Immunocompetent patients:

The safety of famciclovir has been evaluated in active- and placebo-controlled clinical studies involving 816 famciclovir-treated patients with herpes zoster (famciclovir, 250 mg three times daily to 750 mg three times daily), 163 famciclovir-treated patients with recurrent genital herpes (Famciclovir, 1000 mg twice daily); 1,197 patients with recurrent genital herpes treated with famciclovir as suppressive therapy (125 mg once daily to 250 mg three times daily) of which 570 patients received famciclovir (open-labeled and/or double-blind) for at least 10 months; and 447 famciclovir-treated patients with herpes labialis (Famciclovir, 1500 mg once daily or 750 mg twice daily).

Table 2 lists selected adverse events. 0 * Patients may have entered into more than one clinical trial. † 7 days of treatment ‡ 1 day of treatment § daily treatment Table 3 lists selected laboratory abnormalities in genital herpes suppression trials.

7 * Percentage of patients with laboratory abnormalities that were increased or decreased from baseline and were outside of specified ranges. † n values represent the minimum number of patients assessed for each laboratory parameter.

5 WARNINGS AND PRECAUTIONS Acute renal failure: May occur in patients with underlying renal disease who receive higher than recommended doses of famciclovir for their level of renal function. Reduce dosage in patients with renal impairment.

1 Acute Renal Failure Cases of acute renal failure have been reported in patients with underlying renal disease who have received inappropriately high doses of famciclovir for their level of renal function. 6 )].

4 CONTRAINDICATIONS Famciclovir tablets are contraindicated in patients with known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream). Known hypersensitivity to the product, its components, or Denavir ® (penciclovir cream).

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