Famciclovir

Famciclovir, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients. • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV) -Infected Adult Patients. • Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use The efficacy and safety of famciclovir tablets have not been established for: • Patients with first episode of genital herpes • Patients with ophthalmic zoster • Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV- infected patients • Black and African American patients with recurrent genital herpes

Famciclovir is an orally administered prodrug of the anti-alpha herpes viral agent penciclovir.

Famciclovir may be taken with or without food. Immunocompetent Adult Patients. Herpes labialis (cold sores) 1500 mg as a single dose Genital herpes Treatment of recurrent episodes 1000 mg twice daily for 1 day Suppressive therapy 250 mg twice daily Herpes zoster (shingles) 500 mg every 8 hours for 7 days HIV-Infected Adult Patients. Recurrent episodes of orolabial or genital herpes 500 mg twice daily for 7 days Patients with renal impairment: Adjust dose based on creatinine clearance.

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)

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

Acute renal failure is discussed in greater detail in other sections of the label. 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.

Probenecid: May increase penciclovir levels. Monitor for evidence of penciclovir toxicity Potential for Famciclovir to Affect Other Drugs The steady-state pharmacokinetics of digoxin were not altered by concomitant administration of multiple doses of famciclovir (500 mg three times daily). No clinically significant effect on the pharmacokinetics of zidovudine, its metabolite zidovudine glucuronide, or emtricitabine was observed following a single oral dose of 500 mg famciclovir coadministered with zidovudine or emtricitabine. An in vitro study using human liver microsomes suggests that famciclovir is not an inhibitor of CYP3A4 enzymes.

Store at 20° to 25°C (68°to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Store at controlled room temperature.