Famciclovir indications and usage

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Famciclovir
FAMVIR® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Indications And Usage

Immunocompetent Adult Patients

Herpes labialis (cold sores)

FAMVIR is indicated for the treatment of recurrent herpes labialis.

Genital herpes

Recurrent episodes: FAMVIR is indicated for the treatment of recurrent episodes of genital herpes. The efficacy of FAMVIR when initiated more than 6 hours after onset of symptoms or lesions has not been established.

Suppressive therapy: FAMVIR is indicated for chronic suppressive therapy of recurrent episodes of genital herpes. The efficacy and safety of FAMVIR for the suppression of recurrent genital herpes beyond 1 year have not been established.

Herpes zoster (shingles): FAMVIR is indicated for the treatment of herpes zoster. The efficacy of FAMVIR when initiated more than 72 hours after onset of rash has not been established.

HIV-Infected Adult Patients

Recurrent orolabial or genital herpes: FAMVIR is indicated for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected adults. The efficacy of FAMVIR when initiated more than 48 hours after onset of symptoms or lesions has not been established.

Limitation of Use

The efficacy and safety of FAMVIR have not been established for:

  • Patients <18 years of age
  • Patients with first episode of genital herpes
  • Patients with ophthalmic zoster
  • Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
  • Black and African American patients with recurrent genital herpes

[1]

References

  1. "http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020363s037lbl.pdf" (PDF). External link in |title= (help)

Adapted from the FDA Package Insert.