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Famvir (Famciclovir) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Immunocompetent Adult Patients

Herpes l abialis ( c old s ores): FAMVIR is indicated for the treatment of recurrent herpes labialis.

Genital h erpes:  

Recurrent e pisodes: 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 t herapy: 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 z oster (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

DOSAGE AND ADMINISTRATION

FAMVIR may be taken with or without food.

Dosing Recommendation in Immunocompetent Adult Patients

Herpes l abialis ( c old s ores):  The recommended dosage of FAMVIR for the treatment of recurrent herpes labialis is 1500 mg as a single dose. Therapy should be initiated at the first sign or symptom of herpes labialis (e.g., tingling, itching, burning, pain, or lesion).

Genital h erpes:  

Recurrent e pisodes: The recommended dosage of FAMVIR for the treatment of recurrent episodes of genital herpes is 1000 mg twice daily for 1 day. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

Suppressive t herapy: The recommended dosage of FAMVIR for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes z oster (shingles) :  The recommended dosage of FAMVIR 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.

Dosing Recommendation in HIV-Infected Adult Patients

Recurrent orolabial or genital herpes : The recommended dosage of FAMVIR for the treatment of recurrent orolabial or genital herpes in HIV-infected patients is 500 mg twice daily for 7 days. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

Dosing Recommendation in Patients with Renal Impairment

Dosage recommendations for adult patients with renal impairment are provided in Table 1 [see Use i n Specific Populations (8.6), Clinical Pharmacology (12.3 )].

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 for 1 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

DOSAGE FORMS AND STRENGTHS

FAMVIR tablets are available in 3 strengths:

  • 125 mg: White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “125” on the other side
  • 250 mg: White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “250” on the other side
  • 500 mg: White, oval film-coated, biconvex, debossed with “FAMVIR” on one side and “500” on the other side

HOW SUPPLIED/STORAGE AND HANDLING

FAMVIR tablets are supplied as film-coated tablets as follows: 125 mg in bottles of 30; 250 mg in bottles of 30; 500 mg in bottles of 30, and Single Unit Packages of 50 (intended for institutional use only).

  • FAMVIR 125 mg tablet:
    White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “125” on the other.
    125 mg 30’s………………………………………………………………………………………… NDC 0078-0366-15
  • FAMVIR 250 mg tablet:
    White, round film-coated, biconvex, beveled edges, debossed with “FAMVIR” on one side and “250” on the other.
    250 mg 30’s………………………………………………………………………………………… NDC 0078-0367-15
  • FAMVIR 500 mg tablet:
    White, oval film-coated, biconvex, debossed with “FAMVIR” on one side and “500” on the other.
    500 mg 30’s………………………………………………………………………………………… NDC 0078-0368-15
    500 mg SUP 50’s……………………………………………………………………………...…… NDC 0078-0368-64

      Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

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