Famciclovir

FAMCICLOVIR- famciclovir tablet, film coated
PD-Rx Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

1.1 Immunocompetent Adult Patients

Herpes labialis (cold sores): Famciclovir tablets are indicated for the treatment of recurrent herpes labialis in adult patients.

Genital herpes:

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

Suppressive therapy: Famciclovir tablets are indicated for chronic suppressive therapy of recurrent episodes of genital herpes in adult patients. The efficacy and safety of famciclovir tablets for the suppression of recurrent genital herpes beyond 1 year have not been established.

Herpes zoster (shingles): Famciclovir tablets are indicated for the treatment of herpes zoster in adult patients. The efficacy of famciclovir tablets when initiated more than 72 hours after onset of rash has not been established.

1.2 HIV-Infected Adult Patients

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

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 orolabial or genital herpes in HIV-infected patients
  • Black and African American patients with recurrent genital herpes

2 DOSAGE AND ADMINISTRATION

Famciclovir tablets may be taken with or without food.

2.1 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. Therapy should be initiated at the first sign or symptom of herpes labialis (e.g., 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. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., 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.

2.2 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. Therapy should be initiated at the first sign or symptom of a recurrent episode (e.g., tingling, itching, burning, pain, or lesion).

2.3 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 ( 8.6), Clinical Pharmacology ( 12.3) ] .

*
Hemodialysis

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 to 59

500

every 12 hours for 1 day

20 to 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 to 59

750

single dose

20 to 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 to 59

500

every 12 hours

20 to 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 to 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 to 39

500

every 24 hours

<20

250

every 24 hours

HD *

250

following each dialysis

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