Famciclovir

FAMCICLOVIR- famciclovir tablet
West-Ward Pharmaceuticals Corp.

1 INDICATIONS AND USAGE

1.1 Immunocompetent Adult Patients

Herpes Labialis (Cold Sores)

Famciclovir is indicated for the treatment of recurrent herpes labialis.

Genital Herpes

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

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

Herpes Zoster (Shingles)

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

1.3 Limitation of Use

The efficacy and safety of famciclovir has 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

2 DOSAGE AND ADMINISTRATION

Famciclovir may be taken with or without food.

2.1 Dosing Recommendation in Immunocompetent Adult Patients

Herpes Labialis (Cold Sores)

The recommended dosage of famciclovir for the treatment of recurrent herpes labialis is 1,500 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 for the treatment of recurrent episodes of genital herpes is 1,000 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 for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.

Herpes Zoster (Shingles)

The recommended dosage of famciclovir 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 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)].

Table 1: Dosage Recommendations for Adult Patients with Renal Impairment
*
Hemodialysis

Indication and Normal Dosage Regimen

Creatinine Clearance (mL/min)

Adjusted Dosage Regimen Dose (mg)

Dosing Interval

Single-Day Dosing Regimens

Recurrent Genital Herpes

1,000 mg Every 12 Hours for 1 Day

≥60

1,000

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

1,500 mg Single-Dose

≥60

1,500

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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