Famciclovir
FAMCICLOVIR- famciclovir tablet
Roxane Laboratories, 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.
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. The efficacy and safety of Famciclovir Tablets for the suppression of recurrent genital herpes beyond 1 year have 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.
1.3 Limitation of Use
The efficacy and safety of Famciclovir Tablets has not been established for:
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- Patients <18 years of age
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- Patients with first episode of genital herpes
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- Patients with ophthalmic zoster
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- Immunocompromised patients other than for the treatment of recurrent orolabial or genital herpes in HIV-infected patients
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 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 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 for chronic suppressive therapy of recurrent episodes of genital herpes is 250 mg twice daily.
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)].
| |||
| 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 | |||
| 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 | |
