Rx Item-Famciclovir 125MG 30 Tab by Teva Pharma USA

FAMVIR- famciclovir tablet, film coated
Novartis Pharmaceuticals Corporation

1 INDICATIONS AND USAGE

1.1 Immunocompetent Adult Patients
Herpes labialis (cold sores): 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 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.

1.2 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 less than 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

FAMVIR may be taken with or without food.

2.1 Dosing Recommendation in Immunocompetent Adult Patients
Herpes labialis (cold sores): 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 zoster (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.

2.2 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).

Rx Item-Famciclovir 125MG 30 Tab by Teva
Item No. RX619344, 619344, NDC No.: 00093-8117-56, 00093-117-56, 0009311756, 00093811756, 8117-56, 811756 UPC No. 3-00938-11756-7, 300938-117567, 300938117567

Rx Item-Famciclovir 125MG 30 Tab by Teva
Item No. RX619344, 619344, NDC No.: 00093-8117-56, 00093-117-56, 0009311756, 00093811756, 8117-56, 811756 UPC No. 3-00938-11756-7, 300938-117567, 300938117567

Rx Item-Famciclovir 125MG 30 Tab by Teva
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