famciclovir 500 MG Oral Tablet
1 INDICATIONS AND USAGE Famciclovir Tablets, a prodrug of penciclovir, is a nucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) Herpes labialis (cold sores) Treatment of recurrent episodes Genital herpes Treatment of recurrent episodes Suppressive therapy of recurrent episodes Herpes zoster (shingles) HIV-Infected Adult Patients ( 1.2 ) Treatment of recurrent episodes of orolabial or genital herpes Limitation of Use ( 1.3 ) The efficacy and safety of Famciclovir Tablets have not been established for: Patients < 18 years of age Immunocompromised patients other than for the treatment of recurrent episodes of orolabial or genital herpes in HIV-infected patients Black and African American patients with recurrent genital herpes 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. Herpes zoster (shingles): Famciclovir Tablets are indicated for the treatment of herpes zoster. 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. 1.3 Limitation of Use The efficacy and safety of Famciclovir Tablets 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
AvKARE, Inc.
OVAL WHITE 8119 93
8119 93 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Famciclovir Tablets are supplied as follows: 125 mg – white, round, film-coated unscored tablets, debossed with “8117” on one side and “93” on the other side; available in bottles of 30. NDC 42291-275-30 250 mg – white, round, film-coated, unscored tablets, debossed with “8118” on one side and “93” on the other side; available in bottles of 30. NDC 42291-276-30 500 mg – white, capsule-shaped, film-coated, unscored tablets, debossed with “8119” on one side and “93” on the other side; available in bottles of 30. NDC 42291-277-30 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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