famciclovir 500 MG Oral Tablet
1 INDICATIONS & USAGE Famciclovir tablet, a prodrug of penciclovir, is a deoxynucleoside analog DNA polymerase inhibitor indicated for: Immunocompetent Adult Patients ( 1.1 ) • Herpes labialis (cold sores) o Treatment of recurrent episodes • Genital herpes o Treatment of recurrent episodes o Suppressive therapy of recurrent episodes • Herpes zoster (shingles) Human Immunodeficiency Virus (HIV)-Infected Adult Patients ( 1.2 ) • Treatment of recurrent episodes of orolabial or genital herpes 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 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 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
camber pharmaceuticals, inc.
OVAL WHITE I 48
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16 HOW SUPPLIED/STORAGE AND HANDLING •
FAMCICLOVIR Tablets 125 mg: Off white, round, biconvex, film coated tablets, debossed with 'I' on one side and '50' on the other side. They are available as follows Bottles of 30 tablets NDC 31722-706-30 Bottles of 60 tablets NDC 31722-706-60 Bottles of 100 tablets NDC31722-706-01 Bottles of 500 tablets NDC 31722-706-05 Bottles of 1000 tablets NDC 31722-706-10 •
FAMCICLOVIR Tablets 250 mg: Off white, round, biconvex, film coated tablets, debossed with 'I' on one side and '49' on the other side. They are available as follows Bottles of 30 tablets NDC 31722-707-30 Bottles of 60 tablets NDC 31722-707-60 Bottles of 100 tablets NDC 31722-707-01 Bottles of 500 tablets NDC 31722-707-05 Bottles of 1000 tablets NDC 31722-707-10 •
FAMCICLOVIR Tablets 500 mg: Off white, oval, film coated, biconvex tablets, debossed with 'I' on one side and '48' on the other side. They are available as follows Bottles of 30 tablets NDC 31722-708-30 Bottles of 60 tablets NDC 31722-708-60 Bottles of 100 tablets NDC 31722-708-01 Bottles of 500 tablets NDC 31722-708-05 Bottles of 1000 tablets NDC 31722-708-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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