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1 Indications & Usage Famciclovir, Usp A Prodrug Of Penciclovir, Is A Deoxynucleoside Analogue 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 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 Patient Herpes Labialis(Cold Sores): Famciclovir Is Indicated For The Treatment Of Recurrent Herpes Labialis In Adult Patients. 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 In Adult Patients. 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 In Adult Patients. 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, Usp Is Indicated For The Treatment Of Recurrent Episodes Of Orolabial Or Genital Herpes In Hiv-Infected Adults. The Efficacy Of Famciclovir, Usp 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 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
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