Famvir

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Famvir Information

Herpes Zoster

Famvir (famciclovir) is indicated for the treatment of acute herpes zoster (shingles).

Herpes Simplex Infections

Famvir is indicated for:

• treatment or suppression of recurrent genital herpes in immunocompetent patients
• treatment of recurrent mucocutaneous herpes simplex infections in HIV infected patients.

Famvir Ingredients and Composition

How Does Famvir Work?

Mechanism of Famvir Antiviral Activity

Famciclovir, the active ingredient in Famvir, undergoes rapid biotransformation to the active antiviral compound penciclovir, which has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). In cells infected with HSV-1, HSV-2 or VZV, viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV-2 DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited.

Penciclovir triphosphate has an intracellular half-life of 10 hours in HSV-1-,20 hours in HSV-2- and 7 hours in VZV-infected cells cultured in vitro; however, the clinical significance is unknown.

HIV-lnfected Patients

Following oral administration of a single dose of 500 mg Famvir (famciclovir) (the oral prodrug of penciclovir) to HIV-positive patients, the pharmacokinetic parameters of penciclovir were comparable to those observed in healthy subjects.

How To Take Famvir and Famvir Dosage and Administration

Herpes Zoster

The recommended Famvir dosage is 500 mg every 8 hours for 7 days. Therapy should be initiated promptly as soon as herpes zoster is diagnosed. No data are available on efficacy of treatment started greater than 72 hours after rash onset.

Herpes Simplex Infections

Recurrent genital herpes: The recommended Famvir dosage is 125 mg twice daily for 5 days. Initiate therapy at the first sign or symptom if medical management of a genital herpes recurrence is indicated. The efficacy of Famvir has not been established when treatment is initiated more than 6 hours after onset of symptoms or lesions.

Suppression of recurrent genital herpes: The recommended Famvir dosage is 250 mg twice daily for up to 1 year. The safety and efficacy of Famvir therapy beyond 1 year of treatment have not been established.

HIV-Infected Patients: For recurrent orolabial or genital herpes simplex infection, the recommended Famvir dosage is 500 mg twice daily for 7 days. In patients with reduced renal function, dosage reduction is recommended.

Administration with Food: When famciclovir was administered with food, penciclovir Cmax decreased approximately 50%. Because the systemic availability of penciclovir (AUC) was not altered, it appears that Famvir may be taken without regard to meals.

If you suspect a Famvir Overdose

Appropriate symptomatic and supportive therapy should be given. Famvir (famciclovir) is removed by hemodialysis.

Famvir Side Effects

Famvir Precautions and Contraindications

General

The efficacy of Famvir has not been established for initial episode genital herpes infection, ophthalmic zoster, disseminated zoster or in immunocompromised patients with herpes zoster.

Dosage adjustment is recommended when administering Famvir to patients with creatinine clearance values <60 mL/min. In patients with underlying renal disease who have received inappropriately high doses of Famvir for their level of renal function, acute renal failure has been reported.

Taking Famvir during Pregnancy or Breast-feeding

Following oral administration of Famvir (famciclovir) to lactating rats, penciclovir was excreted in breast milk at concentrations higher than those seen in the plasma. It is not known whether it is excreted in human milk. There are no data on the safety of Famvir in infants.

Contraindications to Famvir

Famvir (famciclovir) is contraindicated in patients with known hypersensitivity to the product, its components, and Denavir (penciclovir cream).

Famvir Drug Interactions

Concurrent Famvir use with probenecid or other drugs significantly eliminated by active renal tubular secretion may result in increased plasma concentrations of penciclovir.

The conversion of 6-deoxy penciclovir to penciclovir is catalyzed by aldehyde oxidase. Interactions with other drugs metabolized by this enzyme could potentially occur.

Famvir Clinical Trials and Studies

Storing Famvir

Store between 15° and 30° C (59° and 86° F).

Additional Patient Information for Famvir

Patients should be informed that Famvir is not a cure for genital herpes. There are no data evaluating whether Famvir will prevent transmission of infection to others. As genital herpes is a sexually transmitted disease, patients should avoid contact with lesions or intercourse when lesions and/or symptoms are present to avoid infecting partners. Genital herpes can also be transmitted in the absence of symptoms through asymptomatic viral shedding. If medical management of recurrent episodes is indicated, patients should be advised to initiate Famvir therapy at the first sign or symptom.

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