A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Famvir Indications, Dosage, Storage, Stability - Famciclovir
Famvir Indications, Dosage, Storage, Stability - Famciclovir
INDICATIONS
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.
DOSAGE AND ADMINISTRATION
Herpes Zoster
The recommended 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 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
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
dosage is 500 mg twice daily for 7 days. In patients with reduced renal
function, dosage reduction is recommended (see PRECAUTIONS,
General).
Table 7
| Indication and Normal
Dosage Regimen |
Creatinine Clearance (mL/ min.) |
Adjusted
Dosage Regimen Dose (mg) |
Dosing
Interval |
| Herpes Zoster |
| 500 mg every 8 hours |
>60 |
500 |
every
8 hours |
| |
40—59 |
500 |
every 12
hours |
| |
20—39 |
500 |
every 24
hours |
| |
<20 |
250 |
every
24 hours |
| |
HD* |
250 |
following
each dialysis |
| Recurrent
Genital Herpes |
| 125 mg every 12 hours |
³40 |
125 |
every12
hours |
| |
20—39 |
125 |
every
24 hours |
| |
<20 |
125 |
every
24 hours |
| |
HD* |
125 |
following
each dialysis |
| Suppression
of Recurrent Genital Herpes |
| 250 mg every 12 hours |
³40 |
250 |
every12
hours |
| |
20—39 |
125 |
every
12 hours |
| |
<20 |
125 |
every
24 hours |
| |
HD* |
125 |
following
each dialysis |
| Recurrent
Orolabial and Genital Herpes Simplex Infection in HIV-Infected Patients |
| 500 mg every 12 hours |
³40 |
500 |
every12
hours |
| |
20—39 |
500 |
every
24 hours |
| |
<20 |
250 |
every
24 hours |
| |
HD* |
250 |
following
each dialysis |
*Hemodialysis
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.
HOW SUPPLIED
Famvir is supplied as film-coated tablets as follows: 125 mg in
bottles of 30; 250 mg in bottles of 30; and 500 mg in bottles of 30 and
Single Unit Packages of 50 (intended for institutional use only).
Famvir 125 mg tablets are white, round, debossed with FAMVIR
on one side and 125 on the other.
125 mg 30’s: NDC 0007-4115-13
Famvir 250 mg tablets are white, round, debossed with FAMVIR
on one side and 250 on the other.
250 mg 30’s: NDC 0007-4116-13
Famvir 500 mg tablets are white, oval, debossed with FAMVIR
on one side and 500 on the other.
500 mg 30’s: NDC 0007-4117-13
500mg SUP 50’s: NDC 0007-4117-19
Store between 15° and 30° C (59° and 86° F).
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