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
Valtrex Indications, Dosage, Storage, Stability - Valacyclovir hydrochloride
Valtrex Indications, Dosage, Storage, Stability - Valacyclovir hydrochloride
INDICATIONS
AND USAGE
Herpes Zoster: VALTREX is indicated for the treatment
of herpes zoster (shingles).
Genital Herpes: VALTREX is indicated for the
treatment or suppression of genital herpes.
Cold Sores (Herpes Labialis): VALTREX is indicated
for the treatment of cold sores (herpes labialis).
DOSAGE AND ADMINISTRATION
VALTREX Caplets may be given without regard to meals.
Herpes Zoster: The recommended dosage of VALTREX
for the treatment of herpes zoster is 1 gram orally 3 times daily for 7 days.
Therapy should be initiated at the earliest sign or symptom of herpes zoster
and is most effective when started within 48 hours of the onset of zoster rash.
No data are available on efficacy of treatment started greater than 72 hours
after rash onset.
Genital Herpes
Initial Episodes: The recommended dosage
of VALTREX for treatment of initial genital herpes is 1 gram twice daily for
10 days.
There are no data on the effectiveness of treatment with VALTREX
when initiated more than 72 hours after the onset of signs and symptoms. Therapy
was most effective when administered within 48 hours of the onset of signs and
symptoms.
Recurrent Episodes: The recommended dosage of
VALTREX for the treatment of recurrent genital herpes is 500 mg twice daily
for 3 days.
If medical management of a genital herpes recurrence is indicated,
patients should be advised to initiate therapy at the first sign or symptom
of an episode. There are no data on the effectiveness of treatment with VALTREX
when initiated more than 24 hours after the onset of signs or symptoms.
Suppressive Therapy: The recommended dosage
of VALTREX for chronic suppressive therapy of recurrent genital herpes is 1
gram once daily. In patients with a history of 9 or fewer recurrences per year,
an alternative dose is 500 mg once daily. The safety and efficacy of therapy
with VALTREX beyond 1 year have not been established.
Cold Sores (Herpes Labialis): The recommended dosage
of VALTREX for the treatment of cold sores is 2 grams twice daily for 1 day
taken about 12 hours apart. Therapy should be initiated at the earliest symptom
of a cold sore (e.g., tingling, itching, or burning). There are no data on the
effectiveness of treatment initiated after the development of clinical signs
of a cold sore (e.g., papule, vesicle, or ulcer).
Patients with Acute or Chronic Renal Impairment: In
patients with reduced renal function, reduction in dosage is recommended (see
Table 5).
|
Table 5. Dosages for Patients with Renal Impairment
|
|
Indications
|
Normal Dosage Regimen (Creatinine Clearance ³50)
|
Creatinine Clearance (mL/min)
|
|
30-49
|
10-29
|
<10
|
|
|
|
Herpes zoster
|
1 gram every 8 hours
|
1 gram every 12 hours
|
1 gram every 24 hours
|
500 mg every 24 hours
|
|
Genital herpes
|
|
Initial treatment
|
1 gram every 12 hours
|
no reduction
|
1 gram every 24 hours
|
500 mg every 24 hours
|
|
Recurrent episodes
|
500 mg every 12 hours
|
no reduction
|
500 mg every 24 hours
|
500 mg every 24 hours
|
|
Suppressive therapy
|
1 gram every 24 hours
|
no reduction
|
500 mg every 24 hours
|
500 mg every 24 hours
|
|
Suppressive therapy
|
500 mg every 24 hours
|
no reduction
|
500 mg every 48 hours
|
500 mg every 48 hours
|
|
Herpes labialis (cold sores)
Do not exceed 1 day of treatment.
|
Two 2-gram doses taken about 12 hours apart
|
Two 1-gram Doses taken About 12 hours Apart
|
Two 500-mg doses taken about 12 hours apart
|
500-mg single dose
|
Hemodialysis: During hemodialysis, the half-life
of acyclovir after administration of VALTREX is approximately 4 hours. About
one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis
session. Patients requiring hemodialysis should receive the recommended dose
of VALTREX after hemodialysis.
Peritoneal Dialysis: There is no information
specific to administration of VALTREX in patients receiving peritoneal dialysis.
The effect of chronic ambulatory peritoneal dialysis (CAPD) and continuous arteriovenous
hemofiltration/dialysis (CAVHD) on acyclovir pharmacokinetics has been studied.
The removal of acyclovir after CAPD and CAVHD is less pronounced than with hemodialysis,
and the pharmacokinetic parameters closely resemble those observed in patients
with ESRD not receiving hemodialysis. Therefore, supplemental doses of VALTREX
should not be required following CAPD or CAVHD.
HOW SUPPLIED
VALTREX Caplets (blue, film-coated, capsule-shaped tablets)
containing valacyclovir hydrochloride equivalent to 500 mg valacyclovir and
printed with "VALTREX 500 mg" - Bottle of 42 (NDC 0173-0933-03) and unit dose
pack of 100 (NDC 0173-0933-56).
VALTREX Caplets (blue, film-coated, capsule-shaped tablets)
containing valacyclovir hydrochloride equivalent to 1 gram valacyclovir and
printed with "VALTREX 1 gram" -
Bottle of 21 (NDC 0173-0565-02).
Store at 15° to 25°C (59° to 77°F).
GlaxoSmithKline, Research Triangle Park, NC
27709, © 2002, GlaxoSmithKline. All rights reserved., September 2002 RL-1131
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