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 Warnings, Precautions, Pregnancy, Nursing, Abuse - Valacyclovir hydrochloride
Valtrex Warnings, Precautions, Pregnancy, Nursing, Abuse - Valacyclovir hydrochloride
WARNINGS
Thrombotic thrombocytopenic purpura/hemolytic uremic syndrome
(TTP/HUS), in some cases resulting in death, has occurred in patients with advanced
HIV disease and also in allogeneic bone marrow transplant and renal transplant
recipients participating in clinical trials of VALTREX at doses of 8 grams per
day.
PRECAUTIONS
Dosage reduction is recommended when administering VALTREX
to patients with renal impairment (see DOSAGE
AND ADMINISTRATION). Acute renal failure and central nervous system
symptoms have been reported in patients with underlying renal disease who have
received inappropriately high doses of VALTREX for their level of renal function.
Similar caution should be exercised when administering VALTREX to geriatric
patients and patients receiving potentially nephrotoxic agents.
Given the dosage recommendations for treatment of cold sores,
special attention should be paid when prescribing VALTREX for cold sores in
patients who are elderly or who have impaired renal function (see DOSAGE
AND ADMINISTRATION and Geriatric Use). Treatment should not exceed 1
day (2 doses of 2 grams in 24 hours). Therapy beyond 1 day does not provide
additional clinical benefit.
Precipitation of acyclovir in renal tubules may occur when
the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. In the event
of acute renal failure and anuria, the patient may benefit from hemodialysis
until renal function is restored (see DOSAGE
AND ADMINISTRATION).
The safety and efficacy of VALTREX have not been established
in immunocompromised patients (see WARNINGS
),
or for the treatment of disseminated herpes zoster.
INFORMATION FOR PATIENTS
Herpes Zoster: There are no data on treatment
initiated more than 72 hours after onset of the zoster rash. Patients should
be advised to initiate treatment as soon as possible after a diagnosis of herpes
zoster.
Genital Herpes: Patients should be informed that
VALTREX is not a cure for genital herpes. There are no data evaluating whether
VALTREX will prevent transmission of infection to others. Because 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 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 initiated
more than 72 hours after the onset of signs and symptoms of a first episode
of genital herpes or more than 24 hours of the onset of signs and symptoms of
a recurrent episode.
There are no data on the safety or effectiveness of chronic
suppressive therapy of more than 1 year’s duration.
Cold Sores (Herpes Labialis): Patients should
be advised to initiate treatment 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 should be instructed that treatment for cold sores
should not exceed 1 day (2 doses) and that their doses should be taken about
12 hours apart. Patients should be informed that VALTREX is not a cure for cold
sores (herpes labialis).
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