Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/4185
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VALTREX (Tablet)
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VALTREX Caplets may be given without regard to meals.<br/>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.<br/>Genital Herpes:<br/>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.<br/>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.<br/>Suppressive Therapy: The recommended
dosage of VALTREX for chronic suppressive therapy of recurrent genital
herpes is 1 gram once daily in patients with normal immune function.
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 beyond1 year have not been established. In HIV-infected patients with CD4 cell count���100 cells/mm, the recommended dosage of VALTREX for chronic suppressive
therapy of recurrent genital herpes is 500 mg twice daily. The
safety and efficacy of therapy with VALTREX beyond 6 months in
patients with HIV infection have not been established.<br/>Reduction of Transmission: The recommended
dosage of VALTREX for reduction of transmission of genital herpes
in patients with a history of 9 or fewer recurrences per year is 500 mg
once daily for the source partner. Patients should be counseled to
use safer sex practices in combination with suppressive therapy with
VALTREX. The efficacy of reducing transmission beyond 8 months
in discordant couples has not been established.<br/>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).<br/>Patients with Acute or Chronic
Renal Impairment: In patients with reduced renal function, reduction
in dosage is recommended (see Table 7).<br/>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.<br/>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, andthe 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.
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| dailymed-instance:descripti... |
VALTREX (valacyclovir hydrochloride) is the hydrochloride
salt of L-valyl ester of the
antiviral drug acyclovir (ZOVIRAX Brand, GlaxoSmithKline). VALTREX Caplets are for oral administration. Each caplet
contains valacyclovir hydrochloride equivalent to 500 mg or 1 gram
valacyclovir and the inactive ingredients carnauba wax, colloidal
silicon dioxide, crospovidone, FD&C Blue No. 2 Lake, hypromellose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polysorbate 80, povidone, and titanium dioxide. The blue, film-coated
caplets are printed with edible white ink. The
chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9H-purin-9-yl)methoxy]ethyl ester, monohydrochloride.
It has the following structural formula: Valacyclovir hydrochloride is a white to off-white powder with the
molecular formula CHNO���HCl and a molecular weight of 360.80. The maximum solubility
in water at 25��C is 174 mg/mL. The pk's
for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.
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After oral administration,
valacyclovir hydrochloride is rapidly absorbed from the gastrointestinal
tract and nearly completely converted to acyclovir and L-valine by first-pass intestinal and/or
hepatic metabolism.<br/>Pharmacokinetics: The pharmacokinetics
of valacyclovir and acyclovir after oral administration of VALTREX
have been investigated in 14 volunteer studies involving 283 adults.<br/>Absorption and Bioavailability: The absolute
bioavailability of acyclovir after administration of VALTREX is 54.5%��9.1%
as determined following a 1-gram oral dose of VALTREX and a 350-mg
intravenous acyclovir dose to 12 healthy volunteers. Acyclovir
bioavailability from the administration of VALTREX is not altered
by administration with food (30 minutes after an 873 Kcal
breakfast, which included 51 grams of fat). There was a lack of dose proportionality in acyclovir maximum concentration
(C) and area under the acyclovir concentration-time
curve (AUC) after single-dose administration of 100 mg, 250 mg,
500 mg, 750 mg, and 1 gram of VALTREX to 8 healthy
volunteers. The mean C(��SD) was 0.83 (��0.14),
2.15 (��0.50), 3.28 (��0.83), 4.17 (��1.14),
and 5.65 (��2.37) mcg/mL, respectively; and the mean
AUC (��SD) was 2.28 (��0.40), 5.76 (��0.60),
11.59 (��1.79), 14.11 (��3.54), and 19.52 (��6.04) hr���mcg/mL,
respectively. There was also a lack of dose
proportionality in acyclovir Cand AUC after the multiple-dose
administration of 250 mg, 500 mg, and 1 gram of VALTREX
administered 4 times daily for 11 days in parallel groups
of 8 healthy volunteers. The mean C(��SD)
was 2.11 (��0.33), 3.69 (��0.87), and 4.96 (��0.64) mcg/mL,
respectively, and the mean AUC (��SD) was 5.66 (��1.09),
9.88 (��2.01), and 15.70 (��2.27) hr���mcg/mL,
respectively. There is no accumulation of acyclovir
after the administration of valacyclovir at the recommended dosage
regimens in healthy volunteers with normal renal function.<br/>Distribution: The binding of valacyclovir to human plasma proteins
ranged from 13.5% to 17.9%.<br/>Metabolism: After oral administration, valacyclovir hydrochloride
is rapidly absorbed from the gastrointestinal tract. Valacyclovir
is converted to acyclovir and L-valine by first-pass intestinal and/or hepatic metabolism. Acyclovir
is converted to a small extent to inactive metabolites by aldehyde
oxidase and by alcohol and aldehyde dehydrogenase. Neither valacyclovir
nor acyclovir is metabolized by cytochrome P450 enzymes. Plasma concentrations
of unconverted valacyclovir are low and transient, generally becoming
non-quantifiable by 3 hours after administration. Peak plasma
valacyclovir concentrations are generally less than 0.5 mcg/mL
at all doses. After single-dose administration of 1 gram of VALTREX,
average plasma valacyclovir concentrations observed were 0.5, 0.4,
and 0.8 mcg/mL in patients with hepatic dysfunction, renal insufficiency,
and in healthy volunteers who received concomitantcimetidine and
probenecid, respectively.<br/>Elimination: The pharmacokinetic
disposition of acyclovir delivered by valacyclovir is consistent with
previous experience from intravenous and oral acyclovir. Following
the oral administration of a single 1-gram dose of radiolabeled valacyclovir
to 4 healthy subjects, 45.60% and 47.12% of administered radioactivity
was recovered in urine and feces over 96 hours, respectively.
Acyclovir accounted for 88.60% of the radioactivity excreted in the
urine. Renal clearance of acyclovir following the administration of
a single 1-gram dose of VALTREX to 12 healthy volunteers was
approximately 255��86 mL/min which represents
41.9% of total acyclovir apparent plasma clearance. The plasma elimination half-life of acyclovir typically averaged
2.5 to 3.3 hours in all studies of VALTREX in volunteers with
normal renal function.<br/>End-Stage Renal Disease (ESRD): Following administration of VALTREX to volunteers
with ESRD, the average acyclovir half-life is approximately 14 hours.
During hemodialysis, the acyclovir half-life is approximately 4 hours.
Approximately one third of acyclovir in the body is removed by dialysis
during a 4-hour hemodialysis session. Apparent plasma clearance of
acyclovir in dialysis patients was 86.3��21.3 mL/min/1.73 m, compared with 679.16��162.76 mL/min/1.73 min healthy volunteers. Reduction in
dosage is recommended in patients with renal impairment (see DOSAGE
AND ADMINISTRATION).<br/>Geriatrics: After single-dose administration of 1 gram of
VALTREX in healthy geriatric volunteers, the half-life of acyclovir
was 3.11��0.51 hours, compared with 2.91��0.63 hours
in healthy volunteers. The pharmacokinetics of acyclovir following
single- and multiple-dose oral administration of VALTREX in geriatric
volunteers varied with renal function. Dose reduction may be required
in geriatric patients, depending on the underlying renal status of
the patient (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).<br/>Pediatrics: Valacyclovir
pharmacokinetics have not been evaluated in pediatric patients.<br/>Liver Disease: Administration of VALTREX to patients with moderate
(biopsy-proven cirrhosis) or severe (with and without ascites and
biopsy-proven cirrhosis) liver disease indicated that the rate butnot the extent of conversion of valacyclovir to acyclovir is reduced,
and the acyclovir half-life is not affected. Dosage modification is
not recommended for patients with cirrhosis.<br/>HIV Disease: In 9 patients
with HIV disease and CD4 cell counts<150 cells/mmwho received VALTREX at a dosage of 1 gram 4 times daily
for 30 days, the pharmacokinetics of valacyclovir and acyclovir
were not different from that observed in healthy volunteers (see WARNINGS).<br/>Drug Interactions: The pharmacokinetics of digoxin was not affected
by coadministration of VALTREX 1 gram 3 times daily, and
the pharmacokinetics of acyclovir after a single dose of VALTREX (1 gram)
was unchanged by coadministration of digoxin (2 doses of 0.75 mg),
single doses of antacids (Alor Mg), or
multiple doses of thiazide diuretics. Acyclovir Cand
AUC following a single dose of VALTREX (1 gram) increased by
8% and 32%, respectively, after a single dose of cimetidine (800 mg),
or by 22% and 49%, respectively, after probenecid (1 gram), or
by 30% and 78%, respectively, after a combination of cimetidine and
probenecid, primarily due to a reduction in renal clearance of acyclovir.
These effects are not considered to be of clinical significance insubjects with normal renal function. Therefore, no dosage adjustment
is recommended when VALTREX is coadministered with digoxin, antacids,
thiazide diuretics, cimetidine, or probenecid in subjects with normal
renal function.
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VALTREX is contraindicated in patients with a known
hypersensitivity or intolerance to valacyclovir, acyclovir, or any
component of the formulation.
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| dailymed-instance:supply |
VALTREX Caplets (blue, film-coated, capsule-shaped
tablets) containing valacyclovir hydrochloride equivalent to 500 mg
valacyclovir and printed with���VALTREX 500 mg.��� Bottle of 30 (NDC 0173-0933-08). Bottle of 90 (NDC 0173-0933-010). Unit dose
pack of 100 (NDC 0173-0933-56). VALTREX Caplets
(blue, film-coated, capsule-shaped tablets, with a partial scorebar
on both sides) containing valacyclovir hydrochloride equivalent to
1 gram valacyclovir and printed with���VALTREX 1 gram.��� Bottle of 30 (NDC 0173-0565-04). Bottle of 90 (NDC 0173-0565-10). Store at 15��to 25��C (59��to 77��F).
Dispense in a well-closed container as defined in the USP. VALTREX and ZOVIRAX are registered trademarks
of GlaxoSmithKline. Distributed by GlaxoSmithKline Research Triangle
Park, NC 27709 Manufactured by: GlaxoSmithKline Research Triangle Park, NC
27709 or DSM Pharmaceuticals,
Inc. Greenville, NC 27834 ��2007, GlaxoSmithKline. All rights reserved. PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS
TO PATIENT
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dailymed-ingredient:FD&C_Blue_No._2_lake,
dailymed-ingredient:carnauba_wax,
dailymed-ingredient:colloidal_silicon_dioxide,
dailymed-ingredient:crospovidone,
dailymed-ingredient:edible_white_ink,
dailymed-ingredient:hypromellose,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:polyethylene_glycol,
dailymed-ingredient:polysorbate_80,
dailymed-ingredient:povidone,
dailymed-ingredient:titanium_dioxide
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| dailymed-instance:precautio... |
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 (see Geriatric Use)
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. Adequate hydration should be maintained. 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 other than for the suppression of genital
herpes in HIV-infected patients. The safety and efficacy of VALTREX
for suppression of recurrent genital herpes in patients with advanced
HIV disease (CD4 cell count<100 cells/mm) have
not been established. The efficacy of VALTREX for the treatment of
genital herpes in HIV-infected patients has not been established.
The safety and efficacy of VALTREX have not been established for the
treatment of disseminated herpes zoster. The
efficacy of VALTREX for reducing transmission of genital herpes has
not been established in individuals with multiple partners and non-heterosexual
couples.<br/>Information for Patients: Patients should
be advised to maintain adequate hydration.<br/>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.<br/>Genital Herpes: Patients should be informed that VALTREX is not
a cure for genital herpes. 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 is frequently transmitted in the absence of symptoms
through asymptomatic viral shedding. Therefore, patients should be
counseled to use safer sex practices in combination with suppressive
therapy with VALTREX. Sex partners of infected persons should be advised
that they might be infected even if they have no symptoms. Type-specific
serologic testing of asymptomatic partners of persons with genital
herpes can determine whether risk for HSV-2 acquisition exists. VALTREX has not been shown to reduce transmission of sexually
transmitted infections other than HSV-2. 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 after 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 in otherwise healthy patients. There are no data on the safety
or effectiveness of chronic suppressive therapy of more than 6 months'
duration in HIV-infected patients.<br/>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).<br/>Drug Interactions: See CLINICAL PHARMACOLOGY: Pharmacokinetics.<br/>Carcinogenesis, Mutagenesis,
Impairment of Fertility: The data presented below include references to the
steady-state acyclovir AUC observed in humans treated with 1 gram
VALTREX given orally 3 times a day to treat herpes zoster. Plasma
drug concentrations in animal studies are expressed as multiples of
human exposure to acyclovir (see CLINICAL PHARMACOLOGY: Pharmacokinetics). Valacyclovir was noncarcinogenic in lifetime carcinogenicity
bioassays at single daily doses (gavage) of valacyclovir giving plasma
acyclovir concentrations equivalent to human levels in the mouse bioassay
and 1.4 to 2.3 times human levels in the rat bioassay. There
was no significant difference in the incidence of tumors between treated
and control animals, nor did valacyclovir shorten the latency of tumors. Valacyclovir was tested in 5 genetic toxicity assays.
An Ames assay was negative in the absence or presence of metabolic
activation. Also negative were an in vitro cytogenetic study
with human lymphocytes and a rat cytogenetic study. In the mouse lymphoma assay, valacyclovir was not mutagenic in the
absence of metabolic activation. In the presence of metabolic activation
(76% to 88% conversion to acyclovir), valacyclovir was mutagenic. Valacyclovir was mutagenic in a mouse micronucleus assay. Valacyclovir did not impair fertility or reproduction
in rats at 6 times human plasma levels.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy
Category B. Valacyclovir was not teratogenic in rats or rabbits at
10 and 7 times human plasma levels, respectively, during the
period of major organogenesis. There are no
adequate and well-controlled studies of VALTREX or ZOVIRAX in pregnant
women. A prospective epidemiologic registry of acyclovir use during
pregnancy was established in 1984 and completed in April 1999. There
were 749 pregnancies followed in women exposed to systemic acyclovir
during the first trimester of pregnancy resulting in 756 outcomes.
The occurrence rate of birth defects approximates that found in the
general population. However, the small size of the registry is insufficient
to evaluate the risk for less common defects or to permit reliable
or definitive conclusions regarding the safety of acyclovir in pregnant
women and their developing fetuses. VALTREX should be used during
pregnancy only if the potential benefit justifies the potential risk
to the fetus.<br/>Nursing Mothers: Following oral administration of a 500-mg dose of
VALTREX to 5 nursing mothers, peak acyclovir concentrations (C) in breast milk ranged from 0.5 to 2.3 times (median 1.4)
the corresponding maternal acyclovir serum concentrations. The acyclovir
breast milk AUC ranged from 1.4 to 2.6 times (median 2.2) maternal
serum AUC. A 500-mg maternal dosage of VALTREX twice daily would provide
a nursing infant with an oral acyclovir dosage of approximately 0.6 mg/kg/day.
This would result in less than 2% of the exposure obtained after administration
of a standard neonatal dose of 30 mg/kg/day of intravenous acyclovir
to the nursing infant. Unchanged valacyclovir was not detected in
maternal serum, breast milk, or infant urine. VALTREX should be administered
to a nursing mother with caution and only when indicated.<br/>Pediatric Use: Safety and effectiveness of VALTREX in pre-pubertal
pediatric patients have not been established.<br/>Geriatric Use: Of the total number of subjects in clinical studies
of VALTREX, 906 were 65 and over, and 352 were 75 and over. In a clinical
study of herpes zoster, the duration of pain after healing (post-herpetic
neuralgia) was longer in patients 65 and older compared with younger
adults. Elderly patients are more likely to have reduced renal function
and require dose reduction. Elderly patients are also more likely
to have renal or CNS adverse events. With respect to CNS adverse events
observed during clinical practice, agitation, hallucinations, confusion,
delirium, and encephalopathy were reported more frequently in elderly
patients (see CLINICAL PHARMACOLOGY, ADVERSE REACTIONS: Observed During
Clinical Practice, and DOSAGE AND ADMINISTRATION).
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Caution should
be exercised to prevent inadvertent overdose (see PRECAUTIONS). 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).
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valacyclovir hydrochloride
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VALTREX (Tablet)
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| dailymed-instance:adverseRe... |
Frequently reported adverse events in clinical trials
of VALTREX in healthy patients are listed in Tables 4 and 5. Laboratory abnormalities reported in clinical trials
of VALTREX in otherwise healthy patientsare listed in Table 6. *Data were not collected prospectively. LLN = Lower limit of normal. ULN = Upper limit of normal.<br/>Suppression of Genital Herpes
in HIV-Infected Patients: In HIV-infected
patients, frequently reported adverse events for VALTREX (500 mg
twice daily; n = 194, median days on therapy = 172)
and placebo (n = 99, median days on therapy = 59),
respectively, included headache (13% vs. 8%), fatigue (8% vs. 5%),
and rash (8% vs. 1%). Post-randomization laboratory abnormalities
that were reported more frequently in valacyclovir subjects versus
placebo included elevated alkaline phosphatase (4% vs. 2%), elevated
ALT (14% vs. 10%), elevated AST (16% vs. 11%), decreased neutrophil
counts (18% vs. 10%), and decreased platelet counts (3% vs. 0%).<br/>Reduction of Transmission: In a clinical study for the reduction of transmission
of genital herpes, the adverse events reported by patients receiving
VALTREX 500 mg once daily (n = 743) or placebo once
daily (n = 741) included headache (VALTREX 29%, placebo
26%), nasopharyngitis (VALTREX 16%, placebo 15%), and upper respiratory
tract infection (VALTREX 9%, placebo 10%). In this 8-month study,
there were no clinically significant changes from baseline laboratory
parameters in subjects receiving VALTREX compared with placebo.<br/>Cold Sores (Herpes Labialis): In clinical studies for the treatment of cold sores,
the adverse events reported by patients receiving VALTREX (n = 609)
or placebo (n = 609) included headache (VALTREX 14%, placebo
10%) and dizziness (VALTREX 2%, placebo 1%). The frequencies of abnormal
ALT (>2 x ULN) were 1.8% for patients receiving VALTREX compared with
0.8% for placebo. Other laboratory abnormalities (hemoglobin, white
blood cells, alkaline phosphatase, and serum creatinine) occurred
with similar frequencies in the 2 groups.<br/>Observed During Clinical Practice: The following events have been identified during
post-approval use of VALTREX in clinical practice. Because they are
reported voluntarily from a population of unknown size, estimates
of frequency cannot be made. These events have been chosen for inclusion
due to either their seriousness, frequency of reporting, causal connectionto VALTREX, or a combination of these factors.<br/>General: Facial edema, hypertension, tachycardia.<br/>Allergic: Acute
hypersensitivity reactions including anaphylaxis, angioedema, dyspnea,
pruritus, rash, and urticaria.<br/>CNS Symptoms: Aggressive behavior; agitation; ataxia; coma; confusion;
decreased consciousness; dysarthria; encephalopathy; mania; and psychosis,
including auditory and visual hallucinations; seizures, tremors (see
PRECAUTIONS).<br/>Eye: Visual abnormalities.<br/>Gastrointestinal: Diarrhea.<br/>Hepatobiliary Tract and Pancreas: Liver enzyme abnormalities, hepatitis.<br/>Renal: Elevated
creatinine, renal failure, renal pain (may be associated with renal
failure).<br/>Hematologic: Thrombocytopenia,
aplastic anemia, leukocytoclastic vasculitis, TTP/HUS.<br/>Skin: Erythema multiforme, rashes including photosensitivity,
alopecia.<br/>Renal Impairment: Renal failureand CNS symptoms have been reported in patients with renal impairment
who received VALTREX or acyclovir at greater than the recommended
dose. Dose reduction is recommended in this
patient population (see DOSAGE AND ADMINISTRATION).
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| dailymed-instance:warning |
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.
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| dailymed-instance:indicatio... |
Herpes Zoster: VALTREX is indicated for the treatment of herpes
zoster (shingles).<br/>Genital Herpes: VALTREX is indicated for the treatment or suppression
of genital herpes in immunocompetent individuals and for the suppression
of recurrent genital herpes in HIV-infected individuals. When VALTREX is used as suppressive therapy in immunocompetent
individuals with genital herpes, the risk of heterosexual transmission
to susceptible partners is reduced. Safer sex practices should be
used with suppressive therapy (see current Centers for Disease Control
and Prevention (CDC) Sexually Transmitted
Diseases Treatment Guidelines).<br/>Cold Sores (Herpes Labialis): VALTREX is indicated for the treatment of cold sores
(herpes labialis).
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| dailymed-instance:name |
VALTREX
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