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These highlights do not include all the information needed to use valacyclovir hydrochloride safely and effectively. See full prescribing information for valacyclovir hydrochloride tablets.Valacyclovir Hydrochloride TabletsInitial U.S. Approval: 1995 | Valacyclovir Hydrochloride

05:20 EDT 27th August 2014 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Labeling describing use of valacyclovir hydrochloride tablets in pediatric patients with chickenpox (ages of 2 to ≤ 18 years) is approved for GlaxoSmithKline’s Valtrex Caplets. However, due to GlaxoSmithKline’s marketing exclusivity rights, a description of that pediatric use is not approved for this valacyclovir hydrochloride tablet product.

Table 1. Valacyclovir Hydrochloride Tablets Dosage Recommendations for Adults With Renal Impairment
Indications
Normal Dosage
Regimen
(Creatinine
Clearance ≥50 mL/min)
Creatinine Clearance (mL/min)
30-49
10-29
<10
   Cold sores (Herpes labialis)

   Do not exceed 1 day of treatment.
Two 2 gram
doses taken
12 hours apart
Two 1 gram
doses taken
12 hours apart

Two 500 mg
doses taken
12 hours apart

500 mg
single dose
   Genital herpes:
      Initial episode
1 gram every
12 hours
no reduction
1 gram every
24 hours
500 mg every
24 hours
   Genital herpes:
      Recurrent episode
500 mg every
12 hours
no reduction
500 mg every
24 hours
500 mg every
24 hours
   Genital herpes: 
      Suppressive therapy
      Immunocompetent patients 


      Alternate dose for
      immunocompetent 
      patient with 
      ≤9 recurrences/year 

      HIV-infected patients


1 gram every
24 hours

500 mg every
24 hours



500 mg every
12 hours


no reduction


no reduction




no reduction



500 mg every
24 hours

500 mg every
48 hours



500 mg every
24 hours


500 mg every
24 hours

500 mg every
48 hours



500 mg every
24 hours
   Herpes zoster 1 gram every
8 hours
1 gram every
12 hours
1 gram every
24 hours
500 mg every
24 hours

In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)].

Table 2. Incidence (%) of Laboratory Abnormalities in Herpes Zoster and Genital Herpes Study Populations
a Data were not collected prospectively.
LLN = Lower limit of normal.
ULN = Upper limit of normal.
Laboratory Abnormality
Herpes Zoster
Genital Herpes Treatment
Genital Herpes Suppression
Valacyclovir
Hydrochloride
1 gram
3 times daily
(n = 967)
Placebo
(n = 195)
Valacyclovir
Hydrochloride
1 gram
twice daily
(n = 1,194)
Valacyclovir
Hydrochloride
500 mg
twice daily
(n = 1,159)
Placebo
(n = 439)
Valacyclovir
Hydrochloride
1 gram
once daily
(n = 269)
Valacyclovir
Hydrochloride
500 mg
once daily
(n = 266)
Placebo
(n =134)
   Hemoglobin 
   (<0.8 x LLN) 

   White blood cells 
   (<0.75 x LLN)

   Platelet count 
   (<100,000/mm3

   AST (SGOT) 
   (>2 x ULN) 

   Serum creatinine 
   (>1.5 x ULN)
0.8%


1.3%


1%


1%


0.2%
0%


0.6%


1.2%


0%


0%
0.3%


0.7%


0.3%


1%


0.7%
0.2%


0.6%


0.1%


a


0%
0%


0.2%


0.7%


0.5%


0%
0%


0.7%


0.4%


4.1%


0%
0.8%


0.8%


1.1%


3.8%


0%
0.8%


1.5%


1.5%


3%


0%
IMAGE valacyclovir-str.jpg
Table 3. Mean (±SD) Plasma Acyclovir Pharmacokinetic Parameters Following Administration of Valacyclovir Hydrochloride to Healthy Adult Volunteers
a Administered 4 times daily for 11 days.
ND = not done.

Dose
Single-Dose Administration
(N = 8)
Multiple-Dose Administrationa
(N = 24, 8 per treatment arm)
Cmax (±SD)
(mcg/mL)
AUC (±SD)
(hr•mcg/mL)
Cmax (±SD)
(mcg/mL)
AUC (±SD)
(hr•mcg/mL)
   100 mg
0.83 (±0.14)
2.28 (±0.4)
ND
ND
   250 mg
2.15 (±0.5)
5.76 (±0.6)
2.11 (±0.33)
5.66 (±1.09)
   500 mg
3.28 (±0.83)
11.59 (±1.79)
3.69 (±0.87)
9.88 (±2.01)
   750 mg
4.17 (±1.14)
14.11 (±3.54)
ND
ND
   1,000 mg    
5.65 (±2.37)
19.52 (±6.04)
4.96 (±0.64)
15.7 (±2.27)
Table 4. Recurrence Rates in Immunocompetent Adults at 6 and 12 Months
a Includes lost to follow-up, discontinuations due to adverse events, and consent withdrawn.
Outcome
6 Months
12 Months
Valacyclovir Hydrochloride
1 gram once daily
(n = 269)
Oral acyclovir
400 mg twice daily
(n = 267)
Placebo
(n = 134)
Valacyclovir Hydrochloride
1 gram once daily
(n = 269)
Oral acyclovir
400 mg twice daily
(n = 267)
Placebo
(n = 134)
   Recurrence free
55%
54%
7%
34%
34%
4%
   Recurrences
35%
36%
83%
46%
46%
85%
   Unknowna
10%
10%
10%
19%
19%
10%
Table 5. Recurrence Rates in HIV-Infected Adults at 6 Months
a Includes lost to follow-up, discontinuations due to adverse events, and consent withdrawn.
Outcome
Valacyclovir Hydrochloride
500 mg twice daily
(n = 194)
Placebo
(n = 99)
   Recurrence free
65%
26%
   Recurrences
17%
57%
   Unknowna
18%
17%
Table 6. Percentage of Susceptible Partners Who Acquired HSV-2 Defined by the Primary and Selected Secondary Endpoints
a Results show reductions in risk of 75% (symptomatic HSV-2 acquisition), 50% (HSV-2 seroconversion), and 48% (overall HSV-2 acquisition) with valacyclovir hydrochloride versus placebo. Individual results may vary based on consistency of safer sex practices.
Endpoint
Valacyclovir Hydrochloridea
(n = 743)
Placebo
(n = 741)
   Symptomatic HSV-2 acquisition
4 (0.5%)
16 (2.2%)
   HSV-2 seroconversion
12 (1.6%)
24 (3.2%)
   Overall HSV-2 acquisition
14 (1.9%)
27 (3.6%)

See FDA-Approved Patient Labeling.

Patients should be advised to maintain adequate hydration.

IMAGE valacyclovir-fig1.jpgIMAGE valacyclovir-fig2.jpg

Manufacturer

NorthStar Rx LLC

Active Ingredients

Source

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