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
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.
| Indications |
Normal Dosage Regimen (Creatinine Clearance ≥50) |
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)].
|
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% |
|
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) |
|
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% |
|
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% |
|
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.
Manufacturer
Aurobindo Pharma Limited
Active Ingredients
Source
- U.S. National Library of Medicine
- DailyMed
- Last Updated: 4 May 2013
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