Dosage recommendations for adult patients with reduced renal function are provided in Table 1 [see Use in Specific Populations (8.5, 8.6), Clinical Pharmacology (12.3)]. Data are not available for the use of valacyclovir tablets in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2.
|Indications||Normal Dosage Regimen (Creatinine Clearance ≥50 mL/min)||Creatinine Clearance (mL/min)|
|30 to 49||10 to 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 patients with less than or equal to 9 recurrences/year HIV-1-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|
Patients requiring hemodialysis should receive the recommended dose of valacyclovir tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets is approximately 4 hours. About one-third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.
There is no information specific to administration of valacyclovir tablets 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 end-stage renal disease (ESRD) not receiving hemodialysis. Therefore, supplemental doses of valacyclovir tablets should not be required following CAPD or CAVHD.
- 500 mg: Each blue, film-coated, capsule shaped tablets with “F 82” on one side and plain on the otherside contains 556 mg of valacyclovir hydrochloride equivalent to 500 mg of valacyclovir.
- 1 gram: Each blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing “F” on one side and “8” and “3” on the otherside contain 1.112 grams of valacyclovir hydrochloride equivalent to 1 gram of valacyclovir.
Valacyclovir tablets are contraindicated in patients who have had a demonstrated clinically significant hypersensitivity reaction (e.g., anaphylaxis) to valacyclovir, acyclovir, or any component of the formulation [see Adverse Reactions (6.3)].
TTP/HUS, in some cases resulting in death, has occurred in patients with advanced HIV-1 disease and also in allogeneic bone marrow transplant and renal transplant recipients participating in clinical trials of valacyclovir hydrochloride at doses of 8 grams per day. Treatment with valacyclovir hydrochloride should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.
Cases of acute renal failure have been reported in:
- Elderly patients with or without reduced renal function. Caution should be exercised when administering valacyclovir hydrochloride to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)].
- Patients with underlying renal disease who received higher-than-recommended doses of valacyclovir hydrochloride for their level of renal function. Dosage reduction is recommended when administering valacyclovir hydrochloride to patients with renal impairment [see Dosage and Administration (2.4), Use in Specific Populations (8.6)].
- Patients receiving other nephrotoxic drugs. Caution should be exercised when administering valacyclovir hydrochloride to patients receiving potentially nephrotoxic drugs.
- Patients without adequate hydration. 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 for all patients.
Central nervous system adverse reactions, including agitation, hallucinations, confusion, delirium, seizures, and encephalopathy, have been reported in both adult and pediatric patients with or without reduced renal function and in patients with underlying renal disease who received higher-than-recommended doses of valacyclovir hydrochloride for their level of renal function. Elderly patients are more likely to have central nervous system adverse reactions. Valacyclovir hydrochloride should be discontinued if central nervous system adverse reactions occur [see Adverse Reactions (6.3), Use in Specific Populations (8.5, 8.6)].
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome [see Warnings and Precautions (5.1)].
- Acute Renal Failure [see Warnings and Precautions (5.2)].
- Central Nervous System Effects [see Warnings and Precautions (5.3)].
The most common adverse reactions reported in at least 1 indication by greater than 10% of adult subjects treated with valacyclovir hydrochloride and observed more frequently with valacyclovir hydrochloride compared with placebo are headache, nausea, and abdominal pain. The only adverse reaction reported in greater than 10% of pediatric subjects aged less than 18 years was headache.
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