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, USP in pediatric patients with a creatinine clearance <50 mL/min/1.73 m 2.
|Normal Dosage Regimen||Creatinine Clearance (mL/min)|
|Indications||(Creatinine Clearance ≥50 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||1 gram every 24 hours||no reduction||500 mg every 24 hours||500 mg every 24 hours|
|Alternate dose for immunocompetent patients with ≤9 recurrences/year||500 mg every 24 hours||no reduction||500 mg every 48 hours||500 mg every 48 hours|
|HIV-infected patients||500 mg every 12 hours||no reduction||500 mg every 24 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|
Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir tablets, USP after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir tablets, USP are approximately 4 hours. About one third of acyclovir in the body is removed by dialysis during a 4-hour hemodialysis session.
Peritoneal Dialysis: There is no information specific to administration of valacyclovir tablets, USP 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, USP should not be required following CAPD or CAVHD.
- 500 mg: blue, film-coated, capsule-shaped tablets debossed with “W152” on one side and plain and other side.
- 1 gram: blue, film-coated, capsule-shaped tablets, debossed with “W153” on one side and partial bisect on both sides.
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 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.
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