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 hydrochloride in pediatric patients with a creatinine clearance less than 50 mL/min/1.73 m2.
|Normal Dosage||Creatinine Clearance (mL/min)|
|Cold sores (Herpes labialis)||Two 2 gram||Two 1 gram||Two 500 mg||500 mg single|
|doses taken||doses taken||doses taken||dose|
|Do not exceed 1 day of treatment.||12 hours apart||12 hours apart||12 hours apart|
|Genital herpes:||1 gram every||no reduction||1 gram every||500 mg every|
|Initial episode||12 hours||24 hours||24 hours|
|Genital herpes:||500 mg every||no reduction||500 mg every||500 mg every|
|Recurrent episode||12 hours||24 hours||24 hours|
|Immunocompetent patients||1 gram every||no reduction||500 mg every||500 mg every|
|24 hours||24 hours||24 hours|
|Alternate dose for||500 mg every||no reduction||500 mg every||500 mg every|
|immunocompetent||24 hours||48 hours||48 hours|
|HIV-infected patients||500 mg every||no reduction||500 mg every||500 mg every|
|12 hours||24 hours||24 hours|
|Herpes zoster||1 gram every||1 gram every||1 gram every||500 mg every|
|8 hours||12 hours||24 hours||24 hours|
Hemodialysis: Patients requiring hemodialysis should receive the recommended dose of valacyclovir hydrochloride after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride is 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 hydrochloride 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 hydrochloride should not be required following CAPD or CAVHD.
- 500 mg: blue, oval, biconvex, film coated tablets containing valacyclovir hydrochloride, USP equivalent to 500 mg valacyclovir and debossed with “V.5” on one side and “”on the other side.
- 1 gram: blue, oval, biconvex, film coated tablets containing valacyclovir hydrochloride, USP equivalent to 1 gram valacyclovir and debossed with “V 1” separated by score line on one side and “”on the other side.
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