Valacyclovir Hydrochloride (Page 2 of 8)

2.4 Patients with Renal Impairment

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.

Table 1. Valacyclovir Hydrochloride Dosage Recommendations for Adults With Renal Impairment
Normal Dosage Creatinine Clearance (mL/min)
Regimen
(Creatinine
Clearance
Indications ≥50 mL/min) 30-49 10-29 <10
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
Genital herpes:
Suppressive therapy
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
patients with
≤9 recurrences/year
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.

3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • 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 “ad9e54ac-figure-01”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 “ad9e54ac-figure-02”on the other side.
ad9e54ac-figure-01ad9e54ac-figure-02

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