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 tablets, USP in pediatric patients with a creatinine clearance <50 mL/min/1.73 m 2.

Table 1. Valacyclovir Tablets, USP Dosage Recommendations for Adults With Renal Impairment
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.

3 DOSAGE FORMS AND STRENGTHS

Tablets:

  • 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.

4 CONTRAINDICATIONS

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)].

5 WARNINGS AND PRECAUTIONS

5.1 Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS)

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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