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 tablets in pediatric patients with a creatinine clearance <50 mL/min/1.73 m2.

Table 1. Valacyclovir hydrochloride Dosage Recommendations for Adults With Renal Impairment

Indications	Normal Dosage Regimen		Creatinine Clearance	(mL/min)
	(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 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 coloured, film-coated, capsule-shaped, biconvex tablets, “CIPLA” debossed on one side and “153” on other.
• 1 gram: blue coloured, film-coated, capsule-shaped, biconvex tablets, with a partial scorebar on both sides, and “CIPLA” debossed on one side and “154” on other.

4 CONTRAINDICATIONS

Valacyclovir hydrochloride is 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)] .