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 Tablets Dosage Recommendations for Adults With Renal Impairment

Indications

Normal Dosage Regimen (Creatinine Clearance ≥ 50 mL/min)

Creatinine Clearance (mL/min)

30 to 49

10 to 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 tablets after hemodialysis. During hemodialysis, the half-life of acyclovir after administration of valacyclovir hydrochloride tablets 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 tablets 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 tablets should not be required following CAPD or CAVHD.

3 DOSAGE FORMS AND STRENGTHS

Tablets:

500 mg: blue, film-coated, capsule-shaped tablet, debossed with “93″ on one side and “7258″ on the other
1 gram: blue, film-coated, capsule-shaped tablet, partially scored on both sides and debossed with “93″ on one side and “7259″ on the other

4 CONTRAINDICATIONS

Valacyclovir hydrochloride 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 tablets at doses of 8 grams per day. Treatment with valacyclovir hydrochloride tablets should be stopped immediately if clinical signs, symptoms, and laboratory abnormalities consistent with TTP/HUS occur.

5.2 Acute Renal Failure

Cases of acute renal failure have been reported in:

Elderly patients with or without reduced renal function. Caution should be exercised when administering valacyclovir hydrochloride tablets to geriatric patients, and dosage reduction is recommended for those with impaired renal function [see Dosage and Administration (2.4), Use in Specific Populations (8.5)].
Patients with underlying renal disease who received higher than recommended doses of valacyclovir hydrochloride tablets for their level of renal function. Dosage reduction is recommended when administering valacyclovir hydrochloride tablets to patients with renal impairment [see Dosage and Administration (2.4), Use in Specific Populations (8.6)].
Patients receiving other nephrotoxic drugs. Caution should be exercised when administering valacyclovir hydrochloride tablets to patients receiving potentially nephrotoxic drugs.
Patients without adequate hydration. Precipitation of acyclovir in renal tubules may occur when the solubility (2.5 mg/mL) is exceeded in the intratubular fluid. Adequate hydration should be maintained for all patients.

In the event of acute renal failure and anuria, the patient may benefit from hemodialysis until renal function is restored [see Dosage and Administration (2.4), Adverse Reactions (6.3)].

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