Valacyclovir (Valaciclovir)

Indications
 Oral
Herpes zoster (shingles)
Adult: 1 g tid for 7 days; commence within 72 hr of rash.
Renal impairment: Patients on haemodialysis: 1 g daily after haemodialysis.
CrCl (ml/min)Dosage Recommendation
15-301 g bid.
<151 g daily.
Hepatic impairment: Use with caution.
Oral
Genital herpes
Adult: Initial episode: 1 g bid for up to 10 days, begin course within 72 hr of symptom onset.
CrCl (ml/min)Dosage Recommendation
10-291 g once daily.
<10500 mg once daily.
Hepatic impairment: Use with caution.
Oral
Prophylaxis of herpes simplex infections
Adult: Immunocompetent patients: 500 mg daily in 1-2 divided doses. Immunocompromised patients: 500 mg bid.
Renal impairment: Patients on haemodialysis: immunocompetent patients: 250 mg once daily after haemodialysis; immunocompromised patients: 500 mg once daily after haemodialysis
CrCl (ml/min)Dosage Recommendation
<15Immunocompetent patients: 250 mg once daily; immunocompromised patients: 500 mg once daily .
Hepatic impairment: Use with caution.
Oral
Herpes simplex infections of skin and mucous membranes
Adult: Initial episode: 500 mg bid for up to 10 days, start treatment as early as possible. For recurrent episodes, 500 mg bid for 5 days, begin during prodromal period or as soon as symptoms appear.
Renal impairment: Patients on haemodialysis: 500 mg daily after haemodialysis.
CrCl (ml/min)Dosage Recommendation
<15500 mg once daily.
Hepatic impairment: Use with caution.
Oral
Recurrent genital herpes
Adult: 500 mg bid for 3 days within 24 hr of first sign or symptom.
CrCl (ml/min)Dosage Recommendation
≤29500 mg once daily.
Hepatic impairment: Use with caution.
Oral
Suppression of recurrent episodes of genital herpes
Adult: Immunocompetent patients: 1 g once daily or 500 mg once daily for patients with ≤9 recurrences per year; HIV infected patients with CD4 cells count ≥100 cells/mm3: 500 mg bid up to 6 mth.
CrCl (ml/min)Dosage Recommendation
≤29500 mg once daily if normal dose is 1 g once daily or HIV infected patients; 500 mg every 48 hr if normal dose is 500 mg once daily.
Hepatic impairment: Use with caution.
Oral
Reduction of transmission of genital herpes
Adult: In combination with safer sex practices and abstinence when lesions are present, 500 mg once daily for infected partner with history of ≤9 recurrences per yr.
CrCl (ml/min)Dosage Recommendation
<15250 mg once daily.
Hepatic impairment: Use with caution.
Oral
Prophylaxis of cytomegaloviral infections in immunocompromised patients
Adult: 2 g 4 times daily for 90 days, started within 72 hr after transplant.
Child: >12 yr: 2 g 4 times daily for 90 days, started within 72 hr after transplant.
Renal impairment: Patients on haemodialysis: 1.5 g once daily after haemodialysis.
CrCl (ml/min)Dosage Recommendation
50 to <751.5 g four times daily
25 to <501.5 g tid
10 to <251.5 g bid
<101.5 g once daily.
Hepatic impairment: Use with caution.
Oral
Herpes labialis
Adult: 2 g 12 hrly for 1 day, admin at earliest symptom of cold sore (e.g. tingling, itching or burning).
CrCl (ml/min)Dosage Recommendation
30-491 g 12 hrly for 1 day.
10-29500 mg 12 hrly for 1 day.
<10500 mg as a single dose.
Hepatic impairment: Use with caution.

Special Populations: Dosing in renal impairment: Herpes zoster: Creatinine clearance 1-30 mL/min: 1 g bid; < 15 mL/min: 1 g daily. Herpes simplex: Creatinine clearance 15-30 mL/min: no modification; < 15mL/min: 500 mg/day. Prophylaxis of herpes simplex: If CrCl < 15 mL/min: Dose is halved to 250 mg once daily in immunocompetent and 500 mg once daily in immunocompromised patients.
Contraindications
 Hypersensitvity to valaciclovir, aciclovir.
Warnings / Precautions
 Dehydration; renal or hepatic impairment, pregnancy, lactation. Maintain adequate hydration. Monitor renal function daily especially during first 10 days post transplant.
Adverse Reactions
 Headache, nausea, vomiting, diarrhoea, rash, photosensitivity, LFT abnormalities, psychiatric reactions (e.g. confusion, hallucinations and thinking disorders) especially at high doses.
Potentially Fatal: Hepatitis; renal failure; blood dyscrasias; thrombotic thrombocytopenic purpura-hemolytic uremic syndrome.
Overdose Reactions
 Symptoms: Nausea, vomiting, neurological effects (e.g. headache, confusion, hallucinations, seizures, coma), elevations of serum creatinine and subsequent renal failure. Management: Observe closely for signs of toxicity. Haemodialysis can enhance removal of aciclovir from the blood.
Drug Interactions
 Reduced clearance with probenecid. Increased risk of renal toxicity with ceftriaxone, ciclosporin and other nephrotoxic drugs. Increased risk of neutropenia with mycophenolate.
See Below for More valaciclovir Drug Interactions
Mechanism of Actions
 Valaciclovir is the L-valine ester of aciclovir. A prodrug, it is rapidly converted to aciclovir by intestinal and hepatic metabolism. Aciclovir inhibits DNA synthesis and viral replication and has antiviral activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella-zoster virus.
Absorption: Readily absorbed from GI tract. Bioavailability of aciclovir (after valaciclovir admin): 54%. Peak plasma concentrations of aciclovir: 1.5 hr. Food does not affect bioavailability.
Distribution: Protein binding: 15%. Crosses placenta.
Metabolism: Rapidly converted to active aciclovir by first pass intestinal or hepatic metabolism. Elimination half life of aciclovir: 3 hr.
Excretion: Excreted via urine mainly as aciclovir and metabolites with <1% of valaciclovir excreted unchanged.
Administration
 May be taken with or without food. (May be taken w/ meals to reduce GI discomfort.)
Storage Conditions
 Oral: Store below 30°C.
ATC Classification
 J05AB11 - valaciclovir ; Belongs to the class of nucleosides and nucleotides excluding reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Storage
 Oral: Store below 30°C.
Available As
  • Valacyclovir (Valaciclovir) 1000 mg
  • Valacyclovir (Valaciclovir) 500 mg

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