Skip to content
ClinCalc Pro
Menu
Antiviral (Prodrug of Aciclovir) Pregnancy: A limited amount of data on valaciclovir and a moderate amount on aciclovir in pregnancy from pregnancy registries and post-marketing experience indicate no malformative or foeto/neonatal toxicity; animal studies do not show reproductive toxicity. Valaciclovir should only be used in pregnancy if the potential benefits outweigh the potential risk. Breast-feeding: aciclovir, the principal metabolite, is excreted in breast milk, but at therapeutic doses no effects on breastfed infants are anticipated since the dose ingested is less than 2% of the therapeutic intravenous aciclovir dose for neonatal herpes — use with caution and only when clinically indicated. Fertility: valaciclovir did not affect fertility in rats; no human fertility studies were performed.

Valaciclovir (ENT — Ramsay Hunt / Bell's Palsy)

Brand names: Valtrex

Valaciclovir is an oral prodrug of aciclovir, with better bioavailability, used for herpes simplex and varicella-zoster infections.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Treatment of herpes zoster (shingles) in immunocompetent adults: 1000 mg three times daily for seven days (3000 mg total daily dose)
Route: Oral
Frequency: Three times daily for seven days
Max: No absolute maximum is stated for the zoster regimen; §4.4 notes there are no data on doses of 4000 mg or more per day in liver disease and that caution is needed above 4000 mg/day in liver transplantation. The highest regimen in §4.2 is 2000 mg four times daily for CMV prophylaxis.
Source: UK SPC (eMC) for Valaciclovir 1000 mg tablets, §4.2 (https://www.medicines.org.uk/emc/product/15072/smpc). INDICATION CAVEAT — READ BEFORE USE: the fetched SPC does NOT name Ramsay Hunt syndrome (herpes zoster oticus) or Bell's palsy anywhere. The dose above is the SPC's regimen for HERPES ZOSTER (SHINGLES) exactly as written; the clinician must confirm that it is the intended regimen for Ramsay Hunt syndrome on this page. BELL'S PALSY IS NOT AN INDICATION IN THIS SPC — no dose for Bell's palsy can be taken from this source, and any Bell's palsy regimen shown on this page must be sourced separately from an ENT/neurology guideline. TIMING: patients should be advised to start treatment as soon as possible after a diagnosis of herpes zoster; there are no data on treatment started more than 72 hours after onset of the zoster rash. IMMUNOCOMPROMISED ADULTS (zoster): 1000 mg three times daily for at least seven days and for 2 days following crusting of lesions; antiviral treatment is suggested for patients presenting within one week of vesicle formation or at any time before full crusting. All doses must be reduced according to creatinine clearance (see renalAdjustment). OTHER INDICATIONS IN THE SAME §4.2 (for completeness, not for this page): HSV treatment in immunocompetent adults and adolescents >= 12 years — 500 mg twice daily (3-5 days for recurrent episodes, up to 10 days for initial episodes); herpes labialis (cold sores) in adults and adolescents — 2000 mg twice in one day, the second dose about 12 hours (no sooner than 6 hours) after the first, treatment not to exceed one day; HSV treatment in immunocompromised adults — 1000 mg twice daily for at least 5 days (up to 10 days for initial episodes), ideally started within 48 hours; HSV suppression in immunocompetent adults and adolescents — 500 mg once daily (some with >= 10 recurrences/year may benefit from 250 mg twice daily), re-evaluate after 6-12 months; HSV suppression in immunocompromised adults — 500 mg twice daily, re-evaluate after 6-12 months; CMV prophylaxis in adults and adolescents >= 12 years — 2000 mg four times a day started as early as possible post-transplant, usually for 90 days. §4.4 ZOSTER MONITORING: clinical response should be closely monitored, particularly in immunocompromised patients; consider intravenous antiviral therapy when the response to oral therapy is insufficient; patients with complicated herpes zoster (visceral involvement, disseminated zoster, motor neuropathies, encephalitis, cerebrovascular complications) should be treated with intravenous antiviral therapy, as should immunocompromised patients with ophthalmic zoster or a high risk of dissemination and visceral organ involvement. ELDERLY: consider the possibility of renal impairment and adjust the dose accordingly; maintain adequate hydration; elderly patients and those with renal impairment are at increased risk of neurological side-effects and should be closely monitored. HEPATIC IMPAIRMENT: dose modification is not required in mild or moderate cirrhosis with maintained hepatic synthetic function, and PK data in advanced cirrhosis do not indicate a need for adjustment although clinical experience is limited. PAEDIATRIC: the efficacy of valaciclovir in children below the age of 12 years has not been evaluated; adolescents >= 12 years receive the fixed adult HSV/CMV doses listed above (no per-kg dose is given). Verify any under-18 use against a children's formulary. Note: §4.5 was not retrieved in this bundle, and §4.4 and §4.8 were truncated at the source-fetch limit.

Dose adjustments

Renal

Aciclovir is eliminated by renal clearance, so the dose must be reduced in renal impairment; maintain adequate hydration and monitor creatinine clearance frequently when renal function is changing rapidly. In patients on intermittent haemodialysis the dose should be given AFTER dialysis on dialysis days. SPC Table 1 — TREATMENT OF HERPES ZOSTER in immunocompetent and immunocompromised adults: CrCl >= 50 mL/min, 1000 mg three times daily; CrCl 30-49, 1000 mg twice daily; CrCl 10-29, 1000 mg once daily; CrCl 10 (as printed in the SPC table), 500 mg once daily. HSV TREATMENT — immunocompetent adults/adolescents: CrCl >= 30, 500 mg twice daily; < 30, 500 mg once daily. HSV TREATMENT — immunocompromised adults: CrCl >= 30, 1000 mg twice daily; < 30, 1000 mg once daily. HERPES LABIALIS 1-day regimen: CrCl >= 50, 2000 mg twice in one day; 30-49, 1000 mg twice in one day; 10-29, 500 mg twice in one day; < 10, 500 mg single dose. HSV SUPPRESSION — immunocompetent: CrCl >= 30, 500 mg once daily (250 mg twice daily may give better results if >= 10 recurrences/year); < 30, 250 mg once daily. HSV SUPPRESSION — immunocompromised: CrCl >= 30, 500 mg twice daily; < 30, 500 mg once daily. CMV PROPHYLAXIS in solid organ transplant recipients: CrCl >= 75, 2000 mg four times daily; 50 to < 75, 1500 mg four times daily; 25 to < 50, 1500 mg three times daily; 10 to < 25, 1500 mg twice daily; < 10 or on dialysis, 1500 mg once daily.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to valaciclovir or aciclovir or to any of the excipients listed in section 6.1

Side effects

  • Headache — very common; nausea — common (the two most common reactions in clinical trials)
  • Dizziness, vomiting, diarrhoea, rashes including photosensitivity and pruritus — common
  • Neurological disorders, sometimes severe and linked to encephalopathy: confusion, hallucinations, decreased consciousness, tremor, agitation (uncommon); ataxia, dysarthria, convulsions, encephalopathy, coma, psychotic symptoms, delirium (rare). Generally reversible and usually seen in patients with renal impairment or other predisposing factors; more frequent in organ transplant patients receiving high doses (8 g daily) for CMV prophylaxis
  • Leucopenia (mainly in immunocompromised patients) and thrombocytopenia — uncommon; anaphylaxis — rare
  • Drug reaction with eosinophilia and systemic symptoms (DRESS) — frequency not known; can be life-threatening or fatal. Withdraw valaciclovir immediately if signs or symptoms appear and never restart it in that patient
  • Reversible increases in liver function tests (bilirubin, liver enzymes), abdominal discomfort, dyspnoea, urticaria — uncommon; angioedema — rare. Thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome and acute renal failure are noted as more serious reactions

Interactions

  • §4.5 was NOT retrieved in this bundle — the full interactions section must be checked by the clinician before publication

Clinical monograph

How it works

It is converted to aciclovir, which after phosphorylation inhibits viral DNA polymerase and terminates the growing viral DNA chain, halting replication.

Prescribing in practice

  • Reduce the dose in renal impairment and maintain adequate hydration, as accumulation can cause reversible neurotoxicity (confusion, agitation, hallucinations).
  • Treatment is most effective when started early, ideally within the first days of symptom or rash onset, including in Ramsay Hunt syndrome and Bell's palsy.
  • Higher antiviral doses are used for zoster than for simple herpes simplex; check current prescribing references for the indication.

Monitoring

Assess renal function in older patients and those with impairment, and watch for neurological symptoms that may indicate accumulation; ensure good fluid intake.

Counselling the patient

  • Start treatment as soon as possible after symptoms begin for the best benefit.
  • Drink plenty of fluids while taking it, particularly in older age.
  • Report confusion, drowsiness or hallucinations, especially if you have kidney problems.

Evidence & guidelines

Improved oral bioavailability over aciclovir allows less frequent dosing; antivirals started early reduce the severity and duration of herpes zoster and are used adjunctively in facial nerve palsy per UK guidance.

Reference: Murakami et al. Ann Neurol 1997 (Ramsay Hunt); Engström et al. NEJM 2008 (Bell's palsy); NICE CG186; AAO-HNS Bell's Palsy Guidelines (2013); SIGN 120; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.