What is the recommended treatment for a pediatric patient with a cold sore?

Treatment of Cold Sores in Pediatric Patients

For pediatric patients aged ≥12 years with cold sores, valacyclovir 2 grams twice daily for 1 day (taken 12 hours apart) is the recommended treatment, initiated at the earliest symptom such as tingling, itching, or burning. 1

Age-Specific Treatment Recommendations

Adolescents (≥12 years)

• Valacyclovir (Valtrex) 2 grams twice daily for 1 day, taken 12 hours apart 1
• Therapy must be initiated at the earliest symptom of a cold sore (tingling, itching, or burning) 1
• This high-dose, short-duration regimen reduces episode duration by approximately 1 day compared to placebo and prevents lesion development in a higher proportion of patients 2
• Efficacy has not been established if treatment is initiated after clinical signs develop (papule, vesicle, or ulcer) 1

Children <12 years

• Valacyclovir is not approved for cold sores in children under 12 years of age 1
• The efficacy and safety have not been established in this age group for herpes labialis 1

Alternative Topical Options (When Oral Therapy Not Feasible)

For patients who cannot take oral antivirals or prefer topical therapy:

• Acyclovir 5% with hydrocortisone 1% cream (ME-609/Xerese) applied 5 times daily for 5 days prevents progression to ulcerative lesions in 42% of patients (vs 26% with placebo) and reduces cumulative lesion area by 50% 3
• Acyclovir 5% cream alone applied 5 times daily for 5 days is less effective than the combination product but superior to placebo 3
• Penciclovir 1% cream can be used but requires frequent application 4

Important caveat: Topical agents are significantly less effective than oral antivirals and should be reserved for situations where oral therapy is contraindicated or refused 4

Critical Timing Considerations

• Treatment must begin in the prodromal stage (tingling, itching, burning) or within 48 hours of lesion onset for optimal efficacy 4
• Delaying treatment until vesicles or ulcers appear substantially reduces therapeutic benefit 1, 4
• The 1-day valacyclovir regimen offers superior convenience compared to 5-day topical regimens while maintaining comparable or superior efficacy 2

When to Consider Chronic Suppressive Therapy

For adolescents (≥12 years) with six or more episodes per year, chronic suppressive therapy should be considered 4:

• Valacyclovir 500 mg once daily for patients with ≤9 recurrences per year 1
• Valacyclovir 1 gram once daily for patients with >9 recurrences per year 1
• Efficacy beyond 1 year has not been established 1

Common Pitfalls to Avoid

• Do not use over-the-counter cough and cold medicines for symptom relief in children with acute viral infections, as they have not been shown to reduce symptom severity 5
• Avoid prescribing valacyclovir to children <12 years for cold sores, as this is an off-label use without established safety and efficacy data 1
• Do not delay treatment waiting for full lesion development—efficacy is highest when initiated during prodrome 1, 4
• Topical antivirals are not effective for prevention of recurrent herpes labialis and should only be used for episodic treatment 4

Dosing for Valacyclovir Oral Suspension (If Needed)

For patients who cannot swallow tablets, an extemporaneous oral suspension can be prepared at 25 mg/mL or 50 mg/mL concentration from 500-mg tablets 1:

• Suspension should be stored refrigerated (2-8°C) and discarded after 28 days 1
• Shake well before each use 1