Usual Adult Dose for Herpes Simplex Labialis

5% Cream:
Apply to the affected area on face or lips 5 times a day for 4 days

• Initiate therapy as early as possible following onset of signs and symptoms of herpes labialis

Use: For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.

Usual Adult Dose for Herpes Simplex - Mucocutaneous/Immunocompromised Host

5% Ointment:
Apply to affected area every 3 hours, 6 times a day for 7 days

• Therapy should be started as early as possible following onset of signs and symptoms

Comments:

• The dose size per application will vary depending upon the total lesion area; it should approximate a one-half inch ribbon of ointment per 4 square inches of surface area.
• A finger cot or rubber glove should be used when applying ointment to prevent autoinoculation of other body sites and transmission to other persons.

Uses: For the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV infections in immunocompromised adults.

Usual Adult Dose for Herpes Simplex

5% Ointment:
Apply to affected area every 3 hours, 6 times a day for 7 days

• Therapy should be started as early as possible following onset of signs and symptoms

Comments:

• The dose size per application will vary depending upon the total lesion area; it should approximate a one-half inch ribbon of ointment per 4 square inches of surface area.
• A finger cot or rubber glove should be used when applying ointment to prevent autoinoculation of other body sites and transmission to other persons.

Uses: For the management of initial genital herpes and in limited non-life-threatening mucocutaneous HSV infections in immunocompromised adults.

Usual Pediatric Dose for Herpes Simplex Labialis

12 years or older:

5% Cream:
Apply to the affected area on face or lips 5 times a day for 4 days

• Initiate therapy as early as possible following onset of signs and symptoms of herpes labialis

Use: For the treatment of recurrent herpes labialis (cold sores) in pediatric patients 12 years of age or older.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

Safety and efficacy for treatment of recurrent herpes labialis have not been established in patients younger than 12 years.

Safety and efficacy for the management of initial genital herpes and in HSV infections have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Cream:

• For topical use on face and lips only; avoid use in the eye, inside the mouth or nose, or on the genitals
• Therapy should begin as soon as possible following onset of signs or symptoms of cold sore (itching, redness, burning or tingling, or when cold sore appears)
• Wash hands prior to and after applying cream
• Apply to affected areas including outer edge; areas should be clean dry before applying cream

Ointment:

• For cutaneous use only; avoid use in the eye
• A finger cot or rubber glove is recommended when applying ointment to prevent autoinoculation of other body sites and transmission of infection to other persons
• Therapy should be initiated as soon as possible following onset of signs and symptoms

Storage requirements:
Ointment: Store in dry place at 15C to 25C (59F to 77F)
Cream: Store below 25C (77F); excursions permitted to 15C to 30C (59F to 86F)

General:

• In clinical trials, use of the 5% cream reduced the mean duration of recurrent herpes labialis by approximately one-half day; this product is not a cure for cold sores.
• In clinical trials, use of 5% ointment has showed a decrease in healing time of initial genital herpes infection, and in some cases, a decrease in duration of vial shedding and duration of pain. Studies of recurrent genital herpes in non-immunocompromised patients have not shown evidence of clinical benefit, although some decrease in duration of viral shedding was observed.
• The recommended dosage, application frequency, and treatment duration of acyclovir topical ointment should not be exceeded.

Patient advice:

• Patients should be instructed on proper administration and counseled on appropriate precautions to take to limit spread of infection to themselves and others.
• Patients should be instructed not to rub cold sores because this may cause the infection to spread to other areas around mouth or make cold sore worse; patients should not apply other skin products to affected area during treatment.