Dosing and uses of Xerese (acyclovir/hydrocortisone)
Adult dosage forms and strengths
acyclovir/hydrocortisone
topical cream
- 5%/1%
Herpes Labialis
Indicated for early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores; shortens lesion healing time in adults and adolescents
Apply topically to lips and around mouth 5 times per day for 5 days; initiate as soon as possible after first signs and symptoms
Administration
Apply sufficient amount to cover affected area, including the outer margin
Avoid unnecessary rubbing of affected area to avoid aggravating or transferring the infection
Pediatric dosage forms and strengths
acyclovir/hydrocortisone
topical cream
- 5%/1%
Herpes Labialis
Indicated for early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores; shortens lesion healing time in adults and adolescents
<6 years: Safety and efficacy not established
≥6 years: As adults; apply topically to lips and around mouth 5 times per day for 5 days; initiate as soon as possible after first signs and symptoms
Administration
Apply sufficient amount to cover affected area, including the outer margin
Avoid unnecessary rubbing of affected area to avoid aggravating or transferring the infection
Xerese (acyclovir/hydrocortisone) adverse (side) effects
<1%
Drying or flaking of the skin
Burning or tingling at application site
Erythema
Dryness
Pigmentation changes
Warnings
Contraindications
Hypersensitivity
Cautions
For topical use only on lips and around the mouth
Local irritation reported
Therapy should be initiated following the first signs or symptoms
Not for application to eye
Contact health care professional of cold sore fails to heal in 2 weeks
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether topical product distributed in breast milk, caution advised
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Xerese (acyclovir/hydrocortisone)
Mechanism of action
Acyclovir: Antiviral agent; synthetic purine nucleoside analogue with inhibitory activity against herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2)
Hydrocortisone: Glucocorticoid; elicits anti-inflammatory effects
