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Overall Adverse Reaction Profile
The safety data derived from XERESE (acyclovir and hydrocortisone cream) clinical studies reflect exposure to XERESE (acyclovir and hydrocortisone cream) in 1002 subjects with recurrent herpes labialis treated 5 times daily for 5 days. The majority of the adverse reactions were local skin reactions and occurred in the area of the application site.
Adverse Reactions in Clinical Studies
Because clinical studies are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical studies and may not reflect the rates observed in clinical practice.
The majority of the adverse reactions were local and occurred in the area of the application site.
Skin and Subcutaneous Tissue Disorders
The following most common adverse reactions ( < 1%) were local skin reactions, and occurred in the area of the application site:
- Drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.
Contact dermatitis following application has been observed when applied under occlusion in dermal safety studies. Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base.
A study enrolling 225 healthy adults was conducted to evaluate the contact sensitization potential of XERESE (acyclovir and hydrocortisone cream) using repeat insult patch testing methodology. Of 205 evaluable subjects, one confirmed case (0.5%) of sensitization to hydrocortisone and 2 additional cases (1.0%) of possible sensitization to the XERESE (acyclovir and hydrocortisone cream) base were identified. Additionally, one subject developed a contact allergy in the photosafety study to propylene glycol, one of the inactive ingredients of the cream base.
Dermal tolerance was assessed in a 21-day cumulative irritation study in 36 healthy subjects. XERESE (acyclovir and hydrocortisone cream) , its cream base and Zovirax® (acyclovir) Cream 5% all showed a high and cumulative irritation potential under occlusive and semi-occlusive conditions.
Photoallergic potential and phototoxicity were assessed in two studies in 50 and 30 healthy volunteers, respectively. No photoallergic or phototoxicity potential was identified for XERESE (acyclovir and hydrocortisone cream) .
Read the Xerese (acyclovir and hydrocortisone cream) Side Effects Center for a complete guide to possible side effects
No drug interaction studies have been performed with XERESE (acyclovir and hydrocortisone cream) .
Read the Xerese Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 6/15/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Xerese Information
- Xerese Drug Interactions Center: acyclovir-hydrocortisone top
- Xerese Side Effects Center
- Xerese FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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