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Xerese (Acyclovir / Hydrocortisone) - Side Effects and Adverse Reactions



Overall Adverse Reaction Profile

The safety data derived from XERESE clinical studies reflect exposure to XERESE 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 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 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, 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.

Drug label data at the top of this Page last updated: 2012-08-08

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