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Xerese

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Xerese

Xerese Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Xerese (acyclovir and hydrocortisone) Cream 5%/1% for Topical Use is a combination antiviral medication and anti-inflammatory corticosteroid used to treat recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time. Common side effects include drying or flaking of the skin, burning or tingling following application, redness, pigmentation changes, and inflammation at the application site.

Topically apply Xerese 5 times per day for 5 days. Apply a dose sufficient to cover the affected area. Xerese may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Xerese. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Xerese (acyclovir and hydrocortisone) Cream 5%/1% for Topical Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Xerese FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Reactions In Clinical Trials

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

The safety data derived from XERESE clinical trials reflect exposure to XERESE in 1056 subjects with recurrent herpes labialis treated 5 times daily for 5 days. The most common adverse reactions ( < 1%) were local skin reactions, and occurred in the area of the application site, including:

  • 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 trials. Where contact sensitivity tests have been conducted, the reactive substances were hydrocortisone or a component of the cream base.

A trial 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 trial in 36 healthy subjects. XERESE, its cream base and Zovirax® (acyclovir) Cream 5% all showed a high and cumulative irritation potential under occlusive and semiocclusive conditions.

Photoallergic potential and phototoxicity were assessed in two trials in 50 and 30 healthy volunteers, respectively. No photoallergic or phototoxicity potential was identified for XERESE.

Read the entire FDA prescribing information for Xerese (Acyclovir and Hydrocortisone Cream) »

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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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