Product: Xerese

Company: Meda

Pharmacologic class: Topical antiviral + anti-inflammatory

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Active ingredients: Acyclovir 5% + hydrocortisone 1%; cream.

Indication: For the early treatment of recurrent herpes labialis (cold sores), to reduce the likelihood of ulcerative cold sores and to shorten the lesion-healing time in adults and adolescents (aged 12 years and older).

Pharmacology: This product combines the antiviral agent acyclovir with the anti-inflammatory corticosteroid hydrocortisone. Acyclovir is a synthetic purine nucleoside analogue with inhibitory activity against herpes simplex viruses type 1 (HSV-1) and type 2 (HSV-2). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase encoded by HSV. Hydrocortisone is used topically for its anti-inflammatory properties that suppress the clinical manifestations of the disease in a wide range of disorders where inflammation is a prominent feature.

Clinical trials: A double-blind study involving 1,443 adult patients with recurrent herpes labialis was conducted to assess the efficacy of this product in reducing the number and severity of cold-sore outbreaks. In the previous 12 months, the patients had an average of 5.6 episodes of herpes labialis. The median age of these patients was 44 years (range 18 to 80 years), 72% were women, and 91% were white. They were randomized to be treated with Xerese, acyclovir 5% in vehicle, or vehicle alone. Patients were instructed to start treatment within one hour of noticing signs and symptoms, to apply the product five times daily, and to continue treatment for five days. Of the patients using Xerese, 58% experienced ulcerative cold sores, compared with 74% of those using vehicle alone and 65% using acyclovir plus vehicle. The mean time to skin normalization was about 1.6 days shorter in patients randomized to Xerese compared with vehicle. In addition, clinical signs (e.g., size of cold sore, tenderness) were reduced with Xerese compared with vehicle.

An open-label study involving 134 adolescents with recurrent herpes labialis was conducted to assess the safety of Xerese. In the previous 12 months, these patients had an average of four episodes of herpes labialis. All subjects were white with a median age of 14 years (range 12 to 17 years) and 50% were girls. The treatment and dosing regimen of Xerese were the same as in the adults study; and subjects were monitored for adverse events and selected efficacy parameters. At the end of treatment, the study demonstrated that the safety and efficacy were similar to that observed in adults.

Adults: Start as soon as possible after the first signs and symptoms emerge (i.e., during the prodrome or when lesions appear). Wash and dry area. Apply topically to affected area on lips or around the mouth five times daily for five days. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. Do not occlude. Wash hands before and after application; wait at least 30 minutes before bathing, showering, or swimming.

Children: Not recommended.

Warnings/Precautions: Immunocompromised. Re-evaluate if symptoms persist more than two weeks. Avoid eyes, inside the mouth and nose, and on the genitals. Pregnancy (Cat. B). Nursing mothers.

Interactions: Do not apply other products (makeup, sunscreen, lip balm) to area during treatment.

Adverse reactions: Drying, flaking, burning/tingling sensation, erythema, pigmentation changes.

How supplied: Cream—2g, 5g

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