The Only Prescription Cold Sore Medication That Fights the Virus and the Inflammation

Full Prescribing Information

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When cold sores happen, be prepared with dual-action XERESE (acyclovir and hydrocortisone) cream 5%/1%, two powerful medications in one easy-to-apply cream.1  Because the virus can no longer replicate, the cold sore outbreak is shortened.1  XERESE also contains hydrocortisone, an anti-inflammatory, clinically proven to reduce inflammation.  XERESE reduces symptoms such as lesion size and tenderness.1  Within an hour of first signs or symptoms, XERESE prevents cold sores from progressing to the painful ulcerative stage.2

In two randomized, double-blind studies of patients who received treatment for 5 days:

  • 42% did not progress to the ulcerative stage2*
  • 1.6-day reduction in mean healing time3
  • Reduced symptoms such as tenderness3
  • 50% reduction in cumulative lesion size2*
*A multicenter, randomized, double-blind, active, and placebo-controlled study involving 2437 patients with a history of HSL, in which 1443 received treatment; 601 were treated with XERESE.  Patients were randomized to self-initiate treatment with XERESE, 5% acyclovir in XERESE vehicle, or XERESE vehicle (placebo) at the earliest sign of a cold sore recurrence.
†A double-blind, randomized, placebo-controlled study involving 417 patients with a history of recurrent herpes labialis after exposure to sunlight, in which 380 received treatment; 50 were treated with XERESE.  Patients were randomized to initiate treatment with XERESE or placebo the second day after UV radiation exposure.

XERESE is for cold sores on lips and around the mouth only and should not be used in eyes, mouth, nose, or on genitals.1  Patients should be advised to apply XERESE topically 5 times per day for 5 days.1  Patients should be instructed to topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin.1  Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.1

REFERENCES:  1. XERESE (acyclovir and hydrocortisone) cream 5%/1% Prescribing Information. January, 2014.  2. Hull CM, Harmenberg J, Arlander E, et al.  Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial.  J Am Acad Dermatol. 2011;64(4):696.e1-11.  3. Evans TG, Bernstein DI, Raborn GW, Harmenberg J, Kowalski J, Spruance SL.  Double-blind, randomized, placebo-controlled study of topical 5% acyclovir-1% hydrocortisone cream (ME-609) for treatment of UV radiation-induced herpes labialis. Antimicrob Agents Chemother. 2002;46(6):1870-1874.

XERESE INDICATION & IMPORTANT SAFETY INFORMATION

INDICATIONXERESE® (acyclovir and hydrocortisone) cream 5%/1% is indicated 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 patients 6 years of age and older.

    IMPORTANT SAFETY INFORMATION
  • XERESE (acyclovir and hydrocortisone) cream 5%/1% is intended for cutaneous use only, on the lips and around the mouth.  XERESE should not be used in the eye, inside the mouth or nose, or on the genitals.
  • Systemic exposure to acyclovir and hydrocortisone following topical administration is minimal.  However, caution should be exercised when XERESE is administered to women who are pregnant or nursing.  The benefit of XERESE has not been adequately assessed in immunocompromised patients.
  • XERESE has a potential for irritation and contact sensitization.
  • In clinical trials, the most common adverse reactions in the area of the application site included drying or flaking of the skin; burning or tingling following application; erythema; pigmentation changes; application site reaction including signs and symptoms of inflammation.  Each event occurred in less than 1% of patients.
  • Patients should be encouraged to seek medical advice when a cold sore fails to heal within 2 weeks.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information.

REFERENCES:  1. XERESE (acyclovir and hydrocortisone) cream 5%/1% Prescribing Information. January, 2014.  2. Hull CM, Harmenberg J, Arlander E, et al.  Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial.  J Am Acad Dermatol. 2011;64(4):696.e1-11.  3. Evans TG, Bernstein DI, Raborn GW, Harmenberg J, Kowalski J, Spruance SL.  Double-blind, randomized, placebo-controlled study of topical 5% acyclovir-1% hydrocortisone cream (ME-609) for treatment of UV radiation-induced herpes labialis. Antimicrob Agents Chemother. 2002;46(6):1870-1874.