XERESE

The plasma concentrations of acyclovir and hydrocortisone were not measured following topical administration of XERESE on cold sores. The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin and can have systemic side effects depending on both the potency of the corticosteroid and the surface area ...

14.1 Clinical Trial Experience in Adults In a double-blind, clinical trial, 1,443 subjects with recurrent labial herpes were randomized to receive XERESE, 5% acyclovir in XERESE vehicle or vehicle alone. Subjects had, on average, 5.6 episodes of herpes labialis in the previous 12 months. The median age was 44 years (range 18 to 80 years), 72% were female, and 91% were Caucasian. Subjects were instructed to initiate treatment within 1 hour of noticing signs or symptoms and continue treatment for 5 days, with application of study medication 5 times per day. Ulcerative cold sores occurred in 58% ...

The following most common adverse reactions (<1%) were local skin reactions: Drying or flaking of the skin; burning or tingling, erythema; pigmentation changes; application site reactions including signs and symptoms of inflammation. (6.1) 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. 6.1 Adverse Reactions in Clinical Trials Because clinical trials are conducted under widely varying conditions, the adverse...

None. None. (4)

• Only for topical use for recurrent herpes labialis on the lips and around the mouth. (5) 5.1 General XERESE is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE should not be used in the eye, inside the mouth or nose, or on the genitals. There are other orofacial lesions, including bacterial and fungal infections, which may be difficult to distinguish from a cold sore. Patients should be encouraged to seek medical advice when a cold sore fails to heal...

7 DRUG INTERACTIONS No drug interaction studies have been performed with XERESE. No drug interaction studies have been performed with XERESE. (7)