"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
XERESE (acyclovir and hydrocortisone cream) is intended for cutaneous use only for herpes labialis of the lips and around the mouth. XERESE (acyclovir and hydrocortisone cream) 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 within 2 weeks.
XERESE (acyclovir and hydrocortisone cream) has a potential for irritation and contact sensitization [see ADVERSE REACTIONS].
Patient Counseling Information
See FDA-Approved Patient Labeling
Patients should be informed that XERESE (acyclovir and hydrocortisone cream) is not a cure for cold sores. Patients should be instructed that XERESE (acyclovir and hydrocortisone cream) is intended for cutaneous use only for herpes labialis of the lips and around the mouth. Patients should be advised that XERESE (acyclovir and hydrocortisone cream) should not be used in the eye, inside the mouth or nose, or on the genitals.
Instructions for Use
Patients should be advised to apply XERESE (acyclovir and hydrocortisone cream) topically 5 times per day for 5 days. Patients should be instructed to topically apply a quantity of XERESE (acyclovir and hydrocortisone cream) sufficient to cover the affected area, including the outer margin. Patients should be advised to avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Systemic exposure following topical administration of acyclovir is minimal. Results from previous studies of carcinogenesis, mutagenesis and fertility for acyclovir and hydrocortisone are not included in the full prescribing information for XERESE (acyclovir and hydrocortisone cream) due to the minimal exposures that result from dermal application. Information on these studies following systemic exposure is available in the full prescribing information for acyclovir and hydrocortisone products approved for oral or parenteral administration. Dermal carcinogenicity studies have not been conducted.
Use In Specific Populations
Pregnancy Category B
Acyclovir was not teratogenic in the mouse, rabbit or rat at exposures greatly in excess of human exposure. There are no adequate and well-controlled studies of systemic acyclovir in pregnant women. A prospective epidemiologic registry of acyclovir use during pregnancy between 1984 and 1999 followed 749 pregnancies in women exposed to systemic acyclovir during the first trimester of pregnancy resulting in 756 outcomes. The occurrence rate of birth defects approximated that found in the general population. However, the size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
Animal reproduction studies have not been conducted with XERESE (acyclovir and hydrocortisone cream) . No studies have been performed in pregnant women. Systemic exposure of acyclovir and hydrocortisone following topical administration of XERESE (acyclovir and hydrocortisone cream) is minimal.
It is not known whether topically applied acyclovir or hydrocortisone is excreted in breast milk. Systemic exposure following topical administration of either drug is expected to be below detection limits. Because many drugs are excreted in human milk, caution should be exercised when XERESE (acyclovir and hydrocortisone cream) is administered to a nursing woman.
Safety and effectiveness in pediatric subjects less than 12 years of age have not been established.
In clinical studies, there were insufficient subjects above 65 years of age to reach a firm conclusion regarding safety and efficacy of XERESE (acyclovir and hydrocortisone cream) in this group, although the available results were similar to lower age subjects.
Even though the safety of XERESE (acyclovir and hydrocortisone cream) has been studied in immunocompromised subjects, data are insufficient to support use in this population. Immunocompromised subjects should be encouraged to consult a physician concerning the treatment of any infection.
Benefit has not been adequately assessed in immunocompromised patients. A randomized, double-blind study was conducted in 107 immunocompromised subjects with stable HIV infection and recurrent herpes labialis. Subjects had on average 3.7 episodes of herpes labialis in the previous 12 months. The median age was 30 years (range 19 to 64 years), 46% were female, and all Caucasian. Median CD4+ T-cell count at screening was 344/mm3 (range 100-500/mm3). Subjects were treated with XERESE (acyclovir and hydrocortisone cream) or 5% acyclovir in XERESE (acyclovir and hydrocortisone cream) vehicle. The primary objective was to exclude a doubling of the healing time in either treatment arm. The mean healing time for cold sores was similar between the two treatment groups: 6.6 days for XERESE (acyclovir and hydrocortisone cream) and 6.9 days for 5% acyclovir in XERESE (acyclovir and hydrocortisone cream) vehicle.
Last reviewed on RxList: 6/15/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Xerese Information
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