Aciclovir / Hydrocortisone

What it is and how it works

Mechanism of Action Acyclovir is an antiviral drug active against α-herpesviruses and hydrocortisone is an anti-inflammatory drug .

Mechanism class: DNA Polymerase Inhibitors · Corticosteroid Hormone Receptor Agonists

Indications

XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, 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 adults and children (6 years of age and older). XERESE, a combination of acyclovir, a herpes simplex virus deoxynucleoside analog DNA polymerase inhibitor, and hydrocortisone, a corticosteroid, 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 adults and children (6 years of age and older).

Dosage and administration (summary)

Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear). For each dose, topically apply a quantity of XERESE sufficient to cover the affected area, including the outer margin. Avoid unnecessary rubbing of the affected area to avoid aggravating or transferring the infection. For children 6 years of age and older, the dosage is the same as in adults. Topically apply XERESE 5 times per day for 5 days. Therapy should be initiated as early as possible after the first signs and symptoms (i.e., during the prodrome or when lesions appear).

Contraindications

None. None.

Warnings and precautions

• Only for topical use for recurrent herpes labialis on the lips and around the mouth. 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 within 2 weeks. XERESE has a potential for irritation and contact sensitization .

Pregnancy

Pregnancy Risk Summary There are no available data on XERESE use in pregnant women. However, published observational studies over decades of use of topical acyclovir and low and medium potency topical corticosteroids during pregnancy have not established any association between use of these products and major birth defects, miscarriage, or adverse …

Storage and supply

is supplied in a plastic-laminated aluminum tube containing 5 g of XERESE. Each gram of XERESE contains 50 mg (equivalent to 5%, w/w) acyclovir and 10 mg (equivalent to 1%, w/w) hydrocortisone in an aqueous cream base. NDC 0187-5104-01 5 g tubes Store at controlled room temperature 20° to 25°C (68° to 77°F).

Source: Acyclovir And Hydrocortisone (Xerese) — US FDA prescribing information, 2020-08-03, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.