Drug Information

Acyclovir and hydrocortisone

Acyclovir and hydrocortisone
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Brand Names: U.S.

  • Xerese™
Pharmacologic Category

  • Antiviral Agent, Topical;
  • Corticosteroid, Topical
Dosing: AdultHerpes labialis (cold sores): Topical: Apply 5 times/day for 5 days

Dosing: PediatricHerpes labialis (cold sores): Topical: Children ≥12 years: Refer to adult dosing.

Dosing: GeriatricRefer to adult dosing.

Generic Equivalent Available: U.S.No

AdministrationFor external use only; not for use in the eye, inside the mouth or nose, or on the genitals. Apply to clean, dry area using a finger cot or rubber glove to avoid transmission to other parts of the body or to other persons. Use sufficient amount to cover the affected area(s), including the outer margin of cold sore; do not rub affected area. Initiate therapy early (ie, during the prodrome or when lesions appear).

UseTreatment of recurrent herpes labialis (cold sores)

ContraindicationsThere are no contraindications listed within the manufacturer’s labeling.

Warnings/PrecautionsConcerns related to adverse effects:

• Sensitization: Use has been associated with local sensitization (irritation).

Disease-related concerns:

• Herpes labialis: Appropriate use: Treatment should begin with the first signs or symptoms. For external use only to the lips and around the mouth; do not apply to eye, inside the mouth or nose, or on the genitals. Contact healthcare provider if cold sore does not heal in 2 weeks.

Special populations:

• Immunocompromised patients: Use with caution in immunocompromised patients.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (Low risk). Risk C: Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Risk C: Monitor therapy

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Telaprevir: May increase the serum concentration of Corticosteroids. Corticosteroids may decrease the serum concentration of Telaprevir. Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. When possible, consider alternatives. If used together, employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. Risk D: Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy

Pregnancy Risk FactorPregnancy Implications

Animal reproduction studies and studies in pregnant women have not been conducted with Xerese™. Systemic exposure of acyclovir and hydrocortisone after topical administration is minimal. See individual agents.

LactationExcretion in breast milk unknown/use caution

Breast-Feeding ConsiderationsSystemic exposure of acyclovir and hydrocortisone after topical administration is minimal. See individual agents.

Mechanism of ActionSee individual agents.

Pharmacodynamics/KineticsSee individual agents.

  1. 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. [PubMed 20851499]