Version May 2024
Herpes labialis (cold sores): Topical: Apply 5 times/day for 5 days.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Acyclovir and hydrocortisone: Pediatric drug information")
Herpes labialis (cold sores): Children ≥6 years and Adolescents: Topical: Apply 5 times daily for 5 days; initiate therapy at first sign of infection (ie, during the prodrome or when lesions appear).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
<1%, postmarketing, and/or case reports: Allergic contact sensitivity, application site reaction, burning sensation of skin, contact dermatitis (when applied under occlusion), dyschromia, erythema, exfoliation of skin, tingling of skin, xeroderma
There are no contraindications listed in the manufacturer's US labeling.
Canadian labeling: Additional contraindications not in US labeling: Known or suspected history of hypersensitivity to acyclovir, valacyclovir, hydrocortisone, or any component of the formulation; untreated infections of bacterial, viral, tuberculous, or fungal origin.
Concerns 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.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Xerese: Acyclovir 5% and hydrocortisone 1% (5 g) [contains cetostearyl alcohol, propylene glycol]
No
Cream (Xerese External)
5-1% (per gram): $294.91
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Xerese: Acyclovir 5% and hydrocortisone 1% (0.5 g, 5 g) [contains cetostearyl alcohol, propylene glycol]
For external use only; not for use in the eye, inside the mouth or nose, or on the genitals. Wash hands before and after application. 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).
Topical: For external use only. Wash hands before and after use. Use sufficient amount to cover the affected area(s), including the outer margin of cold sore; do not rub affected area nor cover area with a bandage. Do not bathe or shower for 30 minutes following application. Not for use in the eye, inside the mouth or nose, or on the genitals.
Herpes labialis: Treatment of recurrent herpes labialis (cold sores) in children ≥6 years and adults.
KIDs List: Medium, high, and very high potency topical corticosteroids, when used in neonates and infants <1 year of age for diaper dermatitis, are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use should be avoided due to risk of adrenal suppression; systemic absorption is higher in pediatric patients than adults (strong recommendation; low quality of evidence) (PPA [Meyers 2020]).
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Talimogene Laherparepvec: Antiherpetic Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec. Risk C: Monitor therapy
Systemic exposure of acyclovir and hydrocortisone after topical administration is minimal.
Refer to individual monographs for additional information.
Systemic exposure of acyclovir and hydrocortisone after topical administration is minimal.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Refer to individual monographs for additional information.
Acyclovir: Acyclovir is converted to acyclovir monophosphate by virus-specific thymidine kinase then further converted to acyclovir triphosphate by other cellular enzymes. Acyclovir triphosphate inhibits DNA synthesis and viral replication by competing with deoxyguanosine triphosphate for viral DNA polymerase and being incorporated into viral DNA.
Hydrocortisone: Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties.
See individual agents.
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