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Acyclovir and Hydrocortisone

Pronunciation

(ay SYE kloe veer & hye droe KOR ti sone)

Index Terms

  • Acyclovir/Hydrocortisone
  • Hydrocortisone and Acyclovir
  • ME-609
  • Xerclear

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, topical:

Xerese: Acyclovir 5% and hydrocortisone 1% (5 g)

Brand Names: U.S.

  • Xerese

Pharmacologic Category

  • Antiviral Agent, Topical
  • Corticosteroid, Topical

Pharmacology

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.

Use: Labeled Indications

Herpes labialis: Treatment of recurrent herpes labialis (cold sores) in children ≥6 years and adults.

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Dosing: Adult

Herpes labialis (cold sores): Topical: Apply 5 times/day for 5 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Herpes labialis (cold sores): Topical: Children ≥6 years and Adolescents: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

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).

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze.

Drug Interactions

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

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. 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. 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. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Talimogene Laherparepvec: Antiherpetic Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec. Monitor therapy

Adverse Reactions

<1% (Limited to important or life-threatening): 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

Warnings/Precautions

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.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Immunocompromised patients: Use with caution in immunocompromised patients.

Pregnancy Risk Factor

B

Pregnancy Considerations

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.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience bad taste, dry skin, burning, skin tingling, or skin discoloration. Have patient report immediately to prescriber severe skin irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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