Acyclovir and hydrocortisone Topical application

Name: Acyclovir and hydrocortisone Topical application

Precautions While Using acyclovir and hydrocortisone

It is very important that your doctor check your progress after you use acyclovir and hydrocortisone to see if the medicine is working properly.

If your symptoms do not improve within 2 weeks, or if they become worse, check with your doctor.

Do not use cosmetics or other skin care products (eg, make-up, sun screen, lip balm) on the treated area.

For Healthcare Professionals

Applies to acyclovir / hydrocortisone topical: topical cream

General

The most frequently reported side effects were local skin reactions and included drying or flaking of the skin; burning or tingling; erythema; pigmentation changes; and application site reactions including signs/symptoms of inflammation.[Ref]

Local

Frequency not reported: Dry skin, flaking skin, burning, tingling, erythema, pigmentation changed, inflammation[Ref]

Hypersensitivity

Frequency not reported: Contact allergy, sensitization[Ref]

Dermatologic

Frequency not reported: Contact dermatitis[Ref]

Some side effects of acyclovir / hydrocortisone topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Herpes Simplex Labialis

6 years or older: Apply a quantity sufficient to the affected area 5 times a day for 5 days

Comments:
-Initiate therapy as early as possible after the first signs/symptoms (i.e., during the prodrome or when lesions appear).
-Each dose should be applied to sufficiently cover the affected area, including the outer margin.

Use: 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

Precautions

Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Acyclovir / hydrocortisone topical Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Topical acyclovir applied to small areas of the mother's body away from the breast should pose no risk to the infant. -Only water-miscible creams or gels should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking. -Any product containing a topical corticosteroid should be wiped off thoroughly prior to nursing if it is being applied to the breast or nipple area.

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