Generic
Acyclovir
Pharmacology
Acyclovir cream should be applied five times per day for four days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis i.e., during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults.
Dosage Administration
Acyclovir cream should be applied five times per day for four days. Therapy should be initiated as early as possible following the onset of signs or symptoms of herpes labialis i.e., during the prodrome or when lesions appear. For adolescents 12 years of age and older, the dosage is the same as in adults.
Contraindications
Acyclovir cream is contraindicated in patients with known hypersensitivity to acyclovir, valacyclovir, or any component of the formulation.
Side Effects
The most common adverse reactions at the site of topical application were dry lips, desquamation, dryness of skin, cracked lips, burning skin, pruritus, flakiness of skin, and stinging on skin; each adverse reaction occurred in less than 1% of patients receiving Acyclovir cream and placebo. Three patients on Acyclovir cream and one patient on placebo discontinued treatment due to an adverse event.
Pregnancy And Lactation
Pregnancy Category B. There are no adequate and well-controlled studies of acyclovir cream in pregnant women. Acyclovir cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topically applied acyclovir is excreted in breast milk. Systemic exposure following topical administration is minimal.
Therapeutic
Acyclovir cream should only be applied on the affected external aspects of the lips and face in patients with herpes labialis. Because no data are available, application to human mucous membranes is not recommended. Acyclovir cream is intended for cutaneous use only and should not be used in the eye or inside the mouth or nose. Cream has a potential for irritation and contact. The effect of Acyclovir cream has not been established in immunocompromised patients.
Storage Conditions
Pediatric Use: An open-label, uncontrolled trial with Acyclovir cream 5% was conducted in 113 patients aged 12 to 17 years with recurrent herpes labialis. In this trial, therapy was applied using the same dosing regimen as in adults and subjects were followed for adverse events. The safety profile was similar to that observed in adults. Safety and effectiveness in pediatric patients less than 12 years of age have not been established. Geriatric Use: Clinical studies of acyclovir cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Systemic absorption of acyclovir after topical administration is minimal.
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