Herpes labialis (cold sores): Topical: Apply cream at the first sign or symptom of cold sore (eg, tingling, swelling) or appearance of lesion; apply every 2 hours during waking hours for 4 days.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
(For additional information see "Penciclovir: Pediatric drug information")
Herpes labialis (cold sores): Children ≥12 years and Adolescents: Topical: Cream: Apply every 2 hours during waking hours for 4 days; start at the first sign or symptom of cold sore (eg, tingling, redness, itching, swelling) or appearance of lesion.
All patients: There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
All patients: There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, External:
Denavir: 1% (5 g) [contains cetostearyl alcohol, propylene glycol]
Generic: 1% (5 g)
Yes
Topical: Apply only to herpes labialis on the lips and face. Clean and dry affected area prior to application. Apply sufficient amount to cover lesions or area of tingling (or other symptoms) before the lesion appears; gently rub into the affected area. Avoid application in or near eyes since it may cause irritation. Wash hands with soap and water after application.
Topical: Apply only to herpes labialis on the lips and face. Apply sufficient amount to cover lesions and gently rub into the affected area. Avoid application in or near eyes since it may cause irritation.
Herpes labialis (cold sores): Topical treatment of recurrent herpes labialis (cold sores) adults and children ≥12 years of age
Denavir may be confused with indinavir
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Dermatologic: Erythema (50%; mild)
1% to 10%:
Central nervous system: Headache (5%)
Local: Application site reaction (1%)
<1%, postmarketing, and/or case reports: Altered sense of smell, erythematous rash, local anesthesia, localized edema, oropharyngeal edema, pain, paresthesia, pruritus, skin discoloration, urticaria
Hypersensitivity to the penciclovir or any component of the formulation
Special populations:
• Immunocompromised patients: The effect of penciclovir has not been established in immunocompromised patients.
Other warnings/precautions:
• Appropriate use: Should only be used on herpes labialis on the lips and face; because no data are available, application to mucous membranes is not recommended. Avoid application in or near eyes since it may cause irritation.
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).
None known.
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.
Talimogene Laherparepvec: Antiherpetic Antivirals may diminish the therapeutic effect of Talimogene Laherparepvec. Risk C: Monitor therapy
Penciclovir is not absorbed systemically following topical administration; exposure to the fetus is not expected.
Penciclovir is not absorbed systemically following topical administration; exposure to an infant via breast milk is not expected.
Resolution of symptoms and healing of cold sore lesion
In cells infected with HSV-1 or HSV-2, viral thymidine kinase phosphorylates penciclovir to a monophosphate form which, in turn, is converted to penciclovir triphosphate by cellular kinases. Penciclovir triphosphate inhibits HSV polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited
Onset of action: Resolution of pain: Adults: 3.5 days (Spruance 1997); Cutaneous healing: Adults: 4.8 days (Spruance 1997)
Absorption: Topical: None
Cream (Denavir External)
1% (per gram): $194.88
Cream (Penciclovir External)
1% (per gram): $175.20 - $185.13
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